New pill targets rosacea inflammation at its source
NCT ID NCT07681271
First seen Jul 02, 2026 · Last updated Sep 15, 2026 · Updated 8 times
Summary
This study tests an oral medication called remibrutinib for adults with moderate-to-severe papulopustular rosacea, a skin condition causing red bumps and pustules on the face. The drug works by blocking a protein involved in inflammation. Researchers will measure whether it reduces the number of facial lesions compared to a placebo, and check for side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- remibrutinib (LOU064)
- What this could lead to
- If successful, this could offer a new oral treatment option for people with moderate-to-severe papulopustular rosacea, reducing facial bumps and pustules.
- What could go wrong
- This is an early Phase 2 study with only 80 participants, so results may not confirm effectiveness or safety. The drug may cause side effects or fail to outperform placebo.
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
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jul 2026
- Expected to finish
-
Dec 2027
An estimate. End dates often move.
- Lead sponsor
-
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
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
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 prior to participation in the study. * Adult ≥18 years with a clinical diagnosis of PPR. * Moderate-to-severe disease defined by a modified Investigator's Global Assessment (IGA) score of 3 or 4 * The presence of 15 - 60 inflammatory (papular/pustular, max. 2 nodular) facial lesions at screening, with at least 15 lesions present at Day 1 (Baseline). * Completed requisite washout of systemic antibiotics (30 days) and other prohibited systemic therapies before randomization. * Willingness to refrain from initiating treatments or undergoing procedures that target or impact PPR during the double-blind period, and to use only protocol-allowed products. Key Exclusion Criteria: * Presence of more than 2 nodular inflammatory lesions * Any active facial dermatoses or skin disease or condition that may interfere with assessment of PPR (e.g., seborrheic dermatitis, perioral dermatitis, acne, acneiform eruptions from biologic medications, steroid-induced dermatitis resembling rosacea or acne). * History of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes * Use of biologics within five half-lives prior to screening or until the expected pharmacodynamic (PD) effect has returned to baseline, whichever is longer; or longer if required by local regulations * Use of small molecules and/or immunosuppressants that are not corticosteroids within 5 half-lives or within 30 days prior to screening, whichever is longer; or longer if required by local regulations * Any use of systemic corticosteroids, systemic antibiotics, or topical treatments (including corticosteroids, antibiotics, ivermectin, azelaic acid, or metronidazole) within 30 days prior to randomization, or any planned use of these agents during the study treatment period. * History of live attenuated vaccine within 6 weeks prior to randomization or requirement to receive these vaccinations at any time while on study treatment. * Use, planned use, or failure to meet the protocol-defined washout periods for prohibited therapies. In particular, patients with pretreatment with remibrutinib or another BTK-inhibitor within 4 months prior to randomization. Other protocol-defined inclusion/exclusion criteria may apply.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Papulopustular rosacea are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
7 sites in 5 countries. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
-
Novartis Investigative Site
RECRUITINGLondon, Ontario, N6H 5L5, Canada
-
Novartis Investigative Site
RECRUITINGMarkham, Ontario, L3P 1X3, Canada
-
Novartis Investigative Site
RECRUITINGShanghai, 200040, China
-
Novartis Investigative Site
RECRUITINGSingapore, 308205, Singapore
-
Novartis Investigative Site
RECRUITINGDongjak Gu, Seoul, 07061, South Korea
-
Novartis Investigative Site
RECRUITINGIcheon, 21431, South Korea
-
Three A Research
RECRUITINGEl Paso, Texas, 79902, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.