A Phase 3 interventional study of Remibrutinib and Placebo in IgE-Mediated Food Allergy, Peanut Allergy and Cow Milk Allergy, sponsored by Novartis Pharmaceuticals. Recruiting at 22 sites in United States. Open to participants aged 12 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 3, Interventional, and Treatment
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.
This study is a Phase III, 52-week, multi-center, placebo controlled pivotal study to evaluate the efficacy and safety of remibrutinib compared to placebo in adolescent and adult participants with peanut, milk, or egg IgE-mediated allergy.
This study will be conducted in 4 Sub-studies: Sub-study 1 to evaluate response to peanut allergen at Week 24, Sub-study 2 to evaluate response to milk allergen at Week 24, Sub-study 3 to evaluate response to egg allergen at Week 24, and Sub-study 4 to evaluate response to peanut or milk, or egg allergen at Week 4.
Treatment period 1: Participants will receive one of the two treatment groups, double-blind remibrutinib or placebo, for a period up to 24 weeks for Sub-studies 1, 2, and 3, and up to 4 weeks for Sub-study 4.
Treatment period 2: For all Sub-studies, the open label period starts at Week 24, except for Sub-study 4, where the open label period starts at Week 4. Participants from each Sub-study will continue in the study and receive, or initiate, active open label remibrutinib until Week 52.
Following completion of the treatment period 2, eligible participants may enroll in a separate open-label post-trial access study and receive remibrutinib to evaluate long-term treatment effects. Participants who do not enroll in the post-trial access study will enter a 4-week safety follow-up period off treatment, during which adverse events will be monitored.
376 studies on the registry are indexed under Food Hypersensitivity; 90 are open to participants now.
This study's planned enrollment of 576 is above the median of 60 across 246 interventional studies indexed under Food Hypersensitivity.
Browse Food Hypersensitivity studies →Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
A positive DBPCFC at baseline (Screening Visit 2), defined as the occurrence of dose-limiting symptoms at a single dose:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Remibrutinib · Drug: 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.
Drug: Placebo
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.
Drug: Remibrutinib · Drug: 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.
Drug: Placebo
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.
Drug: Remibrutinib · Drug: 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.
Drug: Placebo
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.
Drug: Remibrutinib · Drug: 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.
Drug: Placebo
Oral administration of remibrutinib.
Also known as: LOU064
Oral administration of placebo.
Sub-study 1: Number of participants achieving response status (tolerated at least 600 mg of peanut protein)
Response status is defined as tolerating an oral dose of at least 600 mg peanut protein (1044 mg cumulative tolerated dose) without dose-limiting symptoms during the double-blind placebo-controlled food challenge (DBPCFC).
Time frame: Week 24
Sub-study 2: Number of participants achieving response status (tolerated at least 1000 mg of milk protein)
Response status is defined as tolerating an oral dose of at least 1000 mg milk protein (2044 mg cumulative tolerated dose) without dose-limiting symptoms during the double-blind placebo-controlled food challenge (DBPCFC).
Time frame: Week 24
Sub-study 3: Number of participants achieving response status (tolerated at least 1000 mg of egg protein)
Response status is defined as tolerating an oral dose of at least 1000 mg egg protein (2044 mg cumulative tolerated dose) without dose-limiting symptoms during the double-blind placebo-controlled food challenge (DBPCFC).
Time frame: Week 24
Sub-study 1: Number of participants achieving response status (tolerated at least 1000 mg of peanut protein)
Response status is defined as tolerating an oral dose of at least 1000 mg peanut protein (2044 mg cumulative tolerated dose) without dose-limiting symptoms during the double-blind placebo-controlled food challenge (DBPCFC).
Time frame: Week 24
Sub-study 1: Change from baseline in Log10-Transformed Maximum Tolerated Single Dose of peanut protein
Change from baseline in log10-transformed maximum tolerated single dose of peanut protein without dose-limiting symptoms during the DBPCFC.
Time frame: Baseline and Week 24
Sub-study 2: Change from baseline in Log10-Transformed Maximum Tolerated Single Dose of milk protein
Change from baseline in log10-transformed maximum tolerated single dose of milk protein without dose-limiting symptoms during the DBPCFC.
Time frame: Baseline and Week 24
Sub-study 3: Change from baseline in Log10-Transformed Maximum Tolerated Single Dose of egg protein
Change from baseline in log10-transformed maximum tolerated single dose of egg protein without dose-limiting symptoms during the DBPCFC.
Time frame: Baseline and Week 24
Sub-study 1: Number of participants by Maximum Symptom Severity During Peanut Protein Challenge
Maximum severity of symptoms occurring at any challenge dose up to and including 1000 mg peanut protein during the DBPCFC. Symptom severity is categorized as None, Mild, Moderate, or Severe.
Time frame: Week 24
Sub-study 2: Number of participants by Maximum Symptom Severity During Milk Protein Challenge
Maximum severity of symptoms occurring at any challenge dose up to and including 1000 mg milk protein during the DBPCFC. Symptom severity is categorized as None, Mild, Moderate, or Severe.
Time frame: Week 24
Sub-study 3: Number of participants by Maximum Symptom Severity During Egg Protein Challenge
Maximum severity of symptoms occurring at any challenge dose up to and including 1000 mg egg protein during the DBPCFC. Symptom severity is categorized as None, Mild, Moderate, or Severe.
Time frame: Week 24
Sub-study 1: Number of participants achieving response status (tolerated at least 3000 mg of peanut protein)
Response status is defined as tolerating an oral dose of 3000 mg peanut protein (5044 mg cumulative tolerated dose) without dose-limiting symptoms during the DBPCFC.
Time frame: Week 24
Sub-study 2: Number of participants achieving response status (tolerated at least 3000 mg of milk protein)
Response status is defined as tolerating an oral dose of 3000 mg milk protein (5044 mg cumulative tolerated dose) without dose-limiting symptoms during the DBPCFC.
Time frame: Week 24
Sub-study 3: Number of participants achieving response status (tolerated at least 3000 mg of egg protein)
Response status is defined as tolerating an oral dose of 3000 mg egg protein (5044 mg cumulative tolerated dose) without dose-limiting symptoms during the DBPCFC.
Time frame: Week 24
Sub-study 4: Number of participants achieving combined response status (tolerated at least 600 mg of peanut protein, or at least 1000 mg of milk or egg protein)
Combined response status is defined as tolerating at least 600 mg peanut protein (1044 mg cumulative tolerated dose) or at least 1000 mg milk or egg protein (2044 mg cumulative tolerated dose), as applicable, without dose-limiting symptoms during the DBPCFC.
Time frame: Week 4
Sub-study 4: Number of participants achieving combined response status (tolerated at least 1000 mg of peanut, milk or egg protein)
Combined response status is defined as tolerating at least 1000 mg peanut, milk, or egg protein, as applicable (2044 mg cumulative tolerated dose), without dose-limiting symptoms during the DBPCFC.
Time frame: Week 4
Sub-study 4: Change from baseline in Log10-Transformed Maximum Tolerated Single Dose
Combined change from baseline in log10-transformed maximum tolerated single dose of peanut, milk, or egg protein, as applicable, without dose-limiting symptoms during the DBPCFC.
Time frame: Baseline and Week 4
Sub-study 4: Number of participants by Maximum Symptom Severity During Food Challenge
Combined maximum severity of symptoms occurring at any challenge dose up to and including 1000 mg peanut, milk, or egg protein, as applicable, during the DBPCFC. Symptom severity is categorized as None, Mild, Moderate, or Severe.
Time frame: Week 4
Sub-study 4: Number of participants achieving combined response status (tolerated at least 3000 mg of peanut, milk or egg protein)
Combined response status is defined as tolerating an oral dose of 3000 mg peanut, milk, or egg protein, as applicable (5044 mg cumulative tolerated dose), without dose-limiting symptoms during the DBPCFC.
Time frame: Week 4
Sub-studies 1, 2, 3 and 4: Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with AEs and SAEs, including changes in vital signs, electrocardiograms (ECGs) and laboratory values qualifying and reported as AEs.
Time frame: Up to 56 weeks
Plan to share: Yes — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Remibrutinib