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

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 2; Phase 1

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

Treatments: Other: Placebo; Drug: BMS-986251

Study type: Interventional

Funder types: Industry

Identifiers

NCT03329885

IM024-005

2017-003408-38 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 38 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Inclusion Criteria (Healthy Patients):

• 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

Exclusion Criteria (Healthy Patients):

• 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

Inclusion Criteria (Psoriasis Patients):

• 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 (Psoriasis Patients):

• 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

Other protocol defined inclusion/exclusion criteria could apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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38 participants in 3 patient groups

Part A Single Ascending Dose (SAD) in Healthy Patients

Experimental group

Description:

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

Treatment:

Other: Placebo

Drug: BMS-986251

Part B Multiple Ascending Dose (MAD) in Healthy Patients

Experimental group

Description:

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

Treatment:

Other: Placebo

Drug: BMS-986251

Part C Multiple Dosing in Psoriasis Patients

Experimental group

Description:

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

Treatment:

Other: Placebo

Drug: BMS-986251