A Study Investigating Long-term Treatment With Spesolimab in People With a Skin Disease Called Hidradenitis Suppurativa Who Completed a Previous Clinical Trial
NCT ID: NCT04876391
Last Updated: 2025-11-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
45 participants
INTERVENTIONAL
2021-08-24
2024-04-26
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Prior Placebo (PP)
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.
Spesolimab 1200 mg
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.
Spesolimab 600 mg
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.
Placebo matching 600 mg Spesolimab
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 Spesolimab (PS)
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.
Spesolimab 600 mg
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.
Placebo matching 1200 mg Spesolimab
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
Interventions
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Spesolimab 1200 mg
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.
Spesolimab 600 mg
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.
Placebo matching 600 mg Spesolimab
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.
Placebo matching 1200 mg Spesolimab
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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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
HOP Edouard Herriot
Lyon, , France
HOP Larrey
Toulouse, , France
Katholisches Klinikum Bochum gGmbH
Bochum, , Germany
Städtisches Klinikum Dessau
Dessau, , Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, , Germany
Ospedali Riuniti di Ancona
Ancona, , Italy
Azienda Ospedaliera Universitaria Pisana
Pisa, , Italy
Erasmus Medisch Centrum-ROTTERDAM-50697
Rotterdam, , Netherlands
Haukeland Universitetssykehus
Bergen, , Norway
Nordlandssykehuset HF, Bodø
Bodø, , Norway
Oslo Universitetssykehus HF, Rikshospitalet
Oslo, , Norway
Non-Public Health Care Facility LABDERM
Ossy, , Poland
Cityclinic Medical and Psychological Clinic Matusiak Partnership
Wroclaw, , Poland
Hospital Santa Creu i Sant Pau
Barcelona, , Spain
Hospital La Princesa
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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2020-005587-55
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1368-0067
Identifier Type: -
Identifier Source: org_study_id