A Phase 3 Study to Evaluate the Pharmacokinetics, Efficacy and Safety of BMS-986165 in Adolescent Subjects with Moderate to Severe Plaque Psoriasis

Phase 1

• Conditions: Moderate to Severe Plaque Psoriasis; MedDRA version: 20.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2019-004879-39-FR
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-01
• Last Update Posted: 3 May 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

- Male and females between 12 to less than 18 years of age
- diagnosed with stable (defined as no significant flares of disease activity or morphologic changes for 6 months) moderate to severe plaque psoriasis. Moderate to severe psoriasis defined by: (at screening visit and Day 1) Psoriasis Area and Severity Index (PASI) = 12, // static Physician’s Global Assessment (sPGA) = 3, // Body Surface Area (BSA) = 10% involvement
- candidates for phototherapy or systemic therapy
Are the trial subjects under 18? yes
Number of subjects for this age range: 168
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1. Subject has non-plaque forms of psoriasis (e.g. erythrodermic, guttate, inverse or pustular)
2. Subjects weighing < 30 Kg at screening
3. Subject has any of the following TB criteria:
a) History of active TB prior to screening visit, regardless of completion of adequate treatment
b) Signs or symptoms of active TB during screening as judged by the investigator
c) A chest x-ray showing evidence of current active or old active pulmonary TB
d) Latent TB infection (LTBI) defined as positive IGRA (QuantiFERON-TB Gold) at screening
4. Received live vaccine within 60 days or plan to receive a live vaccine during the study or plan to receive live vaccine within 60 days of last dose of study medication
5. Currently being treated with biologic agents
6. History of ongoing, chronic or recurrent infectious disease, and opportunistic infection regardless of successfully treatment

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified