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NCT06868212 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Chronic Spontaneous Urticaria (CSU), sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 400
- Enrollment target
- 20
- Study locations
NCT06868212 is a Phase 3 study of Chronic Spontaneous Urticaria (CSU) that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 400 participants. The trial reports 20 study locations across 4 states.
The verdict
NCT06868212, a Phase 3 study of Chronic Spontaneous Urticaria (CSU), is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 400 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Dupilumab
- DRUG Remibrutinib
- DRUG Remibrutinib matching placebo
- DRUG Placebo solution for injection
Study Locations (20)
California
- First OC Dermatology - Fountain Valley
- Ctr for Dermatology Clinical Res - Fremont
- Allergy and Asthma Specialists Group - Huntington Beach
- Orso Health - Long Beach
- Ark Clinical Research - Long Beach
- California Allergy and Asthma Medical Group - Los Angeles
- Dermatology Research Associates - Los Angeles
- One Of A Kind Clinical Research - Napa
- Empire Clinical Research - Pomona
- Allergy and Asthma Consultants - Redwood City
- Norcal Clinical Research - Rocklin
- Integrative Skin Science and Res - Sacramento
Arizona
- Research Solutions of Arizona - Litchfield Park
- Peak Dermatology - Payson
- Premier Allergy Asthma And Immunology - Phoenix
- Avacare Center for Dermatology - Phoenix
- Orso Health - Scottsdale
Alabama
- Allervie Clinical Research - Birmingham
- Cahaba Derm and skin hlth ctr 27 - Birmingham
Arkansas
- Acuro Research Inc - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2025-07-11 |
| Est. Completion | 2027-05-17 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06868212
The ClinicalTrials.gov registry entry for NCT06868212 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Chronic Spontaneous Urticaria (CSU) appearing as the primary indexed condition, and to 4 interventions - of which Dupilumab is the first listed.
NCT06868212 reports 20 study locations spanning 4 distinct geographic areas - top geographies include California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT06868212 about?
NCT06868212 is a clinical study titled "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". 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 timep...
What is the current status of trial NCT06868212?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 400 participants. The study started on 2025-07-11. Estimated completion is 2027-05-17.
What conditions does trial NCT06868212 study?
This clinical trial studies the following conditions: Chronic Spontaneous Urticaria (CSU).
What interventions are being tested in trial NCT06868212?
The interventions under investigation include: Dupilumab (DRUG), Remibrutinib (DRUG), Remibrutinib matching placebo (DRUG), Placebo solution for injection (DRUG).
Who is sponsoring clinical trial NCT06868212?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06868212 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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