Adults 18 to 70, any sex, with Systemic Lupus Erythematosus. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Mean Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Improvement Compared to Placebo.Primary· Baseline and Days 29, 57, 85, 99, 113, 127, 141, 155, 169
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.
Day 85
Group
Value
95% CI
RSLV-132
-6.2
± 6.7
Placebo
-6.5
± 6.2
Day 169
Group
Value
95% CI
RSLV-132
-6.2
± 8.5
Placebo
-5.7
± 7.0
Percentage of Participants Achieving a 50% Improvement in CLASI Activity ScoreSecondary· Baseline and Days 29, 57, 85, 99, 113, 127, 141, 155, 169
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)
Day 85
Group
Value
95% CI
RSLV-132
11
Placebo
2
Day 169 All Participants
Group
Value
95% CI
RSLV-132
14
Placebo
5
Day 169 Participants with Severe CLASI >/=21
Group
Value
95% CI
RSLV-132
7
Placebo
3
Day 169 Participants with Severe SLEDAI >/=9
Group
Value
95% CI
RSLV-132
4
Placebo
1
Percentage of Participants With SRI-4 ResponseSecondary· Baseline and Day 169
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 in
Day 169 All participants
Group
Value
95% CI
RSLV-132
11
Placebo
7
Day 169 Participants with Severe CLASI >/=21
Group
Value
95% CI
RSLV-132
7
Placebo
1
Day 169 Participants with Severe SLEDAI >/=9
Group
Value
95% CI
RSLV-132
8
Placebo
4
Percentage of Participants With a British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) ResponseSecondary· Baseline and Day 169
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 measur
Day 169 All Participants
Group
Value
95% CI
RSLV-132
10
Placebo
4
Day 169 Participants with Severe CLASI >/=21
Group
Value
95% CI
RSLV-132
5
Placebo
1
Day 169 Participants with Severe SLEDAI >/=9
Group
Value
95% CI
RSLV-132
4
Placebo
1
Adverse events — posted to ClinicalTrials.gov
Time frame: 215 days.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study evaluates the impact of 13 bi-weekly intravenous infusions of RSLV-132 on the cutaneous manifestations in subjects with systemic lupus erythematosus.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06440525 — A Study of RSLV-132 in Females With Sjögren's Disease
· Phase 2
· recruiting
NCT04944121 — Phase 2 Study of RSLV-132 in Subjects With Long COVID
· Phase 2
· completed
NCT03247686 — A Study of RSLV-132 in Subjects With Primary Sjogren's Syndrome
· Phase 2
· completed
Other recruiting trials for Systemic Lupus Erythematosus
Currently open trials in the same condition.
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· EARLY_PHASE1
· recruiting
NCT07363590 — A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004)
· Phase 1
· recruiting
NCT07371468 — A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD)
· Phase 1
· recruiting
Other Resolve Therapeutics trials
Trials by the same sponsor.
NCT06440525 — A Study of RSLV-132 in Females With Sjögren's Disease
· Phase 2
· recruiting
NCT04944121 — Phase 2 Study of RSLV-132 in Subjects With Long COVID
· Phase 2
· completed
NCT03247686 — A Study of RSLV-132 in Subjects With Primary Sjogren's Syndrome
· Phase 2
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Resolve Therapeutics
Last refreshed: 10 March 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02660944.