BridgeMD
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
EU CTIS ID: 2023-508377-82-00
What this study is testing
The primary objective of this trial is to assess the long-term safety of spesolimab in participants with HS who have completed approximately 8 to 12 months of spesolimab treatment in Part 1 or Part 2 of trial 1368-0098.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join 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 HS spesolimab trial (1368-0098) 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 likely can't join 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.
- Further exclusion criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- Malaysia
- Japan
- Chile
- Turkey
- Vietnam
- China
- New Zealand
- Philippines
- United Kingdom
- Switzerland
- Singapore
- United States
- Mexico
- South Africa
- Taiwan
- Canada
- Argentina
- Korea, Republic of
- Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; Malaysia; Japan; Chile; Turkey; Vietnam and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.