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

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

Aug 27, 2026

Status verified

Sep 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

• Novartis Pharmaceuticals
  1-888-669-6682
  [email protected]
• Novartis Pharmaceuticals
  +41613241111
  [email protected]

Locations (10)

Find similar trials in Birmingham, AL

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