Active Not Recruiting PHASE3 INTERVENTIONAL 6-arm NCT05976243

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

A 52-week Multi-center, Randomized, Double-blind, Placebo Controlled, Basket Study With an Open-label Extension to Investigate the Efficacy, Safety, and Tolerability of Remibrutinib (LOU064) in Chronic Inducible Urticaria (CINDU) in Adults Inadequately Controlled by H1-antihistamines

Sponsor: Novartis Pharmaceuticals

Conditions Chronic Inducible Urticaria

Interventions Placebo Remibrutinib

Updated 22 times since 2023 Last updated: Mar 2, 2026 Started: Dec 7, 2023 Primary completion: May 22, 2026 Completion: Jun 15, 2029

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Chronic Inducible Urticaria and is currently ongoing. Novartis Pharmaceuticals leads this study, which shows 22 recorded versions since 2023 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

22 versions recorded

Mar 2026 — Present [monthly]

Active Not Recruiting PHASE3
Jan 2026 — Mar 2026 [monthly]

Active Not Recruiting PHASE3
Dec 2025 — Jan 2026 [monthly]

Active Not Recruiting PHASE3

Status: Recruiting → Active Not Recruiting
Sep 2025 — Dec 2025 [monthly]

Recruiting PHASE3
Aug 2025 — Sep 2025 [monthly]

Recruiting PHASE3

▶ Show 17 earlier versions

Jul 2025 — Aug 2025 [monthly]

Recruiting PHASE3
Jun 2025 — Jul 2025 [monthly]

Recruiting PHASE3
Apr 2025 — Jun 2025 [monthly]

Recruiting PHASE3
Mar 2025 — Apr 2025 [monthly]

Recruiting PHASE3
Nov 2024 — Mar 2025 [monthly]

Recruiting PHASE3
Oct 2024 — Nov 2024 [monthly]

Recruiting PHASE3
Sep 2024 — Oct 2024 [monthly]

Recruiting PHASE3
Aug 2024 — Sep 2024 [monthly]

Recruiting PHASE3
Jul 2024 — Aug 2024 [monthly]

Recruiting PHASE3
Jun 2024 — Jul 2024 [monthly]

Recruiting PHASE3
May 2024 — Jun 2024 [monthly]

Recruiting PHASE3
Apr 2024 — May 2024 [monthly]

Recruiting PHASE3
Mar 2024 — Apr 2024 [monthly]

Recruiting PHASE3
Feb 2024 — Mar 2024 [monthly]

Recruiting PHASE3
Jan 2024 — Feb 2024 [monthly]

Recruiting PHASE3

Status: Not Yet Recruiting → Recruiting
Oct 2023 — Jan 2024 [monthly]

Not Yet Recruiting PHASE3
Sep 2023 — Oct 2023 [monthly]

Not Yet Recruiting PHASE3

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Novartis Pharmaceuticals

Data source: Novartis

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Alicante, Spain , Alphaville Barueri, Brazil , Ancona, Italy , Aventura, United States , Bakersfield, United States , Baltimore, United States , Bangalore, India , Bangkok, Thailand , Barcelona, Spain , Barranquilla, Colombia and 110 more locations