A Study of Experimental Medication BMS-986251, Taken by Mouth, in Healthy Participants and Patients With Average to Very Serious Psoriasis

NCT ID: NCT03329885

Last Updated: 2019-10-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-02
• Study Completion Date: 2018-06-26

Brief Summary

The purpose of this study is to investigate experimental medication BMS-986251 taken by mouth in healthy patients and patients with average to very serious Psoriasis (a condition characterized by itchy, dry skin with a scaly rash).

Conditions

Rheumatoid Arthritis; Psoriasis; Ankylosing Spondylitis; Inflammatory Bowel Diseases; Nonalcoholic Steatohepatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Part A Single Ascending Dose (SAD) in Healthy Patients

Healthy patient will receive single escalating oral doses of BMS-986251 or placebo

Group Type: EXPERIMENTAL

BMS-986251

Intervention Type: DRUG

Escalating oral dose

Placebo

Intervention Type: OTHER

Escalating oral dose

Part B Multiple Ascending Dose (MAD) in Healthy Patients

Healthy patients will receive daily escalating oral doses of BMS-986251 or placebo

Group Type: EXPERIMENTAL

BMS-986251

Intervention Type: DRUG

Escalating oral dose

Placebo

Intervention Type: OTHER

Escalating oral dose

Part C Multiple Dosing in Psoriasis Patients

Psoriasis patients will receive daily escalating oral doses of BMS-986251 or placebo

Group Type: EXPERIMENTAL

BMS-986251

Intervention Type: DRUG

Escalating oral dose

Placebo

Intervention Type: OTHER

Escalating oral dose

Interventions

BMS-986251

Escalating oral dose

Intervention Type: DRUG

Placebo

Escalating oral dose

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Males and females, ages 18 to 55 years, inclusive, at screening
• Healthy subjects, as determined by no clinically significant deviations from normal in medical history, physical examination, 12-lead ECGs, vital signs, and clinical laboratory results
• Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive, at screening
• Body weight between 55 kg and 105 kg, inclusive, at screening
• Women must not be breastfeeding

• Males and females, ages 18 to 70 years, inclusive, at screening
• BMI of 18.0 to 35.0 kg/m2, inclusive, at screening
• Body weight between 55 kg and 120 kg, inclusive, at screening
• Diagnosed with stable chronic plaque psoriasis, for at least 6 months prior to screening and be candidates for either photo-therapy or systemic treatment
• Moderate-to-severe intensity of psoriasis as defined by:

1. Affected body surface area (BSA) of ≥10%

2. Psoriasis Area and Severity Index (PASI) ≥12

3. Physician Global Assessment (PGA; 6-point scale) ≥3

Exclusion Criteria

• Previous participation in the current study
• Participation in a drug study or exposure to any investigational drug or placebo within 2 months prior to (the first) drug administration in the current study
• Employees of PRA or the Sponsor and their relatives
• Any significant acute or chronic medical condition that presents a potential risk to the subject and/or that may compromise the objectives of the study, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome
• Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect pharmacokinetics; history of cholecystectomy is not allowed

• Previous participation in the current study
• Participation in a drug study or exposure to any investigational drug or placebo within 2 months prior to (the first) drug administration in the current study
• Employees of PRA or the Sponsor and their relatives
• Any significant acute or chronic medical condition that presents a potential risk to the subject and/or that may compromise the objectives of the study, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome
• Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect pharmacokinetics; history of cholecystectomy is not allowed

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Local Institution

Groningen, , Netherlands

Countries

Netherlands

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://bms.com/studyconnect/Pages/home.aspx

BMS Clinical Trial Patient Recruiting

http://www.bms.com/clinical_trials/Pages/Investigator_inquiry_form.aspx

Investigator Inquiry Form

Other Identifiers

2017-003408-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

IM024-005

Identifier Type: -

Identifier Source: org_study_id