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 (HS) is a painful, long-term skin condition that causes abscesses and scarring on the skin. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
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 |
The primary objective of this study is to evaluate the efficacy of bimekizumab in subjects with moderate to severe HS.
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E.2.2 | Secondary objectives of the trial |
The secondary objective of this study is to assess the safety, tolerability, immunogenicity, and PK of bimekizumab in subjects with moderate to severe HS.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Adult subjects (18 to 70 years of age, inclusive) must have a diagnosis of HS for at least
1 year prior to Baseline
- Stable HS for at least 2 months prior to Screening and also at the Baseline Visit
- Inadequate response to at least a 3-month study of an oral antibiotic for treatment of HS
- Total abscess and inflammatory nodule count >=3 at the Baseline Visit
- Subject must agree to daily use (and throughout the entirety of the study) of 1 pre-specified
over-the-counter topical antiseptics on their HS lesions
- 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 must be willing to use a method of contraception when sexually active, up till 20 weeks
after the last administration of study medication |
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E.4 | Principal exclusion criteria |
- Prior treatment with anti-IL17s or participation in an anti-IL17 study
- Previously received anti-TNFs
- Subject requires, or is expected to require, opioid analgesics for any reason (excluding
tramadol)
- Subject received prescription topical therapies for the treatment of HS within 14 days prior to
the Baseline Visit
- Subject received systemic non-biologic therapies for HS with potential therapeutic impact for
HS less than 28 days prior to Baseline Visit
- Draining fistula count >20 at the Baseline Visit
- Diagnosis of inflammatory conditions other than HS |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Percentage of subjects achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response (HiSCR) |
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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. Bimekizumab plasma concentration at Visit 2
2. Bimekizumab plasma concentration at Visit 3
3. Bimekizumab plasma concentration at Visit 4
4. Bimekizumab plasma concentration at Visit 8
5. Bimekizumab plasma concentration at Visit 11
6. Bimekizumab plasma concentration at Visit 12
7. Number of Adverse Events (AE)
8. Number of Adverse Events categorized by severity
9. Number of Serious Adverse Events (SAEs)
10. Number of Serious Adverse Events (SAEs) categorized by severity
11. Number of subjects withdrawing due to Adverse Events
12. Change from Baseline in vital signs (blood pressure [BP] and pulse rate) and body weight 13. Change
from Baseline in ECG parameters
14. Change from Baseline in clinical laboratory parameters (hematology, biochemistry, and urinalysis)
15. Change from Baseline in physical examination
16. Bimekizumab Anti-Drug Antibody (ADA) concentration at Visit 2
17. Bimekizumab Anti-Drug Antibody (ADA) concentration at Visit 3
18. Bimekizumab Anti-Drug Antibody (ADA) concentration at Visit 4
19. Bimekizumab Anti-Drug Antibody (ADA) concentration at Visit 8
20. Bimekizumab Anti-Drug Antibody (ADA) concentration at Visit 11
21. Bimekizumab Anti-Drug Antibody (ADA) concentration at Visit 12 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1,16. Visit 2 (Day 1)
2,17. Visit 3 (Week 2)
3,18. Visit 4 (Week 4)
4,19. Visit 8 (Week 8)
5,20. Visit 11 (Week 12)
6,21. Visit 12 (Week 30)
7-15. From Screening to Safety Follow-Up (Week 30) |
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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 | 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) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
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 | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 25 |
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 |
Belgium |
Canada |
Denmark |
Germany |
Greece |
Netherlands |
Norway |
Poland |
Russian Federation |
Spain |
United Kingdom |
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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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 | 15 |
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 | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |