| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01135459 | A Study to Evaluate the Efficacy and Safety of CEP-33457 in Participants With Systemic Lupus Erythematosus (SLE) | PHASE2 | COMPLETED | 183 | — | — | Jun 24, 2010 | Jun 30, 2012 | Dec 16, 2022 | 86 | United States, Belgium +9 |
An SRI response was defined as a reduction from baseline in SLE Disease Activity Index 2000 (SLEDAI-2K) score of ≥4 points, no worsening in Physician Global Assessment (PhGA), no new British Isles Lupus Assessment Group (BILAG) A body system score, and ≤1 new BILAG B body system score from baseline. SLEDAI-2K includes 24 weighted clinical and laboratory variables. Total score = 0 to 105. A score of 6 to 10 = moderate disease activity, and a reduction of \>3 points = improvement. PhGA was completed by physician using a visual analog scale (VAS) from 0=none to 3=severe. A change of \>0.3 points = worsening. BILAG includes 97 clinical and laboratory items. Each organ system is assigned a score displayed as a grade from A to E: A=very active disease; B=patient needs increase in treatment for moderately active disease; C=stable or mild disease; D=previous organ involvement but no current disease activity; and E=no current disease activity and organ system has never been involved.
| Arm | Type | Description |
|---|---|---|
| CEP-33457 | EXPERIMENTAL | Participants will receive CEP-33457 200 mcg SC every 4 weeks for 20 weeks (Day 1, Weeks 4, 8, 12, 16, and 20). |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo matching to CEP-33457 SC every 4 weeks for 20 weeks (Day 1, Weeks 4, 8, 12, 16, and 20). |
| Name | Type | Description |
|---|---|---|
| CEP-33457 | DRUG | CEP-33457 will be administered per dose and schedule specified in the arm description. |
| Placebo | DRUG | Placebo matching to CEP-33457 will be administered per schedule specified in the arm description. |
Inclusion Criteria: * The participant has an established diagnosis of systemic lupus erythematosus (SLE) as defined by ACR Classification Revised Criteria. The diagnosis is fulfilled provided that at least 4 criteria are met. * The participant has a positive test for antinuclear antibody (ANA) at s...