NCT05976243 is a Phase 3 clinical trial of Remibrutinib in Chronic Inducible Urticaria, sponsored by Novartis Pharmaceuticals.

Who is sponsoring NCT05976243?

NCT05976243 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT05976243?

Interventions in NCT05976243: Remibrutinib, Placebo.

What condition does NCT05976243 study?

NCT05976243 studies Chronic Inducible Urticaria.

Is NCT05976243 still recruiting?

NCT05976243 is currently active, enrolled. Last updated 3 March 2026.

Last reviewed 2026-03-03 · How we verify

NCT05976243

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines

Active, enrolled Phase 3 Last updated 3 March 2026

What this trial tests

Phase 3 trial testing Remibrutinib in Chronic Inducible Urticaria in 362 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

7 December 2023

Primary endpoint
22 May 2026

15 June 2029

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	362
Start date	7 December 2023
Primary completion	22 May 2026
Estimated completion	15 June 2029
Sites	133 locations across Hong Kong, Colombia, Italy, Japan, Malaysia, Vietnam, Poland, South Korea

Drugs / interventions tested

Remibrutinib — full drug profile →
Placebo

Conditions studied

Chronic Inducible Urticaria — all drugs for Chronic Inducible Urticaria →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

Adults 18 to 100, any sex, with Chronic Inducible Urticaria. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase 3, parallel group, placebo-controlled, double-blind, confirmatory study in patients with CINDU, with an optional Open-label Extension (OLE). The purpose of the core period (52 weeks of treatment) of this study is to evaluate the efficacy, safety, and tolerability of remibrutinib (LOU064) vs. placebo in adults suffering from CINDU inadequately controlled by H1-antihistamines (H1-AHs). The purpose of the OLE period is to collect long-term efficacy, safety, and tolerability data on remibrutinib in participants after having completed the Core period

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

New insights into chronic inducible urticaria.
Muñoz M, Kiefer LA, Pereira MP, Bizjak M, et al · · 2024 · cited 13× · PMID 39028396 · DOI 10.1007/s11882-024-01160-y
Update on the Treatment of Chronic Spontaneous Urticaria.
Kolkhir P, Fok JS, Kocatürk E, Li PH, et al · · 2025 · cited 10× · PMID 40074986 · DOI 10.1007/s40265-025-02170-4
Emerging IgE and non-IgE targeted therapies for chronic urticaria.
Chhiba KD, Saini SS. · · 2026 · cited 1× · PMID 41270830 · DOI 10.1016/j.anai.2025.11.008
Advancements and challenges in the management of chronic inducible urticaria.
Zhang M, Liu J, Zhi Y. · · 2026 · PMID 42112401 · DOI 10.3389/fimmu.2026.1747542

Verify or expand the search:

Other trials of Remibrutinib

Trials testing the same drug.

NCT07456891 — Remibrutinib Open Label Roll-over Post-trial Access Protocol · Phase 3 · not yet recruiting
NCT06868212 — A Study to Evaluate Efficacy of Remibrutinib Compared to Dupilumab at Early Timepoints in Adults With Chronic Spontaneou · Phase 3 · recruiting
NCT06865651 — Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chron · Phase 2 · recruiting
NCT06042478 — Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo, With Omalizuma · Phase 3 · active not recruiting
NCT05147220 — Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) · Phase 3 · active not recruiting

Other recruiting trials for Chronic Inducible Urticaria

Currently open trials in the same condition.

NCT06931405 — Study of BLU-808 in Chronic Inducible Urticaria (CIndU) and Chronic Spontaneous Urticaria (CSU) · Phase 2 · recruiting

Other Novartis Pharmaceuticals trials

Trials by the same sponsor.

NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary · Phase 3 · not yet recruiting
NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 4 · not yet recruiting
NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy · not yet recruiting
NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05976243 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 3 March 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05976243.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing