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Clinical trials
NCT07681271

A Phase 2 Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Patients With Papulopustular Rosacea (PPR)

ClinicalTrials.gov identifier NCT07681271

Novartis reference CLOU064Q12201

Show study information as

Condition Papulopustular Rosacea

Study status Recruiting

Phase 2

Number of participants 100

Gender All

Age 18 years or above

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Study details

This is a multicenter, randomized, participant and Investigator-blinded, placebo-controlled, parallel-group Phase 2 study designed to evaluate the efficacy, safety, and tolerability of remibrutinib in adults with moderate-to-severe PPR. Following a screening period of up to 30 days, which can be extended by a further 2 weeks only to allow washout from rosacea treatments and other systemic therapies as specified in the prohibited medication section, eligible participants will be randomized at baseline to receive either remibrutinib or matching placebo for a 16-week double-blind treatment phase. A safety follow up visit will occur approximately 30 days after the final dose.

Interventions

DRUG: LOU064|DRUG: Placebo

Official title

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2 Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Patients With Papulopustular Rosacea (PPR)

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Who can take part?

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.

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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Clinical trials
NCT07681271

Study of an Investigational Treatment for Papulopustular Rosacea in Adults

ClinicalTrials.gov identifier NCT07681271

Novartis reference CLOU064Q12201

Show study information as

Condition Papulopustular Rosacea

Study status Recruiting

Phase 2

Number of participants 100

Gender All

Age 18 years or above

Learn More

Study details

This text was simplified by AI to make it easier to read. It may contain mistakes. Switch to Original information for the official version.

The purpose of this research study is to learn whether an investigational treatment can reduce the number of inflamed bumps and pus-filled spots (inflammatory lesions) in adults with moderate-to-severe papulopustular rosacea. The study will also look at safety and tolerability (how well people can handle the treatment).

Participants will receive either the investigational treatment or a placebo. A placebo looks like the investigational treatment but does not contain active medication. Participants will take the assigned study treatment for 16 weeks. Some people may need to stop certain rosacea or other treatments before starting the study treatment. Participants will have a safety follow-up visit about 30 days after the last dose.

This study may be an option for
Adults with moderate-to-severe papulopustular rosacea may be able to participate if they:

Are age 18 or older and have papulopustular rosacea
Have moderate-to-severe symptoms
Have a certain number of inflamed facial lesions at screening and at the start of the study
Have completed required “washout” time (time off) from certain antibiotics and other treatments before starting the study
Are willing not to start new treatments or procedures that target or affect papulopustular rosacea during the main study treatment period, and to use only products allowed by the study

Study timeline and visits:
Screening lasts up to 30 days and may be extended by up to 2 weeks to allow time off certain treatments. Study treatment lasts 16 weeks. There is a safety follow-up visit about 30 days after the final dose.

Interventions

DRUG: LOU064|DRUG: Placebo

Official title

Who can take part?

This text was simplified by AI to make it easier to read. It may contain mistakes. Switch to Original information for the official version.

You might be able to join if

Sign the informed consent form before joining the study
Be an adult age 18 or older with a clinical diagnosis of papulopustular rosacea
Have moderate-to-severe disease based on the study’s skin rating scale
Have 15–60 inflamed facial lesions (papules or pustules), with no more than 2 nodules, at screening, and have at least 15 lesions at Day 1 (baseline)
Have completed the required time off (washout) from systemic antibiotics (30 days) and other prohibited systemic treatments before being assigned to a study group
Be willing not to start treatments or have procedures that target or affect papulopustular rosacea during the blinded treatment period, and to use only products allowed by the study

You might not be able to join if

Have more than 2 nodular inflamed lesions
Have any active facial skin disease or condition that could interfere with checking papulopustular rosacea (for example, seborrheic dermatitis, perioral dermatitis, acne, acne-like eruptions from biologic medications, or steroid-related dermatitis that looks like rosacea or acne)
Have a history of allergy or hypersensitivity to any study treatment, any of its ingredients, or drugs in similar chemical classes
Have used biologic medicines within 5 half-lives before screening, or until the expected drug effect has returned to baseline (whichever is longer), or longer if required by local regulations
Have used small-molecule medicines and/or immunosuppressants that are not corticosteroids within 5 half-lives or within 30 days before screening (whichever is longer), or longer if required by local regulations
Have used any systemic corticosteroids, systemic antibiotics, or topical treatments (including topical corticosteroids, topical antibiotics, ivermectin, azelaic acid, or metronidazole) within 30 days before being assigned to a study group, or plan to use any of these during the study treatment period
Have received a live attenuated vaccine within 6 weeks before being assigned to a study group, or need to receive one at any time while on study treatment
Have used, plan to use, or have not completed the required time off (washout) for prohibited treatments; this includes having taken the investigational treatment or another BTK inhibitor within 4 months before being assigned to a study group

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