Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT06865651 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU), sponsored by Novartis Pharmaceuticals.

Recruiting
Registry status
Phase 2
Development phase
44
Enrollment target
17
Study locations

NCT06865651: Recruiting Phase 2 study of Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU), sponsored by Novartis Pharmaceuticals.

NCT06865651 is a Phase 2 study of Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU) that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 44 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower). The trial reports 17 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT06865651, a Phase 2 study of Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU), is actively recruiting participants, sponsored by Novartis Pharmaceuticals.

RECRUITING
Registry status
Phase 2
Development phase
44 participants
Enrollment target
17
Study locations

Study Summary

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).

Primary Outcome

To investigate the efficacy of remibrutinib versus placebo for the most bothersome symptom in CINDU patients. The USDD was developed to assess daily exposure and avoidance of triggers, severity of urticaria symptoms (including NRS for pain itch and burning). On the first day of completion, the participants will be asked which symptom (itch, pain, and burning) is the most bothersome symptom of urticaria.

Conditions Studied

Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU)

Interventions

  • DRUG Placebo
  • DRUG Remibrutinib

Study Locations (17)

Other

  • Novartis Investigative Site - Grenoble
  • Novartis Investigative Site - Montpellier
  • Novartis Investigative Site - Paris
  • Novartis Investigative Site - Pierre-Bénite
  • Novartis Investigative Site - Berlin
  • Novartis Investigative Site - Mainz
  • Novartis Investigative Site - Tübingen
  • Novartis Investigative Site - Poznan
  • Novartis Investigative Site - Rzeszów
  • Novartis Investigative Site - Warsaw
  • Novartis Investigative Site - Alicante
  • Novartis Investigative Site - Madrid

Florida

  • Ziaderm Research LLC - North Miami Beach

Illinois

  • Endeavor Health - Glenview

Saxony

  • Novartis Investigative Site - Dresden

Catalonia

  • Novartis Investigative Site - Barcelona

Navarre

  • Novartis Investigative Site - Pamplona

Trial Details

FieldValue
Enrollment Target 44 participants
Start Date 2025-05-22
Est. Completion 2027-10-07
Phase Phase 2
Novartis Pharmaceuticals

1,375 total trials

What NCT06865651 shows while recruiting

NCT06865651 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower).

The record links to 1 condition, with Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT06865651 lists 17 locations in 6 states (Other, Florida, Illinois).

Frequently Asked Questions

What is clinical trial NCT06865651 about?

NCT06865651 is a clinical study titled "Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic Urticaria". 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).

What is the current status of trial NCT06865651?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2025-05-22. Estimated completion is 2027-10-07.

What conditions does trial NCT06865651 study?

This clinical trial studies the following conditions: Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU).

What interventions are being tested in trial NCT06865651?

The interventions under investigation include: Placebo (DRUG), Remibrutinib (DRUG).

Who is sponsoring clinical trial NCT06865651?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06865651 being conducted?

This trial has 17 study locations across Florida, Illinois, Saxony, Catalonia, Navarre. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

How this trial's enrollment target compares

Where NCT06865651's enrollment target sits among peer trials

44 1322nd of 2000 higher than 669 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT02323945 · 44 participants · NA

    Effects of Breathing Mild Bouts of Low Oxygen on Limb Mobility After Spinal Injury

  • NCT03093909 · 44 participants · Phase 1

    Study of Aerosol Gemcitabine in Patients With Solid Tumors and Pulmonary Metastases

  • NCT03104491 · 44 participants · Phase 1

    Inotuzumab Ozogamicin Post-Transplant For Acute Lymphocytic Leukemia

  • NCT03781765 · 44 participants · Phase 4

    Stimulant vs. Non-stimulant Treatments and Reward Processing in Drug-naive Youth at SUD Risk

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

More recruiting context for NCT06865651

Source: ClinicalTrials.gov NCT06865651, the US trial registry maintained by the National Library of Medicine. NCT06865651 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.