A Study Investigating Long-term Treatment With Spesolimab in People With a Skin Disease Called Hidradenitis Suppurativa Who Completed a Previous Clinical Trial

Study Overview
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Brief Summary
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This study is open to adults with hidradenitis suppurativa who took part in a previous clinical study of a medicine called spesolimab. Participants who completed treatment can join this study. The purpose of this study is to find out how safe spesolimab is and whether it helps people with hidradenitis suppurativa in the long-term. Participants are in this study for about 2 years and 4 months. For 2 years, participants visit the study site every 2 weeks to get spesolimab injections under the skin. At study visits, doctors check the severity of participants' hidradenitis suppurativa and collect information on any health problems of the participants.

Official Title
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An Open-label, Long-term Extension Trial of Spesolimab Treatment in Adult Patients With Hidradenitis Suppurativa (HS)

Conditions
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Hidradenitis Suppurativa

Intervention / Treatment
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* Drug: Spesolimab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have completed treatment in the parent Hidradenitis suppurativa (HS) spesolimab trial (1368-0052) without premature discontinuation Signed and dated written informed consent in accordance with ICH Harmonized Guideline for Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial Woman 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. A list of contraception methods meeting these criteria is provided in the patient information and consent form. Exclusion Criteria: Women who are pregnant, nursing, or who plan to become pregnant while in the trial Patients who experienced study treatment-limiting adverse events during the 1368-0052 parent trial Severe, progressive, or uncontrolled condition such as renal, hepatic, haematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof Any new documented active or suspected malignancy except appropriately treated basal cell carcinoma, squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix Use of any restricted medication or any drug considered by the investigator likely to interfere with the safe conduct of the study since the last visit of the 1368-0052 parent trial History of allergy/hypersensitivity to the systemically administered trial medication agent or its excipients Major surgery (major according to the investigator's assessment) planned during this extension trial (e.g. hip replacement, aneurysm removal, stomach ligation), as assessed by the investigator Any condition which in the opinion of the investigator affects the safety of the patient, the patient's ability to participate in this trial or could compromise the quality of data 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants from parent trial (1368-0052) who were on placebo or active medication<br> | Drug: Spesolimab<br>* Spesolimab<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of treatment emergent adverse events (TEAE) up to the end of maintenance treatment period including residual effect period (REP) |  | up to week 120 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change in total abscess and inflammatory nodule (AN) count from baseline up to week 12 |  | up to week 12 | 
| Percentage change in total draining fistula (DF) count from baseline up to week 12 |  | up to week 12 | 
| Hidradenitis Suppurativa Clinical Response (HiSCR) | HiSCR is defined as at least a 50% reduction from baseline in abscess and inflammatory nodule (AN) count, with no increase in the abscess or draining fistula count. | up to week 12 | 
| Change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) value up to 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. | up to week 12 | 
| Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) score of 0 or 1 | 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). | up to week 12 | 
| Absolute change from baseline in Hidradenitis Suppurativa Area and Severity Index (HASI) score up to 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). | up to 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 | 
| Achievement of at least 30% reduction from baseline in Numerical Rating Scale (NRS30) in Patient's Global Assessment of HS Pain up to week 12 | The Pain NRS assesses the HS-related pain severity. The Pain NRS is completed by the patients during clinic visits. Response is given by an 11-point scale ranging from 0 (no HS pain) to 10 (HS pain as bad as one can imagine). | up to week 12 |