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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03845517 | A DOSE-RANGING STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-06700841 IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) | PHASE2 | COMPLETED | 350 | — | — | Apr 18, 2019 | Oct 5, 2023 | Sep 5, 2024 | 164 | United States, Argentina +24 |
SRI-4 components included Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), British Isles Lupus Assessment Group (BILAG) 2004 and Physician's Global Assessment (PhGA). Participants were classified as SRI-4 responders, if they met all of the following criteria compared with baseline: 1) greater than or equal to (\>=) 4 point reduction in SLEDAI-2K score; 2) no new BILAG A organ domain score or 2 new BILAG B organ domain scores; 3) no worsening (less than \[\<\] 0.3 point increase) in PhGA score. SLEDAI-2K: assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). BILAG: assesses disease extent, severity in individual organ system (range: A \[severe\] to E \[no disease\]; higher score = less severity). PhGA: assesses worsening in participant's general health status (range: 0 \[none\] to 3 \[severe\]; higher score = higher severity).
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo |
| PF-06700841 15 mg | EXPERIMENTAL | PF-06700841 15 mg |
| PF-06700841 30 mg | EXPERIMENTAL | PF-06700841 30 mg |
| PF-06700841 45 mg | EXPERIMENTAL | PF-06700841 45 mg |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Placebo |
| PF-06700841 15 mg | DRUG | PF-06700841 15 mg |
| PF-06700841 30 mg | DRUG | PF-06700841 30 mg |
| PF-06700841 45 mg | DRUG | PF-06700841 45 mg |
Inclusion Criteria: * Male and/or female subjects between ≥18 and ≤75 years of age inclusive. * Diagnosis of moderate to severe active Lupus. * Receiving a stable dose of methotrexate, azathioprine, leflunomide, mizoribine, mycophenolate/mycophenolic acid, anti-malarials or corticosteroids. Exclus...