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Tests treatment safety and results for Chronic Urticaria (CU): Chronic Inducible Urticaria...
Official title Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic Urticaria
ClinicalTrials.gov ID: NCT06865651
What this study is testing
What is Remibrutinib?
Remibrutinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for chronic urticaria (cu): chronic inducible urticaria (cindu) and chronic spontaneous urticaria (csu).
Also referred to as LOU064.
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 purpose of this study is to explore the effect and Mechanism of Action (MoA) of remibrutinib (LOU064) vs. placebo on clinical outcomes in participants with Chronic Urticaria (CU), including both Chronic Spontaneous Urticaria (CSU) and Chronic Inducible Urticaria (CINDU).
- 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 to 100
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...
- 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...
- CSU patients: Diagnosis of CSU (acc. to Zuberbier et al 2022c) not adequately controlled with H1-AH at approved doses alone for at least 4 weeks...
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...
- 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 any confounding effect of CSU symptoms, the CINDU study population will consist of participants with predominant...
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...
- 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 2022c) 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 any confounding effect of CSU symptoms, the CINDU study population will consist of participants with predominant CINDU and should not have a significant share of CSU symptoms (that might...
- 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 (e.g., atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis...
- 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...
- Evidence of an ongoing Hepatitis C infection (defined by the detection at screening of Hepatitis C virus antibodies (anti-HCVAb) and hepatitis C ribonucleic acid (HCV-RNA) in participants who are positive for...
- Major surgery within 8 weeks prior to screening or planned surgery for the duration of the study.
- Evidence of clinically significant cardiovascular (such as but not limited to myocardial infarction, unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, arrhythmia and uncontrolled hypertension...
- Uncontrolled disease states, such as asthma, or inflammatory bowel disease, or any other disease where flares are commonly treated with oral or parenteral corticosteroids.
- History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years (except for basal cell carcinoma or actinic keratosis that have been treated with no...
- History or presence of impaired renal function as indicated by clinically significantly abnormal creatinine or BUN values, or abnormal urinary constituents (e.g. proteinuria, hematuria)
- Evidence of urinary obstruction, or difficulty in voiding at screening
- Evidence of congenital renal abnormalities with known effect on renal function
- Calculated eGFR \< 60 mL/min
- Hematology parameters at screening:
- Hemoglobin: \< 10 g/dL
- Platelets: \< 100,000/mm3
- Leucocytes: \< 3,000/mm3
- Neutrophils:\< 1,500/mm3
- History or current hepatic disease including but not limited to acute or chronic hepatitis, cirrhosis or hepatic failure or Aspartate Aminotransferase (AST)/ Alanine Aminotransferase (ALT) levels of more than 1.5 x...
- Use of other investigational drugs s within 5 half-lives or within 30 days (for small molecules) prior to Screening or until the expected pharmacodynamic (PD) effect has returned to baseline (for biologics), whichever...
- Contraindications to or hypersensitivity to remibrutinib (or its excipients or to drugs of similar chemical classes) or other substances provided to the people as rescue medication to control symptoms, such as...
- Participants taking prohibited therapies as listed in Section 6.6.2. In particular patients with pretreatment with remibrutinib or another BTK-inhibitor within 4 months prior to randomization.
- History of live or live attenuated vaccine within 6 weeks prior to randomization or requirement to receive these vaccinations at any time during the study drug treatment.
- Requirement for anti-platelet medication, except for acetylsalicylic acid up to 100 mg/d or clopidogrel up to 75 mg/d which are allowed. The use of dual anti-platelet therapy (e.g., acetylsalicylic acid + clopidogrel)...
- Requirement for anticoagulant medication (for example, warfarin or Novel Oral Anti-Coagulants (NOAC)).
- History of gastrointestinal bleeding, e.g., in association with use of nonsteroidal anti-inflammatory drugs (NSAID), that was clinically relevant (e.g., where intervention was indicated or requiring hospitalization or...
- Significant bleeding risk or coagulation disorders.
- Known history or evidence of ongoing alcohol or drug abuse within the last 6 months before randomization as per source records.
- Pregnant or nursing (breast feeding) women.
- Women of child-bearing potential, defined as fertile, following menarche and until becoming post-menopausal unless they are permanent sterile or they are using highly effective methods of contraception during dosing for...
- Total abstinence (when this is in line with the preferred and usual lifestyle of the participant). Note that periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not...
- Bilateral oophorectomy with or without hysterectomy, total hysterectomy or bilateral salpingectomy at least six weeks prior to the first dose of study treatment. In case of oophorectomy alone, only when the reproductive...
- Bilateral tubal occlusion, Bilateral tubal ligation (at least six weeks prior to the first dose of study treatment)
- Male partner sterilization (vasectomy) of male partner(s) of the female participant at least six months prior to screening). The vasectomized male partner should be sole partner for that participant and received medical...
- Use of oral (estrogen and progesterone), injected, or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that...
The study team makes the final eligibility decision.
Where it's taking place
- North Miami Beach, Florida, United States
- Glenview, Illinois, United States
- Grenoble, France
- Montpellier, France
- Paris, France
- Pierre-Bénite, France
- Dresden, Saxony, Germany
- Berlin, Germany
- Mainz, Germany
- Tübingen, Germany
- Poznan, Poland
- Rzeszów, Poland
- Warsaw, Poland
- Barcelona, Catalonia, Spain
- Pamplona, Navarre, Spain
- Alicante, Spain
- Madrid, 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 - 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 to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include North Miami Beach, Florida, United States; Glenview, Illinois, United States; Grenoble, France; Montpellier, France; Paris, France; Pierre-Bénite, France and 11 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 ClinicalTrials.gov; the study team decides eligibility.