Phase 2
N=41
A Study to Assess the Pharmacokinetics, Safety, and Efficacy of Two Doses of Bimekizumab in Adolescent Study Participants With Moderate to Severe Plaque Psoriasis
Moderate to Severe Plaque Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT04718896 ↗Enrolled (actual)
41
Serious AEs
12.2%
Results posted
May 2026
Primary outcome: Primary: Plasma Concentration of Bimekizumab at Week 0 — NA; NA microgram per milliliter (µg/mL)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- bimekizumab (Drug)
- Age
- Pediatric · 12+ yrs
- Sex
- All
- Sponsor
- UCB Biopharma SRL
- Primary completion
- Mar 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plasma Concentration of Bimekizumab at Week 0 |
NA; NA | — |
| PRIMARY Plasma Concentration of Bimekizumab at Week 1 |
21.145; 3.811 | — |
| PRIMARY Plasma Concentration of Bimekizumab at Week 4 |
11.718; 1.986 | — |
| PRIMARY Plasma Concentration of Bimekizumab at Week 8 |
16.344; 2.562 | — |
| PRIMARY Plasma Concentration of Bimekizumab at Week 12 |
19.312; 2.600 | — |
| PRIMARY Plasma Concentration of Bimekizumab at Week 16 |
20.163; 2.560 | — |
| PRIMARY Plasma Concentration of Bimekizumab at Week 20 |
21.579; 2.689 | — |
| PRIMARY Plasma Concentration of Bimekizumab at Week 40 |
20.404; 3.354 | — |
| PRIMARY Plasma Concentration of Bimekizumab at Week 64 |
23.177; 3.339 | — |
| PRIMARY Plasma Concentration of Bimekizumab at Week 88 |
20.342; 2.928 | — |
| PRIMARY Plasma Concentration of Bimekizumab at Week 112 |
18.770; 3.017 | — |
| PRIMARY Plasma Concentration of Bimekizumab at Week 124 |
17.495; 3.104 | — |
| PRIMARY Plasma Concentration of Bimekizumab at Safety Follow up (SFU) |
0.762; NA | — |
| SECONDARY Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) |
85.0; 81.0 | — |
| SECONDARY Percentage of Participants With Serious Treatment-emergent Adverse Events |
10.0; 14.3 | — |
| SECONDARY Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Discontinuation of Investigational Medicinal Product (IMP) |
5.0; 0 | — |
| SECONDARY Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal From the Study |
0; 0 | — |
| SECONDARY Exposure-adjusted Incidence Rates (EAIR) of Selected Safety Topics of Interest |
0; 0; 4.06; 0; 0; 0 | — |
| SECONDARY Change From Baseline in Vital Signs (Systolic and Diastolic Blood Pressure) |
1.9; -2.1; -0.2; -2.1; 2.7; 0.8 | — |
| SECONDARY Change From Baseline in Vital Signs (Pulse Rate) |
-1.1; -3.2; -3.0; -1.4; -5.2; -10.3 | — |
| SECONDARY Change From Baseline in Vital Signs (Temperature) |
-0.06; 0.10; -0.19; -0.09; -0.13; 0.00 | — |
| SECONDARY Change From Baseline in Hematology Parameters (Platelet Count) |
-3.1; 3.6; -12.1; -8.1; -34.1; -29.5 | — |
| SECONDARY Change From Baseline in Hematology Parameters (Mean Corpuscular Hemoglobin) |
-0.03; -0.14; 0.54; 0.02; 1.32; -0.20 | — |
| SECONDARY Change From Baseline in Hematology Parameters (Mean Corpuscular Volume) |
-1.22; -1.57; 1.42; -0.23; 3.54; 1.98 | — |
| SECONDARY Change From Baseline in Hematology Parameters (Erythrocytes) |
-0.011; 0.039; -0.013; -0.017; -0.152; -0.143 | — |
| SECONDARY Change From Baseline in Hematology Parameters (Hemoglobin) |
-0.5; 0.4; 2.2; -0.4; 1.9; -5.0 | — |
| SECONDARY Change From Baseline in Hematology Parameters (Hematocrit) |
-0.72; -0.39; 0.61; -0.20; 0.32; -0.38 | — |
| SECONDARY Change From Baseline in Clinical Chemistry Parameters (Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase) |
-2.0; -2.4; -52.5; -22.3; -80.1; -19.0 | — |
| SECONDARY Change From Baseline in Hematology Parameters (Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes) |
-0.002; -0.007; 0.001; -0.006; -0.032; 0.005 | — |
| SECONDARY Change From Baseline in Clinical Chemistry Parameters (Calcium, Potassium, Sodium, Blood Urea Nitrogen, Glucose (Nonfasting) |
0.014; 0.009; -0.044; -0.013; 0.003; -0.058 | — |
| SECONDARY Change From Baseline in Clinical Chemistry Parameters (Creatinine, Total and Direct Bilirubin) |
-0.82; 1.85; 7.31; 8.23; 9.83; 7.94 | — |
| SECONDARY Change From Baseline in Clinical Chemistry Parameters (Total Protein) |
-0.2; 0.1; 1.1; 0.7; -0.2; -1.8 | — |
| SECONDARY Change From Baseline in Height |
0.61; 0.56; 4.01; 3.04 | — |
| SECONDARY Change From Baseline in Weight |
2.62; 0.71; 4.01; 5.88 | — |
| SECONDARY Percentage of Participants With Psoriasis Area and Severity Index (PASI) 90 Response at Week 16 |
95.0; 90.5 | — |
| SECONDARY 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 |
95.0; 90.5 | — |
| SECONDARY Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75 Response at Week 4 |
80.0; 52.4 | — |
| SECONDARY Percentage of Participants With Anti-bimekizumab Antibody (AbAb) Detection Prior to Investigational Medicinal Product (IMP) Administration |
0; 0; 95.0; 100; 5.0; 0 | — |
| SECONDARY Percentage of Participants With Anti-bimekizumab Antibody (AbAb) Detection Following Investigational Medicinal Product (IMP) Administration |
68.4; 45.0; 26.3; 55.0; 5.3; 0 | — |
| SECONDARY Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Response at Week 16 |
-3.9; -5.5 | — |
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).
Eligibility Criteria
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:
- 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:
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
Data sourced from ClinicalTrials.gov (NCT04718896). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.