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 |
Hidradenitis Suppurativa, a chronic skin disease that appears after puberty, may lead to painful nodules and scarring in armpits, groin and other areas. Nodules may rupture to form draining tunnels. |
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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 | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020041 |
E.1.2 | Term | Hidradenitis suppurativa |
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 efficacy of bimekizumab in study participants with moderate to severe Hidradenitis Suppurativa (HS)
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E.2.2 | Secondary objectives of the trial |
- Evaluate the efficacy of bimekizumab on other measures of disease activity in study participants with moderate to severe HS - Evaluate the safety of bimekizumab in study participants with moderate to severe HS
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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 |
Pharmacogenetics sub-study: For individuals consenting to the pharmacogenetic substudy, blood samples will be drawn for exploratory genetic/epigenetic analyses at specified timepoints. A separate ICF will be required for those study participants who agree to participate in the pharmacogenetics substudy. Refusal to participate in the substudy will not affect a study participant's ability to participate in the main study. Photography sub-study: At certain sites, where feasible, representative photographs of the changes in skin will be captured. Photographs will be anonymized. This is optional for study participants and requires a separate informed consent. A decision not to consent does not exclude the study participant from the study. |
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E.3 | Principal inclusion criteria |
- Participant must be at least 18 years of age, at the time of signing the informed consent. If a study participant is under the local age of consent and is at least 18 years of age, written informed consent will be obtained from both the study participant and the legal representative - Study participants must have a diagnosis of Hidradenitis Suppurativa (HS) based on clinical history and physical examination for at least 6 months prior to the Baseline visit; diagnosis must be verifiable through medical notes and documentation - Study participant must have HS lesions present in at least 2 distinct anatomic areas (eg, left and right axilla), 1 of which must be at least Hurley Stage II or Hurley Stage III at both the Screening and Baseline visits - Study participant must have moderate to severe HS defined as a total of ≥5 inflammatory lesions (ie, number of abscesses plus number of inflammatory nodules) at both the Screening and Baseline visits - Study participant must have had a history of inadequate response to a course of a systemic antibiotics for treatment of HS at the Screening Visit as assessed by the Investigator through study participant interview and review of medical history; inadequate response must be verifiable through medical notes and documentation - A female study participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: a) Not a woman of childbearing potential (WOCBP) OR b) A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 20 weeks |
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E.4 | Principal exclusion criteria |
Draining tunnel count of >20 at the Baseline Visit - Any other active skin disease or condition (eg, bacterial cellulitis, candida intertrigo, extensive condyloma) that may, in the opinion of the Investigator, interfere with the assessment of hidradenitis suppurativa (HS) - Study participant has a diagnosis of sarcoidosis, systemic lupus erythematosus, or active inflammatory bowel disease (IBD) - Primary immunosuppressive condition, including taking immunosuppressive therapy following an organ transplant, or has had a splenectomy - Female who is breastfeeding, pregnant, or plans to become pregnant during the study or within 20 weeks following the final dose of investigational medicinal product (IMP) - Active infection or history of certain infection(s) - Active tuberculosis (TB) infection, latent TB infection, high risk of exposure to TB infection, current or history of nontuberculous mycobacterium (NTM) infection - Concurrent malignancy. Study participants with a history of malignancy within the past 5 years prior to the Screening Visit are excluded, EXCEPT if the malignancy was a cutaneous squamous or basal cell carcinoma, or in situ cervical cancer that has been treated and is considered cured - History of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease - Known hypersensitivity to any components of bimekizumab or comparative drugs as stated in this protocol - Concomitant and prior medication restrictions - Myocardial infarction or stroke within the 6 months prior to the Screening Visit - Study participant has the presence of active suicidal ideation, or positive suicide behavior using the "Screening" version of the electronic Columbia Suicide Severity Rating Scale (eC-SSRS) - Presence of moderately severe major depression or severe major depression - Subject has a history of chronic alcohol or drug abuse within 6 months prior to Screening |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 16 2. Absolute change from Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16 3. Absolute change from Baseline in Skin Pain score at Week 16 4. Percentage of participants achieving Skin Pain response at Week 16 5. Percentage of participants with treatment-emergent adverse events (TEAEs) during the study 6. Percentage of participants with serious treatment-emergent adverse events during the study 7. Percentage of participants with treatment-emergent adverse events (TEAEs) leading to withdrawal from the stud |
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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) |
1. Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 16 2. Percentage of participants with Flare by Week 16 3. Absolute change from Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16 4. Absolute change from Baseline in Skin Pain score at Week 16 5. Percentage of participants achieving Skin Pain response at Week 16 6. Percentage of participants with treatment-emergent adverse events (TEAEs) during the study 7. Percentage of participants with serious treatment-emergent adverse events during the study 8. Percentage of participants with treatment-emergent adverse events (TEAEs) leading to withdrawal from the study |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1: Week 16 2, 3, 4: From Baseline (Day 1) to Week 16 5, 6, 7: From Baseline (Day 1) until Safety Follow-Up (up to Week 71) |
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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 | Yes |
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 | Yes |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Tolerability, Immunogenicity
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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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 4 |
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 | 55 |
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 |
Israel |
United States |
France |
Netherlands |
Spain |
Switzerland |
Germany |
Greece |
Italy |
Belgium |
Denmark |
Norway |
Turkey |
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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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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 | 1 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 11 |