Study to Evaluate Effectiveness and Safety in Subjects With Moderate to Severe Psoriasis

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 2

Conditions

Psoriasis

Treatments

Drug: BMS-986165

Drug: Placebo for BMS-986165

Study type

Interventional

Funder types

Industry

Identifiers

IM011-011

Details and patient eligibility

About

A Study to evaluate efficacy and safety in subjects with moderate to severe Psoriasis treated with BMS-986165

Enrollment

268 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

Male and female, ages 18 to 70 years
Diagnosis of plaque psoriasis for 6 months
Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test, must not be pregnant, lactating, breastfeeding or planning pregnancy
Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment plus 5 half-lives of the study drug plus 90 days.

Exclusion Criteria:

Any significant acute or chronic medical illness
Blood transfusion within 4 weeks of study drug administration
Inability to tolerate oral medication
Positive hepatitis-B (HBV) surface antigen
Positive hepatitis-C (HCV) antibody
Any history or risk for tuberculosis (TB)
Any major illness/condition or evidence of an unstable clinical condition
Chest X-ray findings suspicious of infection at screening
has received ustekinumab, secukinumab or ixekizumab within 6 months of first administration of study medication
Has received anti-Tumor Necrosis Factor (TNF) inhibitor(s) within 2 months of first administration of study medication
Has received Rituximab within 6 months of first administration of study medication
Topical medications/treatments for psoriasis within 2 weeks of the first administration of any study medication
Any systemic medications/treatments for psoriasis within 4 weeks of the first administration of any study medication

Other protocol defined inclusion/exclusion criteria could apply

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

268 participants in 6 patient groups, including a placebo group

BMS-986165 Dose 1

Experimental group

Description: