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

Launched by BOEHRINGER INGELHEIM · Jan 29, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a medication called spesolimab for people with a skin condition known as hidradenitis suppurativa (HS) who have previously participated in another study with this medication. The main goal is to see how well people tolerate spesolimab and if it helps manage HS symptoms over a long period of time. Participants will receive injections of spesolimab every two weeks for about 1.5 years and will be involved in the study for a total of about 2 years, which includes 41 visits—24 at the study site and 17 that can be done through video calls from home.

To join the trial, participants need to have completed the earlier spesolimab study without stopping early and must be willing to continue with treatment. Women who can become pregnant must agree to use reliable birth control during the study. It's important for potential participants to know that those who are pregnant, nursing, or planning to become pregnant, as well as those with certain health issues or infections, may not be eligible. Throughout the study, doctors will monitor the participants’ HS and any health concerns they may have.

Gender

ALL

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.