Papulopustular Rosacea
Conditions
Keywords
Papulopustular Rosacea, PPR, Ph2, efficacy, safety, tolerability
Brief summary
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.
Detailed description
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
DRUGLOU064
LOU064 administered by oral route
DRUGPlacebo
Matching placebo
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute change from baseline in facial inflammatory lesion count | Baseline, Week 16 | The facial inflammatory lesion count is defined as the sum of papules, pustules, and nodules present on the face. Lesions are visually counted across the full facial area (forehead, cheeks, nose, chin). A negative value indicates a reduction in lesions (clinical improvement), as lower counts reflect less inflammatory activity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with Investigator's Global Assessment (IGA,modified scale without erythema) grade 0 or 1, with at least 2 grade reduction from baseline | Baseline, Week 16 | The Investigator's Global Assessment is a clinician-reported outcome using a 5-point ordinal scale (0-4). Higher scores indicate more severe disease; lower scores indicate improvement. 0 = Clear 1. = Near clear 2. = Mild 3. = Moderate 4. = Severe |
| Percentage change from baseline in facial inflammatory lesion count | Baseline, Week 16 | The facial inflammatory lesion count is defined as the sum of papules, pustules, and nodules present on the face. Lesions are visually counted across the full facial area (forehead, cheeks, nose, chin). Lower values indicate fewer lesions. A reduction from baseline represents clinical improvement. |
Countries
United States
Contacts
CONTACTNovartis Pharmaceuticals
Outcome results
None listed