A study to test whether spesolimab helps people with a skin disease called hidradenitis suppurativa

Phase 1

Conditions: hidradenitis suppurativa
MedDRA version: 20.0Level: LLTClassification code 10020041Term: Hidradenitis suppurativaSystem Organ Class: 100000004858
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2020-003672-40-DE

Lead Sponsor: Boehringer Ingelheim Pharma GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 45

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: Not applicable;Primary end point(s): 1) percent change from baseline in total abscess and inflammatory nodule count at Week 12;Timepoint(s) of evaluation of this end point: 1) week 12

Secondary Outcome Measures

Name	Time	Method

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