Phase 2
Completed 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
Source: ClinicalTrials.gov NCT04718896 ↗
Enrolled (actual)
41
Serious AEs
12.2%
Results posted
May 2026
Primary outcomePrimary: Plasma Concentration of Bimekizumab at Week 0 — NA; NA microgram per milliliter (µg/mL)
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).
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 | — |
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. Informational only — not medical advice.