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 |
Assess the long-term safety and tolerability of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis |
|
E.2.2 | Secondary objectives of the trial |
- Assess the safety of maintenance therapy bimekizumab dose regimens as measured by Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) leading to study withdrawal
- Assess the efficacy of maintenance therapy bimekizumab dose regimens as measured by Psoriasis Area Severity Index 90 (PASI90; defined as a subject who achieves 90% reduction in the PASI score from the feeder study Baseline) and Investigator’s Global Assessment (IGA) response (Clear or Almost Clear with at least a 2 category improvement from Baseline on a 5-point scale) |
|
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 |
There are two sub-studies, DV0002 and DV0006.
The purpose of the sub-studies is to evaluate the safe and effective use of self-injecting device presentations (ie, prefilled safety syringe and auto-injector presentations) for subcutaneous (sc) self-injection of bimekizumab by subjects in the US, Canada (DV0002) and in select sites in Europe, Japan (DV0006). |
|
E.3 | Principal inclusion criteria |
- Subject is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and medication intake according to the judgment of the Investigator
- Subject completes the feeder study (PS0008 [NCT03412747], PS0009 [NCT03370133], PS0013 [NCT03410992]) without meeting any withdrawal criteria
- Female subjects must be:
a) Postmenopausal: Menopause is defined as 12 consecutive months of amenorrhea, for which there is no other obvious pathological or
physiological cause
b) Permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral
salpingectomy)
c) Or, if of childbearing potential (and engaged in sexual activity that
could result in procreation), must be willing to use a highly effective
method of contraception throughout the duration of the study until 20
weeks after last administration of investigational medicinal product
(IMP), and have a negative pregnancy test at the feeder study in final
visit/Baseline visit in PS0014
|
|
E.4 | Principal exclusion criteria |
- Subject has previously participated in this study
- Female subjects who plan to become pregnant during the study or within 20 weeks following last dose of study medication
- Subject has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the subject’s ability to participate in this study. Note: For any subject with an ongoing Serious Adverse Event (SAE), or a history of serious infections in the feeder study, the Medical Monitor must be consulted prior to the subject’s entry into PS0014, although the decision on whether to enroll the subject remains with the investigator
- Subject has a positive or indeterminate interferon gamma release
assay (IGRA) in a feeder study, unless appropriately evaluated and
treated
- Subject must have a negative interferon gamma release assay (IGRA) as measured at the final dosing visit of the feeder study
- Subject may not participate in another study of a medicinal product or device under investigation other than the substudy
- Subject has a history of chronic alcohol or drug abuse within 6 months prior to Baseline as assessed by medical history, site interview, and/or results of the specified urine drug screen |
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to Investigational Medicinal Product (IMP) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
From Baseline to Safety Follow Up (up to Week 160) |
|
E.5.2 | Secondary end point(s) |
1. Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to IMP
2. Number of TEAEs leading to withdrawal adjusted by duration of subject exposure to IMP
3. Psoriasis Area Severity Index 90 (PASI90) response at Week 144
4. Investigator´s Global Assessment (IGA) 0/1 response at Week 144 |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1, 2: From Baseline to Safety Follow Up (up to week 160)
3, 4: Week 144 |
|
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 | 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) | 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 | 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 | Yes |
E.8.1.7.1 | Other trial design description |
Single group (Subjects will be randomized to receive dosage regimen 1 or dosage regimen 2) |
|
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 | 17 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 65 |
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 |
Canada |
Japan |
Korea, Republic of |
Taiwan |
United States |
Poland |
Germany |
Italy |
Belgium |
Hungary |
Russian Federation |
United Kingdom |
|
E.8.7 | Trial has a data monitoring committee | No |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 25 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 26 |