Papulopustular Rosacea study: LOU064
Official title A Phase 2 Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Patients With Papulopustular Rosacea (PPR)
ClinicalTrials.gov ID: NCT07681271
What this study is testing
What is LOU064?
LOU064 is an investigational oral medicine being studied for moderate-to-severe papulopustular rosacea.
Also referred to as Remibrutinib.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to find out if blocking a protein called BTK with remibrutinib can lower the number of inflammatory skin lesions in people with moderate‑to‑severe papulopustular rosacea, and to check the drug’s safety and how well people can tolerate it.
- Who it's for
- Adults who have moderate to severe papulopustular rosacea.
- What's involved
- Participants will receive remibrutinib and have regular visits where doctors check their skin, monitor side effects, and perform safety tests.
- Time commitment
- The study lasts several weeks to months, with multiple scheduled visits for treatment and monitoring.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Completed requisite washout of systemic antibiotics (30 days) and other prohibited systemic therapies before randomization.
You likely can't join if
- 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...
- 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...
- Use of small molecules and/or immunosuppressants that are not corticosteroids within 5 half-lives or within 30 days prior to screening, whichever is...
- Any use of systemic corticosteroids, systemic antibiotics, or topical treatments (including corticosteroids, antibiotics, ivermectin, azelaic acid...
See the full eligibility 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 blinded period, and to use only protocol-allowed products. Key
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- El Paso, Texas, United States
- Sofia, Bulgaria
- London, Ontario, Canada
- Markham, Ontario, Canada
- Guangzhou, Guangdong, China
- Shanghai, China
- Hamburg, Germany
- Tübingen, Germany
- Cona, FE, Italy
- Singapore, Singapore
- Dongjak Gu, Seoul, South Korea
- Icheon, South Korea
- Santiago de Compostela, A Coruna, Spain
- Córdoba, Spain
- Granada, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at El Paso, Texas, United States; Sofia, Bulgaria; London, Ontario, Canada; Markham, Ontario, Canada; Guangzhou, Guangdong, China; Shanghai, China and 9 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.