A study to learn how safe bimekizumab, how well it works and how it moves through the bloodstream in adolescents with moderate to severe plaque psoriasis
- Conditions
- Moderate to Severe Plaque PsoriasisMedDRA version: 20.0Level: LLTClassification code: 10071117Term: Plaque psoriasis Class: 10040785Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- CTIS2023-509832-24-00
- Lead Sponsor
- CB Biopharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 43
Participant must be =12 to <18 years of age at the time of signing the informed consent/assent according to local regulation -Participant has had a diagnosis of moderate to severe plaque psoriasis (PSO) for at least 3 months prior to the Screening Visit and: a) Body surface area (BSA) affected by PSO =10% b) Investigator's Global Assessment (IGA) score =3 (on a scale from 0 to 4) c) Psoriasis Area and Severity Index (PASI) score =12 OR d) PASI score =10 plus at least 1 of the following: i. Clinically relevant facial involvement ii. Clinically relevant genital involvement iii. Clinically relevant hand and foot involvement -Participant must be candidate for systemic PSO therapy and/or photo/chemotherapy -Body weight =30 kg and body mass index for age percentile of =5 at Baseline -Male or female A female participant will be eligible to participate if she is not pregnant, not breastfeeding, and a woman of childbearing potential (WOCBP) agrees to follow the contraceptive guidance -Capable of giving/having parent(s) or legal representative provide signed informed consent/assent (where appropriate)
-Participant has a presence of guttate, inverse, pustular, or erythrodermic PSO or other dermatological condition that may impact the clinical assessment of PSO -Participant has a history of inflammatory bowel disease (IBD) or symptoms suggestive of IBD - History of active tuberculosis unless successfully treated, latent TB unless prophylactically treated -Participant has an active infection or history of infections (such as serious infection, chronic infections, opportunistic infections, unusually severe infections) -Participant has laboratory abnormalities at Screening -Participant has experienced primary failure to one or more interleukin-17 (IL-17) biologic response modifier OR primary failure to more than 1 biologic response modifier other than an IL-17 biologic response modifier -Presence of active suicidal ideation, or positive suicide behavior -Participant has been diagnosed with severe depression in the past 6 months
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