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Compares treatment options for Chronic Spontaneous Urticaria (CSU)
Official title A Study to Evaluate Efficacy of Remibrutinib Compared to Dupilumab at Early Timepoints in Adults With Chronic Spontaneous Urticaria Inadequately Controlled by Second Generation H1-antihistamines
ClinicalTrials.gov ID: NCT06868212
What this study is testing
What is Remibrutinib?
Remibrutinib is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for chronic spontaneous urticaria (csu).
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
- This is a US, multi-center, randomized, double-blind, double-dummy, Phase 3b study to evaluate efficacy of remibrutinib (25 mg twice daily [b.i.d.] by mouth [p.o.]) compared to dupilumab (600 mg loading dose administered subcutaneously (s.c.) followed by 300 mg every 2 weeks s.c.) at early timepoints (4 weeks and earlier), when administered as an add-on treatment to second generation H1-antihistamines (sgH1-AH) (standard label dose as background therapy) in adult US participants with moderate to severe chronic spontaneous urticaria (CSU) inadequately controlled by sgH1-AHs.
- Phase 3: a large, late-stage study
- 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
- Adults ≥ 18 years of age at the time of signing the informed consent
- CSU duration for ≥ 6 months prior to screening (defined as the onset of CSU determined by the Investigator based on all available supporting...
- Diagnosis of CSU inadequately controlled by sgH1-AH at the time of randomization, defined as:
- The presence of itch and hives for ≥ 6 consecutive weeks prior to screening despite the use of sgH1-AH during the 7 days prior to randomization (Day...
- UAS7 score (range, 0-42) ≥ 16, and
You likely can't join if
- Previous use of remibrutinib or other bruton's tyrosine kinase (BTK) inhibitors
- Previous use of dupilumab
- Evidence of clinically significant cardiovascular (such as but not limited to myocardial infarction, unstable ischemic heart disease, NYHA Class...
- Evidence of hematological disorders (including coagulation disorders or significant bleeding risk)
- History or evidence of gastrointestinal disease (including gastrointestinal bleeding, e.g., in association with use of nonsteroidal anti-inflammatory...
- Requirement for anti-platelet medication, except for acetylsalicylic acid up to 100 mg/d or clopidogrel up to 75 mg/d. The use of dual anti-platelet...
See the full eligibility criteria
- Adults ≥ 18 years of age at the time of signing the informed consent
- CSU duration for ≥ 6 months prior to screening (defined as the onset of CSU determined by the Investigator based on all available supporting documentation)
- Diagnosis of CSU inadequately controlled by sgH1-AH at the time of randomization, defined as:
- The presence of itch and hives for ≥ 6 consecutive weeks prior to screening despite the use of sgH1-AH during the 7 days prior to randomization (Day 1):
- UAS7 score (range, 0-42) ≥ 16, and
- ISS7 score (range, 0-21) ≥ 6, and
- HSS7 score (range, 0-21) ≥ 6
- Documentation of hives within 3 months before randomization (either at screening and/or at randomization); or documented in the participants medical history
- Willing and able to complete an Urticaria Patient Daily Diary (UPDD) for the duration of the study and adhere to the study protocol
- Participants must not have had more than one missing UPDD entry (either morning or evening) in the 7 days prior to randomization (Day 1)
- Previous use of remibrutinib or other bruton's tyrosine kinase (BTK) inhibitors
- Previous use of dupilumab
- 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...
- Evidence of hematological disorders (including coagulation disorders or significant bleeding risk)
- History or evidence of gastrointestinal disease (including gastrointestinal bleeding, e.g., in association with use of nonsteroidal anti-inflammatory drugs (NSAID), that was clinically relevant (e.g., where intervention...
- Requirement for anti-platelet medication, except for acetylsalicylic acid up to 100 mg/d or clopidogrel up to 75 mg/d. The use of dual anti-platelet therapy (e.g., acetylsalicylic acid + clopidogrel) is prohibited.
- Requirement for anticoagulant medication (for example, warfarin or Novel Oral Anti-Coagulants [NOAC])
- History or current hepatic disease including but not limited to acute or chronic hepatitis, cirrhosis or hepatic failure or hepatic parameters at screening: Aspartate Aminotransferase (AST)/ Alanine Aminotransferase...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Litchfield Park, Arizona, United States
- Payson, Arizona, United States
- Phoenix, Arizona, United States
- Scottsdale, Arizona, United States
- Fayetteville, Arkansas, United States
- Little Rock, Arkansas, United States
- Fountain Valley, California, United States
- Fremont, California, United States
- Huntington Beach, California, United States
- Long Beach, California, United States
- Los Angeles, California, United States
- Napa, California, United States
- Pomona, California, United States
- Redwood City, California, United States
- Rocklin, California, United States
- Rolling Hills Estates, California, United States
- Sacramento, California, United States
- San Diego, California, United States
- Santa Monica, California, United States
+ 86 more site(s).
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Litchfield Park, Arizona, United States; Payson, Arizona, United States; Phoenix, Arizona, United States; Scottsdale, Arizona, United States; Fayetteville, Arkansas, United States and 100 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.