Moderate to Severe Plaque PsoriasisPhase 2BE CONNECTEDNCT04718896
A Study to Assess the Pharmacokinetics, Safety, and Efficacy of Two Doses of Bimekizumab in Adolescent Study Participants With Moderate to Severe Plaque Psoriasis
A Phase 2 study testing bimekizumab in people with Moderate to Severe Plaque Psoriasis, run by UCB Biopharma SRL at 11 sites in 4 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Moderate to Severe Plaque Psoriasis
- What is being tested?
- bimekizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 11 sitesin 4 countries
- Study dates
- 6 Apr 2021to 12 Mar 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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:
- Body surface area (BSA) affected by PSO ≥10%
- Investigator's Global Assessment (IGA) score ≥3 (on a scale from 0 to 4)
- Psoriasis Area and Severity Index (PASI) score ≥12 OR
- PASI score ≥10 plus at least 1 of the following:
Show all 11Show fewer
- 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)
Who cannot join
- 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 locations and contacts
11 sites in 4 countries.
11 sites in 4 countries
Poland6 sites
Ps0020 40626
Bialystok
Ps0020 40625
Lodz
Ps0020 40396
Rzeszów
Ps0020 40335
Warsaw
Ps0020 40333
Wroclaw
Ps0020 40334
Wroclaw
United States2 sites
Ps0020 50359
Cypress, Texas, 77433
Ps0020 50344
Indianapolis, Indiana, 46250
About this study
Official title: 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).
- Conditions
- Moderate to Severe Plaque Psoriasis
- Being tested
- bimekizumab
- Keywords
- bimekizumab, BKZ, adolescent study participants, psoriasis, PSO
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bimekizumabDrug
Also called BKZ, UCB4940
Study participants will receive subcutaneously administered bimekizumab (BKZ) at pre-specified time points during the study.
| Study group | Role | What they receive |
|---|---|---|
| Bimekizumab Dose A | Experimental | Study participants randomized to this arm will receive bimekizumab (BKZ) Dose A at pre-specified time points during the study. Receives: Drug: bimekizumab |
| Bimekizumab Dose B | Experimental | Study participants randomized to this arm will receive bimekizumab (BKZ) Dose B at pre-specified time points during the study. Receives: Drug: bimekizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Week 0)
Plasma Concentration of Bimekizumab at Week 1
Blood samples were collected to determine the bimekizumab plasma concentration at Week 1.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Week 140 (SFU)
Secondary outcomes (27)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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.
Measured: Baseline (Week 0), Weeks 16, 124
Change From Baseline in Weight
Growth assessment, as assessed by the change from Baseline in weight.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline, Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start6 Apr 2021
- Primary completion12 Mar 2025
- Study completion12 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Moderate to Severe Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by UCB Biopharma SRLThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, 001 844 599 2273
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04718896
- Sponsor's protocol ID
- PS0020
- Other IDs
- 2020-001724-34, 2023-509832-24, U1111-1303-1875, 2023
- Acronym
- BE CONNECTED
- Status last verified
- Jul 2026
- First submitted
- 18 Jan 2021
- Last updated
- 3 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04718896
- Acronym / sponsor ID
- BE CONNECTED / PS0020
- Conditions
- Moderate to Severe Plaque Psoriasis
- Keywords
- bimekizumab, BKZ, adolescent study participants, psoriasis, PSO
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- UCB Biopharma SRLIndustry (pharma, biotech, devices)
- Study start
- 6 Apr 2021 (actual)
- Primary completion
- 12 Mar 2025 (actual)
- Study completion
- 12 Mar 2025 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Posted 18 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bimekizumab Dose A | Experimental | Drug: bimekizumabStudy participants randomized to this arm will receive bimekizumab (BKZ) Dose A at pre-specified time points during the study. |
| Bimekizumab Dose B | Experimental | Drug: bimekizumabStudy participants randomized to this arm will receive bimekizumab (BKZ) Dose B at pre-specified time points during the study. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 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:
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bimekizumabAlso: BKZ, UCB4940Study participants will receive subcutaneously administered bimekizumab (BKZ) at pre-specified time points during the study. | Drug | Bimekizumab Dose A, Bimekizumab Dose B |
Primary outcome
Plasma Concentration of Bimekizumab at Week 0
Time frame: Baseline (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.
Plasma Concentration of Bimekizumab at Week 1
Time frame: Week 1
Blood samples were collected to determine the bimekizumab plasma concentration at Week 1.
Plasma Concentration of Bimekizumab at Week 4
Time frame: Week 4
Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 4.
Plasma Concentration of Bimekizumab at Week 8
Time frame: Week 8
Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 8.
Plasma Concentration of Bimekizumab at Week 12
Time frame: Week 12
Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 12.
Plasma Concentration of Bimekizumab at Week 16
Time frame: Week 16
Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 16.
Plasma Concentration of Bimekizumab at Week 20
Time frame: Week 20
Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 20.
Plasma Concentration of Bimekizumab at Week 40
Time frame: Week 40
Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 40.
Plasma Concentration of Bimekizumab at Week 64
Time frame: Week 64
Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 64.
Plasma Concentration of Bimekizumab at Week 88
Time frame: Week 88
Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 88.
Plasma Concentration of Bimekizumab at Week 112
Time frame: Week 112
Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 112.
Plasma Concentration of Bimekizumab at Week 124
Time frame: Week 124
Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 124.
Plasma Concentration of Bimekizumab at Safety Follow up (SFU)
Time frame: Week 140 (SFU)
Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 140 (SFU).
27 secondary outcomes
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Change From Baseline in Vital Signs (Pulse Rate)
Time frame: Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Change From Baseline in Vital Signs (Temperature)
Time frame: Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Change From Baseline in Hematology Parameters (Platelet Count)
Time frame: Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Change From Baseline in Hematology Parameters (Mean Corpuscular Hemoglobin)
Time frame: Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Change From Baseline in Hematology Parameters (Mean Corpuscular Volume)
Time frame: Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Change From Baseline in Hematology Parameters (Erythrocytes)
Time frame: Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Change From Baseline in Hematology Parameters (Hemoglobin)
Time frame: Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Change From Baseline in Hematology Parameters (Hematocrit)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Change From Baseline in Clinical Chemistry Parameters (Total Protein)
Time frame: Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140)
Change From Baseline in Height
Time frame: Baseline (Week 0), Weeks 16, 124
Change From Baseline in Weight
Time frame: Baseline (Week 0), Weeks 16, 124
Percentage of Participants With Psoriasis Area and Severity Index (PASI) 90 Response at Week 16
Time frame: 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
Time frame: Week 16
Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75 Response at Week 4
Time frame: Week 4
Percentage of Participants With Anti-bimekizumab Antibody (AbAb) Detection Prior to Investigational Medicinal Product (IMP) Administration
Time frame: Baseline (Week 0)
Percentage of Participants With Anti-bimekizumab Antibody (AbAb) Detection Following Investigational Medicinal Product (IMP) Administration
Time frame: 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
Time frame: Baseline, Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Cares study director
001 844 599 2273
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bimekizumab in people with Moderate to Severe Plaque Psoriasis, run by UCB Biopharma SRL at 11 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Poland, United States, Canada, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Concentration of Bimekizumab at Week 0 (time frame: Baseline (Week 0)). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.