Papulopustular RosaceaPhase 2NCT07681271
A Phase 2 Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Patients With Papulopustular Rosacea (PPR)
A Phase 2 study testing LOU064 in people with Papulopustular Rosacea, run by Novartis Pharmaceuticals at 12 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Papulopustular Rosacea
- What is being tested?
- LOU064
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 12 sitesin 8 countries
- Study dates
- 30 Jul 2026to 7 Dec 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
12 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
12 sites in 8 countries
Bulgaria2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Sofia, 1528
- Recruiting
Novartis Investigative Site
Sofia, 1618
Canada2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
London, Ontario, N6H 5L5
- Recruiting
Novartis Investigative Site
Markham, Ontario, L3P 1X3
Singapore2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Singapore, 119074
- Recruiting
Novartis Investigative Site
Singapore, 308205
South Korea2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Dongjak Gu, Seoul, 07061
- Recruiting
Novartis Investigative Site
Icheon, 21431
United States1 site, 1 recruiting
- Recruiting
Three A Research
El Paso, Texas, 79902
Genesis Jaramillo, genesis@3aresearch.com
Brenda Simpson
China1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Shanghai, 200040
Germany1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Hamburg, 20095
About this study
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)
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.
Read the 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.
- Conditions
- Papulopustular Rosacea
- Being tested
- LOU064, Placebo
- Keywords
- Papulopustular Rosacea, PPR, Ph2, efficacy, safety, tolerability
- Medical subject headings
- Rosacea, Primary hyperoxaluria type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LOU064Drug
Also called Remibrutinib
LOU064 administered by oral route
PlaceboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| LOU064 | Experimental | LOU064 administered by oral route Receives: Drug: LOU064 |
| Placebo | Placebo comparator | Matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change from baseline in facial inflammatory lesion count
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.
Measured: Baseline, Week 16
Secondary outcomes (2)
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
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
- = Near clear
- = Mild
- = Moderate
- = Severe
Measured: Baseline, Week 16
Percentage change from baseline in facial inflammatory lesion count
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.
Measured: Baseline, Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start30 Jul 2026
- Primary completion7 Dec 2027 (estimated)
- Study completion7 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papulopustular RosaceaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07681271
- Sponsor's protocol ID
- CLOU064Q12201
- Other IDs
- 2025-524496-23-00, 2025
- Status last verified
- Oct 2026
- First submitted
- 26 Jun 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.