A Study to Test Long-term Treatment With Spesolimab in People With a Skin Condition Disease Called Hidradenitis Suppurativa (HS) Who Took Part in a Previous Study With Spesolimab

NCT06241573 | Terminated Phase 2 DMC FDA Drug

• 3 other identifiers: 1368-01302023-508377-82-00U1111-1300-2310
• Study Type: interventional
• Target: 39
• Locations: 14 countries
• Sites: 36

Brief Summary

This study is open to people with hidradenitis suppurativa (HS) who have completed another study with spesolimab (study 1368-0098 (NCT05819398) or study 1368-0100). The purpose of this study is to find out how well people tolerate spesolimab and whether it helps people with HS in the long-term. For about 1.5 years, participants get spesolimab injections under the skin every 2 weeks. Participants are in the study for about 2 years. During this time, participants have 41 visits. 24 visits are done at the study site. 17 visits can be done by video call at the participant's home. At study visits, doctors check the severity of the participant's HS and collect information on any health problems of the participants.

Conditions

Hidradenitis Suppurativa (HS)

Outcome Measures

Primary Outcomes (1)

• Occurrence of treatment emergent adverse events (TEAE)

  up to 92 weeks

Study Arms (3)

Patients treated in Part I of parent trial 1368-0098 (NCT05819398)

EXPERIMENTAL

Drug: Spesolimab

Patients treated in Part II of parent trial 1368-0098 (NCT05819398)

EXPERIMENTAL

Drug: Spesolimab

Patients treated in parent trial 1368-0100

EXPERIMENTAL

Drug: Spesolimab

Interventions

Spesolimab DRUG

Spesolimab

Patients treated in Part I of parent trial 1368-0098 (NCT05819398); Patients treated in Part II of parent trial 1368-0098 (NCT05819398); Patients treated in parent trial 1368-0100

Eligibility Criteria

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

You may qualify if:

• 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.
• Participants must be within the defined Residual Effect Period corresponding to 16 weeks since last spesolimab administration.
• Participants who have completed treatment in the parent hidradenitis suppurativa (HS) spesolimab trial (1368-0098 (NCT05819398) or 1368-0100) without premature discontinuation and are willing and able to continue treatment in this 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.

You may not qualify if:

• Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
• Use of any drug considered by the investigator likely to interfere with the safe conduct of the trial since the last visit of the parent trials.
• Use of immunomodulatory biologics or investigational agents since the last visit of the parent trials.
• Participants who require / intend to use certain restricted medications such as immunomodulatory biologics or other investigational drugs/devices during the course of the trial.
• Relevant chronic or acute infections including human immunodeficiency virus (HIV) and viral hepatitis. The corresponding laboratory tests will be performed at Visit 1. A participant can be re-screened if the participant was treated and is cured from the acute infection.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (36)

First OC Dermatology

Fountain Valley, California, 92708, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

Integrative Skin Science and Research-Sacramento-69402

Sacramento, California, 95815, United States

Location

Clinical Trials Research Institute

Thousand Oaks, California, 91320, United States

Location

STAT Research

CABA, C1023AAB, Argentina

Location

Hospital Italiano de Buenos Aires

CABA, C1199ABB, Argentina

Location

Hospital Alemán

Capital Federal, C1118AAT, Argentina

Location

Holdsworth House Medical Practice

Sydney, New South Wales, 2010, Australia

Location

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Medical Center "Kordis"

Pleven, 5800, Bulgaria

Location

ASMC-IPSMC-skin and Veneral Diseases

Sofia, 1407, Bulgaria

Location

SimcoDerm Medical and Surgical Dermatology Centre

Barrie, Ontario, L4M 7G1, Canada

Location

Guelph Dermatology Research

Guelph, Ontario, N1L 0B7, Canada

Location

Dr. S. K. Siddha Medicine Professional Corporation

Newmarket, Ontario, L3Y 5G8, Canada

Location

HOP Privé Antony

Antony, 92160, France

Location

HOP Edouard Herriot

Lyon, 69437, France

Location

Fachklinik Bad Bentheim

Bad Bentheim, 48455, Germany

Location

Hautmedizin Saar

Merzig, 66663, Germany

Location

Kurume University Hospital

Fukuoka, Kurume, 830-0011, Japan

Location

Ogaki Municipal Hospital

Gifu, Ogaki, 503-8502, Japan

Location

The University of Tokyo Hospital

Tokyo, Bunkyo-ku, 113-8655, Japan

Location

Nihon University Itabashi Hospital

Tokyo, Itabashi-ku, 173-8610, Japan

Location

Tokyo Medical University Hospital

Tokyo, Shinjuku-ku, 160-0023, Japan

Location

Hospital of Lithuanian University of Health Sciences Kauno Klinikos

Kaunas, 50161, Lithuania

Location

Vilnius University Hospital, Santariskiu

Vilnius, 08411, Lithuania

Location

Hospital Pulau Pinang-Pulau Pinang-21953

Georgetown Pulau Pinang, 10990, Malaysia

Location

Hospital Sultan Ismail

Johor Bahru, 81100, Malaysia

Location

Hospital Kuala Lumpur

Kuala Lumpur, 50586, Malaysia

Location

Sarawak General Hospital

Kuching, 93586, Malaysia

Location

Sunway Medical Centre

Selangor Darul Ehsan, 47500, Malaysia

Location

Non-Public Health Care Facility LABDERM

Ossy, 42624, Poland

Location

Provita Clinic

Warsaw, 02-647, Poland

Location

Royalderm

Warsaw, 02-962, Poland

Location

National University Hospital-Singapore-42005

Singapore, 119074, Singapore

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, 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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON 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: January 29, 2024
• First Posted: February 5, 2024
• Study Start: May 8, 2024
• Primary Completion: April 11, 2025
• Study Completion: April 11, 2025
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1); AR (3); JP (5); ES (1); CA (3); AU (2); MY (5); PL (3); US (4); FR (2); KR (1); DE (2); LI (2); BU (2)