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Trial record 1 of 1 for:    IFN-K 002
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Phase IIb Study of IFN-K in 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: NCT02665364
Recruitment Status : Terminated (Reorganization proceedings of the sponsor)
First Posted : January 27, 2016
Results First Posted : March 26, 2020
Last Update Posted : April 9, 2020
Sponsor:
Information provided by (Responsible Party):
Neovacs

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Systemic Lupus Erythematosus
Interventions Biological: IFNα-Kinoid
Other: Placebo
Other: ISA 51 VG
Enrollment 185
Recruitment Details  
Pre-assignment Details

The number of participants enrolled is the number of participants who signed informed condent form.

One subject was randomized in IFN-K group and did not receive IFN-K. A total of 185 subjects were randomized and 184 subjects were treated : 91 subjects received IFN-K and 93 subjects received placebo.
Arm/Group Title IFN-K Placebo
Hide Arm/Group Description Subjects received IFN-K adjuvanted with ISA 51 VG via intramuscular injection. 1 administration of 240 μg at W0, W1, W4 and 1 administration of 120 μg at month 3 (W12) and month 6 (W24) in addition to standard of care treatment. Subjects received placebo normal saline (0.9% Sodium Chloride) adjuvanted with ISA 51 VG via intramuscular injection. 1 administration of 240 μg at week (W)0, W1, W4 and 1 administration of 120 μg at month 3 (W12) and month 6 (W24) in addition to standard of care treatment.
Period Title: Overall Study
Started 91 93
Completed 85 84
Not Completed 6 9
Arm/Group Title IFN-Kinoid Placebo Total
Hide Arm/Group Description IFN-K adjuvanted with ISA 51 VG Placebo adjuvanted with ISA 51 VG Total of all reporting groups
Overall Number of Baseline Participants 91 93 184
Hide Baseline Analysis Population Description
A total of 185 subjects were randomized. One subject was randomized in IFN-K group and did not receive IFN-K. 184 subjects were treated; 91 subjects received IFN-K and 93 subjects received placebo.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants 93 participants 184 participants
<=18 years 0 0 0
Between 18 and 65 years 91 93 184
>=65 years 0 0 0
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants 93 participants 184 participants
Female 84 88 172
Male 7 5 12
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Eyhnic origin Number Analyzed 91 participants 93 participants 184 participants
Black
1
   1.1%
1
   1.1%
2
   1.1%
Asian
16
  17.6%
10
  10.8%
26
  14.1%
Caucasian/Hispanic
68
  74.7%
72
  77.4%
140
  76.1%
Other
6
   6.6%
10
  10.8%
16
   8.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 91 participants 93 participants 184 participants
Colombia 9 9 18
United States 2 4 6
Philippines 10 9 19
Moldova 6 14 20
Thailand 3 0 3
Russia 9 13 22
South Korea 1 0 1
Belgium 1 0 1
Taiwan 1 1 2
Poland 13 5 18
Italy 3 3 6
Mexico 10 9 19
Georgia 2 3 5
France 1 0 1
Chile 2 4 6
Peru 10 11 21
Germany 2 2 4
Croatia 1 1 2
Argentina 0 1 1
Tunisia 5 4 9
1.Primary Outcome
Title Percent Change From Baseline in IFN Gene Signature at W36
Hide Description The biological endpoint aimed at evaluating the neutralization of the IFN gene signature following treatment with IFN-K compared to placebo, as measured by the % change from baseline of the expression of IFN-induced genes.
Time Frame Baseline and Last Available Value (LVA) between week 24 and week 36
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 185 subjects were randomized and 184 were treated. 91 subjects received IFN-K, among them, 87 had a Last available value (LAV) between Week 24 and Week 36 analyzed. 93 subjects received placebo, among them, 84 had LAV between Week 24 and Week 36 analyzed.
Arm/Group Title IFN-K Placebo
Hide Arm/Group Description:
IFN-K adjuvanted with ISA 51 VG
Placebo adjuvanted with ISA 51 VG
Overall Number of Participants Analyzed 87 84
Mean (Standard Deviation)
Unit of Measure: percent change
-31.04  (38.96) -0.44  (27.34)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IFN-K, Placebo
Comments The percent of change from baseline to last available value between W24 and W36 of treatment in the expression of IFN-induced genes was analyzed using an analysis of covariance (ANCOVA) model.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter arithmetic mean
Estimated Value -30.2802
Confidence Interval (2-Sided) 95%
-40.6653 to -19.8951
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.2588
Estimation Comments [Not Specified]
2.Primary Outcome
Title Number of Participants Who Achieved a British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) With Superimposed CS Tapering at Week 36
Hide Description

British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) responder was defined as a subject who had the following criteria at week 36:

  • All BILAG A scores at baseline improve to B/C/D and all BILAG B scores improve to C/D at W36, and
  • No BILAG worsening in other body systems: no new BILAG A or ≥ 2 new BILAG B scores at W36, and
  • No worsening in SLEDAI-2K total score at W36 compared with baseline, and
  • No deterioration in Physician Global Assessment (PGA) (< 10% worsening) on Visual Analog Scale (VAS) 100 mm at W36 compared with baseline, and
  • No addition or increased dose level of anti-malarial drugs or immunosuppressive drugs or CS* between W24 and W36 (*≤5 mg prednisolone or equivalent /day at W24 and no increase until W36).
Time Frame At Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 185 subjects were randomized and 184 were treated. 91 subjects received IFN-K, among them, 85 completed Week 36 visit. 93 subjects received placebo, among them, 84 completed Week 36 visit.
Arm/Group Title IFN-K Placebo
Hide Arm/Group Description:
IFN-K adjuvanted with ISA 51 VG
Placebo adjuvanted with ISA 51 VG
Overall Number of Participants Analyzed 85 84
Measure Type: Count of Participants
Unit of Measure: Participants
35
  41.2%
29
  34.5%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IFN-K, Placebo
Comments Descriptive statistics for the response to treatment according to BICLA at week 36 were presented by treatment group. The response to treatment according to BICLA was analyzed using a logistic regression with the response rate as dependent variable and treatment as independent variable, while adjusting for the minimization factors used for randomization.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.34
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.38
Confidence Interval (2-Sided) 95%
0.716 to 2.657
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants Who Achieved a Systematic Lupus Erythematosus (SLE) Responder Index (SRI)-4 at Week 36
Hide Description

SLE Responder Index (SRI); SRI-4 responder was defined as a subject who had the following criteria at week 36:

  • reduction ≥4 points in SELENA-SLEDAI at week 36 compared with baseline, and
  • no new BILAG A at week 36, and
  • no more than 1 new BILAG B at week 36, and
  • no deterioration in PGA (<10% worsening) on 100-mm VAS compared with baseline
Time Frame W36 (9 months)
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 185 subjects were randomized and 184 were treated. 91 subjects received IFN-K, among them, 84 completed Week 36 visit. 93 subjects received placebo, among them, 83 completed Week 36 visit.
Arm/Group Title IFN-K Placebo
Hide Arm/Group Description:
IFN-K adjuvanted with ISA 51 VG
Placebo adjuvanted with ISA 51 VG
Overall Number of Participants Analyzed 84 83
Measure Type: Count of Participants
Unit of Measure: Participants
57
  67.9%
54
  65.1%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IFN-K, Placebo
Comments The SRI-4 response was analyzed using a logistic regression using the response rate as dependent variable and treatment as independent variable, while adjusting for the minimization factors used for randomization.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6243
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.18
Confidence Interval (2-Sided) 95%
0.602 to 2.329
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Participants Who Achieved a Lupus Low Disease Activity State (LLDAS) at Week 36
Hide Description

Lupus low disease activity state (LLDAS) was conceptually defined as 'a state which, if sustained, is associated with a low likelihood of adverse outcome, considering disease activity and medication safety'. Subsequently defined using consensus methodology, LLDAS is attained if all the following items are met:

  • SLEDAI-2K ≤4, with no activity in major organ systems (renal, central nervous system (CNS), cardiopulmonary, vasculitis, fever) and no hemolytic anemia or gastrointestinal activity
  • No new features of lupus disease activity compared with the previous assessment
  • SELENA-SLEDAI physician global assessment (PGA, scale 0-3) ≤1
  • Current prednisolone (or equivalent) dose ≤7.5 mg daily
  • Well tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents, excluding investigational drugs
Time Frame At Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IFN-K Placebo
Hide Arm/Group Description:
IFN-K adjuvanted with ISA 51 VG
Placebo adjuvanted with ISA 51 VG
Overall Number of Participants Analyzed 85 84
Measure Type: Count of Participants
Unit of Measure: Participants
45
  52.9%
25
  29.8%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IFN-K, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0022
Comments [Not Specified]
Method Pearson's Chi-squared
Comments [Not Specified]
5.Secondary Outcome
Title BILAG Global Score Change From Baseline to Last Available Value (LVA) Between Week 24 and Week 36
Hide Description

British Isles Lupus Assessment Group (BILAG)-2004 index, it categorizes disease activity into 5 different levels from A to E, with Grade A representing very active disease and Grade E indicating no current or previous disease activity. Scoring was based on a total of 101 items, grouped into 9 organ/systems and the summation of the numerical values for the nine-system scores was given by the following formula: Numerical global score = A*12 + B*8 + C*1, where A, B and C represent the number of Grades A, B and C respectively at each assessment. Grades D and E are considered as 0 (Chee-Seng Yee et al, 2010). The minimum score is 0 with no predefined maximum. The higher scores mean a worse outcome.

The BILAG global score change from baseline to Last Available Value (LVA) week 24 and week 36 were presented analyzed.
Time Frame Last Available Value (LVA) between week 24 and week 36
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 185 subjects were randomized and 184 were treated. 91 subjects received IFN-K, among them, 87 had a Last available value (LAV) between Week 24 and Week 36 analyzed. 93 subjects received placebo, among them, 84 had LAV between Week 24 and Week 36 analyzed.
Arm/Group Title IFN-K Placebo
Hide Arm/Group Description:
IFN-K adjuvanted with ISA 51 VG
Placebo adjuvanted with ISA 51 VG
Overall Number of Participants Analyzed 87 84
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-11.43  (8.57) -10.76  (7.84)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IFN-K, Placebo
Comments Baseline to last available value between W24 and W36
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7946
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Secondary Outcome
Title SELENA-SLEDAI - Change From Baseline to Week 36
Hide Description Safety of Estrogens in Systemic Lupus Erythematosus National Assessment (SELENA)-SLEDAI, is a slightly modified version of the SLEDAI. This is a weighted index in which signs and symptoms, laboratory tests, and Physician's Global Assessment (PGA) for each of nine organ systems are given a weighted score and summed up if present at the time of the visit or in the preceding 10 days. The maximum theoretical score for the SELENA SLEDAI is 105 (all 24 descriptors present simultaneously) with 0 indicating inactive disease.
Time Frame Baseline and Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 185 subjects were randomized and 184 were treated. 91 subjects received IFN-K, among them, 84 completed Week 36 visit. 93 subjects received placebo, among them, 83 completed Week 36 visit.
Arm/Group Title IFN-K Placebo
Hide Arm/Group Description:
IFN-K adjuvanted with ISA 51 VG
Placebo adjuvanted with ISA 51 VG
Overall Number of Participants Analyzed 84 83
Mean (Standard Deviation)
Unit of Measure: SELENA SLEDAI Score
-5.48  (4.30) -5.54  (4.44)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IFN-K, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9224
Comments [Not Specified]
Method student - pooled
Comments [Not Specified]
7.Secondary Outcome
Title SLICC/ACR-DI Change From Baseline at Week 36
Hide Description Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index for systemic lupus erythematosus (SLICC/ACR-DI) captures permanent changes which have occurred in patients with SLE, regardless of causality. The questionnaire contains 41 items covering 12 different organ systems. The score of items ranges from 1 to 3 and the total score from 0 to 47. By definition score 0 corresponds to diagnostics and damage over time can only be stable or increase, theoretically to a maximum of 47 points.
Time Frame Baseline and Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 185 subjects were randomized and 184 were treated. 91 subjects received IFN-K, among them, 82 completed SLICC/ACR/DI questionnaire at Week 36 visit. 93 subjects received placebo, among them, 83 completed Week 36 visit.
Arm/Group Title IFN-K Placebo
Hide Arm/Group Description:
IFN-K adjuvanted with ISA 51 VG
Placebo adjuvanted with ISA 51 VG
Overall Number of Participants Analyzed 82 83
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.09  (0.59) -0.17  (0.49)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IFN-K, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3258
Comments [Not Specified]
Method student - pooled
Comments [Not Specified]
8.Secondary Outcome
Title CLASI Total Activity Change From Baseline at Week 36
Hide Description Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) was specifically developed to assess the cutaneous manifestations of SLE. It measures both disease activity and permanent damage (e.g. dyspigmentation and scarring) over the entire body surface. CLASI total activity score ranges from 0 to 70, with higher scores indicating more severe skin disease.
Time Frame Baseline and Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IFN-K Placebo
Hide Arm/Group Description:
IFN-K adjuvanted with ISA 51 VG
Placebo adjuvanted with ISA 51 VG
Overall Number of Participants Analyzed 85 84
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-3.22  (5.94) -2.85  (3.60)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IFN-K, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6169
Comments [Not Specified]
Method Student - Satterthwaite
Comments [Not Specified]
9.Secondary Outcome
Title Number of Participants Who Achieved a Composite SRI-4 Including CS ≤7,5mg/Day at Week 36
Hide Description

SRI (4) plus CS ≤ 7.5 mg/day responder was defined as a participant who had the following criteria at week 36:

  • reduction ≥4 points in SELENA-SLEDAI at week 36 compared with baseline, and
  • no new BILAG A at week 36, and
  • no more than 1 new BILAG B at week 36, and
  • no deterioration in PGA (<10% worsening) on 100-mm VAS compared with baseline plus CS ≤7.5mg equivalent prednisolone per day at week 36
Time Frame At Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 185 subjects were randomized and 184 were treated. 91 subjects received IFN-K, among them, 79 had CS ≤7,5mg/day at Week 36 visit. 93 subjects received placebo, among them, 77 had CS ≤7,5mg/day at Week 36 visit.
Arm/Group Title IFN-K Placebo
Hide Arm/Group Description:
IFN-K adjuvanted with ISA 51 VG
Placebo adjuvanted with ISA 51 VG
Overall Number of Participants Analyzed 79 77
Measure Type: Count of Participants
Unit of Measure: Participants
46
  58.2%
33
  42.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IFN-K, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0796
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.81
Confidence Interval (2-Sided) 95%
0.932 to 3.524
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Number of Participants Who Achieved a Composite SRI-4 Including CS ≤5mg/Day at Week 36
Hide Description

SRI-4 plus CS ≤ 5mg/day responder was defined as a participant who had the following criteria at Week 36:

  • reduction ≥4 points in SELENA-SLEDAI at week 36 compared with baseline, and
  • no new BILAG A at week 36, and
  • no more than 1 new BILAG B at week 36, and
  • no deterioration in PGA (<10% worsening) on 100-mm VAS compared with baseline plus corticosteroids (CS) ≤5mg equivalent prednisolone per day at week 36
Time Frame At Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 185 subjects were randomized and 184 were treated. 91 subjects received IFN-K, among them, 79 had CS ≤5mg/day at Week 36 visit. 93 subjects received placebo, among them, 77 had CS ≤5mg/day at Week 36 visit.
Arm/Group Title IFN-K Placebo
Hide Arm/Group Description:
IFN-K adjuvanted with ISA 51 VG
Placebo adjuvanted with ISA 51 VG
Overall Number of Participants Analyzed 79 77
Measure Type: Count of Participants
Unit of Measure: Participants
43
  54.4%
30
  39.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IFN-K, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0762
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.83
Confidence Interval (2-Sided) 95%
0.938 to 3.574
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Number of Participants With Neutralizing Anti-IFN-alpha Antibodies at W36
Hide Description Individual serum antibody neutralizing capacity against recombinant IFN-alpha2b was measured by reporter gene assay using Interferon Sensitive Response Element (ISRE) reporter.
Time Frame At week 36
Hide Outcome Measure Data
Hide Analysis Population Description

91 subjects received IFN-K, among them, 79 were positive for Anti-IFN-alpha antibodies at Week 36 visit.

No Neutralizing Anti-IFN-alpha antibodies were performed on placebo subjects.
Arm/Group Title IFN-K Placebo
Hide Arm/Group Description:
IFN-K adjuvanted with ISA 51 VG
Placebo adjuvanted with ISA 51 VG
Overall Number of Participants Analyzed 79 0
Measure Type: Count of Participants
Unit of Measure: Participants
72
  91.1%
 0
12.Secondary Outcome
Title Number of Participants With Treatment-related Adverse Events
Hide Description Number of participants who reported any treatment-related adverse events until month 9
Time Frame 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IFN-K Placebo
Hide Arm/Group Description:
IFN-K adjuvanted with ISA 51 VG
Placebo adjuvanted with ISA 51 VG
Overall Number of Participants Analyzed 91 93
Measure Type: Count of Participants
Unit of Measure: Participants
75
  82.4%
71
  76.3%
13.Other Pre-specified Outcome
Title CS Mean Daily Dose at W36
Hide Description mean daily dose of corticosteroid (CS) (prednisone equivalent)
Time Frame At W36
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IFN-K Placebo
Hide Arm/Group Description:
IFN-K adjuvanted with ISA 51 VG
Placebo adjuvanted with ISA 51 VG
Overall Number of Participants Analyzed 85 84
Mean (Standard Error)
Unit of Measure: mg/day
5.42  (3.28) 7.06  (4.69)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IFN-K, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0097
Comments [Not Specified]
Method Student - Satterthwaite
Comments [Not Specified]
14.Post-Hoc Outcome
Title Number of Participants Who Achieved a Composite SRI-4 (CS ≤5mg/Day) Excluding IFN-K Subjects Without Positive Anti-IFNalpha Neutralizing Antibodies at Week 36
Hide Description Subjects who had the following criteria defined as : SRI-4 plus CS ≤5mg/day -excluding IFN-K subjects without positive anti-IFN-alpha neutralizing antibodies
Time Frame At week 36
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 185 subjects were randomized and 184 were treated. 91 subjects received IFN-K, among them, 72 had a Composite SRI-4 (CS ≤5mg/day) at Week 36 visit. 93 subjects received placebo, among them, 77 had a Composite SRI-4 CS ≤5mg/day at Week 36 visit.
Arm/Group Title IFN-K Placebo
Hide Arm/Group Description:
IFN-K adjuvanted with ISA 51 VG
Placebo adjuvanted with ISA 51 VG
Overall Number of Participants Analyzed 72 77
Measure Type: Count of Participants
Unit of Measure: Participants
40
  55.6%
30
  39.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IFN-K, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0425
Comments [Not Specified]
Method Pearson's Chi-squared
Comments [Not Specified]
15.Post-Hoc Outcome
Title Number of Participants Who Achieved a Composite SRI-4 (CS ≤7.5mg/Day) Excluding IFN-K Subjects Without Positive Anti-IFNalpha Neutralizing Antibodies at Week 36
Hide Description participant who had the following criteria defined as : SRI-4 plus CS ≤7.5mg/day -excluding IFN-K Patients without positive anti-IFN-alpha neutralizing antibodies
Time Frame At week 36
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 185 subjects were randomized and 184 were treated. 91 subjects received IFN-K, among them, 72 had a Composite SRI-4 (CS ≤7.5mg/day) at Week 36 visit. 93 subjects received placebo, among them, 77 had a Composite SRI-4 (CS ≤7.5mg/day) at Week 36 visit.
Arm/Group Title IFN-K Placebo
Hide Arm/Group Description:
IFN-K adjuvanted with ISA 51 VG
Placebo adjuvanted with ISA 51 VG
Overall Number of Participants Analyzed 72 77
Measure Type: Count of Participants
Unit of Measure: Participants
43
  59.7%
33
  42.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IFN-K, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0396
Comments [Not Specified]
Method Pearson's Chi-squared
Comments [Not Specified]
Time Frame Adverse Events (AEs) non serious and serious (SAEs) were collected from the start of study Investigational Medicinal Product (IMP) to Week 36.
Adverse Event Reporting Description Due to IFN-K mechanism of action, i.e. immunization, and the administration route, i.e. intramuscular (IM), some AEs, local and/or systemic AEs, were expected and solicited within 7 days after study Investigational Medicinal Product (IMP) administration.
 
Arm/Group Title IFN-K Placebo
Hide Arm/Group Description IFN-K adjuvanted with ISA 51 VG Placebo adjuvanted with ISA 51 VG
All-Cause Mortality
IFN-K Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/91 (1.10%)      1/93 (1.08%)    
Hide Serious Adverse Events
IFN-K Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/91 (6.59%)      12/93 (12.90%)    
Blood and lymphatic system disorders     
Haemolytic anaemia † 1  1/91 (1.10%)  2 0/93 (0.00%)  0
Gastrointestinal disorders     
Diarrhoea † 1  0/91 (0.00%)  0 1/93 (1.08%)  1
Pancreatitis † 1  0/91 (0.00%)  0 1/93 (1.08%)  1
General disorders     
chest pain † 1  1/91 (1.10%)  1 0/93 (0.00%)  0
Disease progression † 1  1/91 (1.10%)  1 0/93 (0.00%)  0
Immune system disorders     
Systemic lupus erythematosus † 1  2/91 (2.20%)  3 3/93 (3.23%)  3
Lupus Nephritis † 1  0/91 (0.00%)  0 1/93 (1.08%)  1
Neuropsychiatric Lupus † 1  1/91 (1.10%)  1 0/93 (0.00%)  0
Infections and infestations     
Pneumonia † 1  2/91 (2.20%)  2 1/93 (1.08%)  1
Kaposi's varicelliform eruption † 1  1/91 (1.10%)  1 0/93 (0.00%)  0
Urinary tract infection † 1  1/91 (1.10%)  1 0/93 (0.00%)  0
Viral infection † 1  0/91 (0.00%)  0 1/93 (1.08%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Papillary thyroid cancer † 1  0/91 (0.00%)  0 2/93 (2.15%)  2
Central nervous system lymphoma † 1  0/91 (0.00%)  0 1/93 (1.08%)  1
Rectal cancer stage II † 1  0/91 (0.00%)  0 1/93 (1.08%)  1
Renal and urinary disorders     
Renal colic † 1  0/91 (0.00%)  0 1/93 (1.08%)  1
Reproductive system and breast disorders     
Postmenauposal haemorrhage † 1  0/91 (0.00%)  0 1/93 (1.08%)  1
Respiratory, thoracic and mediastinal disorders     
Acute respiratory faillure † 1  1/91 (1.10%)  1 0/93 (0.00%)  0
pleural effusion † 1  0/91 (0.00%)  0 1/93 (1.08%)  1
1
Term from vocabulary, MedDRA 18.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
IFN-K Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   75/91 (82.42%)      71/93 (76.34%)    
Blood and lymphatic system disorders     
Anaemia † 1  0/91 (0.00%)  0 5/93 (5.38%)  6
Lymphopenia † 1  1/91 (1.10%)  1 3/93 (3.23%)  3
Cardiac disorders     
Tachycardia † 1  2/91 (2.20%)  2 0/93 (0.00%)  0
Endocrine disorders     
Hypothyroidism † 1  0/91 (0.00%)  0 2/93 (2.15%)  2
Eye disorders     
Conjonctivitis † 1  2/91 (2.20%)  2 2/93 (2.15%)  2
Gastrointestinal disorders     
Diarrhoea † 1  3/91 (3.30%)  4 3/93 (3.23%)  3
Mouth ulceration † 1  3/91 (3.30%)  3 3/93 (3.23%)  3
Nausea † 1  2/91 (2.20%)  4 1/93 (1.08%)  1
Abdominal pain † 1  2/91 (2.20%)  3 2/93 (2.15%)  2
Adbominal pain upper † 1  3/91 (3.30%)  3 2/93 (2.15%)  2
Vomiting † 1  1/91 (1.10%)  1 3/93 (3.23%)  3
Dyspepsia † 1  2/91 (2.20%)  3 0/93 (0.00%)  0
General disorders     
Fatigue † 1  2/91 (2.20%)  7 3/93 (3.23%)  8
Pyrexia † 1  2/91 (2.20%)  3 5/93 (5.38%)  7
Injection site pain † 1  4/91 (4.40%)  8 0/93 (0.00%)  0
Injection site induration † 1  5/91 (5.49%)  8 0/93 (0.00%)  0
Chest pain † 1  3/91 (3.30%)  3 3/93 (3.23%)  4
Oedema peripheral † 1  2/91 (2.20%)  3 0/93 (0.00%)  0
Injection site haemorrhage † 1  1/91 (1.10%)  1 2/93 (2.15%)  2
Mucosal ulceration † 1  2/91 (2.20%)  2 1/93 (1.08%)  1
Constipation † 1  2/91 (2.20%)  2 1/93 (1.08%)  3
Immune system disorders     
Systemic Lupus Erythematosus † 1  9/91 (9.89%)  11 10/93 (10.75%)  16
Systemic Lupus Erythematosus rash † 1  3/91 (3.30%)  4 3/93 (3.23%)  4
Systemic Lupus Erythematosus arthritis † 1  3/91 (3.30%)  4 4/93 (4.30%)  4
Butterfly rash † 1  1/91 (1.10%)  2 3/93 (3.23%)  3
Chronic cutaneous Lupus Erythematosus † 1  2/91 (2.20%)  2 0/93 (0.00%)  0
Infections and infestations     
Upper respiratory tract infection † 1  16/91 (17.58%)  17 5/93 (5.38%)  6
Urinary tract infection † 1  10/91 (10.99%)  10 9/93 (9.68%)  10
Nasopharyngitis † 1  7/91 (7.69%)  10 2/93 (2.15%)  2
Pharyngitis † 1  6/91 (6.59%)  7 3/93 (3.23%)  4
Bronchitis † 1  5/91 (5.49%)  5 4/93 (4.30%)  4
Respiratory tract infection viral † 1  3/91 (3.30%)  6 0/93 (0.00%)  0
Influenza † 1  3/91 (3.30%)  4 2/93 (2.15%)  2
Cervicitis † 1  3/91 (3.30%)  3 3/93 (3.23%)  3
Pneumonia † 1  2/91 (2.20%)  2 0/93 (0.00%)  0
Abscess limb † 1  2/91 (2.20%)  3 0/93 (0.00%)  0
Cellulitis † 1  2/91 (2.20%)  2 1/93 (1.08%)  1
Cystitis † 1  1/91 (1.10%)  1 2/93 (2.15%)  2
Herpes zoster † 1  2/91 (2.20%)  2 1/93 (1.08%)  1
Respiratory tract infection † 1  1/91 (1.10%)  1 2/93 (2.15%)  2
Sinusitis † 1  1/91 (1.10%)  1 2/93 (2.15%)  2
Viral infection † 1  2/91 (2.20%)  2 0/93 (0.00%)  0
Gastroenteritis † 1  0/91 (0.00%)  0 2/93 (2.15%)  2
Vulvovaginitis † 1  0/91 (0.00%)  0 2/93 (2.15%)  2
Injury, poisoning and procedural complications     
Limb injury † 1  2/91 (2.20%)  2 0/93 (0.00%)  0
Metabolism and nutrition disorders     
Decreased appetite † 1  3/91 (3.30%)  3 1/93 (1.08%)  1
Musculoskeletal and connective tissue disorders     
Myalgia † 1  3/91 (3.30%)  8 7/93 (7.53%)  7
Arthralgia † 1  7/91 (7.69%)  8 2/93 (2.15%)  3
Back pain † 1  4/91 (4.40%)  4 4/93 (4.30%)  4
Pain in extremity † 1  6/91 (6.59%)  6 1/93 (1.08%)  1
Musculoskeletal pain † 1  2/91 (2.20%)  2 1/93 (1.08%)  1
Neck pain † 1  2/91 (2.20%)  2 1/93 (1.08%)  1
Nervous system disorders     
Headache † 1  10/91 (10.99%)  19 2/93 (2.15%)  3
Insomnia † 1  3/91 (3.30%)  4 2/93 (2.15%)  2
Dizziness † 1  2/91 (2.20%)  2 2/93 (2.15%)  3
Paraesthesia † 1  1/91 (1.10%)  2 2/93 (2.15%)  2
Psychiatric disorders     
Anxiety † 1  1/91 (1.10%)  2 2/93 (2.15%)  4
Renal and urinary disorders     
Hematuria † 1  2/91 (2.20%)  2 1/93 (1.08%)  1
Proteinuria † 1  0/91 (0.00%)  0 2/93 (2.15%)  2
Reproductive system and breast disorders     
Dysmenorrhoea † 1  1/91 (1.10%)  1 2/93 (2.15%)  8
Respiratory, thoracic and mediastinal disorders     
Cough † 1  3/91 (3.30%)  4 4/93 (4.30%)  4
Oropharyngeal pain † 1  2/91 (2.20%)  2 2/93 (2.15%)  3
Skin and subcutaneous tissue disorders     
Erythema † 1  2/91 (2.20%)  9 3/93 (3.23%)  3
Pruritus † 1  2/91 (2.20%)  2 0/93 (0.00%)  0
Vascular disorders     
Hypertension † 1  4/91 (4.40%)  5 3/93 (3.23%)  3
Contusion † 1  2/91 (2.20%)  3 0/93 (0.00%)  0
1
Term from vocabulary, MedDRA 18.0
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Head of Regulatory Affairs
Organization: Neovacs
Phone: +33153109300
EMail: info@neovacs.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Neovacs
ClinicalTrials.gov Identifier: NCT02665364    
Other Study ID Numbers: IFN-K-002
First Submitted: November 17, 2015
First Posted: January 27, 2016
Results First Submitted: February 6, 2020
Results First Posted: March 26, 2020
Last Update Posted: April 9, 2020