Hidradenitis Suppurativa study: LOU064
Official title A Study to Explore the Tissue Level Effects of Remibrutinib in Adults With Moderate to Severe HS
ClinicalTrials.gov ID: NCT07855276
What this study is testing
What is LOU064?
This is an investigational medicine being studied to see if it can help treat hidradenitis suppurativa. It is designed to block a specific protein called Bruton's tyrosine kinase (BTK) to reduce inflammation.
Also referred to as remibrutinib.
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 study aims to learn how the drug remibrutinib, which blocks a protein called Bruton's tyrosine kinase, affects the disease.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
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 65
You may be able to join if
- Male and female participants ≥ 18 years to 65 years of age at the time of signing of the informed consent forms (ICF).
- Diagnosis of HS based on clinical history and physical examination for at least 6 months prior to Day 1.
- A total of at least 5 abscesses and inflammatory nodules (AN), i.e. abscesses and/or inflammatory nodules
- Inflammatory lesions should affect at least 2 distinct anatomic areas (e.g., left and right axillae).
- At least 1 chronic lesion, which is defined by the presence of a draining tunnel and further meeting biopsy criteria as defined in the laboratory...
You likely can't join if
- Presence of more than 20 fistulae/tunnels (both draining and non-draining) in total at baseline.
- Use of other investigational drugs within 5 half-lives, or within 30 days (for small molecules) prior to randomization, or until the pharmacodynamic...
- Previous exposure to remibrutinib or other BTK inhibitors.
- Previous exposure to investigational Janus Kinase (JAK) inhibitors.
- Known or suspected infectious disease that is active, chronic or recurrent which precludes the participant from participating in the clinical trial...
- Significant bleeding risk or coagulation disorders.
See the full eligibility criteria
- Male and female participants ≥ 18 years to 65 years of age at the time of signing of the informed consent forms (ICF).
- Diagnosis of HS based on clinical history and physical examination for at least 6 months prior to Day 1.
- A total of at least 5 abscesses and inflammatory nodules (AN), i.e. abscesses and/or inflammatory nodules
- Inflammatory lesions should affect at least 2 distinct anatomic areas (e.g., left and right axillae).
- At least 1 chronic lesion, which is defined by the presence of a draining tunnel and further meeting biopsy criteria as defined in the laboratory manual. Key
- Presence of more than 20 fistulae/tunnels (both draining and non-draining) in total at baseline.
- Use of other investigational drugs within 5 half-lives, or within 30 days (for small molecules) prior to randomization, or until the pharmacodynamic effect has returned to baseline (for biologics), whichever is longer.
- Previous exposure to remibrutinib or other BTK inhibitors.
- Previous exposure to investigational Janus Kinase (JAK) inhibitors.
- Known or suspected infectious disease that is active, chronic or recurrent which precludes the participant from participating in the clinical trial as per Investigator´s assessment.
- Significant bleeding risk or coagulation disorders.
- History or current hepatic disease (moderate to severe Hepatic Impairment (HI) as per Child-Pugh classification), including but not limited to, acute or chronic hepatitis (with the exception of Hepatitis B or C - see...
- Women of childbearing potential, defined as all women physiologically capable of becoming pregnant from menarche until becoming post-menopausal, unless they have had surgical bilateral oophorectomy (with or without...
The study team makes the final eligibility decision.
Where it is enrolling
- San Diego, California, United States
- Mayfield Heights, Ohio, United States
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, 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 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Diego, California, United States; Mayfield Heights, Ohio, United States. 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.