Remibrutinib for moderate-to-severe papulopustular rosacea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized, double-blind study compares remibrutinib to placebo in adults with moderate-to-severe papulopustular rosacea over 16 weeks of treatment, followed by a safety follow-up. Participants are screened, randomized, and receive either the active drug or a matching placebo while safety and tolerability are closely monitored. Key eligibility requires 18+ years old with 15–60 inflammatory facial lesions and a baseline IGA of 3 or 4, after washout of prior treatments. The study aims to determine if BTK inhibition can meaningfully reduce lesions while maintaining an acceptable safety profile.

Why it matters

Who can join: the full rules

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.

Where it's running

• Three A Research
  El Paso, Texas, United States Recruiting
• Novartis Investigative Site
  Sofia, Bulgaria Recruiting
• Novartis Investigative Site
  Sofia, Bulgaria Recruiting
• Novartis Investigative Site
  London, Ontario, Canada Recruiting
• Novartis Investigative Site
  Markham, Ontario, Canada Recruiting
• Novartis Investigative Site
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: 1-888-669-6682

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.