Trial Outcomes & Findings for A Phase 2a of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE) (NCT NCT02660944)
NCT ID: NCT02660944
Last Updated: 2021-03-10
Results Overview
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.
COMPLETED
PHASE2
64 participants
Baseline and Days 29, 57, 85, 99, 113, 127, 141, 155, 169
2021-03-10
Participant Flow
Participant milestones
| Measure |
RSLV-132
10 mg/kg RSLV-132
RSLV-132: RNase-Fc fusion protein
|
Placebo
Saline placebo
Placebo: Saline placebo
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
22
|
|
Overall Study
COMPLETED
|
25
|
12
|
|
Overall Study
NOT COMPLETED
|
17
|
10
|
Reasons for withdrawal
| Measure |
RSLV-132
10 mg/kg RSLV-132
RSLV-132: RNase-Fc fusion protein
|
Placebo
Saline placebo
Placebo: Saline placebo
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
4
|
|
Overall Study
Physician Decision
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
3
|
|
Overall Study
Lost to Follow-up
|
4
|
1
|
|
Overall Study
Subject schedule
|
0
|
1
|
|
Overall Study
Exclusion criteria met
|
2
|
0
|
Baseline Characteristics
A Phase 2a of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE)
Baseline characteristics by cohort
| Measure |
RSLV-132
n=42 Participants
10 mg/kg RSLV-132
RSLV-132: RNase-Fc fusion protein
|
Placebo
n=22 Participants
Saline placebo
Placebo: Saline placebo
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.3 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
45.2 years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
45.3 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
22 participants
n=7 Participants
|
54 participants
n=5 Participants
|
|
CLASI Activity Total Score
|
24.1 Score on a scale
STANDARD_DEVIATION 9.9 • n=5 Participants
|
22.4 Score on a scale
STANDARD_DEVIATION 7.9 • n=7 Participants
|
23.5 Score on a scale
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Oral corticosteroid dose
0
|
20 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Oral corticosteroid dose
>0 and less than or equal to 7.5 mg/kg
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Oral corticosteroid dose
>7.5
|
16 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Days 29, 57, 85, 99, 113, 127, 141, 155, 169Mean 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.
Outcome measures
| Measure |
RSLV-132
n=42 Participants
10 mg/kg RSLV-132
RSLV-132: RNase-Fc fusion protein
|
Placebo
n=22 Participants
Saline placebo
Placebo: Saline placebo
|
|---|---|---|
|
Mean Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Improvement Compared to Placebo.
Day 85
|
-6.2 Scores on a scale
Standard Deviation 6.7
|
-6.5 Scores on a scale
Standard Deviation 6.2
|
|
Mean Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Improvement Compared to Placebo.
Day 169
|
-6.2 Scores on a scale
Standard Deviation 8.5
|
-5.7 Scores on a scale
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: Baseline and Days 29, 57, 85, 99, 113, 127, 141, 155, 169Population: 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.
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)
Outcome measures
| Measure |
RSLV-132
n=42 Participants
10 mg/kg RSLV-132
RSLV-132: RNase-Fc fusion protein
|
Placebo
n=22 Participants
Saline placebo
Placebo: Saline placebo
|
|---|---|---|
|
Percentage of Participants Achieving a 50% Improvement in CLASI Activity Score
Day 85
|
11 Participants
|
2 Participants
|
|
Percentage of Participants Achieving a 50% Improvement in CLASI Activity Score
Day 169 All Participants
|
14 Participants
|
5 Participants
|
|
Percentage of Participants Achieving a 50% Improvement in CLASI Activity Score
Day 169 Participants with Severe CLASI >/=21
|
7 Participants
|
3 Participants
|
|
Percentage of Participants Achieving a 50% Improvement in CLASI Activity Score
Day 169 Participants with Severe SLEDAI >/=9
|
4 Participants
|
1 Participants
|
POST_HOC outcome
Timeframe: Baseline and Day 169Population: A subgroup analysis was also performed on participants with severe CLASI and severe SLEDAI scores
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.
Outcome measures
| Measure |
RSLV-132
n=42 Participants
10 mg/kg RSLV-132
RSLV-132: RNase-Fc fusion protein
|
Placebo
n=22 Participants
Saline placebo
Placebo: Saline placebo
|
|---|---|---|
|
Percentage of Participants With SRI-4 Response
Day 169 All participants
|
11 Participants
|
7 Participants
|
|
Percentage of Participants With SRI-4 Response
Day 169 Participants with Severe CLASI >/=21
|
7 Participants
|
1 Participants
|
|
Percentage of Participants With SRI-4 Response
Day 169 Participants with Severe SLEDAI >/=9
|
8 Participants
|
4 Participants
|
POST_HOC outcome
Timeframe: Baseline and Day 169Population: A subgroup analysis was also performed on participants with severe CLASI and severe SLEDAI scores
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.
Outcome measures
| Measure |
RSLV-132
n=42 Participants
10 mg/kg RSLV-132
RSLV-132: RNase-Fc fusion protein
|
Placebo
n=22 Participants
Saline placebo
Placebo: Saline placebo
|
|---|---|---|
|
Percentage of Participants With a British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) Response
Day 169 Participants with Severe SLEDAI >/=9
|
4 Participants
|
1 Participants
|
|
Percentage of Participants With a British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) Response
Day 169 All Participants
|
10 Participants
|
4 Participants
|
|
Percentage of Participants With a British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) Response
Day 169 Participants with Severe CLASI >/=21
|
5 Participants
|
1 Participants
|
Adverse Events
RSLV-132
Placebo
Serious adverse events
| Measure |
RSLV-132
n=42 participants at risk
10 mg/kg RSLV-132
RSLV-132: RNase-Fc fusion protein
|
Placebo
n=22 participants at risk
Saline placebo
Placebo: Saline placebo
|
|---|---|---|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/42 • 215 days
Treatment emergent adverse events are summarized
|
4.5%
1/22 • Number of events 1 • 215 days
Treatment emergent adverse events are summarized
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/42 • 215 days
Treatment emergent adverse events are summarized
|
4.5%
1/22 • Number of events 1 • 215 days
Treatment emergent adverse events are summarized
|
|
Infections and infestations
Appendicitis
|
2.4%
1/42 • Number of events 1 • 215 days
Treatment emergent adverse events are summarized
|
4.5%
1/22 • Number of events 1 • 215 days
Treatment emergent adverse events are summarized
|
|
Infections and infestations
Escherichia Sepsis
|
0.00%
0/42 • 215 days
Treatment emergent adverse events are summarized
|
4.5%
1/22 • Number of events 1 • 215 days
Treatment emergent adverse events are summarized
|
|
Infections and infestations
Pneumonia
|
0.00%
0/42 • 215 days
Treatment emergent adverse events are summarized
|
4.5%
1/22 • Number of events 1 • 215 days
Treatment emergent adverse events are summarized
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/42 • 215 days
Treatment emergent adverse events are summarized
|
4.5%
1/22 • Number of events 1 • 215 days
Treatment emergent adverse events are summarized
|
|
Infections and infestations
Flank Pain
|
0.00%
0/42 • 215 days
Treatment emergent adverse events are summarized
|
4.5%
1/22 • Number of events 1 • 215 days
Treatment emergent adverse events are summarized
|
|
Musculoskeletal and connective tissue disorders
Systemic Lupus Erythematosus
|
0.00%
0/42 • 215 days
Treatment emergent adverse events are summarized
|
4.5%
1/22 • Number of events 2 • 215 days
Treatment emergent adverse events are summarized
|
|
Nervous system disorders
Hypoaesthesia
|
2.4%
1/42 • Number of events 1 • 215 days
Treatment emergent adverse events are summarized
|
0.00%
0/22 • 215 days
Treatment emergent adverse events are summarized
|
|
Nervous system disorders
Syncope
|
0.00%
0/42 • 215 days
Treatment emergent adverse events are summarized
|
4.5%
1/22 • Number of events 1 • 215 days
Treatment emergent adverse events are summarized
|
|
Skin and subcutaneous tissue disorders
Cutaneous Lupus Erythematosus
|
2.4%
1/42 • Number of events 1 • 215 days
Treatment emergent adverse events are summarized
|
0.00%
0/22 • 215 days
Treatment emergent adverse events are summarized
|
|
Vascular disorders
Hypertension
|
0.00%
0/42 • 215 days
Treatment emergent adverse events are summarized
|
4.5%
1/22 • Number of events 1 • 215 days
Treatment emergent adverse events are summarized
|
Other adverse events
| Measure |
RSLV-132
n=42 participants at risk
10 mg/kg RSLV-132
RSLV-132: RNase-Fc fusion protein
|
Placebo
n=22 participants at risk
Saline placebo
Placebo: Saline placebo
|
|---|---|---|
|
Vascular disorders
Hypertension
|
14.3%
6/42 • Number of events 6 • 215 days
Treatment emergent adverse events are summarized
|
18.2%
4/22 • Number of events 4 • 215 days
Treatment emergent adverse events are summarized
|
|
Nervous system disorders
Headache
|
14.3%
6/42 • Number of events 7 • 215 days
Treatment emergent adverse events are summarized
|
13.6%
3/22 • Number of events 4 • 215 days
Treatment emergent adverse events are summarized
|
|
Gastrointestinal disorders
Nausea
|
11.9%
5/42 • Number of events 5 • 215 days
Treatment emergent adverse events are summarized
|
9.1%
2/22 • Number of events 3 • 215 days
Treatment emergent adverse events are summarized
|
|
Infections and infestations
Urinary Tract Infection
|
9.5%
4/42 • Number of events 5 • 215 days
Treatment emergent adverse events are summarized
|
18.2%
4/22 • Number of events 4 • 215 days
Treatment emergent adverse events are summarized
|
|
Skin and subcutaneous tissue disorders
Cutaneous Lupus Erythematosus
|
9.5%
4/42 • Number of events 5 • 215 days
Treatment emergent adverse events are summarized
|
0.00%
0/22 • 215 days
Treatment emergent adverse events are summarized
|
|
Infections and infestations
Sinusitis
|
9.5%
4/42 • Number of events 4 • 215 days
Treatment emergent adverse events are summarized
|
0.00%
0/22 • 215 days
Treatment emergent adverse events are summarized
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
7.1%
3/42 • Number of events 4 • 215 days
Treatment emergent adverse events are summarized
|
18.2%
4/22 • Number of events 5 • 215 days
Treatment emergent adverse events are summarized
|
|
Renal and urinary disorders
Proteinuria
|
7.1%
3/42 • Number of events 4 • 215 days
Treatment emergent adverse events are summarized
|
0.00%
0/22 • 215 days
Treatment emergent adverse events are summarized
|
|
Infections and infestations
Bronchitis
|
4.8%
2/42 • Number of events 2 • 215 days
Treatment emergent adverse events are summarized
|
9.1%
2/22 • Number of events 2 • 215 days
Treatment emergent adverse events are summarized
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.8%
2/42 • Number of events 2 • 215 days
Treatment emergent adverse events are summarized
|
9.1%
2/22 • Number of events 2 • 215 days
Treatment emergent adverse events are summarized
|
|
Musculoskeletal and connective tissue disorders
Systemic Lupus Erythematosus
|
2.4%
1/42 • Number of events 1 • 215 days
Treatment emergent adverse events are summarized
|
18.2%
4/22 • Number of events 4 • 215 days
Treatment emergent adverse events are summarized
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.4%
1/42 • Number of events 1 • 215 days
Treatment emergent adverse events are summarized
|
9.1%
2/22 • Number of events 2 • 215 days
Treatment emergent adverse events are summarized
|
|
Renal and urinary disorders
Dysuria
|
2.4%
1/42 • Number of events 1 • 215 days
Treatment emergent adverse events are summarized
|
9.1%
2/22 • Number of events 2 • 215 days
Treatment emergent adverse events are summarized
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place