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RECRUITING 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

NCT06868212 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 400 participants
Start Date 2025-07-11
Est. Completion 2027-05-17
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

792 total trials

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06868212 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Arizona, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06868212?

This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial