A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Hidradenitis Suppurativa

Study Overview
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Brief Summary
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This study is open to adults with a chronic inflammatory skin disease called hidradenitis suppurativa. The purpose of this study is to find out whether a medicine called spesolimab helps people with moderate to severe hidradenitis suppurativa. Participants are put into 2 groups by chance. One group takes spesolimab. The other group takes placebo. Every participant has twice the chance of being in the spesolimab group than in the placebo group. Participants get spesolimab or placebo as an infusion into a vein every week for the first 3 weeks. Afterwards, they get spesolimab or placebo as injections under the skin every 2 weeks. Placebo infusions and injections look like spesolimab infusions and injections but do not contain any medicine. Participants are treated in the study for about 3 months. During this time, they visit the study site about 9 times. After completing this part of the study, participants are offered to join another clinical study in which all participants get spesolimab. Participants who cannot join the other study, stay in this study for about 4 more months. During this time, participants do not take spesolimab nor placebo but they visit the study site 2 times to have their health checked. At study visits, doctors thoroughly check the skin of participants to count lumps (nodules) and boils (abscesses). The results between the spesolimab group and the placebo group are compared after 3 months of treatment. The doctors also regularly check the general health of the participants.

Official Title
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Randomized, Double-blind, Placebo-controlled, Study of Spesolimab in Patients With Moderate to Severe Hidradenitis Suppurativa

Conditions
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Hidradenitis Suppurativa

Intervention / Treatment
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* Drug: Spesolimab
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female adult patients, 18 years of age or older Signed and dated written informed consent in accordance with International Council on Harmonisation (ICH) Good Clinical Practice (GCP) and local legislation prior to the start of any screening procedures Moderate to severe Hidradenitis suppurativa (HS), based on International Hidradenitis Suppurativa Severity Score System (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 TNF inhibitor (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 Further inclusion criteria apply Exclusion Criteria: Presence of active skin lesions other than HS that interfere 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 for HS 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 other than TNFi for HS Prior exposure to Interleukin 36 Receptor (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) Further exclusion criteria apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spesolimab<br> | Drug: Spesolimab<br>* Spesolimab<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change from baseline in total abscess and inflammatory nodule count (AN) at week 12 |  | baseline, week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change from baseline in draining fistula count at week 12 |  | baseline, week 12 | 
| 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. | week 12 | 
| Absolute change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) value at week 12 | The IHS4 assesses the HS severity and the resulting IHS4 score is arrived at by the number of nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4). A total score of 3 or less signifies mild, 4-10 signifies moderate and 11 or higher signifies severe disease. | baseline, week 12 | 
| Absolute change from baseline in Hidradenitis Suppurativa Area and Severity Index (HASI) score at week 12 | HASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (severe disease). | baseline, week 12 | 
| Achievement of Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) score of 0 or 1 at week 12 | The HS-PGA score ranges from 0 to 5, where 0 (clear: no abscesses, draining tunnels, inflammatory nodules or noninflammatory nodules), 1 (minimal: no abscesses, draining tunnels or inflammatory nodules and the presence of noninflammatory nodules), 2 (mild: no abscesses or draining tunnels and 1-4 inflammatory nodules, or 1 abscess or draining tunnel and no inflammatory nodules), 3 (moderate: no abscesses or draining tunnels and ≥5 inflammatory nodules, or 1 abscess or draining tunnel and ≥1 inflammatory nodule, or 2-5 abscesses or draining tunnels and <10 inflammatory nodules), 4 (severe: 2-5 abscesses or draining tunnels and ≥10 inflammatory nodules), 5 (very severe: >5 abscesses or draining tunnels). | week 12 | 
| Achievement of at least 30% reduction from baseline in Numerical rating scale (NRS30) in Patient's Global Assessment of Hidradenitis suppurativa (HS) Pain at week 12 | The Pain NRS assesses the HS-related pain severity. The Pain NRS will be completed on a daily diary by subjects from Screening through Week 12. Response is given by an 11-point scale ranging from 0 (no HS pain) to 10 (HS pain as bad as one can imagine). | baseline, week 12 | 
| Occurrence of complete elimination of draining fistulas at Week 12 |  | week 12 | 
| 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 |  | up to week 12 | 
| Absolute change from baseline in Dermatology Life Quality Index (DLQI) score at week 12 | DLQI is a patient-administered, ten-question, quality of life questionnaire that covers six domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. It's total score is calculated by summing the scores of each question resulting in a range of 0 to 30. The higher the score, the more the quality of life is impaired. | baseline, week 12 | 
| Absolute change from baseline in Hidradenitis Suppurativa Quality of Life (HiS-QoL) Total score at week 12 | HiS-QoL is a patient-administered, 17-item instrument to measure HS-specific quality of life in clinical trials. The 17-item HiS-QoL included four symptom items, eight activity-adaptation items and five psychosocial items. The item scores are summed to create a total ranging from 0 to 68, with higher scores indicating more severe impact on quality of life. | baseline, week 12 | 
| The occurrence of Treatment Emergent Adverse Events (TEAEs) |  | up to week 16 |