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

COMPLETEDPHASE2

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

An Open-label, Long-term Extension Trial of Spesolimab Treatment in Adult Patients With Hidradenitis Suppurativa (HS)

NCT04876391•Boehringer Ingelheim

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.

Exclusion Criteria

•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

Locations (26)

Dermatology Research Associates

Los Angeles, California, United States

Dawes Fretzin Clinical Research Group, LLC-Indianapolis-58713

Indianapolis, Indiana, United States

Mayo Clinic, Rochester

Rochester, Minnesota, United States

Unity Clinical Research

Oklahoma City, Oklahoma, United States

Holdsworth House Medical Practice

Sydney, New South Wales, Australia

Royal Melbourne Hospital

Parkville, Victoria, Australia

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Dr. S. K. Siddha Medicine Professional Corporation

Newmarket, Ontario, Canada

University Hospital Ostrava

Ostrava, Czechia

CLI Reims Bezannes

Bezannes, France

Key Dates

Start Date

August 24, 2021

Primary Completion Date

April 26, 2024

Completion Date

April 26, 2024

Last Updated

November 14, 2025

Enrollment

ACTUAL participants

Conditions

Hidradenitis Suppurativa

Interventions

Spesolimab 1200 mg

DRUG

Spesolimab 600 mg

DRUG

Placebo matching 600 mg Spesolimab

DRUG

Placebo matching 1200 mg Spesolimab

DRUG

A Study With CIT-013 in HS Patients

NCT06993233

Hidradenitis Suppurativa (HS)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study With CIT-013 in HS Patients

A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)

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