A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Hidradenitis Suppurativa

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Hidradenitis Suppurativa

Treatments: Drug: Placebo matching to spesolimab- solution for injection; Drug: Placebo matching spesolimab - solution for infusion; Drug: Spesolimab- solution for injection; Drug: Spesolimab - solution for infusion

Study type: Interventional

Funder types: Industry

Identifiers

NCT04762277

2020-003672-40 (EudraCT Number)

1368-0052

Details and patient eligibility

About

This study is open to adults with a chronic inflammatory skin disease called hidradenitis suppurativa. The purpose of this study is to find out whether a medicine called spesolimab helps people with moderate to severe hidradenitis suppurativa.

Participants are put into 2 groups by chance. One group takes spesolimab. The other group takes placebo. Every participant has twice the chance of being in the spesolimab group than in the placebo group. Participants get spesolimab or placebo as an infusion into a vein every week for the first 3 weeks. Afterwards, they get spesolimab or placebo as injections under the skin every 2 weeks. Placebo infusions and injections look like spesolimab infusions and injections but do not contain any medicine.

Participants are treated in the study for about 3 months. During this time, they visit the study site about 9 times. After completing this part of the study, participants are offered to join another clinical study in which all participants get spesolimab. Participants who cannot join the other study, stay in this study for about 4 more months. During this time, participants do not take spesolimab nor placebo but they visit the study site 2 times to have their health checked.

At study visits, doctors thoroughly check the skin of participants to count lumps (nodules) and boils (abscesses). The results between the spesolimab group and the placebo group are compared after 3 months of treatment. The doctors also regularly check the general health of the participants.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female adult patients, 18 years of age or older
• Signed and dated written informed consent in accordance with International Council on Harmonisation (ICH) Good Clinical Practice (GCP) and local legislation prior to the start of any screening procedures
• Moderate to severe Hidradenitis suppurativa (HS), based on International Hidradenitis Suppurativa Severity Score System (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. (If IHS4 scoring is not available, equivalent scoring based on scoring systems as HS-PGA or Hurley are acceptable based on documented investigator assessment)
• HS lesions in at least 2 distinct anatomic area (right/left axillary, inguinal, inframammary, perineal)
• Biologic naive or TNF inhibitor (TNFi)-failure for HS
• 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
• 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 Further inclusion criteria apply

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 for HS 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 Interleukin 36 Receptor (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) Further exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

52 participants in 2 patient groups, including a placebo group

Spesolimab

Experimental group

Treatment:

Drug: Spesolimab- solution for injection

Drug: Spesolimab - solution for infusion

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo matching to spesolimab- solution for injection

Drug: Placebo matching spesolimab - solution for infusion