A Study to Evaluate the Effectiveness of Spesolimab to Treat Hidradenitis Suppurativa


About this study

The purpose of this study is to assess the effectivess and safety of Spesolimab in Hidradenitis Suppurativa (HS) patients.


Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Male or female adult patients.
  •  ≥ 18 years of age.
  • Have moderate to severe Hidradenitis Suppurativa (HS) for at least 1 year prior to the baseline visit, as determined by the investigator.
  • Have HS lesions in at least 2 distinct anatomic area.
  • Has a 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.
  • 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 TNFifailure 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.
  • Women 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, 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.

* A woman is considered of childbearing potential (WOCBP); i.e.. fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Tubal ligation is NOT a method of permanent sterilisation. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.

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 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 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).
  • 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.
  • Active or latent TB:
    • Patients with active tuberculosis should be excluded;
    • 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;
    • Patients with indeterminate QuantiFERON or invalid/borderline T-spot may be retested with IGRA (once) and if inconclusive should have a PPD skin test;
    • 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.
  • Active systemic infection within 2 weeks of visit 2. Patients can be re-screened after treatment of the acute infection, as per investigator discretion.
  • 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.
  • 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).
  • Severe, progressive, or uncontrolled hepatic disease, defined as > 3-fold Upper Limit of Normal (ULN) elevation in AST or ALT or alkaline phosphatase, or > 2-fold ULN elevation in total bilirubin. Patients with Gilbert´s syndrome can be included unless total bilirubin elevation is > 5-fold ULN at screening visit and unless proportions of bilirubin fractions are inconsistent with diagnosis of Gilbert´s syndrome.
  • Evidence of a current or previous disease, medical condition (including chronic alcohol or drug abuse or any condition) other than HS, surgical procedure, psychiatric or social problems, medical examination finding (including vital signs and ECG), or laboratory value at the screening outside the reference range that in the opinion of the investigator is clinically significant and would compromise the safety of the patient or compromise the quality of the data, make the study participant unreliable to adhere to the protocol, comply with all study visits/procedures or to complete the trial.
  • Planned use of laser or other hair removal procedures over HS-affected areas during the trial period.
  • Any suicidal ideation of type 4 or 5 on the C-SSRS in the past 12 months (i.e., active suicidal thoughts with method and intent but without specific plan, or active suicidal thoughts with method, intent and plan).
  • Any suicidal behavior in the past 2 years (i.e., actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior).
  • Previous enrolment in this trial. (exception: patients re-screened).

Eligibility last updated 10/7/21. Questions regarding updates should be directed to the study team contact.



Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Afsaneh Alavi, M.D.

Closed for enrollment

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