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Tests treatment safety and results for Hidradenitis Suppurativa
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?
Remibrutinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for hidradenitis suppurativa.
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
- The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of remibrutinib (LOU064) in adult participants with moderate to severe hidradenitis suppurativa (HS) who have completed either of the preceding Phase 3 studies, CLOU064J12301 or CLOU064J12302.
- 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. Other...
The study team makes the final eligibility decision.
Where it's taking place
- Caba, Buenos Aires, Argentina
- CABA, Argentina
- Sydney, New South Wales, Australia
- Melbourne, Victoria, Australia
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
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 - 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 - 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?
Study sites include Caba, Buenos Aires, Argentina; CABA, Argentina; Sydney, New South Wales, Australia; Melbourne, Victoria, Australia. 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 ClinicalTrials.gov; the study team decides eligibility.