A Phase 3 Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Deucravacitinib (BMS-986165) in Pediatric Subjects with Moderate to Severe Plaque Psoriasis
- Conditions
- Moderate to Severe Plaque PsoriasisMedDRA version: 20.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2019-004879-39-PL
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 153
- Male and females aged 12 to < 18 years for Cohort 1 and aged 4 to <12 years for Cohort 2.
- 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
LTE Period:
- Subjects must be willing to participate in the optional LTE period and must have the ability to sign the ICF.
- Subjects must have completed the Week 52 treatment period in Part A or B of the study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 153
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
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
LTE Period:
a) Any disease or medical condition that, in the opinion of the investigator, would make the subject unsuitable for this treatment period, would interfere with the interpretation of subject safety or study results, or is considered unsuitable by the investigator for any other reason
b) Prior permanent discontinuation of study treatment in Part A or B of the study c) Evidence of active TB (see Section 9.4.4)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method