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

NCT04762277 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 1368-00522020-003672-40
• Study Type: interventional
• Target: 52
• Locations: 12 countries
• Sites: 25

Brief Summary

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.

Conditions

Hidradenitis Suppurativa

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in Total Abscess and Inflammatory Nodule Count at Week 12

  Percent change from baseline in total abscess and inflammatory nodule count at Week 12= \[(Total Abscess at Week 12 + Total Inflammatory Nodule at Week 12) - (Total Abscess at baseline + Total Inflammatory Nodule at baseline)\] \*100/ (Total Abscess at baseline + Total Inflammatory Nodule at baseline). Percent change from baseline in total abscess and inflammatory nodule count at Week 12 was modelled using mixed effects model for repeated measures (MMRM) accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, the effect of stratum (stratification according to tumor necrosis factor inhibitor (TNFi)-naive population vs. TNFi-failure population) and the fixed continuous effects of baseline at each visit (Weeks 1, 2, 4, 6, 8, 10, and 12). The Least Squares Mean (Standard Error) at Week 12 is reported.

  MMRM included measurements from baseline (Week 0) and at Weeks 1, 2, 4, 6, 8, 10, and 12 after first drug administration. MMRM estimates of percent change from baseline to Week 12 is reported.

Secondary Outcomes (11)

• Percent Change From Baseline in Draining Fistula Count at Week 12

  MMRM included measurements from baseline (Week 0) and at Weeks 1, 2, 4, 6, 8, 10, and 12 after first drug administration. MMRM estimates of percent change in draining fistula from baseline to Week 12 is reported.

• Achievement of Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12

  At baseline (Week 0) and at Week 12.

• Absolute Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) Value at Week 12

  MMRM included measurements at baseline (Week 0) and at Weeks 1, 2, 4, 6, 8, 10, and 12 after first drug administration. MMRM estimates of absolute change in IHS4 from baseline to Week 12 is reported.

• Absolute Change From Baseline in Hidradenitis Suppurativa Area and Severity Index (HASI) Score at Week 12

  MMRM included measurements at baseline (Week 0) and at Weeks 1, 2, 4, 6, 8, 10, and 12 after first drug administration. MMRM estimates of absolute change from baseline in HASI score at Week 12 is reported in the table below.

• Achievement of Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) Score of 0 or 1 at Week 12

  At Week 12.

Study Arms (2)

Spesolimab

EXPERIMENTAL

Drug: Spesolimab - solution for infusion; Drug: Spesolimab- solution for injection

Placebo

PLACEBO COMPARATOR

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

Interventions

Spesolimab - solution for infusion DRUG

Solution for infusion

Spesolimab

Placebo matching spesolimab - solution for infusion DRUG

Solution for infusion

Placebo

Spesolimab- solution for injection DRUG

Solution for injection

Spesolimab

Placebo matching to spesolimab- solution for injection DRUG

Solution for injection

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (25)

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250, United States

Location

Mayo Clinic, Rochester

Rochester, Minnesota, 55905, United States

Location

Unity Clinical Research

Oklahoma City, Oklahoma, 73118, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Holdsworth House Medical Practice

Sydney, New South Wales, 2010, Australia

Location

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

ULB Hopital Erasme

Brussels, 1070, Belgium

Location

Dr. S. K. Siddha Medicine Professional Corporation

Newmarket, Ontario, L3Y 5G8, Canada

Location

University Hospital Ostrava

Ostrava, 708 52, Czechia

Location

CLI Reims Bezannes

Bezannes, 51430, France

Location

HOP Edouard Herriot

Lyon, 69003, France

Location

HOP Larrey

Toulouse, 31059, France

Location

Katholisches Klinikum Bochum gGmbH

Bochum, 44791, Germany

Location

Städtisches Klinikum Dessau

Dessau, 06847, Germany

Location

Universitätsklinikum Frankfurt

Frankfurt am Main, 60596, Germany

Location

Ospedali Riuniti di Ancona

Ancona, 60123, Italy

Location

Azienda Ospedaliera Universitaria Pisana

Pisa, 56126, Italy

Location

Erasmus Medisch Centrum

Rotterdam, 3015 GD, Netherlands

Location

Haukeland Universitetssykehus

Bergen, N-5021, Norway

Location

Nordlandssykehuset HF, Bodø

Bodø, 8005, Norway

Location

Oslo Universitetssykehus HF, Rikshospitalet

Oslo, N-0372, Norway

Location

Non-Public Health Care Facility LABDERM

Ossy, 42624, Poland

Location

Cityclinic Medical and Psychological Clinic Matusiak Partnership

Wroclaw, 50-566, Poland

Location

Hospital Santa Creu i Sant Pau

Barcelona, 08026, Spain

Location

Related Publications (1)

• Lebwohl MG, Thoma C, Haeufel T. Spesolimab use in generalised pustular psoriasis flares - Authors' reply. Lancet. 2024 Aug 31;404(10455):847-848. doi: 10.1016/S0140-6736(24)01557-5. No abstract available.

  PMID: 39216969 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

Injections

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: February 21, 2021
• Study Start: April 6, 2021
• Primary Completion: January 19, 2022
• Study Completion: April 21, 2022
• Last Updated: October 20, 2025
• Results First Posted: October 9, 2024

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3); BE (1); NO (3); ES (1); AU (2); FR (3); IT (2); NL (1); CZ (1); US (5); PL (2); CA (1)