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A Phase II Study to Evaluate Safety and Efficacy of ALX-0061 in Subjects With Systemic Lupus Erythematosus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02437890
Recruitment Status : Completed
First Posted : May 8, 2015
Results First Posted : February 6, 2019
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Ablynx

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Lupus Erythematosus, Systemic
Interventions Biological: ALX-0061
Biological: Placebo
Enrollment 312
Recruitment Details A total of 312 subjects were randomized at 91 sites located in Europe (37 sites; 155 subjects), Asia-Pacific (19 sites, 53 subjects), North America (21 sites; 52 subjects), and Latin America (14 sites, 52 subjects). Consent was obtained from the first subject on 02 July 2015; the last subject completed the final visit on 25 January 2018.
Pre-assignment Details Of the 568 subjects screened, 256 were screen failures and 312 were randomly assigned to treatment (modified Intent-to-treat [mITT] population). All subjects received study drug and were included in the safety population. Overall, 254 subjects were included in the Per Protocol (PP) population.
Arm/Group Title Placebo ALX-0061 75 mg q4w ALX-0061 150 mg q4w ALX-0061 150 mg q2w ALX-0061 225 mg q2w
Hide Arm/Group Description

Two s.c. injections with placebo every 2 weeks (q2w).

***

Placebo was supplied as a sterile liquid for s.c. injection at a volume of 0.5 mL and 1.0 mL in pre-filled single-use syringes. To maintain the blind, subjects randomly assigned to the placebo group received 2 s.c. injections q2w:

Syringe A with placebo (1 mL) q2w starting at Day 1, up to and including Week 46.

Syringe B with placebo (0.5 mL) q2w starting at Day 1, up to and including Week 46.

ALX-0061 75 mg every 4 weeks (q4w).

***

Vobarilizumab (ALX-0061) and placebo were supplied as a sterile liquid for s.c. injection at a volume of 0.5 mL and 1.0 mL in pre-filled single-use syringes. To maintain the blind, subjects randomly assigned to ALX-0061 75 mg q4w received 2 s.c. injections q2w:

Syringe A with placebo (1 mL) q2w starting at Day 1, up to and including Week 46.

Syringe B with ALX-0061 (0.5 mL) q4w at Day 1, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44, and syringe B with placebo (0.5 mL) q4w at Weeks 2, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, and 46.

ALX-0061 150 mg every 4 weeks (q4w).

***

Vobarilizumab (ALX-0061) and placebo were supplied as a sterile liquid for s.c. injection at a volume of 0.5 mL and 1.0 mL in pre-filled single-use syringes. To maintain the blind, subjects randomly assigned to ALX-0061 150 mg q4w received 2 s.c. injections q2w:

Syringe A with ALX-0061 (1 mL) q4w at Day 1, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44, and syringe A with placebo (1 mL) q4w at Weeks 2, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, and 46.

Syringe B with placebo (0.5 mL) q2w starting at Day 1, up to and including Week 46.

ALX-0061 150 mg every 2 weeks (q2w).

***

Vobarilizumab (ALX-0061) and placebo were supplied as a sterile liquid for s.c. injection at a volume of 0.5 mL and 1.0 mL in pre-filled single-use syringes. To maintain the blind, subjects randomly assigned to ALX-0061 150 mg q2w received 2 s.c. injections q2w:

Syringe A with ALX-0061 (1 mL) q2w starting at Day 1, up to and including Week 46.

Syringe B with placebo (0.5 mL) q2w starting at Day 1, up to and including Week 46.

ALX-0061 225 mg every 2 weeks (q2w).

***

Vobarilizumab (ALX-0061) was supplied as a sterile liquid for s.c. injection at a volume of 0.5 mL and 1.0 mL in pre-filled single-use syringes. To maintain the blind, subjects randomly assigned to ALX-0061 225 mg q2w received 2 s.c. injections q2w:

Syringe A with ALX-0061 (1 mL) q2w starting at Day 1, up to and including Week 46.

Syringe B with ALX-0061 (0.5 mL) q2w starting at Day 1, up to and including Week 46.

Period Title: Overall Study
Started 62 64 62 62 62
Completed 54 48 47 40 46
Not Completed 8 16 15 22 16
Reason Not Completed
Non-compliance to study drug             0             1             0             0             1
Sponsor's decision             1             1             4             0             2
Physician Decision             0             0             0             1             0
Unable to attend visit(s)             1             0             0             0             0
Lack of Efficacy             1             3             0             3             1
Adverse Event             4             9             5             11             7
Withdrawal by Subject             1             2             6             5             5
Death             0             0             0             2             0
Arm/Group Title Placebo ALX-0061 75 mg q4w ALX-0061 150 mg q4w ALX-0061 150 mg q2w ALX-0061 225 mg q2w Total
Hide Arm/Group Description Two s.c. injections with placebo every 2 weeks (q2w) ALX-0061 75 mg every 4 weeks (q4w) ALX-0061 150 mg every 4 weeks (q4w) ALX-0061 150 mg every two weeks (q2w) ALX-0061 225 mg every two weeks (q2w) Total of all reporting groups
Overall Number of Baseline Participants 62 64 62 62 62 312
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 64 participants 62 participants 62 participants 62 participants 312 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
62
 100.0%
64
 100.0%
62
 100.0%
62
 100.0%
62
 100.0%
312
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 62 participants 64 participants 62 participants 62 participants 62 participants 312 participants
42.3  (10.11) 42.0  (11.00) 41.8  (10.79) 39.2  (11.58) 42.0  (10.44) 41.4  (10.79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 64 participants 62 participants 62 participants 62 participants 312 participants
Female
60
  96.8%
61
  95.3%
61
  98.4%
61
  98.4%
57
  91.9%
300
  96.2%
Male
2
   3.2%
3
   4.7%
1
   1.6%
1
   1.6%
5
   8.1%
12
   3.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 64 participants 62 participants 62 participants 62 participants 312 participants
Hispanic or Latino
13
  21.0%
12
  18.8%
17
  27.4%
11
  17.7%
13
  21.0%
66
  21.2%
Not Hispanic or Latino
49
  79.0%
52
  81.3%
45
  72.6%
51
  82.3%
49
  79.0%
246
  78.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 62 participants 64 participants 62 participants 62 participants 62 participants 312 participants
Argentina 4 4 3 3 4 18
Hungary 2 4 2 2 4 14
United States 10 11 10 11 10 52
Czechia 2 1 0 0 3 6
Philippines 1 3 4 3 2 13
Ukraine 5 6 7 8 7 33
Portugal 2 2 0 1 1 6
Russia 3 6 5 8 6 28
Spain 3 2 2 1 0 8
South Korea 1 1 0 2 1 5
Taiwan 3 1 1 0 2 7
Poland 4 5 3 6 5 23
Mexico 5 6 5 5 5 26
Chile 0 1 1 0 0 2
Serbia 14 11 17 11 10 63
Peru 2 0 2 1 1 6
Germany 1 0 0 0 1 2
1.Primary Outcome
Title Number and Percentage of Subjects Who Achieved a Response at Week 24 According to the Modified British Isles Lupus Assessment Group (BILAG)-Based Composite Lupus Assessment (mBICLA) Score
Hide Description

The primary endpoint was evaluated by determining if there was a dose-response relationship between the mBICLA response rate at Week 24 and the dose administered, using the Multiple Comparison Procedure - Modelling (MCP-Mod) methodology. The existence of several candidate parametric models was assumed and multiple comparison techniques were used to choose the model(s) most likely to represent the true underlying dose-response curve. The selected model could further be used to guide the choice of adequate doses.

mBICLA responders were defined as subjects who met all of the following criteria:

  1. BILAG-2004 normal improvement: all A scores at Baseline improved to B, C or D, and all B scores improved to C or D.
  2. No worsening in disease activity: no new BILAG-2004 A scores and ≤ 1 new increase to B.
  3. No worsening of total mSLEDAI-2K score from Baseline.
  4. No significant deterioration (< 10% worsening from Baseline) in PGA.
  5. No treatment failure (including the premature
Time Frame At Week 24 visit
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population - Non-response imputation (NRI)
Arm/Group Title Placebo ALX-0061 75 mg q4w ALX-0061 150 mg q4w ALX-0061 150 mg q2w ALX-0061 225 mg q2w
Hide Arm/Group Description:
Two s.c. injections with placebo every 2 weeks (q2w)
ALX-0061 75 mg every 4 weeks (q4w)
ALX-0061 150 mg every 4 weeks (q4w)
ALX-0061 150 mg every 2 weeks (q2w)
ALX-0061 225 mg every 2 weeks (q2w)
Overall Number of Participants Analyzed 62 64 62 62 62
Measure Type: Count of Participants
Unit of Measure: Participants
29
  46.8%
28
  43.8%
24
  38.7%
24
  38.7%
23
  37.1%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, ALX-0061 75 mg q4w, ALX-0061 150 mg q4w, ALX-0061 150 mg q2w, ALX-0061 225 mg q2w
Comments

A multiple contrast test was used to establish evidence of a drug effect by testing for a statistically significant dose-response signal for clinical endpoint and patient population investigated in the study. Candidate dose-response models were selected amongst the following types of parametric models: linear model, Emax model, logistic model, a 1st Beta model, and a 2nd Beta model.

Model tested: linear model

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.526
Comments Threshold for statistical significance: p = 0.05
Method Multiple Contrast Test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, ALX-0061 75 mg q4w, ALX-0061 150 mg q4w, ALX-0061 150 mg q2w, ALX-0061 225 mg q2w
Comments

A multiple contrast test was used to establish evidence of a drug effect by testing for a statistically significant dose-response signal for clinical endpoint and patient population investigated in the study. Candidate dose-response models were selected amongst the following types of parametric models: linear model, Emax model, logistic model, a 1st Beta model, and a 2nd Beta model.

Model tested: Emax model

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.504
Comments Threshold for statistical significance: p = 0.05
Method Multiple Contrast Test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, ALX-0061 75 mg q4w, ALX-0061 150 mg q4w, ALX-0061 150 mg q2w, ALX-0061 225 mg q2w
Comments

A multiple contrast test was used to establish evidence of a drug effect by testing for a statistically significant dose-response signal for clinical endpoint and patient population investigated in the study. Candidate dose-response models were selected amongst the following types of parametric models: linear model, Emax model, logistic model, a 1st Beta model, and a 2nd Beta model.

Model tested: logistic model

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.548
Comments Threshold for statistical significance: p = 0.05
Method Multiple Contrast Test
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, ALX-0061 75 mg q4w, ALX-0061 150 mg q4w, ALX-0061 150 mg q2w, ALX-0061 225 mg q2w
Comments

A multiple contrast test was used to establish evidence of a drug effect by testing for a statistically significant dose-response signal for clinical endpoint and patient population investigated in the study. Candidate dose-response models were selected amongst the following types of parametric models: linear model, Emax model, logistic model, a 1st Beta model, and a 2nd Beta model.

Model tested: 1st Beta model

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.985
Comments Threshold for statistical significance: p = 0.05
Method Multiple Contrast Test
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, ALX-0061 75 mg q4w, ALX-0061 150 mg q4w, ALX-0061 150 mg q2w, ALX-0061 225 mg q2w
Comments

A multiple contrast test was used to establish evidence of a drug effect by testing for a statistically significant dose-response signal for clinical endpoint and patient population investigated in the study. Candidate dose-response models were selected amongst the following types of parametric models: linear model, Emax model, logistic model, a 1st Beta model, and a 2nd Beta model.

Model tested: 2nd Beta model

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.524
Comments Threshold for statistical significance: p = 0.05
Method Multiple Contrast Test
Comments [Not Specified]
2.Secondary Outcome
Title Number and Percentage of Subjects With mBICLA Response at Week 24 and Week 48
Hide Description Number and percentage of mBICLA responders at Week 24 and Week 48
Time Frame At Week 24 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Placebo ALX-0061 75 mg q4w ALX-0061 150 mg q4w ALX-0061 150 mg q2w ALX-0061 225 mg q2w
Hide Arm/Group Description:
Two s.c. injections with placebo every 2 weeks (q2w)
ALX-0061 75 mg every 4 weeks (q4w)
ALX-0061 150 mg every 4 weeks (q4w)
ALX-0061 150 mg every 2 weeks (q2w)
ALX-0061 225 mg every 2 weeks (q2w)
Overall Number of Participants Analyzed 62 64 62 62 62
Measure Type: Count of Participants
Unit of Measure: Participants
Week 24 Number Analyzed 61 participants 64 participants 58 participants 62 participants 61 participants
28
  45.9%
28
  43.8%
22
  37.9%
24
  38.7%
22
  36.1%
Week 48 Number Analyzed 59 participants 61 participants 60 participants 60 participants 60 participants
28
  47.5%
32
  52.5%
22
  36.7%
19
  31.7%
22
  36.7%
3.Secondary Outcome
Title Number and Percentage of Subjects With Modified Systemic Lupus Erythematosus Responder Index (mSRI-4) Response at Week 24 and Week 48
Hide Description

The composite index mSRI-4 enables quantification of decrease and increase in disease activity in a broad spectrum of manifestations thereby offering a comprehensive assessment of SLE disease status. mSRI combines advantages from 3 validated measurement tools. The mSRI-4 criteria for response are:

  1. modified SLE disease activity index 2000 (mSLEDAI-2K): ≥ 4 point reduction (covers global disease improvement),
  2. British Isles Lupus Assessment Group 2004 (BILAG-2004): no new A domain score and no more than 1 new increase to B (covers organ-specific disease improvement),
  3. Physician's Global Assessment (PGA) (is used as validity and safety net for items that were not addressed by the other two indices): < 10% increase from Baseline (no worsening) When all 3 criteria are met, the subject is a mSRI-4 responder at that time point.

Subjects who were treatment failures or discontinued from treatment were considered non-responder after treatment failure/discontinuation.

Time Frame At Week 24 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Placebo ALX-0061 75 mg q4w ALX-0061 150 mg q4w ALX-0061 150 mg q2w ALX-0061 225 mg q2w
Hide Arm/Group Description:
Two s.c. injections with placebo every 2 weeks (q2w)
ALX-0061 75 mg every 4 weeks (q4w)
ALX-0061 150 mg every 4 weeks (q4w)
ALX-0061 150 mg every 2 weeks (q2w)
ALX-0061 225 mg every 2 weeks (q2w)
Overall Number of Participants Analyzed 62 64 62 62 62
Measure Type: Count of Participants
Unit of Measure: Participants
Week 24 Number Analyzed 59 participants 63 participants 58 participants 61 participants 60 participants
37
  62.7%
39
  61.9%
30
  51.7%
33
  54.1%
29
  48.3%
Week 48 Number Analyzed 58 participants 60 participants 59 participants 58 participants 60 participants
34
  58.6%
36
  60.0%
29
  49.2%
26
  44.8%
33
  55.0%
4.Secondary Outcome
Title Number and Percentage of Subjects With mSRI-5 Response at Week 24 and Week 48
Hide Description

The mSRI-5 criteria for response are:

  1. mSLEDAI-2K: ≥ 5 point reduction
  2. BILAG-2004: no new A domain score and no more than 1 new increase to B domain score
  3. PGA: no worsening (< 10% increase from Baseline) Only subjects with Baseline mSLEDAI-2K ≥ 5 were considered for the derivation of that endpoint.

Subjects who were treatment failures or discontinued from treatment were considered non-responder after treatment failure/discontinuation.

Time Frame At Week 24 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Placebo ALX-0061 75 mg q4w ALX-0061 150 mg q4w ALX-0061 150 mg q2w ALX-0061 225 mg q2w
Hide Arm/Group Description:
Two s.c. injections with placebo every 2 weeks (q2w)
ALX-0061 75 mg every 4 weeks (q4w)
ALX-0061 150 mg every 4 weeks (q4w)
ALX-0061 150 mg every 2 weeks (q2w)
ALX-0061 225 mg every 2 weeks (q2w)
Overall Number of Participants Analyzed 62 64 62 62 62
Measure Type: Count of Participants
Unit of Measure: Participants
Week 24 Number Analyzed 57 participants 61 participants 54 participants 59 participants 58 participants
17
  29.8%
24
  39.3%
19
  35.2%
20
  33.9%
16
  27.6%
Week 48 Number Analyzed 56 participants 58 participants 55 participants 56 participants 58 participants
20
  35.7%
28
  48.3%
18
  32.7%
16
  28.6%
22
  37.9%
5.Secondary Outcome
Title Number and Percentage of Subjects With mSRI-6 Response at Week 24 and Week 48
Hide Description

The mSRI-6 criteria for response are:

  1. mSLEDAI-2K: ≥ 6 point reduction
  2. BILAG-2004: no new A domain score and no more than 1 new increase to B domain score
  3. PGA: no worsening (< 10% increase from Baseline) Only subjects with Baseline mSLEDAI-2K ≥ 6 were considered for the derivation of that endpoint.

Subjects who were treatment failures or discontinued from treatment were considered non-responder after treatment failure/discontinuation

Time Frame At Week 24 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Placebo ALX-0061 75 mg q4w ALX-0061 150 mg q4w ALX-0061 150 mg q2w ALX-0061 225 mg q2w
Hide Arm/Group Description:
Two s.c. injections with placebo every 2 weeks (q2w)
ALX-0061 75 mg every 4 weeks (q4w)
ALX-0061 150 mg every 4 weeks (q4w)
ALX-0061 150 mg every 2 weeks (q2w)
ALX-0061 225 mg every 2 weeks (q2w)
Overall Number of Participants Analyzed 62 64 62 62 62
Measure Type: Count of Participants
Unit of Measure: Participants
Week 24 Number Analyzed 57 participants 61 participants 54 participants 59 participants 58 participants
16
  28.1%
23
  37.7%
19
  35.2%
19
  32.2%
15
  25.9%
Week 48 Number Analyzed 56 participants 58 participants 55 participants 56 participants 58 participants
20
  35.7%
28
  48.3%
16
  29.1%
16
  28.6%
22
  37.9%
6.Secondary Outcome
Title Number and Percentage of Subjects With mSRI-7 Response at Week 24 and Week 48
Hide Description

The mSRI-7 criteria for response are:

  1. mSLEDAI-2K: ≥ 7 point reduction
  2. BILAG-2004: no new A domain score and no more than 1 new increase to B domain score
  3. PGA: no worsening (< 10% increase from Baseline) Only subjects with Baseline mSLEDAI-2K ≥ 7 were considered for the derivation of that endpoint.

Subjects who were treatment failures or discontinued from treatment were considered non-responder after treatment failure/discontinuation.

Time Frame At Week 24 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Placebo ALX-0061 75 mg q4w ALX-0061 150 mg q4w ALX-0061 150 mg q2w ALX-0061 225 mg q2w
Hide Arm/Group Description:
Two s.c. injections with placebo every 2 weeks (q2w)
ALX-0061 75 mg every 4 weeks (q4w)
ALX-0061 150 mg every 4 weeks (q4w)
ALX-0061 150 mg every 2 weeks (q2w)
ALX-0061 225 mg every 2 weeks (q2w)
Overall Number of Participants Analyzed 62 64 62 62 62
Measure Type: Count of Participants
Unit of Measure: Participants
Week 24 Number Analyzed 46 participants 47 participants 39 participants 50 participants 43 participants
9
  19.6%
8
  17.0%
8
  20.5%
12
  24.0%
7
  16.3%
Week 48 Number Analyzed 46 participants 45 participants 40 participants 47 participants 42 participants
12
  26.1%
14
  31.1%
7
  17.5%
8
  17.0%
9
  21.4%
7.Secondary Outcome
Title Number and Percentage of Subjects With mSRI-8 Response at Week 24 and Week 48.
Hide Description

The mSRI-8 criteria for response are:

  1. mSLEDAI-2K: ≥ 8 point reduction
  2. BILAG-2004: no new A domain score and no more than 1 new increase to B domain score
  3. PGA: no worsening (< 10% increase from Baseline) Only subjects with Baseline mSLEDAI-2K ≥ 8 were considered for the derivation of that endpoint.

Subjects who were treatment failures or discontinued from treatment were considered non-responder after treatment failure/discontinuation.

Time Frame At Week 24 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Placebo ALX-0061 75 mg q4w ALX-0061 150 mg q4w ALX-0061 150 mg q2w ALX-0061 225 mg q2w
Hide Arm/Group Description:
Two s.c. injections with placebo every 2 weeks (q2w)
ALX-0061 75 mg every 4 weeks (q4w)
ALX-0061 150 mg every 4 weeks (q4w)
ALX-0061 150 mg every 2 weeks (q2w)
ALX-0061 225 mg every 2 weeks (q2w)
Overall Number of Participants Analyzed 62 64 62 62 62
Measure Type: Count of Participants
Unit of Measure: Participants
Week 24 Number Analyzed 45 participants 47 participants 37 participants 49 participants 42 participants
9
  20.0%
7
  14.9%
8
  21.6%
10
  20.4%
7
  16.7%
Week 48 Number Analyzed 45 participants 45 participants 38 participants 46 participants 41 participants
11
  24.4%
14
  31.1%
7
  18.4%
7
  15.2%
8
  19.5%
8.Secondary Outcome
Title Change From Baseline in Modified Systemic Lupus Erythematosus Disease Activity Index 2000 (mSLEDAI-2K) Score at Week 24 and Week 48
Hide Description The Systemic Lupus Erythematosus Disease Activity Index 2000 is a 1-page weighted score for 24 items (seizure, psychosis, organic brain syndrome, visual disturbance, cranial nerve disorder, lupus headache, cerebrovascular accident, vasculitis, arthritis, myositis, urinary casts, hematuria, proteinuria, pyuria, rash, alopecia, mucosal ulcers, pleurisy, pericarditis, low complement, etc). The manifestations felt to be most commonly contributing to disease activity are included and scored based on the presence (= 1 multiplied by weight) or absence (= 0) within 30 days prior to the evaluation. The total score ranges from 0-105 (= sum of individual scores), with 105 being higher disease activity. mSLEDAI-2K derives from the standard index by omitting low complement. Mean changes from baseline were derived from an ANCOVA model with treatment as factor and baseline mSLEDAI-2K Score and geographic region as covariates. A negative change from baseline reflects an improvement.
Time Frame At Week 24 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Placebo ALX-0061 75 mg q4w ALX-0061 150 mg q4w ALX-0061 150 mg q2w ALX-0061 225 mg q2w
Hide Arm/Group Description:
Two s.c. injections with placebo every 2 weeks (q2w)
ALX-0061 75 mg every 4 weeks (q4w)
ALX-0061 150 mg every 4 weeks (q4w)
ALX-0061 150 mg every 2 weeks (q2w)
ALX-0061 225 mg every 2 weeks (q2w)
Overall Number of Participants Analyzed 62 64 62 62 62
Mean (Standard Error)
Unit of Measure: score
Week 24 Number Analyzed 53 participants 50 participants 51 participants 48 participants 51 participants
-4.0  (0.42) -4.6  (0.43) -3.8  (0.43) -4.3  (0.44) -3.6  (0.44)
Week 48 Number Analyzed 51 participants 46 participants 47 participants 36 participants 45 participants
-4.5  (0.40) -5.2  (0.43) -4.3  (0.42) -4.9  (0.48) -4.9  (0.44)
9.Secondary Outcome
Title Number and Percentage of Subjects With BILAG-2004 Normal Improvement at Week 24 and Week 48
Hide Description

Normal Improvement: all A scores at baseline improved to B/C/D, and all B scores improved to C or D.

Only subjects with non-missing BILAG-2004 who had at least one A or B score at Baseline were assessed for this endpoint

Time Frame At Week 24 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Placebo ALX-0061 75 mg q4w ALX-0061 150 mg q4w ALX-0061 150 mg q2w ALX-0061 225 mg q2w
Hide Arm/Group Description:
Two s.c. injections with placebo every 2 weeks (q2w)
ALX-0061 75 mg every 4 weeks (q4w)
ALX-0061 150 mg every 4 weeks (q4w)
ALX-0061 150 mg every 2 weeks (q2w)
ALX-0061 225 mg every 2 weeks (q2w)
Overall Number of Participants Analyzed 62 64 62 62 62
Measure Type: Count of Participants
Unit of Measure: Participants
Week 24 Number Analyzed 56 participants 52 participants 56 participants 49 participants 54 participants
31
  55.4%
29
  55.8%
28
  50.0%
25
  51.0%
24
  44.4%
Week 48 Number Analyzed 54 participants 48 participants 50 participants 39 participants 46 participants
34
  63.0%
34
  70.8%
29
  58.0%
22
  56.4%
25
  54.3%
10.Secondary Outcome
Title Number and Percentage of Subjects With BILAG-2004 Enhanced Improvement at Week 24 and Week 48
Hide Description Enhanced improvement: all A scores at baseline improved to B/C/D, and all B scores improved to C or D and no worsening between consecutive visits from baseline up to the considered visit Only subjects with non-missing BILAG-2004 who had at least one A or B score at Baseline were assessed for this endpoint
Time Frame At Week 24 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Placebo ALX-0061 75 mg q4w ALX-0061 150 mg q4w ALX-0061 150 mg q2w ALX-0061 225 mg q2w
Hide Arm/Group Description:
Two s.c. injections with placebo every 2 weeks (q2w)
ALX-0061 75 mg every 4 weeks (q4w)
ALX-0061 150 mg every 4 weeks (q4w)
ALX-0061 150 mg every 2 weeks (q2w)
ALX-0061 225 mg every 2 weeks (q2w)
Overall Number of Participants Analyzed 62 64 62 62 62
Measure Type: Count of Participants
Unit of Measure: Participants
Week 24 Number Analyzed 56 participants 52 participants 56 participants 49 participants 54 participants
7
  12.5%
16
  30.8%
11
  19.6%
6
  12.2%
13
  24.1%
Week 48 Number Analyzed 54 participants 48 participants 50 participants 39 participants 45 participants
5
   9.3%
10
  20.8%
7
  14.0%
6
  15.4%
7
  15.6%
11.Secondary Outcome
Title BILAG-2004 Total Score at Baseline, Week 24 and Week 48
Hide Description

The British Isles Lupus Assessment Group 2004 (BILAG-2004) is a comprehensive composite clinical index that has been developed based on the principle of a physician's intention to treat using a nominal consensus approach. In the index, the nine systems (not organs) considered are: constitutional, mucocutaneous, neuropsychiatric, musculoskeletal, cardiorespiratory, gastrointestinal, renal, ophthalmic and hematological. Disease activity in each of the nine systems is categorized into five levels: grades A (= severe disease activity requiring systemic high dose oral corticosteroids, i.v. pulse corticosteroids, etc.) to E (= system never involved).

BILAG total score is derived by assigning the following value to each grade and summing the sores over all organ systems:

A = 12, B = 8, C = 1, D/E = 0. The total score ranges from 0-108, with 108 representing high disease activity in all 9 systems requiring high doses of corticosteroids, starting/increasing immunosuppressive drugs, etc.

Time Frame At Baseline, Week 24 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Placebo ALX-0061 75 mg q4w ALX-0061 150 mg q4w ALX-0061 150 mg q2w ALX-0061 225 mg q2w
Hide Arm/Group Description:
Two s.c. injections with placebo every 2 weeks (q2w)
ALX-0061 75 mg every 4 weeks (q4w)
ALX-0061 150 mg every 4 weeks (q4w)
ALX-0061 150 mg every 2 weeks (q2w)
ALX-0061 225 mg every 2 weeks (q2w)
Overall Number of Participants Analyzed 62 64 62 62 62
Mean (Standard Error)
Unit of Measure: score
Baseline Number Analyzed 62 participants 64 participants 62 participants 62 participants 62 participants
17.4  (0.78) 17.9  (0.69) 15.2  (0.68) 17.4  (0.71) 17.3  (0.82)
Week 24 Number Analyzed 56 participants 52 participants 56 participants 49 participants 54 participants
6.8  (0.78) 5.7  (0.79) 7.0  (0.76) 7.2  (0.94) 7.4  (0.84)
Week 48 Number Analyzed 53 participants 48 participants 50 participants 39 participants 45 participants
6.0  (0.73) 4.0  (0.72) 5.2  (0.74) 6.0  (0.92) 6.2  (0.91)
12.Secondary Outcome
Title Number and Percentage of Subjects With BILAG-2004 Normal Improvement in Mucocutaneous System at Week 24 and Week 48
Hide Description

An improvement is defined as an A score at Baseline improved to B/C/D, or a B score improved to C or D.

Only subjects with non-missing BILAG-2004 who had at least one A or B score at Baseline were assessed for this endpoint

Time Frame At Week 24 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Placebo ALX-0061 75 mg q4w ALX-0061 150 mg q4w ALX-0061 150 mg q2w ALX-0061 225 mg q2w
Hide Arm/Group Description:
Two s.c. injections with placebo every 2 weeks (q2w)
ALX-0061 75 mg every 4 weeks (q4w)
ALX-0061 150 mg every 4 weeks (q4w)
ALX-0061 150 mg every 2 weeks (q2w)
ALX-0061 225 mg every 2 weeks (q2w)
Overall Number of Participants Analyzed 62 64 62 62 62
Measure Type: Count of Participants
Unit of Measure: Participants
Week 24 Number Analyzed 47 participants 45 participants 43 participants 43 participants 47 participants
25
  53.2%
24
  53.3%
18
  41.9%
21
  48.8%
25
  53.2%
Week 48 Number Analyzed 45 participants 41 participants 37 participants 34 participants 40 participants
26
  57.8%
27
  65.9%
18
  48.6%
18
  52.9%
22
  55.0%
13.Secondary Outcome
Title Number and Percentage of Subjects With BILAG-2004 Normal Improvement in Musculoskeletal System at Week 24 and Week 48
Hide Description

An improvement is defined as an A score at Baseline improved to B/C/D, or a B score improved to C or D.

Only subjects with non-missing BILAG-2004 who had at least one A or B score at Baseline were assessed for this endpoint

Time Frame At Week 24 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Placebo ALX-0061 75 mg q4w ALX-0061 150 mg q4w ALX-0061 150 mg q2w ALX-0061 225 mg q2w
Hide Arm/Group Description:
Two s.c. injections with placebo every 2 weeks (q2w)
ALX-0061 75 mg every 4 weeks (q4w)
ALX-0061 150 mg every 4 weeks (q4w)
ALX-0061 150 mg every 2 weeks (q2w)
ALX-0061 225 mg every 2 weeks (q2w)
Overall Number of Participants Analyzed 62 64 62 62 62
Measure Type: Count of Participants
Unit of Measure: Participants
Week 24 Number Analyzed 47 participants 44 participants 43 participants 45 participants 45 participants
41
  87.2%
39
  88.6%
36
  83.7%
36
  80.0%
33
  73.3%
Week 48 Number Analyzed 45 participants 40 participants 40 participants 37 participants 38 participants
40
  88.9%
38
  95.0%
35
  87.5%
33
  89.2%
31
  81.6%
14.Secondary Outcome
Title Number and Percentage of Subjects With Persistent Minimal or no Activity in 9 Organ Systems According to BILAG-2004 Systems Tally at Week 24 and Week 48
Hide Description [Not Specified]
Time Frame At Week 24 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Placebo ALX-0061 75 mg q4w ALX-0061 150 mg q4w ALX-0061 150 mg q2w ALX-0061 225 mg q2w
Hide Arm/Group Description:
Two s.c. injections with placebo every 2 weeks (q2w)
ALX-0061 75 mg every 4 weeks (q4w)
ALX-0061 150 mg every 4 weeks (q4w)
ALX-0061 150 mg every 2 weeks (q2w)
ALX-0061 225 mg every 2 weeks (q2w)
Overall Number of Participants Analyzed 62 64 62 62 62
Measure Type: Count of Participants
Unit of Measure: Participants
Week 24 Number Analyzed 56 participants 52 participants 56 participants 49 participants 54 participants
15
  26.8%
24
  46.2%
19
  33.9%
16
  32.7%
16
  29.6%
Week 48 Number Analyzed 54 participants 48 participants 50 participants 39 participants 46 participants
20
  37.0%
27
  56.3%
23
  46.0%
16
  41.0%
19
  41.3%
15.Secondary Outcome
Title Change From Baseline in Physician's Global Assessment (PGA) at Week 24 and Week 48
Hide Description

The physician makes a mark between 0 ("no disease") and 100 mm ("severe disease") on the visual analogue scale (VAS) to indicate disease activity (independent of the subject's self-assessment).

Mean changes from baseline were derived from an analysis of covariance (ANCOVA) model with treatment as factor and baseline PGA score and geographic region as covariates.

A negative change from baseline reflects an improvement.

Time Frame At Week 24 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Placebo ALX-0061 75 mg q4w ALX-0061 150 mg q4w ALX-0061 150 mg q2w ALX-0061 225 mg q2w
Hide Arm/Group Description:
Two s.c. injections with placebo every 2 weeks (q2w)
ALX-0061 75 mg every 4 weeks (q4w)
ALX-0061 150 mg every 4 weeks (q4w)
ALX-0061 150 mg every 2 weeks (q2w)
ALX-0061 225 mg every 2 weeks (q2w)
Overall Number of Participants Analyzed 62 64 62 62 62
Mean (Standard Error)
Unit of Measure: score on a scale
Week 24 Number Analyzed 56 participants 52 participants 55 participants 49 participants 54 participants
-25.2  (2.03) -28.4  (2.09) -26.2  (2.04) -23.5  (2.16) -22.7  (2.08)
Week 48 Number Analyzed 54 participants 48 participants 48 participants 39 participants 46 participants
-28.3  (1.73) -32.9  (1.82) -30.2  (1.82) -30.1  (2.00) -30.5  (1.87)
16.Secondary Outcome
Title Change From Baseline in Patient's Global Assessment at Week 24 and Week 48
Hide Description

The subject makes a mark between 0 ("very good") and 100 mm ("very bad") on the VAS to indicate how the subject is doing, while considering all the ways SLE affects him/her.

Mean changes from baseline were derived from an analysis of covariance (ANCOVA) model with treatment as factor and baseline Patient's Global Assessment and geographic region as covariates.

A negative change from baseline reflects an improvement.

Time Frame At Week 24 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Placebo ALX-0061 75 mg q4w ALX-0061 150 mg q4w ALX-0061 150 mg q2w ALX-0061 225 mg q2w
Hide Arm/Group Description:
Two s.c. injections with placebo every 2 weeks (q2w)
ALX-0061 75 mg every 4 weeks (q4w)
ALX-0061 150 mg every 4 weeks (q4w)
ALX-0061 150 mg every 2 weeks (q2w)
ALX-0061 225 mg every 2 weeks (q2w)
Overall Number of Participants Analyzed 62 64 62 62 62
Mean (Standard Error)
Unit of Measure: score on a scale
Week 24 Number Analyzed 56 participants 52 participants 56 participants 49 participants 53 participants
-12.4  (2.87) -13.5  (2.96) -14.9  (2.87) -20.1  (3.05) -16.0  (2.98)
Week 48 Number Analyzed 54 participants 48 participants 49 participants 39 participants 46 participants
-15.1  (2.70) -21.5  (2.87) -22.1  (2.82) -27.2  (3.12) -25.9  (2.94)
17.Secondary Outcome
Title Change From Baseline in Proteinuria at Week 24 and Week 48
Hide Description Mean changes from baseline were derived from an analysis of covariance (ANCOVA) model with treatment as factor and baseline proteinuria and geographic region as covariates
Time Frame At Week 24 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Placebo ALX-0061 75 mg q4w ALX-0061 150 mg q4w ALX-0061 150 mg q2w ALX-0061 225 mg q2w
Hide Arm/Group Description:
Two s.c. injections with placebo every 2 weeks (q2w)
ALX-0061 75 mg every 4 weeks (q4w)
ALX-0061 150 mg every 4 weeks (q4w)
ALX-0061 150 mg every 2 weeks (q2w)
ALX-0061 225 mg every 2 weeks (q2w)
Overall Number of Participants Analyzed 62 64 62 62 62
Mean (Standard Error)
Unit of Measure: g/mol
Week 24 Number Analyzed 48 participants 44 participants 48 participants 42 participants 42 participants
6.17  (3.730) 1.77  (3.847) 1.03  (3.735) -3.02  (3.876) 0.16  (3.962)
Week 48 Number Analyzed 43 participants 37 participants 42 participants 30 participants 36 participants
4.89  (5.732) 3.83  (6.152) -1.62  (5.761) -0.49  (6.582) -1.21  (6.191)
18.Secondary Outcome
Title Number of Subjects Who Were Treatment-emergent Urine Sediment Positive at Week 24 and Week 48
Hide Description Efficacy Laboratory Parameters (Urinalysis) - Active Urine Sediment Number of subjects who were urine sediment negative at Baseline, but positive at Week 24 and Week 48, respectively.
Time Frame At Week 24 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Placebo ALX-0061 75 mg q4w ALX-0061 150 mg q4w ALX-0061 150 mg q2w ALX-0061 225 mg q2w
Hide Arm/Group Description:
Two s.c. injections with placebo every 2 weeks (q2w)
ALX-0061 75 mg every 4 weeks (q4w)
ALX-0061 150 mg every 4 weeks (q4w)
ALX-0061 150 mg every 2 weeks (q2w)
ALX-0061 225 mg every 2 weeks (q2w)
Overall Number of Participants Analyzed 62 64 62 62 62
Measure Type: Count of Participants
Unit of Measure: Participants
Week 24 Number Analyzed 56 participants 52 participants 56 participants 49 participants 54 participants
1 0 0 0 0
Week 48 Number Analyzed 54 participants 48 participants 50 participants 39 participants 46 participants
0 0 0 0 0
19.Secondary Outcome
Title Change From Baseline in Serum Creatinine at Week 24 and Week 48
Hide Description Mean changes from baseline were derived from an analysis of covariance (ANCOVA) model with treatment as factor and baseline serum creatinine and geographic region as covariates
Time Frame At Week 24 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Placebo ALX-0061 75 mg q4w ALX-0061 150 mg q4w ALX-0061 150 mg q2w ALX-0061 225 mg q2w
Hide Arm/Group Description:
Two s.c. injections with placebo every 2 weeks (q2w)
ALX-0061 75 mg every 4 weeks (q4w)
ALX-0061 150 mg every 4 weeks (q4w)
ALX-0061 150 mg every 2 weeks (q2w)
ALX-0061 225 mg every 2 weeks (q2w)
Overall Number of Participants Analyzed 62 64 62 62 62
Mean (Standard Error)
Unit of Measure: umol/L
Week 24 Number Analyzed 56 participants 52 participants 56 participants 49 participants 53 participants
-1.25  (2.172) -3.29  (2.237) -1.50  (2.182) -3.98  (2.309) -0.86  (2.276)
Week 48 Number Analyzed 54 participants 47 participants 50 participants 38 participants 46 participants
1.19  (2.016) -1.87  (2.152) -6.26  (2.085) -4.04  (2.359) -1.24  (2.199)
20.Secondary Outcome
Title Change From Baseline in Creatinine Clearance Estimation (eGFR) at Week 24 and Week 48
Hide Description Mean changes from baseline were derived from an analysis of covariance (ANCOVA) model with treatment as factor and baseline eGFR and geographic region as covariates
Time Frame At Week 24 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Placebo ALX-0061 75 mg q4w ALX-0061 150 mg q4w ALX-0061 150 mg q2w ALX-0061 225 mg q2w
Hide Arm/Group Description:
Two s.c. injections with placebo every 2 weeks (q2w)
ALX-0061 75 mg every 4 weeks (q4w)
ALX-0061 150 mg every 4 weeks (q4w)
ALX-0061 150 mg every 2 weeks (q2w)
ALX-0061 225 mg every 2 weeks (q2w)
Overall Number of Participants Analyzed 62 64 62 62 62
Mean (Standard Error)
Unit of Measure: mL/min/1.73m2
Week 24 Number Analyzed 55 participants 52 participants 56 participants 49 participants 53 participants
-1.63  (2.869) 4.83  (2.931) -1.72  (2.854) -0.90  (3.044) -8.91  (3.014)
Week 48 Number Analyzed 53 participants 47 participants 50 participants 38 participants 46 participants
-6.00  (3.052) 2.47  (3.231) 4.66  (3.125) -1.47  (3.562) -8.08  (3.326)
21.Secondary Outcome
Title Number of and Percentage Treatment Failures From Baseline to Week 24 and Week 48
Hide Description Defined as non-protocol allowed increase in steroid dose, start i.v. or i.m. steroids, or start or increase of immunosuppressant
Time Frame From Baseline to Week 24 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Placebo ALX-0061 75 mg q4w ALX-0061 150 mg q4w ALX-0061 150 mg q2w ALX-0061 225 mg q2w
Hide Arm/Group Description:
Two s.c. injections with placebo every 2 weeks (q2w)
ALX-0061 75 mg every 4 weeks (q4w)
ALX-0061 150 mg every 4 weeks (q4w)
ALX-0061 150 mg every 2 weeks (q2w)
ALX-0061 225 mg every 2 weeks (q2w)
Overall Number of Participants Analyzed 62 64 62 62 62
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline to Week 24
2
   3.2%
0
   0.0%
4
   6.5%
2
   3.2%
3
   4.8%
Baseline to Week 48
5
   8.1%
1
   1.6%
9
  14.5%
6
   9.7%
6
   9.7%
22.Secondary Outcome
Title Number and Percentage of Subjects Experiencing Severe Flares According to BILAG-2004 Flare Index From Baseline to Week 24 and Week 48
Hide Description [Not Specified]
Time Frame From Baseline to Week 24 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Placebo ALX-0061 75 mg q4w ALX-0061 150 mg q4w ALX-0061 150 mg q2w ALX-0061 225 mg q2w
Hide Arm/Group Description:
Two s.c. injections with placebo every 2 weeks (q2w)
ALX-0061 75 mg every 4 weeks (q4w)
ALX-0061 150 mg every 4 weeks (q4w)
ALX-0061 150 mg every 2 weeks (q2w)
ALX-0061 225 mg every 2 weeks (q2w)
Overall Number of Participants Analyzed 62 64 62 62 62
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline to Week 24
8
  12.9%
6
   9.4%
6
   9.7%
7
  11.3%
6
   9.7%
Baseline to Week 48
8
  12.9%
6
   9.4%
10
  16.1%
9
  14.5%
9
  14.5%
23.Secondary Outcome
Title Number and Percentage of Subjects Experiencing Severe Flares According to mSLEDAI-2K Flare Index (mSFI) From Baseline to Week 24 and Week 48
Hide Description [Not Specified]
Time Frame From Baseline to Week 24 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Placebo ALX-0061 75 mg q4w ALX-0061 150 mg q4w ALX-0061 150 mg q2w ALX-0061 225 mg q2w
Hide Arm/Group Description:
Two s.c. injections with placebo every 2 weeks (q2w)
ALX-0061 75 mg every 4 weeks (q4w)
ALX-0061 150 mg every 4 weeks (q4w)
ALX-0061 150 mg every 2 weeks (q2w)
ALX-0061 225 mg every 2 weeks (q2w)
Overall Number of Participants Analyzed 62 64 62 62 62
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline to Week 24
1
   1.6%
0
   0.0%
2
   3.2%
2
   3.2%
1
   1.6%
Baseline to Week 48
4
   6.5%
0
   0.0%
4
   6.5%
4
   6.5%
2
   3.2%
24.Secondary Outcome
Title Percent Change From Baseline in Daily Dose of Steroids at Week 24 and Week 48
Hide Description Mean changes from baseline were derived from an analysis of covariance (ANCOVA) model with treatment as factor and baseline prednisone equivalent total daily dose and geographic region as covariates
Time Frame At Week 24 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Placebo ALX-0061 75 mg q4w ALX-0061 150 mg q4w ALX-0061 150 mg q2w ALX-0061 225 mg q2w
Hide Arm/Group Description:
Two s.c. injections with placebo every 2 weeks (q2w)
ALX-0061 75 mg every 4 weeks (q4w)
ALX-0061 150 mg every 4 weeks (q4w)
ALX-0061 150 mg every 2 weeks (q2w)
ALX-0061 225 mg every 2 weeks (q2w)
Overall Number of Participants Analyzed 62 64 62 62 62
Mean (Standard Error)
Unit of Measure: percentage
Week 24 Number Analyzed 48 participants 43 participants 51 participants 43 participants 48 participants
3.87  (2.781) -0.80  (2.922) 0.25  (2.689) -1.40  (2.940) -3.46  (2.831)
Week 48 Number Analyzed 46 participants 40 participants 45 participants 34 participants 40 participants
6.93  (5.047) -3.22  (5.397) -1.03  (5.050) -2.32  (5.758) -1.73  (5.521)
25.Secondary Outcome
Title Number and Percentage of Subjects Whose Daily Dose of Steroids Was Reduced Without Severe Flares During Weeks 40-48
Hide Description Number and percentage of subjects whose prednisone equivalent dose was >7.5 mg/day at baseline and reduced to ≤7.5 mg/day during Weeks 40-48 without experiencing a BILAG-2004-defined or mSFI-defined severe flare after the first prednisone equivalent dose decrease.
Time Frame Between Week 40 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Placebo ALX-0061 75 mg q4w ALX-0061 150 mg q4w ALX-0061 150 mg q2w ALX-0061 225 mg q2w
Hide Arm/Group Description:
Two s.c. injections with placebo every 2 weeks (q2w)
ALX-0061 75 mg every 4 weeks (q4w)
ALX-0061 150 mg every 4 weeks (q4w)
ALX-0061 150 mg every 2 weeks (q2w)
ALX-0061 225 mg every 2 weeks (q2w)
Overall Number of Participants Analyzed 62 64 62 62 62
Measure Type: Count of Participants
Unit of Measure: Participants
BILAG-2004-defined Flare Number Analyzed 34 participants 36 participants 30 participants 32 participants 36 participants
3
   8.8%
2
   5.6%
5
  16.7%
1
   3.1%
3
   8.3%
mSFI-defined Flare Number Analyzed 34 participants 36 participants 30 participants 32 participants 36 participants
3
   8.8%
2
   5.6%
4
  13.3%
1
   3.1%
4
  11.1%
26.Secondary Outcome
Title Number and Percentage of Subjects Who Discontinued Prednisone (or Equivalent) by Week 48 Without Experiencing a Severe Flare
Hide Description Number and percentage of subjects who discontinued Prednisone (or equivalent) by Week 48 without experiencing a BILAG-2004-defined or mSFI-defined severe flare
Time Frame Up to and including Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Placebo ALX-0061 75 mg q4w ALX-0061 150 mg q4w ALX-0061 150 mg q2w ALX-0061 225 mg q2w
Hide Arm/Group Description:
Two s.c. injections with placebo every 2 weeks (q2w)
ALX-0061 75 mg every 4 weeks (q4w)
ALX-0061 150 mg every 4 weeks (q4w)
ALX-0061 150 mg every 2 weeks (q2w)
ALX-0061 225 mg every 2 weeks (q2w)
Overall Number of Participants Analyzed 62 64 62 62 62
Measure Type: Count of Participants
Unit of Measure: Participants
BILAG-2004-defined Flare Number Analyzed 54 participants 52 participants 55 participants 54 participants 56 participants
0
   0.0%
0
   0.0%
1
   1.8%
1
   1.9%
0
   0.0%
mSFI-defined Flare Number Analyzed 54 participants 52 participants 55 participants 54 participants 56 participants
0
   0.0%
0
   0.0%
2
   3.6%
1
   1.9%
0
   0.0%
27.Secondary Outcome
Title Change From Baseline in Physical Component Scores of Short Form (36) Health Survey (SF-36) at Week 24 and Week 48
Hide Description

The Short Form (36) Health Survey (SF-36) consists of 36 items that can be summarized into 8 domains: physical functioning, role limitations due to physical health problems (role-physical), bodily pain, general health, vitality, social functioning, role limitations due to emotional problems (role-emotional), and mental health. Two summary measures, the physical component summary and the mental component summary, can be derived based on these domain scores. Each score is directly transformed into a 0-100 score on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.

Mean changes from baseline were derived from an analysis of covariance (ANCOVA) model with treatment as factor and baseline SF-36 Score and geographic region as covariates. A positive change denotes an improvement.

Time Frame At Week 24 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Placebo ALX-0061 75 mg q4w ALX-0061 150 mg q4w ALX-0061 150 mg q2w ALX-0061 225 mg q2w
Hide Arm/Group Description:
Two s.c. injections with placebo every 2 weeks (q2w)
ALX-0061 75 mg every 4 weeks (q4w)
ALX-0061 150 mg every 4 weeks (q4w)
ALX-0061 150 mg every 2 weeks (q2w)
ALX-0061 225 mg every 2 weeks (q2w)
Overall Number of Participants Analyzed 62 64 62 62 62
Mean (Standard Error)
Unit of Measure: score
Week 24 Number Analyzed 56 participants 52 participants 56 participants 49 participants 53 participants
4.71  (1.241) 4.56  (1.286) 6.77  (1.242) 4.67  (1.321) 5.01  (1.292)
Week 48 Number Analyzed 54 participants 48 participants 50 participants 39 participants 46 participants
3.73  (1.414) 6.97  (1.510) 8.67  (1.460) 8.62  (1.633) 8.85  (1.535)
28.Secondary Outcome
Title Change From Baseline in Mental Component Scores of SF-36 at Week 24 and Week 48
Hide Description

The Short Form (36) Health Survey (SF-36) consists of 36 items that can be summarized into 8 domains: physical functioning, role limitations due to physical health problems (role-physical), bodily pain, general health, vitality, social functioning, role limitations due to emotional problems (role-emotional), and mental health. Two summary measures, the physical component summary and the mental component summary, can be derived based on these domain scores. Each score is directly transformed into a 0-100 score on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.

Mean changes from baseline were derived from an analysis of covariance (ANCOVA) model with treatment as factor and baseline SF-36 Score and geographic region as covariates. A positive change denotes an improvement.

Time Frame At Week 24 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Placebo ALX-0061 75 mg q4w ALX-0061 150 mg q4w ALX-0061 150 mg q2w ALX-0061 225 mg q2w
Hide Arm/Group Description:
Two s.c. injections with placebo every 2 weeks (q2w)
ALX-0061 75 mg every 4 weeks (q4w)
ALX-0061 150 mg every 4 weeks (q4w)
ALX-0061 150 mg every 2 weeks (q2w)
ALX-0061 225 mg every 2 weeks (q2w)
Overall Number of Participants Analyzed 62 64 62 62 62
Mean (Standard Error)
Unit of Measure: score
Week 24 Number Analyzed 56 participants 52 participants 56 participants 49 participants 53 participants
0.08  (0.703) -0.99  (0.724) -0.56  (0.703) 0.45  (0.749) -1.18  (0.732)
Week 48 Number Analyzed 54 participants 48 participants 50 participants 39 participants 46 participants
1.50  (0.716) -0.58  (0.756) -0.07  (0.737) -1.07  (0.827) -2.02  (0.777)
29.Secondary Outcome
Title Change From Baseline in 28 Joint Count Swollenness (SJC28) Score at Week 24 and Week 48
Hide Description Twenty-eight joints are assessed for swollenness (a score of 1 for a joint denotes a presence of swollenness). The sum is derived to create a total score (ranging from 0 to 28; where the highest score indicate all 28 joints are swollen). Mean changes from baseline were derived from an analysis of covariance (ANCOVA) model with treatment as factor and baseline SJC28 Score and geographic region as covariates. A negative change denotes an improvement.
Time Frame At Week 24 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Placebo ALX-0061 75 mg q4w ALX-0061 150 mg q4w ALX-0061 150 mg q2w ALX-0061 225 mg q2w
Hide Arm/Group Description:
Two s.c. injections with placebo every 2 weeks (q2w)
ALX-0061 75 mg every 4 weeks (q4w)
ALX-0061 150 mg every 4 weeks (q4w)
ALX-0061 150 mg every 2 weeks (q2w)
ALX-0061 225 mg every 2 weeks (q2w)
Overall Number of Participants Analyzed 62 64 62 62 62
Mean (Standard Error)
Unit of Measure: score
Week 24 Number Analyzed 56 participants 52 participants 56 participants 49 participants 54 participants
-4.8  (0.31) -5.0  (0.32) -4.9  (0.31) -4.8  (0.33) -4.5  (0.32)
Week 48 Number Analyzed 54 participants 48 participants 50 participants 39 participants 46 participants
-5.0  (0.28) -5.4  (0.30) -4.7  (0.29) -5.1  (0.32) -4.5  (0.30)
30.Secondary Outcome
Title Change From Baseline in 28 Joint Count Tenderness (TJC28) Score at Week 24 and Week 48
Hide Description Twenty-eight joints are assessed for tenderness (a score of 1 for a joint denotes a presence of tenderness). The sum is derived to create a total score (ranging from 0 to 28; where the highest score indicate all 28 joints are tender). Mean changes from baseline were derived from an analysis of covariance (ANCOVA) model with treatment as factor and baseline TJC28 Score and geographic region as covariates. A negative change denotes and improvement.
Time Frame At Week 24 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Placebo ALX-0061 75 mg q4w ALX-0061 150 mg q4w ALX-0061 150 mg q2w ALX-0061 225 mg q2w
Hide Arm/Group Description:
Two s.c. injections with placebo every 2 weeks (q2w)
ALX-0061 75 mg every 4 weeks (q4w)
ALX-0061 150 mg every 4 weeks (q4w)
ALX-0061 150 mg every 2 weeks (q2w)
ALX-0061 225 mg every 2 weeks (q2w)
Overall Number of Participants Analyzed 62 64 62 62 62
Mean (Standard Error)
Unit of Measure: score
Week 24 Number Analyzed 56 participants 52 participants 56 participants 49 participants 54 participants
-6.8  (0.49) -6.8  (0.50) -6.4  (0.49) -5.8  (0.52) -5.5  (0.50)
Week 48 Number Analyzed 54 participants 48 participants 50 participants 39 participants 46 participants
-6.6  (0.43) -7.4  (0.46) -6.4  (0.45) -6.6  (0.50) -6.5  (0.47)
31.Secondary Outcome
Title Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score at Week 12, Week 24 and Week 48
Hide Description

CLASI Activity is scored based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and nonscarring alopecia. Evaluation of erythema and scale/hyperkeratosis is based on a table: rows represent anatomical areas and columns represent major clinical symptoms. The extent of involvement for each of the skin symptoms is documented for each anatomic area (erythema: 0=absent, 1=pink, 2=red, 3=dark red; scale: 0=absent, 1=scale, 2=verrucous/hypertrophic). Mucous membrane involvement and acute hair loss are scored based on the presence (=1) or absence (=0).

Nonscarring alopecia is scored as 0=absent, 1=diffuse/non-inflammatory, 2=focal or patchy in 1 quadrant, 3=focal or patchy in >1 quadrant. The total score ranges from 0-70, with higher scores indicating more severe skin disease.

Mean changes from baseline were derived from an ANCOVA model with treatment as factor and baseline CLASI Activity Score and geographic region as covariates. Negative change = improvement

Time Frame At Week 12, Week 24 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Placebo ALX-0061 75 mg q4w ALX-0061 150 mg q4w ALX-0061 150 mg q2w ALX-0061 225 mg q2w
Hide Arm/Group Description:
Two s.c. injections with placebo every 2 weeks (q2w)
ALX-0061 75 mg every 4 weeks (q4w)
ALX-0061 150 mg every 4 weeks (q4w)
ALX-0061 150 mg every 2 weeks (q2w)
ALX-0061 225 mg every 2 weeks (q2w)
Overall Number of Participants Analyzed 62 64 62 62 62
Mean (Standard Error)
Unit of Measure: score
Week 12 Number Analyzed 26 participants 25 participants 18 participants 21 participants 24 participants
-2.4  (0.53) -1.9  (0.57) -1.4  (0.65) -1.6  (0.63) -1.3  (0.57)
Week 24 Number Analyzed 25 participants 21 participants 17 participants 19 participants 23 participants
-1.1  (0.53) -2.1  (0.60) -1.6  (0.66) -1.3  (0.65) -1.8  (0.57)
Week 48 Number Analyzed 24 participants 18 participants 16 participants 14 participants 21 participants
-1.3  (0.59) -3.0  (0.70) -2.5  (0.73) -2.1  (0.80) -3.0  (0.64)
32.Secondary Outcome
Title Change From Baseline in CLASI Damage Score at Week 12, Week 24 and Week 48
Hide Description

CLASI Damage is scored based on dyspigmentation and scarring. Evaluation of dyspigmentation and scarring is based on a table: rows represent anatomical areas and columns represent major clinical symptoms. The extent of involvement for each of the skin symptoms is documented for each anatomic area (dyspigmentation: 0=absent, 1=present; scarring: 0=absent, 1=scarring, 2=severely atrophic scarring or panniculitis). Subjects are also asked whether dyspigmentation due to SLE lesions usually remains visible for >12 months, which is considered permanent and results in doubling of the dyspigmentation score. Scarring alopecia is scored as follows: 0=absent, 3=1 quadrant, 4=2 quadrants, 5=3 quadrants, 6=affects the whole skull. Total score ranges from 0-56, with higher scores indicating more damaged skin.

Mean changes from baseline were derived from an ANCOVA model with treatment as factor and baseline CLASI Damage Score and geographic region as covariates. Negative change = improvement.

Time Frame At Week 12, Week 24 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Placebo ALX-0061 75 mg q4w ALX-0061 150 mg q4w ALX-0061 150 mg q2w ALX-0061 225 mg q2w
Hide Arm/Group Description:
Two s.c. injections with placebo every 2 weeks (q2w)
ALX-0061 75 mg every 4 weeks (q4w)
ALX-0061 150 mg every 4 weeks (q4w)
ALX-0061 150 mg every 2 weeks (q2w)
ALX-0061 225 mg every 2 weeks (q2w)
Overall Number of Participants Analyzed 62 64 62 62 62
Mean (Standard Error)
Unit of Measure: score
Week 12 Number Analyzed 11 participants 14 participants 8 participants 13 participants 13 participants
0.1  (0.49) 0.1  (0.47) -0.1  (0.59) -0.3  (0.52) -0.4  (0.52)
Week 24 Number Analyzed 11 participants 11 participants 8 participants 11 participants 12 participants
0.4  (0.61) -0.4  (0.61) -0.4  (0.73) 0.3  (0.67) -0.1  (0.66)
Week 48 Number Analyzed 11 participants 9 participants 8 participants 8 participants 11 participants
0.0  (0.57) -0.1  (0.60) -0.3  (0.68) 0.4  (0.68) -0.7  (0.63)
33.Secondary Outcome
Title ALX-0061 Serum Concentrations at Week 24 and Week 48
Hide Description [Not Specified]
Time Frame At Week 24 and Week 48
Hide Outcome Measure Data
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Safety Population
Arm/Group Title ALX-0061 75 mg 4qw ALX-0061 150 mg q4w ALX-0061 150 mg q2w ALX-0061 225 mg q2w
Hide Arm/Group Description:
ALX-0061 75 mg every 4 weeks (q4w)
ALX-0061 150 mg every 4 weeks (q4w)
ALX-0061 150 mg every 2 weeks (q2w)
ALX-0061 225 mg every 2 weeks (q2w)
Overall Number of Participants Analyzed 64 62 62 62
Geometric Mean (Standard Deviation)
Unit of Measure: µg/mL
Week 24 Number Analyzed 43 participants 53 participants 47 participants 50 participants
0.118  (2.29) 2.05  (3.89) 18.1  (1.60) 30.7  (1.62)
Week 48 Number Analyzed 33 participants 43 participants 32 participants 42 participants
0.155  (3.28) 2.17  (3.45) 17.9  (1.71) 36.1  (1.46)
34.Secondary Outcome
Title Actual Values of Soluble Interleukin 6 Receptor (sIL-6R) Concentrations at Baseline, Week 24, and Week 48
Hide Description [Not Specified]
Time Frame At Baseline, Week 24, and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo ALX-0061 75 mg q4w ALX-0061 150 mg q4w ALX-0061 150 mg q2w ALX-0061 225 mg q2w
Hide Arm/Group Description:
Two s.c. injections with placebo every 2 weeks (q2w)
ALX-0061 75 mg every 4 weeks (q4w)
ALX-0061 150 mg every 4 weeks (q4w)
ALX-0061 150 mg every 2 weeks (q2w)
ALX-0061 225 mg every 2 weeks (q2w)
Overall Number of Participants Analyzed 62 64 62 62 62
Mean (Standard Error)
Unit of Measure: ng/mL
Baseline Number Analyzed 62 participants 63 participants 62 participants 62 participants 60 participants
42.22  (2.496) 37.63  (1.933) 38.10  (1.895) 42.14  (3.366) 36.92  (1.810)
Week 24 Number Analyzed 55 participants 51 participants 54 participants 49 participants 53 participants
39.70  (1.934) 198.26  (18.856) 603.51  (31.678) 668.57  (25.568) 634.49  (23.638)
Week 48 Number Analyzed 53 participants 47 participants 50 participants 38 participants 46 participants
39.41  (2.270) 224.66  (25.515) 610.86  (29.445) 650.73  (38.516) 659.79  (32.862)
35.Secondary Outcome
Title Actual Values of C-reactive Protein (CRP) Concentrations at Baseline, Week 24, and Week 48
Hide Description [Not Specified]
Time Frame At Baseline, Week 24, and Week 48
Hide Outcome Measure Data
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Safety Population
Arm/Group Title Placebo ALX-0061 75 mg q4w ALX-0061 150 mg q4w ALX-0061 150 mg q2w ALX-0061 225 mg q2w
Hide Arm/Group Description:
Two s.c. injections with placebo every 2 weeks (q2w)
ALX-0061 75 mg every 4 weeks (q4w)
ALX-0061 150 mg every 4 weeks (q4w)
ALX-0061 150 mg every 2 weeks (q2w)
ALX-0061 225 mg every 2 weeks (q2w)
Overall Number of Participants Analyzed 62 64 62 62 62
Mean (Standard Error)
Unit of Measure: nmol/L
Baseline Number Analyzed 62 participants 64 participants 62 participants 62 participants 62 participants
43.58  (9.527) 49.05  (12.924) 38.89  (8.394) 66.32  (17.221) 32.23  (4.957)
Week 24 Number Analyzed 56 participants 52 participants 56 participants 49 participants 53 participants
59.43  (11.277) 47.22  (9.607) 26.08  (9.995) 3.83  (0.668) 3.20  (0.357)
Week 48 Number Analyzed 54 participants 46 participants 50 participants 38 participants 46 participants
30.70  (4.709) 37.65  (8.647) 23.20  (6.705) 4.41  (0.988) 4.02  (0.962)
36.Secondary Outcome
Title Actual Values of Fibrinogen Concentrations at Baseline, Week 24, and Week 48
Hide Description [Not Specified]
Time Frame At Baseline, Week 24, and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo ALX-0061 75 mg q4w ALX-0061 150 mg q4w ALX-0061 150 mg q2w ALX-0061 225 mg q2w
Hide Arm/Group Description:
Two s.c. injections with placebo every 2 weeks (q2w)
ALX-0061 75 mg every 4 weeks (q4w)
ALX-0061 150 mg every 4 weeks (q4w)
ALX-0061 150 mg every 2 weeks (q2w)
ALX-0061 225 mg every 2 weeks (q2w)
Overall Number of Participants Analyzed 62 64 62 62 62
Mean (Standard Error)
Unit of Measure: g/L
Baseline Number Analyzed 62 participants 64 participants 62 participants 62 participants 62 participants
3.2  (0.09) 3.2  (0.08) 3.2  (0.09) 3.2  (0.10) 3.1  (0.09)
Week 24 Number Analyzed 55 participants 52 participants 54 participants 49 participants 51 participants
3.3  (0.08) 3.3  (0.10) 2.3  (0.12) 1.9  (0.05) 1.9  (0.05)
Week 48 Number Analyzed 51 participants 48 participants 49 participants 36 participants 46 participants
3.3  (0.09) 3.3  (0.12) 2.3  (0.11) 1.9  (0.06) 1.9  (0.05)
37.Secondary Outcome
Title Actual Values of Anti-double-stranded (ds) DNA Concentrations at Baseline, Week 24, and Week 48
Hide Description [Not Specified]
Time Frame at Baseline, Week 24, and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo ALX-0061 75 mg q4w ALX-0061 150 mg q4w ALX-0061 150 mg q2w ALX-0061 225 mg q2w
Hide Arm/Group Description:
Two s.c. injections with placebo every 2 weeks (q2w)
ALX-0061 75 mg every 4 weeks (q4w)
ALX-0061 150 mg every 4 weeks (q4w)
ALX-0061 150 mg every 2 weeks (q2w)
ALX-0061 225 mg every 2 weeks (q2w)
Overall Number of Participants Analyzed 62 64 62 62 62
Mean (Standard Error)
Unit of Measure: IU/mL
Baseline Number Analyzed 62 participants 64 participants 62 participants 62 participants 62 participants
132.90  (54.467) 145.87  (113.907) 52.88  (17.283) 68.92  (23.226) 73.34  (25.940)
Week 24 Number Analyzed 55 participants 52 participants 55 participants 49 participants 53 participants
81.36  (30.376) 68.27  (35.053) 46.99  (33.534) 14.98  (4.499) 23.25  (6.417)
Week 48 Number Analyzed 54 participants 48 participants 50 participants 39 participants 46 participants
81.80  (24.143) 59.48  (32.190) 74.21  (48.030) 9.13  (2.108) 15.53  (6.069)
38.Secondary Outcome
Title Actual Values of Complement C3 Concentrations at Baseline, Week 24, and Week 48
Hide Description [Not Specified]
Time Frame At Baseline, Week 24, and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo ALX-0061 75 mg q4w ALX-0061 150 mg q4w ALX-0061 150 mg q2w ALX-0061 225 mg q2w
Hide Arm/Group Description:
Two s.c. injections with placebo every 2 weeks (q2w)
ALX-0061 75 mg every 4 weeks (q4w)
ALX-0061 150 mg every 4 weeks (q4w)
ALX-0061 150 mg every 2 weeks (q2w)
ALX-0061 225 mg every 2 weeks (q2w)
Overall Number of Participants Analyzed 62 64 62 62 62
Mean (Standard Error)
Unit of Measure: mg/dL
Baseline Number Analyzed 62 participants 64 participants 62 participants 62 participants 62 participants
102.3  (3.82) 100.2  (4.12) 101.9  (3.79) 105.8  (4.38) 98.6  (3.98)
Week 24 Number Analyzed 55 participants 52 participants 55 participants 47 participants 52 participants
101.7  (4.30) 95.7  (3.81) 82.0  (3.68) 75.3  (2.90) 71.8  (2.82)
Week 48 Number Analyzed 53 participants 48 participants 50 participants 38 participants 45 participants
95.8  (4.25) 93.2  (4.20) 79.0  (3.25) 83.2  (3.18) 72.3  (2.61)
39.Secondary Outcome
Title Actual Values of Complement C4 Concentrations at Baseline, Week 24, and Week 48
Hide Description [Not Specified]
Time Frame At Baseline, Week 24, and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo ALX-0061 75 mg q4w ALX-0061 150 mg q4w ALX-0061 150 mg q2w ALX-0061 225 mg q2w
Hide Arm/Group Description:
Two s.c. injections with placebo every 2 weeks (q2w)
ALX-0061 75 mg every 4 weeks (q4w)
ALX-0061 150 mg every 4 weeks (q4w)
ALX-0061 150 mg every 2 weeks (q2w)
ALX-0061 225 mg every 2 weeks (q2w)
Overall Number of Participants Analyzed 62 64 62 62 62
Mean (Standard Error)
Unit of Measure: mg/dL
Baseline Number Analyzed 62 participants 64 participants 62 participants 62 participants 62 participants
17.3  (1.08) 17.8  (1.07) 15.9  (0.96) 18.7  (1.19) 16.3  (1.04)
Week 24 Number Analyzed 54 participants 52 participants 55 participants 47 participants 52 participants
17.5  (1.09) 17.4  (1.10) 10.6  (0.85) 8.7  (0.40) 7.9  (0.37)
Week 48 Number Analyzed 52 participants 47 participants 48 participants 38 participants 43 participants
16.3  (1.15) 17.3  (1.27) 10.5  (0.84) 9.8  (0.89) 8.1  (0.41)
40.Secondary Outcome
Title Actual Values for Hemolytic Complement Component 50 (CH50) at Baseline, Week 24, and Week 48
Hide Description [Not Specified]
Time Frame At Baseline, Week 24, and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo ALX-0061 75 mg q4w ALX-0061 150 mg q4w ALX-0061 150 mg q2w ALX-0061 225 mg q2w
Hide Arm/Group Description:
Two s.c. injections with placebo every 2 weeks (q2w)
ALX-0061 75 mg every 4 weeks (q4w)
ALX-0061 150 mg every 4 weeks (q4w)
ALX-0061 150 mg every 2 weeks (q2w)
ALX-0061 225 mg every 2 weeks (q2w)
Overall Number of Participants Analyzed 62 64 62 62 62
Mean (Standard Error)
Unit of Measure: unit(s)
Baseline Number Analyzed 62 participants 64 participants 62 participants 62 participants 62 participants
101.1  (7.46) 109.6  (8.83) 98.9  (6.95) 103.0  (7.47) 82.4  (7.09)
Week 24 Number Analyzed 56 participants 52 participants 56 participants 49 participants 53 participants
95.8  (7.94) 107.0  (7.08) 73.6  (6.94) 56.7  (4.91) 41.1  (3.63)
Week 48 Number Analyzed 54 participants 48 participants 50 participants 39 participants 46 participants
102.2  (8.38) 113.1  (8.63) 73.5  (8.26) 68.4  (6.95) 41.9  (3.32)
41.Secondary Outcome
Title Number and Percentage of Subjects Who Were Treatment-emergent (TE) Anti-drug Antibody (ADA) Positive
Hide Description [Not Specified]
Time Frame From first administration of ALX-0061 up to and including follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo ALX-0061 75 mg q4w ALX-0061 150 mg q4w ALX-0061 150 mg q2w ALX-0061 225 mg q2w
Hide Arm/Group Description:
Two s.c. injections with placebo every 2 weeks (q2w)
ALX-0061 75 mg every 4 weeks (q4w)
ALX-0061 150 mg every 4 weeks (q4w)
ALX-0061 150 mg every 2 weeks (q2w)
ALX-0061 225 mg every 2 weeks (q2w)
Overall Number of Participants Analyzed 62 64 62 62 62
Measure Type: Count of Participants
Unit of Measure: Participants
32
  51.6%
16
  25.0%
18
  29.0%
31
  50.0%
38
  61.3%
Time Frame From time of first study drug administration until the subject's study completion/discontinuation date.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo ALX-0061 75 mg q4w ALX-0061 150 mg q4w ALX-0061 150 mg q2w ALX-0061 225 mg q2w
Hide Arm/Group Description Two s.c. injections with placebo every 2 weeks (q2w) ALX-0061 75 mg every 4 weeks (q4w) ALX-0061 150 mg every 4 weeks (q4w) ALX-0061 150 mg every 2 weeks (q2w) ALX-0061 225 mg every 2 weeks (q2w)
All-Cause Mortality
Placebo ALX-0061 75 mg q4w ALX-0061 150 mg q4w ALX-0061 150 mg q2w ALX-0061 225 mg q2w
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/62 (0.00%)      0/64 (0.00%)      0/62 (0.00%)      2/62 (3.23%)      0/62 (0.00%)    
Hide Serious Adverse Events
Placebo ALX-0061 75 mg q4w ALX-0061 150 mg q4w ALX-0061 150 mg q2w ALX-0061 225 mg q2w
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/62 (11.29%)      2/64 (3.13%)      4/62 (6.45%)      5/62 (8.06%)      5/62 (8.06%)    
Blood and lymphatic system disorders           
Anemia of chronic disease  1  0/62 (0.00%)  0 0/64 (0.00%)  0 0/62 (0.00%)  0 1/62 (1.61%)  1 0/62 (0.00%)  0
Thrombotic thrombocytopenic purpura  1  1/62 (1.61%)  1 0/64 (0.00%)  0 0/62 (0.00%)  0 0/62 (0.00%)  0 0/62 (0.00%)  0
Cardiac disorders           
Cardiopulmonary failure  1  0/62 (0.00%)  0 0/64 (0.00%)  0 0/62 (0.00%)  0 1/62 (1.61%)  1 0/62 (0.00%)  0
Endocrine disorders           
Adrenal insufficiency  1  0/62 (0.00%)  0 0/64 (0.00%)  0 0/62 (0.00%)  0 1/62 (1.61%)  1 0/62 (0.00%)  0
Eye disorders           
Open angle glaucoma  1  0/62 (0.00%)  0 0/64 (0.00%)  0 1/62 (1.61%)  1 0/62 (0.00%)  0 0/62 (0.00%)  0
Gastrointestinal disorders           
Gastric ulcer  1  1/62 (1.61%)  1 0/64 (0.00%)  0 0/62 (0.00%)  0 0/62 (0.00%)  0 0/62 (0.00%)  0
Pancreatitis chronic  1  0/62 (0.00%)  0 0/64 (0.00%)  0 0/62 (0.00%)  0 0/62 (0.00%)  0 1/62 (1.61%)  1
General disorders           
Pyrexia  1  1/62 (1.61%)  1 0/64 (0.00%)  0 0/62 (0.00%)  0 0/62 (0.00%)  0 0/62 (0.00%)  0
Immune system disorders           
Allergy to arthropod sting  1  0/62 (0.00%)  0 0/64 (0.00%)  0 1/62 (1.61%)  1 0/62 (0.00%)  0 0/62 (0.00%)  0
Infections and infestations           
Cellulitis  1  0/62 (0.00%)  0 0/64 (0.00%)  0 1/62 (1.61%)  1 0/62 (0.00%)  0 2/62 (3.23%)  2
Pneumonia  1  2/62 (3.23%)  2 0/64 (0.00%)  0 0/62 (0.00%)  0 1/62 (1.61%)  1 0/62 (0.00%)  0
Sinusitis  1  1/62 (1.61%)  1 0/64 (0.00%)  0 1/62 (1.61%)  1 0/62 (0.00%)  0 0/62 (0.00%)  0
Cytomegalovirus infection  1  1/62 (1.61%)  1 0/64 (0.00%)  0 0/62 (0.00%)  0 0/62 (0.00%)  0 0/62 (0.00%)  0
Erysipelas  1  0/62 (0.00%)  0 0/64 (0.00%)  0 1/62 (1.61%)  1 0/62 (0.00%)  0 0/62 (0.00%)  0
Meningitis  1  0/62 (0.00%)  0 1/64 (1.56%)  1 0/62 (0.00%)  0 0/62 (0.00%)  0 0/62 (0.00%)  0
Peritonsillar abscess  1  0/62 (0.00%)  0 0/64 (0.00%)  0 0/62 (0.00%)  0 1/62 (1.61%)  1 0/62 (0.00%)  0
Pulmonary tuberculoma  1  0/62 (0.00%)  0 0/64 (0.00%)  0 0/62 (0.00%)  0 1/62 (1.61%)  1 0/62 (0.00%)  0
Subcutaneous abscess  1  0/62 (0.00%)  0 0/64 (0.00%)  0 1/62 (1.61%)  1 0/62 (0.00%)  0 0/62 (0.00%)  0
Tuberculous pleurisy  1  0/62 (0.00%)  0 0/64 (0.00%)  0 0/62 (0.00%)  0 1/62 (1.61%)  1 0/62 (0.00%)  0
Injury, poisoning and procedural complications           
Ligament rupture  1  1/62 (1.61%)  1 0/64 (0.00%)  0 0/62 (0.00%)  0 0/62 (0.00%)  0 0/62 (0.00%)  0
Ligament sprain  1  1/62 (1.61%)  1 0/64 (0.00%)  0 0/62 (0.00%)  0 0/62 (0.00%)  0 0/62 (0.00%)  0
Post-traumatic pain  1  0/62 (0.00%)  0 0/64 (0.00%)  0 1/62 (1.61%)  1 0/62 (0.00%)  0 0/62 (0.00%)  0
Toxicity to various agents  1  0/62 (0.00%)  0 0/64 (0.00%)  0 0/62 (0.00%)  0 1/62 (1.61%)  1 0/62 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Rotator cuff syndrome  1  0/62 (0.00%)  0 0/64 (0.00%)  0 0/62 (0.00%)  0 0/62 (0.00%)  0 1/62 (1.61%)  1
Nervous system disorders           
Generalized tonic-clonic seizure  1  0/62 (0.00%)  0 1/64 (1.56%)  1 0/62 (0.00%)  0 0/62 (0.00%)  0 0/62 (0.00%)  0
Hypoxic-ischemic encephalopathy  1  0/62 (0.00%)  0 0/64 (0.00%)  0 0/62 (0.00%)  0 1/62 (1.61%)  1 0/62 (0.00%)  0
Seizure  1  0/62 (0.00%)  0 0/64 (0.00%)  0 0/62 (0.00%)  0 1/62 (1.61%)  1 0/62 (0.00%)  0
Psychiatric disorders           
Depression  1  1/62 (1.61%)  1 0/64 (0.00%)  0 0/62 (0.00%)  0 0/62 (0.00%)  0 0/62 (0.00%)  0
Suicidal ideation  1  0/62 (0.00%)  0 0/64 (0.00%)  0 0/62 (0.00%)  0 1/62 (1.61%)  1 0/62 (0.00%)  0
Suicide attempt  1  0/62 (0.00%)  0 0/64 (0.00%)  0 0/62 (0.00%)  0 1/62 (1.61%)  1 0/62 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Pulmonary embolism  1  0/62 (0.00%)  0 0/64 (0.00%)  0 0/62 (0.00%)  0 1/62 (1.61%)  1 0/62 (0.00%)  0
Respiratory failure  1  0/62 (0.00%)  0 0/64 (0.00%)  0 0/62 (0.00%)  0 1/62 (1.61%)  1 0/62 (0.00%)  0
Vascular disorders           
Deep vein thrombosis  1  0/62 (0.00%)  0 0/64 (0.00%)  0 0/62 (0.00%)  0 0/62 (0.00%)  0 1/62 (1.61%)  1
Vasculitis  1  0/62 (0.00%)  0 0/64 (0.00%)  0 0/62 (0.00%)  0 0/62 (0.00%)  0 1/62 (1.61%)  1
1
Term from vocabulary, MedDRA (20.1)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo ALX-0061 75 mg q4w ALX-0061 150 mg q4w ALX-0061 150 mg q2w ALX-0061 225 mg q2w
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   40/62 (64.52%)      40/64 (62.50%)      31/62 (50.00%)      47/62 (75.81%)      44/62 (70.97%)    
Blood and lymphatic system disorders           
Neutropenia  1  2/62 (3.23%)  2 3/64 (4.69%)  6 3/62 (4.84%)  3 5/62 (8.06%)  9 6/62 (9.68%)  7
Gastrointestinal disorders           
Diarrhoea  1  6/62 (9.68%)  6 1/64 (1.56%)  1 0/62 (0.00%)  0 1/62 (1.61%)  1 2/62 (3.23%)  2
Nausea  1  4/62 (6.45%)  6 1/64 (1.56%)  1 2/62 (3.23%)  2 2/62 (3.23%)  2 0/62 (0.00%)  0
General disorders           
Injection site erythema  1  0/62 (0.00%)  0 2/64 (3.13%)  3 2/62 (3.23%)  5 5/62 (8.06%)  17 5/62 (8.06%)  11
Injection site rash  1  0/62 (0.00%)  0 3/64 (4.69%)  3 1/62 (1.61%)  1 4/62 (6.45%)  17 3/62 (4.84%)  6
Injection site reaction  1  0/62 (0.00%)  0 0/64 (0.00%)  0 0/62 (0.00%)  0 4/62 (6.45%)  5 1/62 (1.61%)  5
Infections and infestations           
Urinary tract infection  1  8/62 (12.90%)  11 5/64 (7.81%)  10 7/62 (11.29%)  10 3/62 (4.84%)  5 8/62 (12.90%)  12
Upper respiratory tract infection  1  5/62 (8.06%)  5 5/64 (7.81%)  7 5/62 (8.06%)  5 5/62 (8.06%)  8 3/62 (4.84%)  5
Nasopharyngitis  1  6/62 (9.68%)  8 6/64 (9.38%)  7 5/62 (8.06%)  6 2/62 (3.23%)  3 1/62 (1.61%)  1
Bronchitis  1  2/62 (3.23%)  3 2/64 (3.13%)  3 4/62 (6.45%)  4 2/62 (3.23%)  2 1/62 (1.61%)  1
Sinusitis  1  2/62 (3.23%)  3 3/64 (4.69%)  6 0/62 (0.00%)  0 4/62 (6.45%)  4 1/62 (1.61%)  1
Investigations           
Hepatic enzyme increased  1  0/62 (0.00%)  0 0/64 (0.00%)  0 1/62 (1.61%)  1 6/62 (9.68%)  6 0/62 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Back pain  1  4/62 (6.45%)  5 2/64 (3.13%)  2 1/62 (1.61%)  1 1/62 (1.61%)  1 0/62 (0.00%)  0
Nervous system disorders           
Headache  1  13/62 (20.97%)  16 4/64 (6.25%)  27 3/62 (4.84%)  4 3/62 (4.84%)  6 10/62 (16.13%)  10
Skin and subcutaneous tissue disorders           
Urticaria  1  0/62 (0.00%)  0 1/64 (1.56%)  1 4/62 (6.45%)  6 1/62 (1.61%)  1 2/62 (3.23%)  2
Vascular disorders           
Hypertension  1  4/62 (6.45%)  4 2/64 (3.13%)  2 3/62 (4.84%)  4 3/62 (4.84%)  3 1/62 (1.61%)  1
1
Term from vocabulary, MedDRA (20.1)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Publication of any results from this study will be according to the principles of the Declaration of Helsinki, in particular point 30, and will require prior review and written agreement of the Sponsor.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Monitor
Organization: Ablynx
Phone: +32 (9) 262 00 00
EMail: clinicaltrials@ablynx.com
Layout table for additonal information
Responsible Party: Ablynx
ClinicalTrials.gov Identifier: NCT02437890    
Other Study ID Numbers: ALX0061-C204
2015-000372-95 ( EudraCT Number )
First Submitted: April 29, 2015
First Posted: May 8, 2015
Results First Submitted: November 16, 2018
Results First Posted: February 6, 2019
Last Update Posted: February 26, 2019