Recruiting PHASE3 INTERVENTIONAL 2-arm NCT06868212

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 (RECLAIM)

A US Phase 3b, Multi-center, Randomized, Double-blind, Double-Dummy 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

Sponsor: Novartis Pharmaceuticals

Conditions Chronic Spontaneous Urticaria (CSU)

Interventions Dupilumab Placebo solution for injection Remibrutinib Remibrutinib matching placebo

Updated 6 times since 2025 Last updated: Mar 10, 2026 Started: Jul 11, 2025 Primary completion: Feb 22, 2027 Completion: May 17, 2027

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 Spontaneous Urticaria (CSU) and is currently actively recruiting participants. Novartis Pharmaceuticals leads this study, which shows 6 recorded versions since 2025 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

6 versions recorded

Mar 2026 — Present [monthly]

Recruiting PHASE3
Jan 2026 — Mar 2026 [monthly]

Recruiting PHASE3
Nov 2025 — Jan 2026 [monthly]

Recruiting PHASE3
Sep 2025 — Nov 2025 [monthly]

Recruiting PHASE3
Aug 2025 — Sep 2025 [monthly]

Recruiting PHASE3

Status: Not Yet Recruiting → Recruiting

▶ Show 1 earlier version

Apr 2025 — Aug 2025 [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

Ann Arbor, United States , Arlington, United States , Aurora, United States , Austin, United States , Aventura, United States , Baltimore, United States , Baton Rouge, United States , Bellaire, United States , Belleville, United States , Bellingham, United States and 83 more locations