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)

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

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).

Study Overview

• Status: Completed
• Conditions: Moderate to Severe Plaque Psoriasis
• Intervention / Treatment: Drug: bimekizumab

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Calgary, Canada
    • Ps0020 50354
  • St. John's, Canada
    • Ps0020 50357
• Germany
  • Frankfurt, Germany
    • Ps0020 40645
• Poland
  • Bialystok, Poland
    • Ps0020 40626
  • Lodz, Poland
    • Ps0020 40625
  • Rzeszów, Poland
    • Ps0020 40396
  • Warsaw, Poland
    • Ps0020 40335
  • Wroclaw, Poland
    • Ps0020 40333
  • Wroclaw, Poland
    • Ps0020 40334
• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Ps0020 50344
  • Texas
    • Cypress, Texas, United States, 77433
      • Ps0020 50359

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bimekizumab Dose A; Study participants randomized to this arm will receive bimekizumab (BKZ) Dose A at pre-specified time points during the study.	Drug: bimekizumab; Study participants will receive subcutaneously administered bimekizumab (BKZ) at pre-specified time points during the study.; Other Names: UCB4940; BKZ
Experimental: Bimekizumab Dose B; Study participants randomized to this arm will receive bimekizumab (BKZ) Dose B at pre-specified time points during the study.	Drug: bimekizumab; Study participants will receive subcutaneously administered bimekizumab (BKZ) at pre-specified time points during the study.; Other Names: UCB4940; BKZ

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma Concentration of Bimekizumab at Week 0	Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 0. PK-PPS = Pharmacokinetic per-protocol set, IMP = investigational medicinal product.	Baseline (Week 0)
Plasma Concentration of Bimekizumab at Week 1	Blood samples were collected to determine the bimekizumab plasma concentration at Week 1.	Week 1
Plasma Concentration of Bimekizumab at Week 4	Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 4.	Week 4
Plasma Concentration of Bimekizumab at Week 8	Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 8.	Week 8
Plasma Concentration of Bimekizumab at Week 12	Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 12.	Week 12
Plasma Concentration of Bimekizumab at Week 16	Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 16.	Week 16
Plasma Concentration of Bimekizumab at Week 20	Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 20.	Week 20
Plasma Concentration of Bimekizumab at Week 40	Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 40.	Week 40
Plasma Concentration of Bimekizumab at Week 64	Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 64.	Week 64
Plasma Concentration of Bimekizumab at Week 88	Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 88.	Week 88
Plasma Concentration of Bimekizumab at Week 112	Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 112.	Week 112
Plasma Concentration of Bimekizumab at Week 124	Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 124.	Week 124
Plasma Concentration of Bimekizumab at Safety Follow up (SFU)	Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 140 (SFU).	Week 140 (SFU)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)	An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. Treatment-emergent AEs are defined as those AEs that started date on or following the first dose of IMP through the final dose of IMP +20 weeks. The last dose was given 4 weeks prior end of extension period.	From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)]
Percentage of Participants With Serious Treatment-emergent Adverse Events	An serious adverse event (SAE) must meet 1 or more of the following criteria: Results in death; Is life-threatening; Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent disability/incapacity; Is a congenital anomaly/birth defect; Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or subject and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious. Treatment-emergent AEs are defined as those AEs that started date on or following the first dose of IMP through the final dose of IMP +20 weeks. The data was rounded to one decimal place. The last dose was given 4 weeks prior end of extension period.	From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Discontinuation of Investigational Medicinal Product (IMP)	An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. Treatment-emergent AEs are defined as those AEs that started date on or following the first dose of IMP through the final dose of IMP +20 weeks. This measure considers any TEAE leading to permanent discontinuation of IMP regardless of reason. The last dose was given 4 weeks prior end of extension period.	From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal From the Study	An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. Treatment-emergent AEs are defined as those AEs that started date on or following the first dose of IMP through the final dose of IMP +20 weeks. This measure considers any TEAEs leading to withdrawal from the study. The last dose was given 4 weeks prior end of extension period.	From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
Exposure-adjusted Incidence Rates (EAIR) of Selected Safety Topics of Interest	Selected safety topics of interest (including infection [serious, opportunistic, fungal, and tuberculosis (TB)], inflammatory bowel disease [IBD], and injection site reactions) with onset occurring from day of first dose through 20 weeks after final dose of IMP adjusted by duration of participant exposure to IMP. The exposure-adjusted incidence rate (EAIR) is defined as the number of participants (n) with a specific AE adjusted for the exposure and was scaled to 100 participant-years. The last dose was given 4 weeks prior end of extension period.	From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
Change From Baseline in Vital Signs (Systolic and Diastolic Blood Pressure)	Blood pressure was measured in millimeters of mercury (mmHg).	Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Change From Baseline in Vital Signs (Pulse Rate)	Pulse rate was measured in beats per minute (beats/min).	Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Change From Baseline in Vital Signs (Temperature)	Temperature (oral, axillary, otic or non-contact forehead) was measured in degrees Celsius (°C).	Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Change From Baseline in Hematology Parameters (Platelet Count)	Platelets was measured in number of platelets per liter (10^9/L).	Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Change From Baseline in Hematology Parameters (Mean Corpuscular Hemoglobin)	Mean corpuscular hemoglobin (HGB) was measured in picograms (pg).	Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Change From Baseline in Hematology Parameters (Mean Corpuscular Volume)	Mean corpuscular volume was measured in femtolitres.	Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Change From Baseline in Hematology Parameters (Erythrocytes)	Erythrocytes was measured in number of red blood cells per liter (10^12/L).	Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Change From Baseline in Hematology Parameters (Hemoglobin)	Hemoglobin was measured in grams per liter.	Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Change From Baseline in Hematology Parameters (Hematocrit)	Hematocrit was measured in volume percentage (%) of red blood cells in the blood.	Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Change From Baseline in Clinical Chemistry Parameters (Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase)	Alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase was measured in units per liter.	Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Change From Baseline in Hematology Parameters (Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes)	Basophils, eosinophils, lymphocytes, monocytes, neutrophils and leukocytes was measured in number of white blood cells per liter (10^9/L).	Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Change From Baseline in Clinical Chemistry Parameters (Calcium, Potassium, Sodium, Blood Urea Nitrogen, Glucose (Nonfasting)	Calcium, potassium, sodium, blood urea nitrogen, and glucose (non fasting) was measured in millimoles per liter (mmol/L).	Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Change From Baseline in Clinical Chemistry Parameters (Creatinine, Total and Direct Bilirubin)	Creatinine and bilirubin was measured in micromols per liter (μmol/L).	Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Change From Baseline in Clinical Chemistry Parameters (Total Protein)	Total protein was measured in gram per liter (g/L)	Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Change From Baseline in Height	Growth assessment, as assessed by the change from Baseline in height.	Baseline (Week 0), Weeks 16, 124
Change From Baseline in Weight	Growth assessment, as assessed by the change from Baseline in weight.	Baseline (Week 0), Weeks 16, 124
Percentage of Participants With Psoriasis Area and Severity Index (PASI) 90 Response at Week 16	Percentage of participants with PASI 90 response at Week 16 is reported. PASI90 response assessments are based on at least 90% improvement in PASI score from Baseline. This is scoring system that averages redness, thickness, and scaliness of psoriatic lesions(on a 0-4 scale), and weights resulting score by area of skin involved. Body divided into 4 areas:head, arms, trunk to groin, and legs to top of buttocks. Assignment of average score for redness, thickness, and scaling for each of 4 body areas with score of 0(none) to 4(very marked). Determining percentage of skin covered with psoriasis(PSO) for each of body areas and converting to 0 to 6 scale. Final PASI=average redness, thickness, and scaliness of psoriatic skin lesions, multiplied by involved PSO area score of respective section, and weighted by percentage of person's affected skin for respective section. Minimum possible PASI score is 0=no disease, maximum score is 72=maximal disease. Data was rounded to one decimal place.	Week 16
Percentage of Participants With Investigator's Global Assessment (IGA) 0/1 (Clear [0]/Almost Clear [1] With at Least 2-category Improvement From Baseline) Response at Week 16	The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response (Clear or Almost Clear) is defined as clear [0] or almost clear [1] with at least a two-category improvement from Baseline. The data was rounded to one decimal place.	Week 16
Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75 Response at Week 4	Percentage of participants with PASI75 response at Week 4 is reported. PASI75 response assessments are based on at least 75% improvement in PASI score from Baseline. This is scoring system that averages redness, thickness, and scaliness of psoriatic lesions (on a 0-4 scale), and weights resulting score by area of skin involved. Body divided into 4 areas:head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for redness, thickness, and scaling for each of 4 body areas with a score of 0 (clear) to 4 (very marked). Determining percentage of skin covered with PSO for each of body areas and converting to 0 to 6 scale. Final PASI=average redness, thickness, and scaliness of psoriatic skin lesions, multiplied by involved psoriasis area score of respective section, and weighted by percentage of person's affected skin for respective section. Minimum possible PASI score is 0=no disease, maximum score is 72=maximal disease. Data was rounded to one decimal place.	Week 4
Percentage of Participants With Anti-bimekizumab Antibody (AbAb) Detection Prior to Investigational Medicinal Product (IMP) Administration	Anti-bimekizumab antibody (AbAb) detection prior to IMP administration. Anti-bimekizumab antibodies was measured using 3-tiered assay approach: screening assay, confirmatory assay, and titration assay. Antidrug antibody (ADAb) positive status: any sample that is positive screen and positive immunodepletion (regardless of availability of a titer value). ADAb negative status: any sample that is either negative screen, or positive screen and negative immunodepletion, and where the bimekizumab concentration is less than or equal to the drug tolerance limit of the validated ADAb assay. ADAb missing status: any sample that is either negative screen or positive screen and negative immunodepletion and where the bimekizumab concentration exceeds the validated ADAb assay drug tolerance limit.	Baseline (Week 0)
Percentage of Participants With Anti-bimekizumab Antibody (AbAb) Detection Following Investigational Medicinal Product (IMP) Administration	Anti-bimekizumab antibody (AbAb) detection following IMP administration. Overall ADAb positive is defined as having at least one sample that is confirmed positive following the 1st dose of IMP to SFU (regardless of missing data). Overall ADAb negative is defined as having all samples reported as negative, or has only one missing/inconclusive sample, following the 1st dose of IMP to SFU. Overall ADAb missing if the study participant has more than one missing ADAb sample for any reason and all other available ADAb samples are negative. The data was rounded to one decimal place.	From Baseline (Week 0, post-first dose) to Safety Follow-Up (Week 140)
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Response at Week 16	The CDLQI is a questionnaire designed to measure the impact of skin diseases on the lives of children. The questionnaire consists of 10 questions that are based on the experiences of children with skin disease. The instrument asks participants about symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and treatment. The questions relate to the impact of the skin disease on the child over the last week, (ie, over the last 7 days). The CDLQI total score ranges from 0 to 30 with higher scores indicating higher impact of skin disease on quality of life (Qol).	Baseline, Week 16

Collaborators and Investigators

• Sponsor: UCB Biopharma SRL
• Investigators: Study Director: UCB Cares, 001 844 599 2273

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2021
• Primary Completion (Actual): March 12, 2025
• Study Completion (Actual): March 12, 2025

Study Registration Dates

• First Submitted: January 18, 2021
• First Submitted That Met QC Criteria: January 18, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: psoriasis; PSO; BKZ; bimekizumab; adolescent study participants
• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Psoriasis; bimekizumab
• Other Study ID Numbers: PS0020; 2020-001724-34 (EudraCT Number); 2023-509832-24 (Registry Identifier: EU Clinical Trials); U1111-1303-1875 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
• IPD Sharing Time Frame: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
• IPD Sharing Access Criteria: Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed.All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes