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Clinical Trials in India / NCT06042478
Active, not recruiting Phase 3

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 · tracked via the Priya Life Science India tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 3
Started
2023-11-15
Last updated
2026-08-19

Condition(s) studied

Chronic Spontaneous Urticaria

Investigational drug(s) / intervention(s)

RemibrutinibPlacebo to remibrutinibPlacebo to omalizumabOmalizumab

Remibrutinib: Active treatment

Placebo to remibrutinib: Placebo followed by active treatment

Placebo to omalizumab: Placebo followed by active comparator

Omalizumab: Active comparator

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
Inclusion Criteria: * 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). 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.

Primary outcome measure(s)

Trial sites (110)

FacilityCityRegionStatus
Novartis Investigative Site CABA Buenos Aires
Novartis Investigative Site Mendoza Mendoza Province
Novartis Investigative Site Rosario Santa Fe Province
Novartis Investigative Site Bahía Blanca Argentina
Novartis Investigative Site CABA Argentina
Novartis Investigative Site Capital Federal Argentina
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 Bulgaria
Novartis Investigative Site Sofia Bulgaria
Novartis Investigative Site Varna Bulgaria
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 Czechia
Novartis Investigative Site Plzen Bolevec Czechia
Novartis Investigative Site Prague Czechia
Novartis Investigative Site Nice France
Novartis Investigative Site Grenoble France
Novartis Investigative Site La Rochelle France
Novartis Investigative Site Pierre-Bénite France
Novartis Investigative Site Rouen France
Novartis Investigative Site Freiburg im Breisgau Baden-Wurttemberg
Novartis Investigative Site Munich Bavaria
Novartis Investigative Site Hamburg Free and Hanseatic City of Hamburg
Novartis Investigative Site Göttingen Lower Saxony
Novartis Investigative Site Stade Lower Saxony
Novartis Investigative Site Dresden Saxony
Novartis Investigative Site Leipzig Saxony
Novartis Investigative Site Halle Saxony-Anhalt
Novartis Investigative Site Bad Bentheim Germany
Novartis Investigative Site Berlin Germany
Novartis Investigative Site Bochum Germany
Novartis Investigative Site Bochum Germany

+ 70 more sites — see the full list on the official registry below.

On this site

📄 Xolair (omalizumab) drug profile →

More Novartis Pharmaceuticals trials in India

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06042478 on ClinicalTrials.gov ↗ ← All trials in India