a skin disease called hidradenitis suppurativa Verneuil's disease
Conditions
Interventions
Spesolimab (BI 655130) or matching placebo
1x per week 1200 mg i.v. in week 0, 1 en 2
1x per two weeks 1200 mg s.c. in week 4, 6, 8 en 10
Total duration of intervention: 12 weeks.
2/3 of total num
Sponsors
Boehringer Ingelheim
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Male or female adult patients, 18 years of age or older. 2. 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. 3. 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. 4. HS lesions in at least 2 distinct anatomic area (right/left axillary, inguinal,inframammary, perineal) 5. Biologic naive or TNFi-failure for HS. 6. 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 7. Total abscess and inflammatory nodule (AN) count of greater than or equal to 5. 8. Total draining fistula count of less than or equal to 20. 9. Women of childbearing potential (WOCBP1) 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.
Exclusion criteria
Exclusion criteria: 1. Presence of active skin lesions other than HS that interferes with the assessment of HS. 2. Use of restricted medications as below. Please see section 4.2.2 for further information. - 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. 3. Prior exposure to IL-36R inhibitors including spesolimab. 4. Patients who must or choose to continue the intake of restricted medications (see section 4.2.2.1) or any drug considered likely to interfere with the safe conduct of the trial. 5. 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. 6. 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. 7. History of allergy/hypersensitivity to the systemically administered trial medication agent or its excipients. 8. 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). 9. 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. 10. Active or latent TB: o Patients with active tuberculosis should be excluded. o Patients will be screened with Interferon Gamma Release Assay (IGRA) such as QuantiFERON or T-spot. Patients with positive IGRA are excluded unless they have completed treatment for active or latent tuberculosis per investigator discretion, at the time of screening. o Patients with indeterminate QuantiFERON or invalid/borderline T-spot may be retested with IGRA (once) and if inconclusive should have a PPD skin test. o PPD skin test, also called Tuberculin- Skin testing (TST), can be performed if IGRA is not available or inconclusive. A tuberculin skin test reaction *10mm (*5mm if receiving *15mg/d prednisone or other immunosuppressant) is considered positive. Patients with a positive TST are excluded unless they have completed treatment as above. 11. Active systemic infection within 2 weeks of visit 2. Patients can be re-screened after treatment of the acute infection, as per investigator discretion. 12. Relevant chronic infections as determined by the investigator, including human immunodeficiency virus (HIV) or viral hepatitis. In case of a positive hepatitis C antibody test, a positive reflex testing for Hepatitis C RNA PCR is considered positive. 13. Major surgery (major according to the investigator) performed within 12 weeks prior to first study drug administration or planned during the study (e.g. hip replacement, aneurysm removal, stomach ligation) 14. Severe, progressive, or uncontrolled hepatic disease, defined as >3-fold Upper Limit of Normal (ULN) elevation in AST o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the percent change from baseline in total abcess and inflammatory nodule count at Week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are defined as described below: - Percent change from baseline in draining fistula count at Week 12 - Percentage of patients achieving 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. - Absolute change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) value at Week 12 - Absolute change from baseline in HASI score at Week 12 - Percentage of patients achieving PGA score of 0 or 1 at Week 12 - Percentage of patients with at least 30% reduction from baseline in Numerical rating scale (NRS30) in Patient*s Global Assessment of HS Pain at Week 12 - Complete elimination of draining fistulas at Week 12 - 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. - Absolute change from baseline in DLQI Score at Week 12. - Absolute change from baseline in HiS-QoL Total Score at Week 12. | — |
Countries
Netherlands
Outcome results
None listed