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A Phase 2a of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE)

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: NCT02660944
Recruitment Status : Completed
First Posted : January 21, 2016
Results First Posted : March 10, 2021
Last Update Posted : March 10, 2021
Sponsor:
Information provided by (Responsible Party):
Resolve Therapeutics

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 Drug: RSLV-132
Drug: Placebo
Enrollment 64
Recruitment Details  
Pre-assignment Details  
Arm/Group Title RSLV-132 Placebo
Hide Arm/Group Description

10 mg/kg RSLV-132

RSLV-132: RNase-Fc fusion protein

Saline placebo

Placebo: Saline placebo
Period Title: Overall Study
Started 42 22
Completed 25 12
Not Completed 17 10
Reason Not Completed
Adverse Event             3             4
Physician Decision             3             1
Withdrawal by Subject             5             3
Lost to Follow-up             4             1
Subject schedule             0             1
Exclusion criteria met             2             0
Arm/Group Title RSLV-132 Placebo Total
Hide Arm/Group Description

10 mg/kg RSLV-132

RSLV-132: RNase-Fc fusion protein

Saline placebo

Placebo: Saline placebo

 Total of all reporting groups
Overall Number of Baseline Participants 42 22 64
Hide Baseline Analysis Population Description
All participants who received at least one dose of study treatment
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants 22 participants 64 participants
45.3  (12.8) 45.2  (11.6) 45.3  (12.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 22 participants 64 participants
Female
39
  92.9%
22
 100.0%
61
  95.3%
Male
3
   7.1%
0
   0.0%
3
   4.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 22 participants 64 participants
Hispanic or Latino
13
  31.0%
4
  18.2%
17
  26.6%
Not Hispanic or Latino
29
  69.0%
18
  81.8%
47
  73.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 22 participants 64 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   2.4%
0
   0.0%
1
   1.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
16
  38.1%
11
  50.0%
27
  42.2%
White
22
  52.4%
11
  50.0%
33
  51.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
   7.1%
0
   0.0%
3
   4.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 42 participants 22 participants 64 participants
32 22 54
CLASI Activity Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 42 participants 22 participants 64 participants
24.1  (9.9) 22.4  (7.9) 23.5  (9.2)
[1]
Measure Description: Mean Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score. The CLASI is a single-page tool that separately quantifies disease activity and damage. For the activity score, points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. The total score represents the sum of the individual scores and ranges from 0 to 70. Higher scores are awarded for more severe manifestations.
Oral corticosteroid dose  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 22 participants 64 participants
0
20
  47.6%
7
  31.8%
27
  42.2%
>0 and less than or equal to 7.5 mg/kg
6
  14.3%
5
  22.7%
11
  17.2%
>7.5
16
  38.1%
10
  45.5%
26
  40.6%
1.Primary Outcome
Title Mean Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Improvement Compared to Placebo.
Hide Description

Mean change from baseline (from baseline to Day 85; or baseline to Day 169) in CLASI activity scores (Last Observation Carried Forward [LOCF] post censoring values).

The CLASI is a single-page tool that separately quantifies disease activity and damage. For the activity score, points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. The total score represents the sum of the individual scores and ranges from 0 to 70. Higher scores are awarded for more severe manifestations.
Time Frame Baseline and Days 29, 57, 85, 99, 113, 127, 141, 155, 169
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RSLV-132 Placebo
Hide Arm/Group Description:

10 mg/kg RSLV-132

RSLV-132: RNase-Fc fusion protein

Saline placebo

Placebo: Saline placebo
Overall Number of Participants Analyzed 42 22
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Day 85 -6.2  (6.7) -6.5  (6.2)
Day 169 -6.2  (8.5) -5.7  (7.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RSLV-132, Placebo
Comments Change from baseline at Day 85 RSLV-132 versus placebo
Type of Statistical Test Superiority
Comments Two-sample t-test with Satterthwaite approximation
Statistical Test of Hypothesis P-Value 0.845
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.37
Confidence Interval (2-Sided) 95%
-3.42 to 4.15
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection RSLV-132, Placebo
Comments Change from baseline at Day 169 RSLV-132 versus placebo
Type of Statistical Test Superiority
Comments Two-sample t-test with Satterthwaite approximation
Statistical Test of Hypothesis P-Value 0.818
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.48
Confidence Interval (2-Sided) 95%
-4.66 to 3.70
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Achieving a 50% Improvement in CLASI Activity Score
Hide Description Percentage of participants achieving a 50% improvement in CLASI activity score at Day 85 and Day 169 (LOCF post censoring due to use of exclusionary medications)
Time Frame Baseline and Days 29, 57, 85, 99, 113, 127, 141, 155, 169
Hide Outcome Measure Data
Hide Analysis Population Description
On Day 169, a post hoc exploratory subgroup analysis was performed on participants with severe CLASI and severe SLE Disease Activity Index (SLEDAI-2K) scores at baseline. The SLEDAI-2K is a clinical index for the assessment of lupus disease activity in the previous 30 days. It consists of 24 weighted clinical and laboratory variables of nine organ systems. Scores of the descriptors range from 1 to 8, the total possible score is 105. A higher score indicates more severe disease.
Arm/Group Title RSLV-132 Placebo
Hide Arm/Group Description:

10 mg/kg RSLV-132

RSLV-132: RNase-Fc fusion protein

Saline placebo

Placebo: Saline placebo
Overall Number of Participants Analyzed 42 22
Measure Type: Count of Participants
Unit of Measure: Participants
Day 85 Number Analyzed 37 participants 17 participants
11
  29.7%
2
  11.8%
Day 169 All Participants Number Analyzed 42 participants 22 participants
14
  33.3%
5
  22.7%
Day 169 Participants with Severe CLASI >/=21 Number Analyzed 18 participants 12 participants
7
  38.9%
3
  25.0%
Day 169 Participants with Severe SLEDAI >/=9 Number Analyzed 13 participants 9 participants
4
  30.8%
1
  11.1%
3.Post-Hoc Outcome
Title Percentage of Participants With SRI-4 Response
Hide Description Percentage of participants with an Systemic Lupus Erythematous Responder Index (SRI) 4 response on Day 169. This is a composite responder index incorporating the British Isles Lupus Assessment Group (BILAG) 2004, SLEDAI-2K and Physician Global Assessment (PGA) responses. The BILAG-2004 index, an organ-based transitional activity instrument, provides disease activity scorings across nine organ systems (constitutional, mucocutaneous, neuropsychiatry, musculoskeletal, cardiorespiratory, gastrointestinal, ophthalmic, renal and hematological) on an ordinal scale (A to E) based on the physician's intention-to-treat premise. Grade A represents the most active and Grade E the least active disease. The Physician's Global Assessment is measured on a 0 to 100 mm scale with score 0 to be No Disease Activity and score 100 to be the most Severe Disease Activity.
Time Frame Baseline and Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
A subgroup analysis was also performed on participants with severe CLASI and severe SLEDAI scores
Arm/Group Title RSLV-132 Placebo
Hide Arm/Group Description:

10 mg/kg RSLV-132

RSLV-132: RNase-Fc fusion protein

Saline placebo

Placebo: Saline placebo
Overall Number of Participants Analyzed 42 22
Measure Type: Count of Participants
Unit of Measure: Participants
Day 169 All participants Number Analyzed 39 participants 20 participants
11
  28.2%
7
  35.0%
Day 169 Participants with Severe CLASI >/=21 Number Analyzed 18 participants 12 participants
7
  38.9%
1
   8.3%
Day 169 Participants with Severe SLEDAI >/=9 Number Analyzed 13 participants 9 participants
8
  61.5%
4
  44.4%
4.Post-Hoc Outcome
Title Percentage of Participants With a British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) Response
Hide Description Percentage of participants with a BICLA response on Day 169. This is a composite responder index incorporating the BILAG-2004, SLEDAI-2K and PGA responses. The BILAG-2004 index, an organ-based transitional activity instrument, provides disease activity scorings across nine organ systems (constitutional, mucocutaneous, neuropsychiatry, musculoskeletal, cardiorespiratory, gastrointestinal, ophthalmic, renal and hematological) on an ordinal scale (A to E) based on the physician's intention-to-treat premise. Grade A represents the most active and Grade E the least active disease. The PGA is measured on a 0 to 100 mm scale with score 0 to be No Disease Activity and score 100 to be the most Severe Disease Activity.
Time Frame Baseline and Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
A subgroup analysis was also performed on participants with severe CLASI and severe SLEDAI scores
Arm/Group Title RSLV-132 Placebo
Hide Arm/Group Description:

10 mg/kg RSLV-132

RSLV-132: RNase-Fc fusion protein

Saline placebo

Placebo: Saline placebo
Overall Number of Participants Analyzed 42 22
Measure Type: Count of Participants
Unit of Measure: Participants
Day 169 All Participants Number Analyzed 39 participants 20 participants
10
  25.6%
4
  20.0%
Day 169 Participants with Severe CLASI >/=21 Number Analyzed 18 participants 12 participants
5
  27.8%
1
   8.3%
Day 169 Participants with Severe SLEDAI >/=9 Number Analyzed 13 participants 9 participants
4
  30.8%
1
  11.1%
Time Frame 215 days
Adverse Event Reporting Description Treatment emergent adverse events are summarized
 
Arm/Group Title RSLV-132 Placebo
Hide Arm/Group Description

10 mg/kg RSLV-132

RSLV-132: RNase-Fc fusion protein

Saline placebo

Placebo: Saline placebo
All-Cause Mortality
RSLV-132 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/42 (0.00%)      0/22 (0.00%)    
Hide Serious Adverse Events
RSLV-132 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/42 (7.14%)      5/22 (22.73%)    
Gastrointestinal disorders     
Colitis † 1  0/42 (0.00%)  0 1/22 (4.55%)  1
Diarrhoea † 1  0/42 (0.00%)  0 1/22 (4.55%)  1
Infections and infestations     
Appendicitis † 1  1/42 (2.38%)  1 1/22 (4.55%)  1
Escherichia Sepsis † 1  0/42 (0.00%)  0 1/22 (4.55%)  1
Pneumonia † 1  0/42 (0.00%)  0 1/22 (4.55%)  1
Urinary Tract Infection † 1  0/42 (0.00%)  0 1/22 (4.55%)  1
Flank Pain † 1  0/42 (0.00%)  0 1/22 (4.55%)  1
Musculoskeletal and connective tissue disorders     
Systemic Lupus Erythematosus † 1  0/42 (0.00%)  0 1/22 (4.55%)  2
Nervous system disorders     
Hypoaesthesia † 1  1/42 (2.38%)  1 0/22 (0.00%)  0
Syncope † 1  0/42 (0.00%)  0 1/22 (4.55%)  1
Skin and subcutaneous tissue disorders     
Cutaneous Lupus Erythematosus † 1  1/42 (2.38%)  1 0/22 (0.00%)  0
Vascular disorders     
Hypertension † 1  0/42 (0.00%)  0 1/22 (4.55%)  1
1
Term from vocabulary, MedDRA (19.0)
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
RSLV-132 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   36/42 (85.71%)      20/22 (90.91%)    
Gastrointestinal disorders     
Nausea † 1  5/42 (11.90%)  5 2/22 (9.09%)  3
Infections and infestations     
Urinary Tract Infection † 1  4/42 (9.52%)  5 4/22 (18.18%)  4
Sinusitis † 1  4/42 (9.52%)  4 0/22 (0.00%)  0
Upper Respiratory Tract Infection † 1  3/42 (7.14%)  4 4/22 (18.18%)  5
Bronchitis † 1  2/42 (4.76%)  2 2/22 (9.09%)  2
Musculoskeletal and connective tissue disorders     
Systemic Lupus Erythematosus † 1  1/42 (2.38%)  1 4/22 (18.18%)  4
Back Pain † 1  1/42 (2.38%)  1 2/22 (9.09%)  2
Nervous system disorders     
Headache † 1  6/42 (14.29%)  7 3/22 (13.64%)  4
Renal and urinary disorders     
Proteinuria † 1  3/42 (7.14%)  4 0/22 (0.00%)  0
Dysuria † 1  1/42 (2.38%)  1 2/22 (9.09%)  2
Skin and subcutaneous tissue disorders     
Cutaneous Lupus Erythematosus † 1  4/42 (9.52%)  5 0/22 (0.00%)  0
Rash † 1  2/42 (4.76%)  2 2/22 (9.09%)  2
Vascular disorders     
Hypertension † 1  6/42 (14.29%)  6 4/22 (18.18%)  4
1
Term from vocabulary, MedDRA (19.0)
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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: James Posada
Organization: Resolve Therapeutics LLC
Phone: (208)7277010
EMail: jp@resolvebio.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Resolve Therapeutics
ClinicalTrials.gov Identifier: NCT02660944    
Other Study ID Numbers: 132-03
First Submitted: January 16, 2016
First Posted: January 21, 2016
Results First Submitted: December 1, 2020
Results First Posted: March 10, 2021
Last Update Posted: March 10, 2021