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CTA018

Phase 2

Psoriasis | Small molecule | Immunology |Opko Health Inc.|Last Updated: Sep 29, 2014

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-BlindUNCONTROLLED
Total Trials1
Total Enrollment140
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00384098Safety and Efficacy of Topically Applied CTA018 in Plaque PsoriasisPHASE2 COMPLETED 140 — — Sep 1, 2006May 1, 2007Sep 29, 201416 United States
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Study Endpoints
Primary Endpoints
The primary endpoint will be treatment success or failure based on a Physician's Static Global Assessment (PSGA) of 0 or 1 (success).
Secondary Endpoints
Secondary efficacy outcomes include time to success (PSGA), change in overall PSGA score, and Area Adjusted Psoriasis Area and Severity Index (AAPASI)changes from baseline.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
CTA018 creamDRUG -
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion Criteria: * clinical diagnosis of chronic plaque psoriasis for 6 months to a max 15% body surface area excluding face, scalp, groin, axillae, palms, soles of feet * at least two evaluable plaques with CPSS \>/= 6 * baseline PSGA \>/= 2 * women of childbearing potential msut agree to use a...

Countries:United States
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Competitive Landscape -Psoriasis 54 trials
CompanyTickerTrialsLead PhaseDrugs
Johnson & JohnsonJNJ10PHASE3JNJ-77242113, Deucravacitinib, Ustekinumab, Guselkumab, Etanercept
Bristol-Myers Squibb CompanyBMY14PHASE3BMS-986165, Deucravacitinib, Ustekinumab, Any biologic treatment for psoriasis, Systemic psoriasis medications
AbbVie, Inc.ABBV5PHASE3Risankizumab
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK3PHASE3TAK-279, Zasocitinib
Alumis Inc.ALMS2PHASE3Open-Label Envudeucitinib, Blinded Envudeucitinib, envudeucitinib
Eli Lilly and CompanyLLY1PHASE3Ixekizumab, Tirzepatide
Amgen Inc.AMGN2PHASE3Apremilast
Oruka Therapeutics, Inc.ORKA4PHASE2ORKA-001 Induction Dose, ORKA-002, ORKA-001
Can-Fite BioPharmaCANF1PHASE3piclidenoson
Organon & Co.OGN1PHASE3tapinarof , 1%
Vanda Pharmaceuticals Inc.VNDA1PHASE3Ponesimod
Zai Lab Ltd. Sponsored ADRZLAB1PHASE2ZL-1102 1% w/w for 16 weeks, ZL-1102 3% w/w for 16 weeks
Novartis AG Sponsored ADRNVS3 — Secukinumab
Bausch Health Companies Inc.BHC2 — Brodalumab, Matched cohort, Comparator Drug
Sage BionetworksSAGE1 — Undisclosed
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