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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 12 Years - 17 Years
Gender All
More Inclusion & Exclusion Criteria

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: 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04718896
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

UCB Biopharma SRL
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

UCB Cares
Principal Investigator Affiliation 001 844 599 2273 (UCB)
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Canada, Poland, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Moderate to Severe Plaque Psoriasis
Arms & Interventions

Arms

Experimental: Bimekizumab Dose A

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

Experimental: Bimekizumab Dose B

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

Interventions

Drug: - bimekizumab

Study participants will receive subcutaneously administered bimekizumab (BKZ) at pre-specified time points during the study.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Ps0020 50352, Mountain Brook, Alabama

Status

Recruiting

Address

Ps0020 50352

Mountain Brook, Alabama, 35223

Ps0020 50358, San Diego, California

Status

Recruiting

Address

Ps0020 50358

San Diego, California, 92121

Ps0020 50353, Miami, Florida

Status

Recruiting

Address

Ps0020 50353

Miami, Florida, 33173

Ps0020 50344, Indianapolis, Indiana

Status

Recruiting

Address

Ps0020 50344

Indianapolis, Indiana, 46250

Ps0020 50347, Methuen, Massachusetts

Status

Recruiting

Address

Ps0020 50347

Methuen, Massachusetts, 01844

Ps0020 50356, Kirksville, Missouri

Status

Recruiting

Address

Ps0020 50356

Kirksville, Missouri, 63501

Ps0020 50359, Cypress, Texas

Status

Recruiting

Address

Ps0020 50359

Cypress, Texas, 77433

Ps0020 50355, Dallas, Texas

Status

Recruiting

Address

Ps0020 50355

Dallas, Texas, 75230

International Sites

Ps0020 50354, Calgary, Canada

Status

Recruiting

Address

Ps0020 50354

Calgary, ,

Ps0020 50350, Surrey, Canada

Status

Recruiting

Address

Ps0020 50350

Surrey, ,

Ps0020 50134, Waterloo, Canada

Status

Recruiting

Address

Ps0020 50134

Waterloo, ,

Ps0020 40626, Białystok, Poland

Status

Recruiting

Address

Ps0020 40626

Białystok, ,

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