E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate to Severe Chronic Plaque Psoriasis
|
|
E.1.1.1 | Medical condition in easily understood language |
Moderate to Severe Chronic 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 |
Compare the efficacy of bimekizumab administered for 16 weeks versus placebo in the treatment of subjects with moderate to severe chronic plaque psoriasis (PSO)
|
|
E.2.2 | Secondary objectives of the trial |
- Evaluate the efficacy of bimekizumab compared to placebo at achieving complete clearance (PASI100) after 16 weeks of treatment - Evaluate the efficacy of bimekizumab compared to placebo after 4 weeks of treatment - Evaluate the efficacy of bimekizumab compared to ustekinumab after 4 weeks, 12 weeks, 16 weeks, and 52 weeks of treatment - Evaluate the change in itch, pain, and scaling of bimekizumab compared to placebo after 16 weeks of treatment as reported by subjects using the Patient Symptom Diary - Evaluate the change in psoriatic scalp disease of bimekizumab compared to placebo after 16 weeks of treatment in subjects with scalp PSO at Baseline - Assess Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs leading to withdrawal adjusted by duration of subject exposure to study treatment
|
|
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Genomic, genetic, epigenetic, proteins, and metabolite biomarkers may be measured in the substudy. Selected sites in the US will participate in the photography substudy.
|
|
E.3 | Principal inclusion criteria |
- Must be at least 18 years of age - Chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening Visit - Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Investigator’s Global Assessment (IGA) score >=3 on a 5-point scale - Subject is a candidate for systemic PSO therapy and / or phototherapy - Female subject of child bearing potential must be willing to use highly effective method of contraception
|
|
E.4 | Principal exclusion criteria |
- Subject has an active infection (except common cold), a recent serious infection, or a history of opportunistic or recurrent chronic infections - Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection - Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection - Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study - Presence of active suicidal ideation or positive suicide behavior - Presence of moderately severe major depression or severe major depression - Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
1. Psoriasis Area and Severity Index 90 (PASI90) response at Week 16 2. Investigator’s Global Assessment (IGA) response at Week 16
|
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
1. PASI100 response at Week 16 2. PASI75 response at Week 4 3. Patient Symptom Diary response for itch at Week 16 4. Patient Symptom Diary response for pain at Week 16 5. Patient Symptom Diary response for scaling at Week 16 6. Scalp IGA response (Clear or Almost Clear with at least a 2-category improvement from Baseline) at Week 16 for subjects with scalp psoriasis (PSO) at Baseline 7. PASI90 response at Week 12 8. PASI90 response at Week 52 9. IGA response at Week 12 10. IGA response at Week 52 11. Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment 12. Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment 13. Number of Treatment Emergent Adverse Events (TEAEs) leading to withdrawal adjusted by duration of subject exposure to study treatment
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1, 3, 4, 5, 6: Week 16 2: Week 4 7, 9: Week 12 8, 10: Week 52 11,12,13: From Baseline to Safety Follow Up (up to Week 72)
|
|
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 | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
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 | 24 |
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 |
Australia |
Belgium |
Canada |
Czech Republic |
France |
Germany |
Hungary |
Italy |
Japan |
Poland |
Russian Federation |
United Kingdom |
United States |
|
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
|
Last Subject Last Visit (LSLV)
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 17 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 17 |