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BMS-986202

Phase 1

Psoriasis | Small molecule | Immunology |Bristol-Myers Squibb Company|Last Updated: Aug 3, 2017

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-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment357
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02763969Safety Study of BMS-986202 in Healthy Subjects and to Treat PsoriasisPHASE1 COMPLETED 357 — — May 18, 2016Dec 15, 2016Aug 3, 20172 Australia
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Study Endpoints
Primary Endpoints
Safety of a single oral dose of BMS-986202 based on number of incidence of AEs, SAEs, AEs leading to discontinuation or death, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, telemetry, and physical examinations
4 weeks after the start of treatment
Safety of a multiple oral dose of BMS-986202 based on number of incidence of AE, SAEs, AEs leading to discontinuation or death, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, telemetry, and physical examinations
4 weeks after the start of treatment
Change from baseline in the psoriasis area
4 weeks after the start of treatment
Severity index (PASI) score
4 weeks after the start of treatment
Secondary Endpoints
Effect of BMS-986202 on electrocardiographic (ECG) parameters such as heart rate in healthy subjects of any ethnic background (Parts A, B, C, D)
Approximately 3 months
Effect of BMS-986202 on electrocardiographic (ECG) parameters such as PR interval in healthy subjects of any ethnic background (Parts A, B, C, D)
Approximately 3 months
Effect of BMS-986202 on electrocardiographic (ECG) parameters such as QRS interval in healthy subjects of any ethnic background (Parts A, B, C, D)
Approximately 3 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelFACTORIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part A: Single Ascending DoseEXPERIMENTALBMS-986202 or Placebo specified dose on specified days
Part B: Multiple Ascending DoseEXPERIMENTALBMS-986202 or Placebo + Interferon alpha-2a recombinant specified dose on specified days
Part C: Multiple Ascending Dose-Japanese descentEXPERIMENTALBMS-986202 or Placebo specified dose on specified days in patients of Japanese descent
Part D: Relative BioavailabilityEXPERIMENTALBMS-986202 (Liquid) or BMS-986202 (Capsule) + Famotidine specified dose on specified days
Part E: Proof of MechanismEXPERIMENTALBMS-986202 or Placebo + Ustekinumab specified dose on specified days
Interventions
NameTypeDescription
BMS-986202DRUG -
PlaceboDRUG -
Interferon alpha-2a recombinantDRUG -
FamotidineDRUG -
UstekinumabDRUG -
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersYes
Study Sites2

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Healthy Male and Female participants * 18 to 50 years of age (Parts A-D) * 18 to 70 years of age (Part E) * Diagnosed with plaque psoriasis (Part E) Exclusi...

Countries:Australia
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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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