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BMS-986202

Phase 1

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

Success Probability

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment357

FDA Designations

No designations recorded

Clinical trial landscape

BMS-986202 · 1 trial · 1 indication

Phase 1 1
NCT02763969Safety Study of BMS-986202 in Healthy Subjects and to Treat PsoriasisPsoriasis
COMPLETED357 Analytics
PHASE1COMPLETED
Safety Study of BMS-986202 in Healthy Subjects and to Treat Psoriasis
PsoriasisUnlock trial analytics

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 to 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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Frequently asked questions about BMS-986202

What is BMS-986202 used for?

BMS-986202 is an investigational small molecule being developed for the treatment of psoriasis, a dermatological condition. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied for its safety and potential efficacy in treating this condition.

Who makes BMS-986202?

BMS-986202 is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company listed on the stock exchange under the ticker symbol BMY. The company is conducting clinical trials to evaluate the safety and potential efficacy of this investigational drug for the treatment of psoriasis.

What phase is BMS-986202 in?

BMS-986202 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and potential efficacy. The drug is being studied for the treatment of psoriasis.

What clinical trials is BMS-986202 in?

BMS-986202 has been studied in a Phase 1 clinical trial with the identifier NCT02763969, titled "Safety Study of BMS-986202 in Healthy Subjects and to Treat Psoriasis." This trial, which has been completed, enrolled 357 participants and was conducted in Australia. The study included healthy volunteers and individuals with psoriasis.

Is BMS-986202 the same as any other drug?

BMS-986202 is a unique investigational drug candidate developed by Bristol-Myers Squibb. It is not known to be the same as any other marketed drug. It is being studied as a potential treatment for psoriasis and is currently in Phase 1 clinical development.