E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate to Severe Plaque Psoriasis
|
|
E.1.1.1 | Medical condition in easily understood language |
Moderate to Severe Plaque Psoriasis is a chronic inflammatory disease characterized by changes in the skin.
|
|
E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10071117 |
E.1.2 | Term | Plaque psoriasis |
E.1.2 | System Organ Class | 100000004858 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Assess the pharmacokinetics (PK) of bimekizumab administered subcutaneously (sc) in adolescents with moderate to severe plaque psoriasis (PSO)
|
|
E.2.2 | Secondary objectives of the trial |
-Evaluate the safety of bimekizumab in adolescents with moderate to severe plaque PSO -Evaluate the efficacy of bimekizumab in adolescents with moderate to severe plaque PSO -Evaluate the immunogenicity of bimekizumab in adolescents with moderate to severe plaque PSO -Evaluate the change in quality of life in adolescents with moderate to severe plaque PSO
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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: a) Body surface area (BSA) affected by PSO ≥10% b) Investigator’s Global Assessment (IGA) score ≥3 (on a scale from 0 to 4) c) Psoriasis Area and Severity Index (PASI) score ≥12 OR d) 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)
|
|
E.4 | Principal 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
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
1. Plasma concentration of bimekizumab at Week 0 2. Plasma concentration of bimekizumab at Week 1 3. Plasma concentration of bimekizumab at Week 4 4. Plasma concentration of bimekizumab at Week 8 5. Plasma concentration of bimekizumab at Week 12 6. Plasma concentration of bimekizumab at Week 16 7. Plasma concentration of bimekizumab at Week 20 8. Plasma concentration of bimekizumab at Week 36 9. Plasma concentration of bimekizumab at Week 40 10. Plasma concentration of bimekizumab at Week 64 11. Plasma concentration of bimekizumab at Week 88 12. Plasma concentration of bimekizumab at Week 112 13. Plasma concentration of bimekizumab at Week 124 14. Plasma concentration of bimekizumab at safety follow up (SFU)
|
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. Baseline (Week 0) 2. Week 1 3. Week 4 4. Week 8 5. Week 12 6. Week 16 7. Week 20 8. Week 36 9. Week 40 10. Week 64 11. Week 88 12. Week 112 13. Week 124 14. Week 140 (SFU) |
|
E.5.2 | Secondary end point(s) |
1. Percentage of participants with treatment-emergent adverse events (TEAEs) 2. Percentage of participants with serious TEAEs 3. Percentage of participants with TEAEs leading to discontinuation of investigational medicinal product (IMP) 4. Percentage of participants with selected safety topics of interest 5. Change from Baseline in vital signs (systolic and diastolic blood pressure) 6. Change from Baseline in vital signs (heart rate or pulse rate) 7. Change from Baseline in vital signs (temperature) 8. Change from Baseline in physical examination findings reported as TEAEs with onset occurring from day of first dose through 20 weeks after final dose of IMP 9. Change from Baseline in hematology parameters (platelet count) 10. Change from Baseline in hematology parameters (mean corpuscular hemoglobin) 11. Change from Baseline in hematology parameters (mean corpuscular volume) 12. Change from Baseline in hematology parameters (erythrocytes) 13. Change from Baseline in hematology parameters (hemoglobin) 14. Change from Baseline in hematology parameters (hematocrit) 15. Change from Baseline in hematology parameters (basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes) 16. Change from Baseline in clinical chemistry parameters (calcium, potassium, sodium, blood urea nitrogen, glucose (nonfasting)) 17. Change from Baseline in clinical chemistry parameters (alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase) 18. Change from Baseline in clinical chemistry parameters (creatinine, total and direct bilirubin) 19. Change from Baseline in clinical chemistry parameters (total protein) 20. Change from Baseline in height 21. Change from Baseline in weight 22. Percentage of participants with Psoriasis Area and Severity Index (PASI) 90 response at Week 16 23. 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 24. Percentage of participants with Psoriasis Area and Severity Index (PASI) 75 response at Week 4 25. Percentage of participants with anti-bimekizumab antibody (AbAb) detection prior to investigational medicinal product (IMP) administration 26. Percentage of participants with anti-bimekizumab antibody (AbAb) detection following investigational medicinal product (IMP) administration 27. Change from Baseline in Children’s Dermatology Life Quality Index (CDLQI) response at Week 16 |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. - 21. From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140) 22.; 23. Week 16 24. Week 4 25. Baseline (Week 0) 26. From Week 1 through 20 weeks after final dose of IMP (up to Week 140) 27. Week 16, compared to Baseline
|
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Immunogenicity; Tolerability |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 10 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Canada |
United States |
Poland |
Germany |
|
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 12 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 11 |
E.8.9.2 | In all countries concerned by the trial days | 4 |