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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 63

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.
- 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 16

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 within 1 week of Visit 2
-- Systemic antibiotics within 4 weeks of visit 2.
-- Systemic non-biologic therapies for HS within 4 weeks of visit 2.
-- Biologic 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 IL-36R inhibitors including spesolimab.
- Patients who must or choose to continue the intake of restricted
medications or any drug considered likely to interfere with the safe
conduct of the trial.
- 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 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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