Hidradenitis Suppurativa study: Remibrutinib
Official title An Extension Study to Assess Safety and Efficacy of Remibrutinib in Participants With Moderate to Severe HS
ClinicalTrials.gov ID: NCT07665437
What this study is testing
What is Remibrutinib?
This is an investigational oral medicine being studied as a potential treatment for moderate to severe hidradenitis suppurativa. It is designed to block specific immune signals in the body that contribute to inflammation.
Also referred to as LOU064.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if remibrutinib remains safe, well-tolerated, and effective over a longer period of time.
- Who it's for
- Adults with moderate to severe hidradenitis suppurativa who have already finished one of two previous Phase 3 studies.
- What's involved
- Participants will continue taking remibrutinib and undergo regular check-ups and tests to monitor their health and the condition.
- Time commitment
- The study duration and specific visit schedule are not detailed in the provided text.
- Phase 3: a large, late-stage study
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- Signed informed consent must be obtained before any assessment is performed.
- Participant has completed the full study treatment period according to the protocol (68 weeks) in the core studies (CLOU064J12301 or CLOU064J12302).
- Participant does not meet any treatment discontinuation criteria of the core study at Week 68. Key
You likely can't join if
- Ongoing or planned use of prohibited HS or non-HS treatments.
- Participants not expected to benefit from participation in the extension study or participants expected to be exposed to an undue safety risk if...
- Current severe progressive or uncontrolled disease, which in the judgment of the Investigator renders the participant unsuitable for the study.
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Fort Smith, Arkansas, United States
- North Little Rock, Arkansas, United States
- Fremont, California, United States
- Los Angeles, California, United States
- Sylmar, California, United States
- Thousand Oaks, California, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Glenview, Illinois, United States
- West Dundee, Illinois, United States
- New Albany, Indiana, United States
- Troy, Michigan, United States
- Omaha, Nebraska, United States
- New York, New York, United States
- Rochester, New York, United States
- Huntersville, North Carolina, United States
- Boardman, Ohio, United States
- Mayfield Heights, Ohio, United States
- Pittsburgh, Pennsylvania, United States
+ 36 more site(s).
Compensation & support
This study's listing mentions compensation or reimbursement.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
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, but 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, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Fort Smith, Arkansas, United States; North Little Rock, Arkansas, United States; Fremont, California, United States; Los Angeles, California, United States; Sylmar, California, United States and 50 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.