Phase 2
N=47
Study to Evaluate Safety and Efficacy of Filgotinib and Lanraplenib in Females With Moderately-to-Severely Active Cutaneous Lupus Erythematosus (CLE)
Cutaneous Lupus Erythematosus
Bottom Line
View on ClinicalTrials.gov: NCT03134222 ↗Enrolled (actual)
47
Serious AEs
5.7%
Results posted
Apr 2020
Primary outcome: Primary: Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score From Baseline to Week 12 — -4.5; -8.7; -5.5 score on a scale — p=0.7500
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Lanraplenib (Drug); Filgotinib (Drug); Lanraplenib placebo (Drug); Filgotinib placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Gilead Sciences
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score From Baseline to Week 12 |
-4.5; -8.7; -5.5 | 0.7500 |
| SECONDARY Percentage of Participants at Week 12 With Decrease of ≥ 5 Points in CLASI Activity Score From Baseline |
47.4; 64.7; 44.4 | 0.8869 |
| SECONDARY Percentage of Participants at Week 12 With No Worsening in CLASI Activity Score From Baseline |
84.2; 94.1; 88.9 | 0.7456 |
| SECONDARY Percentage of Participants at Week 24 With Decrease of ≥ 5 Points in CLASI Activity Score From Baseline |
50.0; 83.3 | <0.0001 sig |
| SECONDARY Percentage of Participants at Week 24 With No Worsening in CLASI Activity Score From Baseline |
85.7; 100.0 | <0.0001 sig |
Summary
The primary objective of this study is to evaluate the efficacy of filgotinib and lanraplenib (formerly GS-9876) in females with moderately-to-severely active cutaneous lupus erythematosus (CLE).
Eligibility Criteria
Key Inclusion Criteria
- Must have a diagnosis of CLE, either chronic (e.g., discoid) or subacute CLE per investigator evaluation, with the following:
- Moderately-to-severely active CLE (Cutaneous lupus erythematosus disease area and severity index [CLASI] activity score ≥ 10) at screening and Day 1
- Prior intolerance or inadequate response to at least one of the listed medications for the treatment of CLE
- Stable dose (defined as no change in prescription for at least 28 days prior to Day 1) of antimalarials and/or topical or oral corticosteroids is permitted during the study. Individuals who are not planning to continue these medications during the study must have discontinued them at least 28 days prior to Day 1
Key Exclusion Criteria
- Use of prohibited concomitant medications per study protocol
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT03134222). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.