A Study to Assess the Pharmacokinetics, Safety, and Efficacy of Two Doses of Bimekizumab in Adolescent Study Participants With Moderate to Severe Plaque Psoriasis (BE CONNECTED)

UCB

Status and phase: Completed; Phase 2

Conditions: Moderate to Severe Plaque Psoriasis

Treatments: Drug: bimekizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04718896

2020-001724-34 (EudraCT Number)

U1111-1303-1875 (Other Identifier)

2023-509832-24 (Registry Identifier)

PS0020

Details and patient eligibility

About

The purpose of the study is to assess th pharmacokinetics (PK) of bimekizumab administered subcutaneously (sc) in adolescents with moderate to severe plaque psoriasis (PSO).

Enrollment: 41 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant must be ≥12 to less than 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:

  1. Body surface area (BSA) affected by PSO ≥10%
  2. Investigator's Global Assessment (IGA) score ≥3 (on a scale from 0 to 4)
  3. Psoriasis Area and Severity Index (PASI) score ≥12 OR
  4. 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)

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 2 patient groups

Bimekizumab Dose A

Experimental group

Description:

Study participants randomized to this arm will receive bimekizumab (BKZ) Dose A at pre-specified time points during the study.

Treatment:

Drug: bimekizumab

Bimekizumab Dose B

Experimental group

Description:

Study participants randomized to this arm will receive bimekizumab (BKZ) Dose B at pre-specified time points during the study.

Treatment:

Drug: bimekizumab