Phase 2
Completed N=45
A Study Investigating Long-term Treatment With Spesolimab in People With a Skin Disease Called Hidradenitis Suppurativa Who Completed a Previous Clinical Trial
Source: ClinicalTrials.gov NCT04876391 ↗Enrolled (actual)
45
Serious AEs
22.2%
Results posted
Jun 2025
Primary outcomePrimary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) — 15; 28 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
15; 28 | — |
| SECONDARY Percent Change in Total Abscess and Inflammatory Nodule (AN) Count From Baseline up to Week 12 |
-18.3; -35.0 | — |
| SECONDARY Percentage Change in Total Draining Fistula (DF) Count From Baseline up to Week 12 |
25.4; -44.6 | — |
| SECONDARY Achievement of Hidradenitis Suppurativa Clinical Response (HiSCR) up to Week 12 |
33.3; 40.7 | — |
| SECONDARY Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) Value up to Week 12 |
-3.1; -10.5 | — |
| SECONDARY Percentage of Participants With Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) Score of 0 or 1 up to Week 12 |
0; 3.7 | — |
| SECONDARY Absolute Change From Baseline in Hidradenitis Suppurativa Area and Severity Index (HASI) Score up to Week 12 |
5.0; -22.8 | — |
| SECONDARY Patients With 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 |
8.3; 14.8 | — |
| SECONDARY 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 |
25.0; 33.3 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04876391). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.