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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06015737 | A Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus | PHASE3 | ACTIVE NOT_RECRUITING | 306 | — | — | Jun 29, 2024 | Aug 11, 2027 | May 1, 2026 | 188 | United States, Argentina +30 |
The CLASI is a validated index used for assessing the cutaneous lesions of SLE. It consists of 2 separate scores: i) activity of the disease, and ii) measure of damage. The CLASI instrument will be used at each study visit to capture individual skin manifestation scores. CLASI-70 responder (Yes/No) is defined as a participant who achieves a 70% reduction relative to baseline in CLASI-A score. Otherwise, the participant is considered a non-responder.
| Arm | Type | Description |
|---|---|---|
| Anifrolumab | EXPERIMENTAL | Participants will receive anifrolumab as a SC injection from Week 0/Day 1 up to Week 51. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo as a SC injection from Week 0/Day 1 up to Week 23. From Week 24 the participants will receive anifrolumab up to and including Week 51. |
| Name | Type | Description |
|---|---|---|
| Anifrolumab | COMBINATION_PRODUCT | Anifrolumab will be provided as a solution for injection in accessorized pre-filled syringe (aPFS). |
| Placebo | OTHER | Matching placebo solution for injection in aPFS. |
Key inclusion criteria: * Participants must have a confirmed diagnosis of CLE. Diagnosis must be clinically and histologically confirmed with the following: * CLASI-A total score ≥ 10 points at Screening and confirmed at randomization. * Inadequate response or intolerant to antimalarial therap...