Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03134222 | Study to Evaluate Safety and Efficacy of Filgotinib and Lanraplenib in Females With Moderately-to-Severely Active Cutaneous Lupus Erythematosus (CLE) | PHASE2 | COMPLETED | 47 | — | — | May 24, 2017 | Dec 18, 2019 | Jun 9, 2020 | 16 | United States, Canada |
CLASI Activity is scored based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and nonscarring alopecia. Evaluation of erythema and scale/hyperkeratosis is based on a table: rows represent anatomical areas and columns represent major clinical symptoms. The extent of involvement for each of the skin symptoms is documented for each anatomic area. The total score ranges from 0-70, with higher scores indicating more severe skin disease.
| Arm | Type | Description |
|---|---|---|
| Lanraplenib 30 mg | EXPERIMENTAL | Lanraplenib + filgotinib placebo for 48 weeks |
| Filgotinib 200 mg | EXPERIMENTAL | Filgotinib + lanraplenib placebo for 48 weeks |
| Placebo | PLACEBO_COMPARATOR | Filgotinib placebo + lanraplenib placebo for 12 weeks |
| Placebo to Lanraplenib 30 mg | EXPERIMENTAL | After Week 12 Visit, participants on placebo will be rerandomized 1:1 and receive lanraplenib + filgotinib placebo in a blinded fashion through Week 48. |
| Placebo to Filgotinib 200 mg | EXPERIMENTAL | After Week 12 Visit, participants on placebo will be rerandomized 1:1 and receive filgotinib + lanraplenib placebo in a blinded fashion through Week 48. |
| Name | Type | Description |
|---|---|---|
| Lanraplenib | DRUG | 30 mg tablets administered orally once daily with or without food |
| Filgotinib | DRUG | 200 mg tablets administered orally once daily with or without food |
| Lanraplenib placebo | DRUG | Tablets administered orally once daily with or without food |
| Filgotinib placebo | DRUG | Tablets administered orally once daily with or without food |
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 a...