A Study to Evaluate the Drug Levels, Efficacy and Safety of BMS-986165 in Adolescent Participants With Moderate to Severe Plaque Psoriasis

Study Purpose

The purpose of this pediatric study is to evaluate the drug levels, efficacy and safety of BMS-986165 in adolescent participants aged 12 to <18 years with moderate to severe plaque psoriasis. This study has two parts. Part A will evaluate the drug levels of BMS-986165 in adolescent participants ages 12 to <18 years to enable selection of 2 dose levels to be studied in Part B. Part B will assess the efficacy and safety of two dose levels in adolescents participants with moderate to severe plaque psoriasis.

Recruitment Criteria

Accepts Healthy Volunteers

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

No
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 12 Years - 18 Years
Gender All
More Inclusion & Exclusion Criteria

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

Inclusion Criteria:

  • - Males and females aged 12 to <18 years.
  • - Plaque psoriasis for at least 6 months.
  • - Moderate to severe disease.
  • - Candidate for phototherapy or systemic therapy.

Exclusion Criteria:

  • - Weighing ≤ 30.0 kg at screening.
  • - Other forms of psoriasis.
  • - History of recent infection.
  • - Prior exposure to BMS-986165 or active comparator.
Other protocol-defined inclusion/exclusion criteria 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.

NCT04772079
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 3
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 Australia, Canada, France, Poland, Spain, United Kingdom
Conditions

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

Plaque Psoriasis
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Active treatment (BMS-986165) standard dose

Experimental: Active treatment (BMS-986165) half-standard dose

Placebo Comparator: Placebo

Interventions

Drug: - BMS-986165

Specified dose on specified days

Other: - Placebo matching BMS-986165

Specified dose on specified days

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

The Skin Hospital, Sydney, New South Wales, Australia

Status

Recruiting

Address

The Skin Hospital

Sydney, New South Wales, 2010

Site Contact

Johanna Kuchel, Site 0020

[email protected]

+61286512027

Local Institution, Westmead, New South Wales, Australia

Status

Not yet recruiting

Address

Local Institution

Westmead, New South Wales, 2145

Site Contact

Site 0002

[email protected]

please email:

Veracity Clinical Research, Brisbane, Queensland, Australia

Status

Recruiting

Address

Veracity Clinical Research

Brisbane, Queensland, 4102

Site Contact

Lynda Spelman, Site 0003

[email protected]

+61730391300

Sinclair Dermatology, East Melbourne, Victoria, Australia

Status

Recruiting

Address

Sinclair Dermatology

East Melbourne, Victoria, 3002

Site Contact

Samantha Eisman, Site 0001

[email protected]

+61390130099

Local Institution, Calgary, Alberta, Canada

Status

Recruiting

Address

Local Institution

Calgary, Alberta, T2J 7E1

Site Contact

Site 0010

[email protected]

please email:

Local Institution, Markham, Ontario, Canada

Status

Recruiting

Address

Local Institution

Markham, Ontario, L3P 1X2

Site Contact

Site 0008

[email protected]

please email:

Local Institution, Montreal, Quebec, Canada

Status

Not yet recruiting

Address

Local Institution

Montreal, Quebec, H3T 1C5

Site Contact

Site 0009

[email protected]

please email:

Local Institution, Nice, France

Status

Not yet recruiting

Address

Local Institution

Nice, , 06202

Site Contact

Site 0012

[email protected]

please email:

Local Institution, Paris, France

Status

Not yet recruiting

Address

Local Institution

Paris, , 75019

Site Contact

Site 0021

[email protected]

please email:

Local Institution, Krakow, Poland

Status

Not yet recruiting

Address

Local Institution

Krakow, , 30-510

Site Contact

Site 0011

[email protected]

please email:

Local Institution, Lodz, Poland

Status

Not yet recruiting

Address

Local Institution

Lodz, , 90-436

Site Contact

Site 0006

[email protected]

please email:

Local Institution, Wroclaw, Poland

Status

Not yet recruiting

Address

Local Institution

Wroclaw, , 51-620

Site Contact

Site 0005

[email protected]

please email:

Local Institution, Alicante, Spain

Status

Recruiting

Address

Local Institution

Alicante, , 03010

Site Contact

Site 0017

[email protected]

please email:

Local Institution, Barakaldo, Spain

Status

Recruiting

Address

Local Institution

Barakaldo, , 48903

Site Contact

Site 0026

[email protected]

please email:

Local Institution, Esplugues de Llobregat, Spain

Status

Recruiting

Address

Local Institution

Esplugues de Llobregat, , 08950

Site Contact

Site 0014

[email protected]

please email:

Local Institution, Las Palmas De GC, Spain

Status

Recruiting

Address

Local Institution

Las Palmas De GC, , 35019

Site Contact

Site 0016

[email protected]

please email:

Local Institution, Madrid, Spain

Status

Not yet recruiting

Address

Local Institution

Madrid, , 28041

Site Contact

Site 0027

[email protected]

please email:

Local Institution, Madrid, Spain

Status

Recruiting

Address

Local Institution

Madrid, , 28046

Site Contact

Site 0022

[email protected]

please email:

Local Institution, Connor Downs, United Kingdom

Status

Not yet recruiting

Address

Local Institution

Connor Downs, , TR27 5DT

Site Contact

Site 0019

[email protected]

please email:

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