A study to assess the pharmacokinetics, safety, and efficacy of two doses of bimekizumab in adolescent study participants 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: EUCTR2020-001724-34-DE
• Lead Sponsor: CB Biopharma SR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-20
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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)

Are the trial subjects under 18? yes
Number of subjects for this age range: 40
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-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