Who is eligible for clinical trial NCT06042478?

Participants must meet protocol criteria for Chronic Spontaneous Urticaria. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT06042478 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-08-18

Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo, With Omalizumab as Active Control, in Adult CSU Patients, Followed by an Open-label 52-week Optional Extension. (NCT06042478)

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Novartis Pharmaceuticals

🩺 Plain-English Summary (8th-Grade Level)

The purpose of the core phase of the trial is to assess the efficacy, safety and tolerability of remibrutinib (LOU064) 25 milligrams (mg) twice a day (b.i.d.) over placebo for 24 weeks and in comparison to omalizumab 300 mg every 4 weeks (q4w) for 52 weeks in participants with chronic spontaneous urticaria (CSU) inadequately controlled by H1-antihistamines (H1-AH). The purpose of the open-label extension phase is to assess efficacy, safety and tolerability up to two years for patients treated with remibrutinib and patients transitioned from omalizumab to remibrutinib at Week 52. In the extension phase, treatment will be with remibrutinib only (i.e., no background therapy). The extension phase will also fulfill the Novartis commitment to provide post-trial access to participants of the previous core phase.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (10 items).

Location: Novartis Investigative Site — CABA, Buenos Aires

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Male and female adult participants ≥18 years of age at the time of signing the informed consent.
CSU duration for ≥ 6 months prior to screening.
Diagnosis of CSU inadequately controlled by second generation H1-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 second-generation H1-AH during this time period.
UAS7 score (range 0-42) ≥16, ISS7 score (range 0-21) ≥ 6 and HSS7 score (range 0- 21) ≥ 6 during the 7 days prior to randomization (Day 1).
Documentation of hives within three months before randomization.
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).

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Prior exposure to ligelizumab, omalizumab and other biologics with any effect in CSU, including anti-IgE therapies.
Significant bleeding risk or coagulation disorders.
History of gastrointestinal bleeding.
Requirement for anti-platelet or anti-coagulant medication.
History or current hepatic disease.
Evidence of clinically significant cardiovascular, neurological, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, hematological disorders, gastrointestinal disease or immunodeficiency that, in the investigator's opinion, would compromise the safety of the participant, interfere with the interpretation of the study results or otherwise preclude participation or protocol adherence of the participant.
Evidence of helminthic parasitic infection as evidenced by stools being positive for a pathogenic organism according to local guidelines.
Documented history of anaphylaxis.
Pregnant or nursing (lactating) women.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (110 Sites)

Novartis Investigative Site — CABA, Buenos Aires
Novartis Investigative Site — Mendoza, Mendoza Province
Novartis Investigative Site — Rosario, Santa Fe Province
Novartis Investigative Site — Bahía Blanca,
Novartis Investigative Site — CABA,
Novartis Investigative Site — Capital Federal,
Novartis Investigative Site — Porto Alegre, Rio Grande do Sul
Novartis Investigative Site — Alphaville Barueri, São Paulo
Novartis Investigative Site — Santo André, São Paulo
Novartis Investigative Site — Sorocaba, São Paulo
Novartis Investigative Site — Sofia,
Novartis Investigative Site — Sofia,
Novartis Investigative Site — Varna,
Novartis Investigative Site — Edmonton, Alberta
Novartis Investigative Site — Hamilton, Ontario
Novartis Investigative Site — Hamilton, Ontario
Novartis Investigative Site — London, Ontario
Novartis Investigative Site — Niagara Falls, Ontario
Novartis Investigative Site — Québec, Quebec
Novartis Investigative Site — Verdun, Quebec
Novartis Investigative Site — Brno,
Novartis Investigative Site — Plzen Bolevec,
Novartis Investigative Site — Prague,
Novartis Investigative Site — Nice, France
Novartis Investigative Site — Grenoble,

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗