A Study to Test Long-term Treatment With Spesolimab in People With a Skin Condition Disease Calle… (NCT06241573) | Clinical Trial Compass
TerminatedPhase 2/3
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
United States, Argentina, Australia39 participantsStarted 2024-05-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
. 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.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Occurrence of Treatment Emergent Adverse Events (TEAE) up to the End of Maintenance Treatment Period
Timeframe: From first drug administration, up to 16 weeks after last administration, up to 39 weeks.
. 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.