E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
Psoriatic Arthritis is a type of Inflammatory Arthritis |
|
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 | 10037160 |
E.1.2 | Term | Psoriatic arthritis |
E.1.2 | System Organ Class | 100000018188 |
|
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 dose-response based on the efficacy of bimekizumab |
|
E.2.2 | Secondary objectives of the trial |
- Assess the efficacy of the individual dose regimens of bimekizumab compared to placebo - Assess skin and nail psoriasis in the subgroup of affected subjects at baseline - Assess the safety and tolerability of bimekizumab - Assess the pharmacokinetics (PK) of bimekizumab - Assess the pharmacodynamics (PD) of bimekizumab - Assess the immunogenicity of bimekizumab - Assess the exposure: response relationship of bimekizumab as it relates to efficacy and safety
|
|
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 |
A substudy will be initiated to asses genomic, genetic/epigenetic and proteomic variables.
|
|
E.3 | Principal inclusion criteria |
- Subject has a documented diagnosis of adult-onset PsA classified by CASPAR criteria with symptoms for at least 6 months prior to Screening, with active PsA at Baseline/Day 1, and must have at Baseline TJC >=3 out of 78 and SJC >=3 out of 76 - Subject must be rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies negative - Subject must have a hs-CRP >=ULN - Subject must have active psoriatic lesion(s) and/or a documented history of psoriasis - Subjects who are regularly taking NSAIDs/COX-2 inhibitors as part of their PsA therapy are required to be on a stable dose/dose regimen for at least 14 days before Baseline - Subjects taking corticosteroids must be on an average daily dose of <=10mg/day prednisone or equivalent for at least 14 days before Baseline and should remain on a stable dose through the Week 16 visit - Subjects taking MTX (<=25mg /week) are allowed to continue their medication if started at least 12 weeks prior to Baseline, with a stable dose for at least 8 weeks before randomization - Subjects taking LEF (<=20mg/day or an average of 20mg/day if not dosed daily) are allowed to continue their medication if started at least 3 months prior to Baseline, with a stable dose for at least 8 weeks before randomization. Dose and dosing schedule should remain stable up to Week 16 - Subjects may be TNF inhibitor naïve or may have received 1 prior TNF inhibitor. Subjects who have been on a TNF inhibitor previously must have: - -experienced an inadequate response to previous treatment given for at least 3 months - -been intolerant to administration (eg, had a side-effect/AE that led to discontinuation) - -lost access to TNF inhibitor for other reasons |
|
E.4 | Principal exclusion criteria |
- Subjects with any current sign or symptom that may indicate an active infection (with the exception of the common cold) or has had an infection requiring systemic antibiotics within 2 weeks of Baseline/Day 1 - Subjects with a history of chronic or recurrent infections, or a serious or life-threatening infection within the 6 months prior to the Baseline Visit - Subjects with concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection - Subjects with known history of or current clinically active infection with Histoplasma, Coccidioides, Paracoccidioides, Pneumocystis, Blastomyces, or Aspergillus or current active Candidiasis - Subjects receiving any live (includes attenuated) vaccination within the 8 weeks prior to Baseline - Subjects with known tuberculosis (TB) infection, at high risk of acquiring TB infection, with latent TB infection (LTBI), or current or history of nontuberculous mycobacteria (NTMB) infection - Subjects with a diagnosis of inflammatory conditions other than psoriasis or psoriatic arthritis - Subjects with concurrent malignancy or a history of malignancy during the past 5 years will be excluded, with following exceptions that may be included: a) <= 3 excised or ablated basal cell carcinomas of the skin b) One squamous cell carcinoma of the skin (stage T1 maximum) successfully excised, or ablated only (other treatments, ie, chemotherapy, do not apply), with no signs of recurrence or metastases for more than 2 years prior to Screening c) Actinic keratosis (-es) d) Squamous cell carcinoma-in-situ of the skin successfully excised, or ablated, more than 6 months prior to Screening |
|
E.5 End points |
E.5.1 | Primary end point(s) |
ACR50 (American College of Rheumatology 50% Improvement) Response at Week 12 |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
- ACR20 (American College of Rheumatology 20% Improvement) Response at Week 12 - ACR70 (American College of Rheumatology 70% Improvement) Response at Week 12 - Psoriasis Area Severity Index (PASI90) Response at Week 12 in the Subgroup of Subjects With Psoriasis Involving at Least 3 % Body Surface Area (BSA) at Baseline/Day 1 - Psoriasis Area Severity Index (PASI75) Response at Week 12 in the Subgroup of Subjects With Psoriasis Involving at Least 3 % Body Surface Area (BSA) at Baseline/Day 1 |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline Baseline/Day 1 Week 12 |
|
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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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 | 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 | 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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 5 |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 40 |
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 |
Czech Republic |
Germany |
Hungary |
Poland |
Russian Federation |
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 8 |
E.8.9.2 | In all countries concerned by the trial days | 0 |