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CEP-33457

Phase 2

Systemic Lupus Erythematosus | Small molecule | Immunology |Teva Pharmaceutical Industries Limited|Last Updated: Dec 16, 2022

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment183
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01135459A Study to Evaluate the Efficacy and Safety of CEP-33457 in Participants With Systemic Lupus Erythematosus (SLE)PHASE2 COMPLETED 183Jun 24, 2010Jun 30, 2012Dec 16, 202286 United States, Belgium +9
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Study Endpoints
Primary Endpoints
Number of Participants Achieving a Combined Clinical Response Using the Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 24
Week 24

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.

Secondary Endpoints
Number of Participants Achieving an SRI Response at Each Visit During the Treatment Period
Weeks 4, 8, 12, 16, and 20
Number of Participants Achieving a Reduction of at Least 4 Points in the SLEDAI-2K Total Score
Week 24
Number of Participants Achieving a British Isles Lupus Assessment Group (BILAG) 2004 Response
Weeks 4, 8, 12, 16, 20, and 24
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CEP-33457EXPERIMENTALParticipants will receive CEP-33457 200 mcg SC every 4 weeks for 20 weeks (Day 1, Weeks 4, 8, 12, 16, and 20).
PlaceboPLACEBO_COMPARATORParticipants will receive placebo matching to CEP-33457 SC every 4 weeks for 20 weeks (Day 1, Weeks 4, 8, 12, 16, and 20).
Interventions
NameTypeDescription
CEP-33457DRUGCEP-33457 will be administered per dose and schedule specified in the arm description.
PlaceboDRUGPlacebo matching to CEP-33457 will be administered per schedule specified in the arm description.
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites86

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...

Countries:United StatesBelgiumCzechiaFranceGermanyHungaryPolandPortugalSpainUkraineUnited Kingdom
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