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 time-course of PASI over a 28-week period following the administration of bimekizumab given at Baseline and Week 4 to subjects with moderate to severe chronic plaque psoriasis. |
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E.2.2 | Secondary objectives of the trial |
- Evaluate the time-course of PASI over a 28-week period following the administration of bimekizumab given at Baseline and Weeks 4 and 16 in subjects with moderate to severe plaque psoriasis
- Assess the pharmacokinetics (PK) and immunogenicity of bimekizumab
- Assess the safety and tolerability of bimekizumab |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Male or female at least 18 years of age and less than or equal to 70
- Chronic plaque psoriasis for at least 6 months prior to Screening
- Psoriasis Area and Severity Index (PASI) >=12 and body surface area (BSA) >=10% and Investigator’s Global Assessment (IGA) score >=3 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, and have a negative pregnancy test at Visit 1 (Screening) and immediately prior to first dose
- 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 (anticipated 5 half-lives) |
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E.4 | Principal exclusion criteria |
- Subjects previously participating in a bimekizumab study
- Subjects with erythrodermic, guttate, pustular form of psoriasis, or drug-induced psoriasis
- History of chronic or recurrent infections, or a serious or life-threatening infection within the 6 months prior to the Baseline Visit (including herpes zoster)
- High risk of infection in the Investigator’s opinion
- Current sign or symptom that may indicate an active infection
- Concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection
- Live (includes attenuated) vaccination within the 8 weeks prior to Baseline
- Subjects with concurrent malignancy or history of malignancy during the past 5 years (except for specific malignat condition as defined in the protocol)
- Primary immunosuppressive conditions
- TB infection, high risk of acquiring TB infection, latent TB infection (LTBI), or current or history of NTMB infection
- Laboratory abnormalities, as defined in the study protocol
- Any condition which, in the Investigator's judgement, would make the subject unsuitable for inclusion in the study
- Exposure to more than 1 biological response modifier (limited to anti-TNF or IL-12/-23) or any biologic response modifier during the three months prior to the Baseline Visit
- Subjects have received previous treatment with any anti-IL-17 therapy for the treatment of psoriasis or psoriatic arthritis
- Subjects with a diagnosis of inflammatory conditions other than psoriasis or psoriatic arthritis, including but not limited to rheumatoid arthritis, sarcoidosis, or systemic lupus erythematosus.
- Subjects with a diagnosis of Crohn’s disease or ulcerative colitis are allowed as long as they have no active symptomatic disease at Screening or Baseline
- Subjects taking psoriatic arthritis medications other than nonsteroidal anti-inflammatory drugs (NSAIDs) or analgesics |
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E.5 End points |
E.5.1 | Primary end point(s) |
- Change from Baseline in Psoriasis Area and Severity Index (PASI) at Week 28
- Mean plasma concentration of bimekizumab at Week 16
- Number of participants reporting positive Anti-Drug-Antibodies (ADA) titre prior to and following study treatment with bimekizumab
- Incidence of adverse events (AEs) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
- Week 28
- Week 16
- From Baseline to the End of Treatment (Week 28)
- From Baseline to Safety Follow Up Visit (Week 36) |
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E.5.2 | Secondary end point(s) |
- Number of subjects achieving a 75% or higher improvement from Baseline in PASI (Psoriasis Area and Severity Index) score at Week 16
- Number of subjects achieving a 90% or higher improvement in PASI (Psoriasis Area and Severity Index) score at Week 16
- Number of subjects achieving a 100% improvement from Baseline in PASI (Psoriasis Area and Severity Index) score at Week 16
- Percentage of subjects with IGA (Investigator´s Global Assessment) response at Week 16 |
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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 | No |
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 | 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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 8 |
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 |
Georgia |
Germany |
Moldova, Republic of |
Romania |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |