A Phase 2 Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Patients With Papulopustular Rosacea (PPR)
Recruiting
Phase 2Interventional Study
Papulopustular Rosacea
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
100 (estimated)
Sponsor
Novartis Pharmaceuticals · Industry
Who this trial is looking for
This trial is looking for adults with moderate-to-severe papulopustular rosacea. Participants will receive treatment with remibrutinib and will be monitored for its effects and safety.
Are You a Good Fit for This Trial?
You may be able to join if
I am an adult aged 18 or older.
I have been diagnosed with papulopustular rosacea.
I have moderate-to-severe disease based on a specific score.
I have 15 to 60 inflammatory facial lesions.
I stopped using certain antibiotics and therapies before starting.
I agree not to use other treatments for my condition during the study.
You may not be able to join if
I have more than 2 nodular inflammatory lesions.
I have active skin conditions that might affect my rosacea assessment.
I am allergic to any of the study treatments or similar drugs.
I have used biologics recently.
I have taken certain medications before the study that are not allowed.
I have used corticosteroids, antibiotics, or specific topical treatments recently.
I have received a live vaccine recently.
I have used remibrutinib or another BTK-inhibitor in the last 4 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
This Phase 2 study aims to evaluate whether Bruton's tyrosine kinase (BTK) inhibition with remibrutinib can produce a clinically meaningful reduction in inflammatory lesions in adults with moderate-to-severe papulopustular rosacea, while also assessing safety and tolerability of remibrutinib in this indication.
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Eligibility Criteria
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 inflammator…
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.
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