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 |
a skin disease called hidradenitis suppurativa |
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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 is to estimate the effect of spesolimab compared to placebo for the mean percent change from baseline in total abscess and inflammatory nodule count at Week 12. Secondary objectives are the evaluation of efficacy of spesolimab on secondary endpoints versus placebo. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Male or female adult patients, 18 years of age or older. - Signed and dated written informed consent in accordance with ICH Good Clinical Practice (GCP) and local legislation prior to the start of any screening procedures. - Moderate to severe HS, based on IHS4 criteria, for at least 1 year prior to the baseline visit, as determined by the investigator through participant interview and/or review of the medical history. (If IHS4 scoring is not available, equivalent scoring based on scoring systems as HS-PGA or Hurley are acceptable, based on documented investigator assessment.) - HS lesions in at least 2 distinct anatomic area (right/left axillary, inguinal, inframammary, perineal) - Biologic naive or TNFi-failure for HS. - Inadequate response to an adequate course of appropriate oral antibiotics for treatment of HS in the last 1 year, as per investigator discretion. This is not applicable for TNFi-failure patients - Total abscess and inflammatory nodule (AN) count of greater than or equal to 5. - Total draining fistula count of less than or equal to 20. - Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly, for the duration of the trial and 16 weeks after last administration. A list of contraception methods meeting these criteria is provided in the patient information. |
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E.4 | Principal exclusion criteria |
- Presence of active skin lesions other than HS that interferes with the assessment of HS. - Use of restricted medications as below. -- Topical corticosteroids over HS lesions within 1 week of Visit 2. -- Systemic antibiotics within 4 weeks of visit 2. -- Systemic non-biologic immunomodulatory and/or immunosuppressive agents use within 4 weeks or 5 half-lives, whichever is longer, of visit 2. -- Biologic agents use within 12 weeks or 5 half-lives, whichever is longer, prior to visit 2. -- Opioid analgesics within 2 weeks of visit 2. -- Live virus vaccine within 6 weeks of visit 2. - Prior exposure to any immunosuppressive biologic agent other than TNFi for HS. - Prior exposure to IL-36R inhibitors including spesolimab.
- Treatment with any investigational device or investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives of the drug, whichever is longer, prior to visit 2. - Women who are pregnant, nursing, or who plan to become pregnant while in the trial. Women who stop nursing before the study drug administration do not need to be excluded from participating. - History of allergy/hypersensitivity to the systemically administered trial medication agent or its excipients. - Patient with a transplanted organ (with exception of a corneal transplant > 12 weeks prior to screening) or who have ever received stem cell therapy (e.g., Remestemcel-L). - Any documented active or suspected malignancy or history of malignancy within 5 years prior to the screening visit, except appropriately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix.
Further criteria apply. |
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E.5 End points |
E.5.1 | Primary end point(s) |
1) percent change from baseline in total abscess and inflammatory nodule count 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) |
1) Percent change from baseline in draining fistula count at Week 12. 2) Achievement of Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12. HiSCR is defined as at least a 50% reduction in the total AN count with no increase in abscess count and no increase in draining fistula count relative to baseline. 3) Absolute change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) value at Week 12. 4) Absolute change from baseline in HASI score at Week 12. 5) Achievement of PGA score of 0 or 1 at Week 12. 6) Achievement of at least 30% reduction from baseline in Numerical rating scale (NRS30) in Patient’s Global Assessment of HS Pain at Week 12. 7) Occurrence of complete elimination of draining fistulas at Week 12. 8) Occurrence of at least one flare (defined as at least 25 % increase in AN count with a minimum increase of 2 relative to baseline) up to Week 12. 9) Absolute change from baseline in DLQI Score at Week 12. 10) Absolute change from baseline in HiS-QoL Total Score at Week 12. 11) Occurrence of Treatment Emergent Adverse Events (TEAEs). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) Week 12 2) Week 12 3) Week 12 4) Week 12 5) Week 12 6) Week 12 7) Week 12 8) Week 12 9) Week 12 10) Week 12 11) Week 12
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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 | No |
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 | 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 | 30 |
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 |
United States |
Belgium |
Denmark |
France |
Germany |
Hungary |
Italy |
Netherlands |
Norway |
Poland |
Spain |
United Kingdom |
Czechia |
Greece |
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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 | 5 |
E.8.9.1 | In the Member State concerned days | 13 |
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 | 13 |