New pill shows promise for controlling painful skin condition in long-term trial
NCT ID NCT07665437
First seen Jun 25, 2026 · Last updated Sep 15, 2026 · Updated 8 times
Summary
This phase 3 study tests the long-term safety and effectiveness of remibrutinib, an oral drug, in 710 adults with moderate to severe hidradenitis suppurativa (HS), a chronic skin condition causing painful abscesses. Participants have already completed a prior remibrutinib study. The trial compares two doses and tracks side effects and reduction in skin lesions over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- remibrutinib (oral drug)
- What this could lead to
- If successful, this could provide a new long-term treatment option to control painful skin abscesses and inflammation in hidradenitis suppurativa.
- What could go wrong
- This is an extension study, so participants already tolerated the drug, but long-term safety and effectiveness are still being confirmed. Results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 710 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Oct 2031
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 100 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion Criteria: * 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 Exclusion Criteria: * 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 participating in the extension study, as assessed by the Investigator. * Current severe progressive or uncontrolled disease, which in the judgment of the Investigator renders the participant unsuitable for the study. Other protocol-defined inclusion/exclusion criteria may apply.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
20 sites in 4 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Apex Clinical Research Center LLC
RECRUITINGMayfield Heights, Ohio, 44124, United States
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Cameron Dermatology
RECRUITINGNew York, New York, 10023, United States
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Clinical Research Ctr of Carolinas
RECRUITINGCharleston, South Carolina, 29407, United States
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Clinical Trials Research Institute
RECRUITINGThousand Oaks, California, 91320, United States
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Ctr for Dermatology Clinical Res
RECRUITINGFremont, California, 95438, United States
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Dundee Dermatology
RECRUITINGWest Dundee, Illinois, 60118, United States
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Endeavor Health
RECRUITINGGlenview, Illinois, 60077, United States
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Johnson Dermatology
RECRUITINGFort Smith, Arkansas, 72916, United States
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Novartis Investigative Site
RECRUITINGCaba, Buenos Aires, C1119ACN, Argentina
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Novartis Investigative Site
RECRUITINGCABA, Buenos Aires, C1425BEA, Argentina
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Novartis Investigative Site
RECRUITINGRosario, Santa Fe Province, S2000DBS, Argentina
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Novartis Investigative Site
RECRUITINGCABA, C1428DZF, Argentina
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Novartis Investigative Site
RECRUITINGSydney, New South Wales, 2010, Australia
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Novartis Investigative Site
RECRUITINGMelbourne, Victoria, 3004, Australia
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Novartis Investigative Site
RECRUITINGLondon, Ontario, N6H 5L5, Canada
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Olive View UCLA Medical Center
RECRUITINGSylmar, California, 91342, United States
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Optima Research Boardman
RECRUITINGBoardman, Ohio, 44512, United States
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Skin Specialists PC
RECRUITINGOmaha, Nebraska, 68144, United States
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Southern IN Clinical Trials
RECRUITINGNew Albany, Indiana, 47150, United States
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USC Keck School of Medicine
RECRUITINGLos Angeles, California, 90033, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Weight-Loss drug also calm a painful skin disease?
- Viruses that kill bacteria: a new weapon against superbugs?
- Can an injected drug calm the painful flares of hidradenitis suppurativa?
- Nanobody drug tested against painful skin condition
- Can a mediterranean diet tame hidradenitis suppurativa?
- Can we predict the path of chronic skin disease?