A 52-week Study of Remibrutinib in IgE-mediated Food Allergy

Part of paid clinical trials in Los Angeles, California.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT07768371
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Cow Milk Allergy
  • Egg Allergy
  • IgE-Mediated Food Allergy
  • Peanut Allergy

Eligibility Criteria

Sex
ALL
Age
12 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Remibrutinib — DRUG
    Oral administration of remibrutinib.
  • Placebo — DRUG
    Oral administration of placebo.

Study Details

The purpose of this Phase III study is to evaluate the clinical efficacy and safety of remibrutinib in participants with peanut, or cow's milk ("milk", cooked and uncooked) or hen's egg ("egg", cooked and uncooked) immunoglobulin E (IgE)- mediated allergy in comparison to placebo.

Key Dates

First listed
Aug 17, 2026
Start date
Sep 11, 2026
Status verified
Aug 2026
Primary completion
Mar 30, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
576 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Sub-study 1- LOU064
    Participants with peanut allergy will receive remibrutinib during the double-blind treatment period (up to Week 24), followed by open-label remibrutinib treatment through Week 52.
  • Placebo Comparator: Sub-study 1- Placebo
    Participants with peanut allergy will receive matching placebo during the double-blind treatment period (up to Week 24), followed by open-label remibrutinib treatment through Week 52.
  • Experimental: Sub-study 2- LOU064
    Participants with cow's milk allergy will receive remibrutinib during the double-blind treatment period (up to Week 24), followed by open-label remibrutinib treatment through Week 52.
  • Placebo Comparator: Sub-study 2- Placebo
    Participants with cow's milk allergy will receive matching placebo during the double-blind treatment period (up to Week 24), followed by open-label remibrutinib treatment through Week 52.
  • Experimental: Sub-study 3- LOU064
    Participants with hen's egg allergy will receive remibrutinib during the double-blind treatment period (up to Week 24), followed by open-label remibrutinib treatment through Week 52.
  • Placebo Comparator: Sub-study 3- Placebo
    Participants with hen's egg allergy will receive matching placebo during the double-blind treatment period (up to Week 24), followed by open-label remibrutinib treatment through Week 52.
  • Experimental: Sub-study 4- LOU064
    Participants with peanut, cow's milk, and hen's egg allergy will receive remibrutinib during the double-blind treatment period (up to Week 4), followed by open-label remibrutinib treatment through Week 52.
  • Placebo Comparator: Sub-study 4- Placebo
    Participants with peanut, cow's milk, and hen's egg allergy will receive matching placebo during the double-blind treatment period (up to Week 4), followed by open-label remibrutinib treatment through Week 52.

Primary Outcome Measure

Sub-study 1: Number of participants achieving response status (tolerated at least 600 mg of peanut protein) [ Time Frame: Week 24 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
California Allergy and Asthma Medical GroupLos AngelesCalifornia90025
Vivienne An
[email protected]
+1 310 966 9050
Ricardo Tan (PRINCIPAL_INVESTIGATOR)
National Allergy and Asthma Research LLSNorth CharlestonSouth Carolina29420
Faye Singleton
[email protected]
+1 843 820 1036
Patricia Gerber (PRINCIPAL_INVESTIGATOR)
Western Sky Medical ResearchEl PasoTexas79924
Laura Herrera
[email protected]
Todd Funkhouser (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By research site
California Allergy and Asthma Medical Group· Los Angeles, CANational Allergy and Asthma Research LLS· North Charleston, SCWestern Sky Medical Research· El Paso, TX

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