E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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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 | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10071117 |
E.1.2 | Term | Plaque psoriasis |
E.1.2 | System Organ Class | 100000004858 |
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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 |
Evaluate the dose response of Bimekizumab administered subcutaneously in subjects with moderate to severe chronic plaque psoriasis. |
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E.2.2 | Secondary objectives of the trial |
- evaluate the efficacy of individual dose regimens of Bimekizumab compared to placebo after 12 weeks of treatment
- compare the efficacy of the Bimekizumab dosage regimen 2 treatment group versus the Bimekizumab dosage regimen 3 treatment group (where dosage regimen 3 is the same as dosage regimen 2 but with a loading dose at Baseline)
- assess the safety, immunogenicity and tolerability of Bimekizumab
- assess the exposure response relationship of Bimekizumab
- asses the pharmacokinetics of Bimekizumab and characterize the population pharmacokinetics of Bimekizumab |
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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 |
The substudy will cover the pharmacogenomic assessments. |
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E.3 | Principal inclusion criteria |
- Subject has provided informed consent
- Chronic plaque psoriasis for at least 6 months prior to Screening
- PASI (Psoriasis Area and Severity Index) >=12 and BSA (body surface area) >=10% and IGA (Investigator’s Global Assessment) score 3 or greater on a 5-point scale
- Candidates for systemic psoriasis therapy and/or phototherapy and/or chemophototherapy
- Female subjects must be postmenopausal, permanently sterilized or, if of childbearing potential, must be willing to use a highly effective method of contraception up till 20 weeks after last administration of study drug
- Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active, up till 20 weeks after the last administration of study medication |
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E.4 | Principal exclusion criteria |
- Subjects with erythrodermic, guttate, pustular form of psoriasis, or drug-induced psoriasis
- Subject has any severe, progressive and/or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, gastrointestinal or neurological disease
- Subject has any significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol
- Subject taking prohibited psoriatic medications
- Subject receiving any live vaccines within 8 weeks prior to the Baseline and subjects receiving BCG vaccination within 1 year prior to study drug administration
- Subject has previously received treatment with any anti-IL-17 therapy or has been exposed to more than 1 biological response modifier (limited
to anti-TNF or IL-12/23) for psoriatic arthritis or psoriasis prior to the Baseline
- Subject has any current sign or symptom that may indicate an active infection (except for common cold) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Percentage of subjects achieving a 90% or higher improvement from Baseline in Psoriasis Area and Severity Index (PASI) score at Week 12 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- Percentage of subjects with IGA (Investigator´s Global Assessment) response at Week 12
- Percentage of subjects with IGA (Investigator´s Global Assessment) response at Week 8
- Percentage of subjects achieving a 90% or higher improvement from Baseline in PASI (Psoriasis Area and Severity Index) score at Week 8
- Percentage of subjects achieving a 75% or higher improvement in PASI (Psoriasis Area and Severity Index) score at Week 12
- Percentage of subjects achieving a 100% improvement from Baseline in PASI (Psoriasis Area and Severity Index) score at Week 12 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
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 | 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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 6 |
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 | 4 |
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 |
Canada |
Czech Republic |
Hungary |
Japan |
Poland |
United States |
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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
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Last Subject Last Visit (LSLV) |
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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 | 2 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 5 |
E.8.9.2 | In all countries concerned by the trial days | 0 |