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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03329885
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Bristol-Myers Squibb
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Bristol-Myers Squibb
Principal Investigator Affiliation Bristol-Myers Squibb
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Netherlands
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Rheumatoid Arthritis, Psoriasis, Ankylosing Spondylitis, Inflammatory Bowel Diseases, Nonalcoholic Steatohepatitis
Study Website: View Trial Website

Contact a Trial Team

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International Sites

Local Institution, Groningen, Netherlands

Status

Recruiting

Address

Local Institution

Groningen, , 9728 NZ

Site Contact

Site 0001

please email:

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