A Study Investigating Long-term Treatment With Spesolimab in People With a Skin Disease Called Hidradenitis Suppurativa Who Completed a Previous Clinical Trial

NCT04876391 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 1368-00672020-005587-55
• Study Type: interventional
• Target: 45
• Locations: 12 countries
• Sites: 26

Brief Summary

This study is open to adults with hidradenitis suppurativa who took part in a previous clinical study of a medicine called spesolimab. Participants who completed treatment can join this study. The purpose of this study is to find out how safe spesolimab is and whether it helps people with hidradenitis suppurativa in the long-term. Participants are in this study for about 2 years and 4 months. For 2 years, participants visit the study site every 2 weeks to get spesolimab injections under the skin. At study visits, doctors check the severity of participants' hidradenitis suppurativa and collect information on any health problems of the participants.

Conditions

Hidradenitis Suppurativa

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

  TEAEs were defined as all adverse events (AEs) occurring from the start of treatment in this extension trial to the end of its residual effect period. AEs that began during the on-treatment period of the parent Proof of Concept and Confirmatory (PoCC) trial (1368-0052) and were still ongoing in this extension trial will also be considered as treatment-emergent.

  From drug administration until the end of maintenance treatment period (120 weeks). This period includes the Residual effect period (REP) (i.e., 16 weeks after the last study treatment).

Secondary Outcomes (8)

• Percent Change in Total Abscess and Inflammatory Nodule (AN) Count From Baseline up to Week 12

  MMRM included measurements from baseline (Week 12 of 1368-0052) and at Weeks 1, 2, 4, 6, 8, 10, and 12 after first drug administration.

• Percentage Change in Total Draining Fistula (DF) Count From Baseline up to Week 12

  MMRM included measurements from baseline (Week 12 of 1368-0052) and at Weeks 1, 2, 4, 6, 8, 10, and 12 after first drug administration. MMRM estimates of percentage change in draining fistula from baseline to Week 12 is reported.

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

  At baseline (Week 0) and at Week 12.

• Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) Value up to 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.

• Percentage of Participants With Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) Score of 0 or 1 up to Week 12

  At Week 12.

Study Arms (2)

Prior Placebo (PP)

EXPERIMENTAL

Participants in the placebo arm of the 1368-0052 Proof of Concept Clinical (PoCC) trial received an initial 1200 mg intravenous (i.v.) loading dose of spesolimab plus subcutaneous (s.c.) placebo at Visit 1, followed by 600 mg s.c. doses of spesolimab every two weeks for the next 12 weeks. Further dosing was based on changes in HS-PGA grade assessment from baseline to week 12.

Drug: Spesolimab 1200 mg; Drug: Spesolimab 600 mg; Drug: Placebo matching 600 mg Spesolimab

Prior Spesolimab (PS)

EXPERIMENTAL

Participants in the active arm of the 1368-0052 Proof of Concept Clinical (PoCC) trial received an initial 600 mg subcutaneous (s.c.) loading dose of spesolimab plus intravenous (i.v.) placebo at Visit 1, followed by 600 mg s.c. doses of spesolimab every two weeks for the next 12 weeks. Further dosing was based on changes in HS-PGA grade assessment from baseline to week 12.

Drug: Spesolimab 600 mg; Drug: Placebo matching 1200 mg Spesolimab

Interventions

Spesolimab 1200 mg DRUG

Participants in the 1368-0052 PoCC trial's placebo arm received a 1200 mg intravenous (i.v.) loading dose at Visit 1, then 600 mg s.c. every two weeks for 12 weeks.

Prior Placebo (PP)

Spesolimab 600 mg DRUG

Participants in the 1368-0052 PoCC trial's active arm received a 600 mg subcutaneous (s.c.) loading dose of spesolimab at Visit 1, followed by 600 mg s.c. every two weeks for 12 weeks.

Prior Placebo (PP); Prior Spesolimab (PS)

Placebo matching 600 mg Spesolimab DRUG

Participants from the placebo arm of the 1368-0052 PoCC trial will receive a subcutaneous (s.c.) administration of placebo matching 600 mg spesolimab at Visit 1.

Prior Placebo (PP)

Placebo matching 1200 mg Spesolimab DRUG

Participants from the active arm of the 1368-0052 PoCC trial will receive an intravenous (i.v.) infusion of placebo matching 1200 mg spesolimab at Visit 1

Prior Spesolimab (PS)

Eligibility Criteria

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

You may qualify if:

• Patients who have completed treatment in the parent Hidradenitis suppurativa (HS) spesolimab trial (1368-0052) without premature discontinuation
• Signed and dated written informed consent in accordance with ICH Harmonized Guideline for Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
• Woman 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. A list of contraception methods meeting these criteria is provided in the patient information and consent form.

You may not qualify if:

• Women who are pregnant, nursing, or who plan to become pregnant while in the trial
• Patients who experienced study treatment-limiting adverse events during the 1368-0052 parent trial
• Severe, progressive, or uncontrolled condition such as renal, hepatic, haematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof
• Any new documented active or suspected malignancy except appropriately treated basal cell carcinoma, squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix
• Use of any restricted medication or any drug considered by the investigator likely to interfere with the safe conduct of the study since the last visit of the 1368-0052 parent trial
• History of allergy/hypersensitivity to the systemically administered trial medication agent or its excipients
• Major surgery (major according to the investigator's assessment) planned during this extension trial (e.g. hip replacement, aneurysm removal, stomach ligation), as assessed by the investigator

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (26)

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

Dawes Fretzin Clinical Research Group, LLC-Indianapolis-58713

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

Holdsworth House Medical Practice

Sydney, New South Wales, 2010, Australia

Location

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, 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, 69437, 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-50697

Rotterdam, 3015 GD, Netherlands

Location

Haukeland Universitetssykehus

Bergen, N-5021, Norway

Location

Nordlandssykehuset HF, Bodø

Bodø, N-8092, 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

Hospital La Princesa

Madrid, 28006, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Related Links

• Related Info

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

spesolimab

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

Results Point of Contact

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

clintriage.rdg@boehringer-ingelheim.com

018002430127

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: All medication kit assignments will occur in an open label fashion except for medications provided for visit 1. Only administration of study medication at visit 1 is blinded.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 6, 2021
• Study Start: August 24, 2021
• Primary Completion: April 26, 2024
• Study Completion: April 26, 2024
• Last Updated: November 14, 2025
• Results First Posted: June 8, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2); NL (1); US (4); FR (3); CA (1); BE (1); CZ (1); DE (3); AU (2); NO (3); PL (2); ES (3)