NCT06868212 · Novartis Pharmaceuticals
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
(RECLAIM)
What this study is about
This is a US, multi-center, randomly assigned, where neither patients nor doctors know which treatment is given, double-dummy, Phase 3b study to evaluate effectiveness of remibrutinib (25 mg twice daily \[b.i.d.\] by mouth \[p.o.\]) compared to dupilumab (600 mg loading dose administered injected under the skin (s.c.) followed by 300 mg every 2 weeks s.c.
View original scientific description
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.
Interventions
DRUG
Remibrutinib
Film-coated tablet, oral administration, 25 mg b.i.d.
DRUG
Remibrutinib matching placebo
Film-coated tablet, oral administration, b.i.d.
DRUG
Dupilumab
Solution for injection in pre-filled syringe 600 mg loading dose followed by 300 mg dose every 2 weeks
DRUG
Placebo solution for injection
Solution for injection in pre-filled syringe every 2 weeks
Primary outcome measures
Absolute change from baseline in Weekly Urticaria Activity Score (UAS7) at Week 4
Time frame: Baseline, Week 4
The UAS7 is the sum of the Weekly Hives Severity (HSS7) score and the Weekly Itch Severity (ISS7) score, and ranges from 0-42. Weekly scores (HSS7 and ISS7 scores) will be derived by adding up the average daily scores of the 7 days preceding the visit.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion 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
Where
- Birmingham, Alabama
- Litchfield Park, Arizona
- Payson, Arizona
- Phoenix, Arizona
- Scottsdale, Arizona
- Fayetteville, Arkansas
- Little Rock, Arkansas
- Fountain Valley, California
- Fremont, California
- Huntington Beach, California
- Long Beach, California
- Los Angeles, California
And 94 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 10, 2026 · Source of record for eligibility and locations