Who is sponsoring NCT06865651?

NCT06865651 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT06865651?

Interventions in NCT06865651: Remibrutinib, Placebo.

Is NCT06865651 still recruiting?

NCT06865651 is currently recruiting now. Last updated 30 March 2026.

Last reviewed 2026-03-30 · How we verify

NCT06865651

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

Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic Urticaria

Recruiting now Phase 2 Last updated 30 March 2026

What this trial tests

Phase 2 trial testing Remibrutinib in Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU) in 44 participants. Currently enrolling.

Timeline

22 May 2025

Primary endpoint
23 August 2027

28 September 2027

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	basic science
Enrollment	44
Start date	22 May 2025
Primary completion	23 August 2027
Estimated completion	28 September 2027
Sites	17 locations across France, Germany, Poland, United States, Spain

Drugs / interventions tested

Remibrutinib — full drug profile →
Placebo

Conditions studied

Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU) — all drugs for Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU) →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

Adults 18 to 100, any sex, with Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to explore the effect and Mechanism of Action (MoA) of remibrutinib (LOU064) vs. placebo on clinical outcomes in participants with Chronic Urticaria (CU), including both Chronic Spontaneous Urticaria (CSU) and Chronic Inducible Urticaria (CINDU).

Publications & conference data

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

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
NCT05976243 — A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Ina · Phase 3 · active not 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 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 NCT06865651 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 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: 30 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/NCT06865651.

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