Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being developed for the treatment of systemic lupus erythematosus (SLE). It is currently in Phase 2 clinical development and has not been approved by regulatory authorities. The drug is being studied to evaluate its efficacy and safety in participants with SLE.
CEP-33457 is being developed by Teva Pharmaceutical Industries Limited, a company traded on the stock exchange under the ticker TEVA. The drug is in Phase 2 clinical development for systemic lupus erythematosus, an autoimmune disease.
CEP-33457 is in Phase 2 clinical development. It is an investigational drug and has not been approved for use. A Phase 2 clinical trial of CEP-33457 in systemic lupus erythematosus has been completed.
CEP-33457 has been studied in a completed Phase 2 clinical trial with the identifier NCT01135459. This trial evaluated the efficacy and safety of CEP-33457 in participants with systemic lupus erythematosus and enrolled 183 participants across multiple countries, including the United States, Belgium, France, Germany, and the United Kingdom.
Yes, the Phase 2 clinical trial of CEP-33457 in systemic lupus erythematosus was a randomized, double-blind, placebo-controlled study. The trial enrolled 183 participants aged 18 years and older and was conducted at sites in the United States, Europe, and Ukraine.