BridgeMD
A 52-week multi-center, randomized, double-blind, placebo controlled, basket study with an open-label extension to investigate the efficacy, safety, and tolerability of remibrutinib (LOU064) in Chronic Inducible Urticaria (CINDU) in adults inadequately controlled by H1-antihistamines
EU CTIS ID: 2023-505739-12-01
What this study is testing
The purpose of this study is to measure the difference in the proportion of participants achieving complete response with remibrutinib XX mg b.i.d compared with placebo in participants with CINDU (symptomatic dermographism, cold urticaria and cholinergic urticaria) at Week 12.
- Therapeutic confirmatory (Phase III)
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
- Male and female participants ≥18 years of age at the time of signing of the ICFs
- Confirmed CINDU diagnosis (as per guidelines) for symptomatic dermographism, cold urticaria or cholinergic urticaria for ≥ 4 months (defined as onset of CINDU with supporting documentation (e.g medical record, clinical history, photographs)) and inadequate control with H1-AH at local label approved doses at the time of randomization
- The following response to the provocation test for each subtype is required at the randomization visit : • Symptomatic Dermographism: A Total Fric Score of ≥3 using the FricTest® 4.0 and a numerical rating scale score of ≥5 for itch after the provocation test. • Cold Urticaria: A Critical Threshold Temperature of ≥15°C using the TempTest® 4.0 and a numerical rating scale score of ≥5 for itch after the provocation test. • Cholinergic Urticaria: A physician global assessment of severity of hives ≥ 2 using the Pulse-controlled ergometry test and a numerical rating scale score of ≥5 for itch after the provocation test.
- Cold Urticaria
- Cholinergic urticaria: XX
You likely can't join if
- Previous use of remibrutinib or other BTK inhibitors.
- Participants who have concomitant CSU at screening. Participants with resolved CSU at the time of screening can be included in the study.
- Participants who have a familial form (e.g familial cold autoinflammatory syndrome, familial cold urticaria) of the target CINDU that is being considered for the participant's inclusion in this study.
- Participants having a more defined other form of inducible urticaria than the target CINDU that is being considered for the participant's inclusion in this study.
- Diseases, other than chronic inducible urticaria, with urticaria or angioedema symptoms including but not limited to urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa) and hereditary or acquired angioedema
- Any other skin disease associated with chronic itching that might influence, in the investigator’s opinion, the study evaluations and results (e.g., atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.) or skin diseases associated with only wheals and no itch e.g asymptomatic dermographism.
The study team makes the final eligibility decision.
Where it's taking place
- Malaysia
- Turkey
- Thailand
- China
- Brazil
- Canada
- Japan
- Argentina
- United States
- Vietnam
- Korea, Republic of
- Colombia
- Hong Kong
- South Africa
- Israel
- India
- Singapore
- Australia
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Malaysia; Turkey; Thailand; China; Brazil; Canada and 12 more location(s). 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.