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A 12-week randomized, participant and investigator blinded, placebo-controlled, exploratory study in adult participants with Chronic Urticaria to assess the efficacy and safety and explore the Mechanism of Action of remibrutinib (LOU064)
EU CTIS ID: 2024-516355-41-00
What this study is testing
CINDU cohorts: To investigate the efficacy of remibrutinib versus placebo for the most bothersome symptom in CINDU patients All cohorts: To investigate the impact of remibrutinib versus placebo on urticaria symptom control
- 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.
- Male and female participants ≥ 18 years of age at the time of signing of the informed consent forms.
- CINDU patients: Confirmed diagnosis of CINDU with a duration of ≥ 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 CINDU subtype is required before randomization (either during screening or prior to randomization on Day 1): • Symptomatic dermographism: A Total Fric Score of ≥3 using the FricTest® 4.0. • Cold urticaria: A Critical Threshold Temperature of ≥15°C using the TempTest® 4.0. • Cholinergic urticaria: A physician global assessment of severity of hives ≥ 2 using the Pulse-controlled ergometry test after the provocation test. • Heat urticaria: Documented emergence of urticaria symptoms following heat exposure • Solar urticaria: Documented emergence of urticaria symptoms following sunlight exposure and UVA/B or light exposure/phototesting record from source records • Delayed pressure urticaria: symptoms of urticaria as diagnosed by pressure provocation with dermographometer or local application of weight on the lesional skin area (symptoms should be observed 4h to 6h after the trigger) and can be documented by the participant when outpatient. • Aquagenic urticaria: Evidence of urticaria (in patient records) after local exposure to water (e.g. wet blanket or other suitable testing approach). • Contact urticaria: Evidence of urticaria following contact to identified material causing urticaria symptoms.
- CINDU patients: Patients should be symptomatic for their most bothersome symptom as assessed with the USDD during baseline with a NRS score of 3 or more
- CSU patients: Diagnosis of CSU (acc. to Zuberbier et al 2022a) not adequately controlled with H1‑AH at approved doses alone for at least 4 weeks prior to randomization, as defined by all of the following: • UAS7 score (range 0-42) ≥ 16 and HSS7 (range 0-21) ≥ 8 during 7 days prior to randomization • CSU for ≥ 6 months
- Participants must be willing and able to attend the protocol defined test procedure throughout the study
You likely can't join if
- Participants who have a familial/hereditary 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
- Diseases, other than CSU or CINDU, with urticaria or angioedema symptoms including but not limited to: • urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa), • food allergies yielding urticaria symptoms when the allergen is not avoided by the dietary habits of the participant • hereditary or acquired angioedema.
- CINDU patients only: To prevent a confounding effect of CSU symptoms, the CINDU study population will consist of participants with predominant CINDU and shoud not have a signficant share of CSU symptoms (that might make the assessment of CINDU symptoms difficult) as per the investigator's judgement.
- CSU patients only: Patients should have no relevant inducible urticaria trigger
- Any other skin disease associated with chronic itching that might influence, in the investigator’s opinion, the study evaluations and results (eg, atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.) or skin diseases associated with only wheals and no itch e.g asymptomatic dermographism.
- Known or suspected ongoing, chronic or recurrent infectious disease including but not limited to opportunistic infections (e.g., tuberculosis, atypical mycobacterioses, listeriosis or aspergillosis) and/or known positivity for Human Immunodeficiency Virus (HIV) infection
See the full eligibility criteria
Who can join
- Signed informed consent must be obtained prior to participation in the study.
- Male and female participants ≥ 18 years of age at the time of signing of the informed consent forms.
- CINDU patients: Confirmed diagnosis of CINDU with a duration of ≥ 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 CINDU subtype is required before randomization (either during screening or prior to randomization on Day 1): • Symptomatic dermographism: A Total Fric Score of ≥3 using the FricTest® 4.0. • Cold urticaria: A Critical Threshold Temperature of ≥15°C using the TempTest® 4.0. • Cholinergic urticaria: A physician global assessment of severity of hives ≥ 2 using the Pulse-controlled ergometry test after the provocation test. • Heat urticaria: Documented emergence of urticaria symptoms following heat exposure • Solar urticaria: Documented emergence of urticaria symptoms following sunlight exposure and UVA/B or light exposure/phototesting record from source records • Delayed pressure urticaria: symptoms of urticaria as diagnosed by pressure provocation with dermographometer or local application of weight on the lesional skin area (symptoms should be observed 4h to 6h after the trigger) and can be documented by the participant when outpatient. • Aquagenic urticaria: Evidence of urticaria (in patient records) after local exposure to water (e.g. wet blanket or other suitable testing approach). • Contact urticaria: Evidence of urticaria following contact to identified material causing urticaria symptoms.
- CINDU patients: Patients should be symptomatic for their most bothersome symptom as assessed with the USDD during baseline with a NRS score of 3 or more
- CSU patients: Diagnosis of CSU (acc. to Zuberbier et al 2022a) not adequately controlled with H1‑AH at approved doses alone for at least 4 weeks prior to randomization, as defined by all of the following: • UAS7 score (range 0-42) ≥ 16 and HSS7 (range 0-21) ≥ 8 during 7 days prior to randomization • CSU for ≥ 6 months
- Participants must be willing and able to attend the protocol defined test procedure throughout the study
What rules you out
- Participants who have a familial/hereditary 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
- Diseases, other than CSU or CINDU, with urticaria or angioedema symptoms including but not limited to: • urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa), • food allergies yielding urticaria symptoms when the allergen is not avoided by the dietary habits of the participant • hereditary or acquired angioedema.
- CINDU patients only: To prevent a confounding effect of CSU symptoms, the CINDU study population will consist of participants with predominant CINDU and shoud not have a signficant share of CSU symptoms (that might make the assessment of CINDU symptoms difficult) as per the investigator's judgement.
- CSU patients only: Patients should have no relevant inducible urticaria trigger
- Any other skin disease associated with chronic itching that might influence, in the investigator’s opinion, the study evaluations and results (eg, atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.) or skin diseases associated with only wheals and no itch e.g asymptomatic dermographism.
- Known or suspected ongoing, chronic or recurrent infectious disease including but not limited to opportunistic infections (e.g., tuberculosis, atypical mycobacterioses, listeriosis or aspergillosis) and/or known positivity for Human Immunodeficiency Virus (HIV) infection
- 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
- United States
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 United States. 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.