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Also known as Lupuzor
CEP-33457 · 1 trial · 1 indication
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...
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CEP-33457 is an investigational small molecule drug developed by Teva Pharmaceutical Industries Limited for systemic lupus erythematosus, an autoimmune disease. It is in Phase 2 clinical development and has been studied in a completed placebo-controlled trial. CEP-33457 has not been approved by the FDA and remains an investigational therapy.
CEP-33457 was studied for the treatment of systemic lupus erythematosus (SLE), a chronic autoimmune condition. Its clinical development has focused on this immunology indication. The drug is investigational and is not approved for any use.
CEP-33457 is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva sponsored the Phase 2 clinical study of the drug in systemic lupus erythematosus.
CEP-33457 is in Phase 2 clinical development. One Phase 2 trial has been completed, and no trials are currently active. The drug is investigational and has not received FDA approval.
CEP-33457 was evaluated in one Phase 2 trial, NCT01135459, titled A Study to Evaluate the Efficacy and Safety of CEP-33457 in Participants With Systemic Lupus Erythematosus (SLE). The completed trial enrolled 183 participants across the United States, Belgium, Czechia, France, Germany, Hungary, Poland, Portugal, Spain, Ukraine, and the United Kingdom.
The Phase 2 trial NCT01135459 was a randomized, double-blind, placebo-controlled study of CEP-33457 in adults with systemic lupus erythematosus. It enrolled 183 participants aged 18 years and older, across eleven countries. The trial has been completed.