Clinical trial NCT06241573: 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
Official title: Lunsayil LTE: An Extension Trial Assessing Long-term Spesolimab Treatment in Patients With Hidradenitis Suppurativa (HS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hidradenitis Suppurativa (HS)
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2024-02-05
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. 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.
2. Participants must be within the defined Residual Effect Period corresponding to 16 weeks since last spesolimab administration.
3. 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.
4. 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.

Exclusion Criteria:

1. Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
2. 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.
3. Use of immunomodulatory biologics or investigational agents since the last visit of the parent trials.
4. Participants who require / intend to use certain restricted medications such as immunomodulatory biologics or other investigational drugs/devices during the course of the trial.
5. 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.

Further exclusion criteria apply.

Primary outcomes:
measure: Occurrence of treatment emergent adverse events (TEAE)
timeFrame: up to 92 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: First OC Dermatology
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Sacramento
country: United States
facility: Integrative Skin Science and Research-Sacramento-69402
state: California
city: Thousand Oaks
country: United States
facility: Clinical Trials Research Institute
state: California
city: Caba
country: Argentina
facility: STAT Research
city: Caba
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Capital Federal
country: Argentina
facility: Hospital Alemán
city: Sydney
country: Australia
facility: Holdsworth House Medical Practice
state: New South Wales
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Pleven
country: Bulgaria
facility: Medical Center "Kordis"
city: Sofia
country: Bulgaria
facility: ASMC-IPSMC-skin and Veneral Diseases
city: Barrie
country: Canada
facility: SimcoDerm Medical and Surgical Dermatology Centre
state: Ontario
city: Guelph
country: Canada
facility: Guelph Dermatology Research
state: Ontario
city: Newmarket
country: Canada
facility: Dr. S. K. Siddha Medicine Professional Corporation
state: Ontario
city: Antony
country: France
facility: HOP Privé Antony
city: Lyon
country: France
facility: HOP Edouard Herriot
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim
city: Merzig
country: Germany
facility: Hautmedizin Saar
city: Fukuoka, Kurume
country: Japan
facility: Kurume University Hospital
city: Gifu, Ogaki
country: Japan
facility: Ogaki Municipal Hospital
city: Tokyo, Bunkyo-ku
country: Japan
facility: The University of Tokyo Hospital
city: Tokyo, Itabashi-ku
country: Japan
facility: Nihon University Itabashi Hospital
city: Tokyo, Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kauno Klinikos
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital, Santariskiu
city: Georgetown Pulau Pinang
country: Malaysia
facility: Hospital Pulau Pinang-Pulau Pinang-21953
city: Johor Bahru
country: Malaysia
facility: Hospital Sultan Ismail
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur
city: Kuching
country: Malaysia
facility: Sarawak General Hospital
city: Selangor Darul Ehsan
country: Malaysia
facility: Sunway Medical Centre
city: Ossy
country: Poland
facility: Non-Public Health Care Facility LABDERM
city: Warsaw
country: Poland
facility: Provita Clinic
city: Warszawa
country: Poland
facility: Royalderm
city: Singapore
country: Singapore
facility: National University Hospital-Singapore-42005
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
Study officials:
References: