A clinical trial to learn more about the effects of remibrutinib (LOU064) in people with papulopustular rosacea
EU CTIS ID: 2025-524496-23-00
What this study is testing
To assess the efficacy of remibrutinib compared to placebo at Week 16
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
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 (Baseline)
- Completed requisite washout of systemic antibiotics (30 days) and other prohibited systemic therapies before randomization (see Section 6.6.2).
- 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.
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 dermatitis, acne, acneiform eruptions from biologic History of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes 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.
See the full eligibility criteria
Who can 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 (see Section 6.6.2).
- 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.
What rules you out
- 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 History of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes 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 as detailed in Section 6.6.2. In particular, patients with pretreatment with remibrutinib or another BTK-inhibitor within 4 months prior to randomization.
The study team makes the final eligibility decision.
Where it's taking place
- Singapore
- Canada
- Korea, Republic of
- United States
- China
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 - 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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Singapore; Canada; Korea, Republic of; United States; China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.