Randomized, double-blind, placebo-controlled, study of spesolimab in patients with moderate or severe hidradenitis suppurativa.
- Conditions
- a skin disease called hidradenitis suppurativaVerneuil's disease10040798
- Registration Number
- NL-OMON51225
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 3
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is the percent change from baseline in total abcess and<br /><br>inflammatory nodule count at Week 12.</p><br>
- Secondary Outcome Measures
Name Time Method