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Clinical trials
NCT07768371

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

ClinicalTrials.gov identifier NCT07768371

Novartis reference CLOU064I12301

Show study information as

Condition IgE-Mediated Food Allergy, Peanut Allergy, Cow Milk Allergy, Egg Allergy

Study status Recruiting

Phase 3

Number of participants 576

Gender All

Age 12 to 65 years

Learn More

Study details

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.

Interventions

DRUG: Remibrutinib|DRUG: Placebo

Official title

A 52-week Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess Efficacy and Safety of Remibrutinib (LOU064) in Adult and Adolescent Participants With IgE-mediated Food Allergy

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Who can take part?

Inclusion Criteria

Signed informed consent and/or assent (where applicable) must be obtained prior to study participation. Participant (and parent/legal guardian for adolescents) must be able to understand and provide informed consent and assent, as applicable. If a minor participant providing assent reaches the age of legal majority (as defined by local law), he/she must be re-consented (ICF) at the next study visit.
Male or female participants who are 12 to 65 years of age, inclusive, at the time of signing informed consent/assent.
Positive allergen-specific (peanut, milk, or egg), IgE (≥ 0.35 kUA/L) at Screening Visit 1.
Positive Skin Prick Testing (SPT) for peanut, milk, or egg at Screening Visit 1. This is defined as the average diameter (longest diameter and mid-point orthogonal diameter) ≥ 4 mm wheal compared to the negative control.
A positive DBPCFC at baseline (Screening Visit 2), defined as the occurrence of dose-limiting symptoms at a single dose:
- ≤ 100 mg of peanut allergen protein
- ≤ 300 mg for milk or egg allergen protein
Participants must be able and willing to participate in the DBPCFC and must be willing to continue avoiding exposure to peanut, milk (cooked and uncooked), or egg (cooked and uncooked) and any other foods that they are allergic to throughout this study.

Exclusion Criteria

Previous use of remibrutinib or other Bruton Tyrosine Kinase (BTK) inhibitors.
History of hypersensitivity to study drug or its excipients or to drugs of similar chemical classes.
Hypersensitivity or intolerance to any of the matrix components used within the material for the DBPCFC.
Any occurrence of dose-limiting symptoms against placebo allergen at baseline DBPCFC (Screening Visit Part 1 and/or Part 2).
Medical examination, medical conditions or laboratory findings that, in the opinion of the investigator, renders the participant unsuitable for the study.

Other protocol-defined inclusion/exclusion criteria may apply.

Home
Clinical trials
NCT07768371

Study of an Investigational Treatment for Peanut, Milk, or Egg Food Allergy

ClinicalTrials.gov identifier NCT07768371

Novartis reference CLOU064I12301

Show study information as

Condition IgE-Mediated Food Allergy, Peanut Allergy, Cow Milk Allergy, Egg Allergy

Study status Recruiting

Phase 3

Number of participants 576

Gender All

Age 12 to 65 years

Learn More

Study details

This text was simplified by AI to make it easier to read. It may contain mistakes. Switch to Original information for the official version.

The purpose of this research study is to learn about the effects and safety of an investigational treatment in adolescents and adults with immunoglobulin E (IgE)-mediated food allergy to peanut, cow’s milk, or hen’s egg.

Participants will receive either the investigational treatment or a placebo. A placebo looks like the investigational treatment but does not contain active medication. In some parts of the study, this first treatment period lasts up to 24 weeks, and in one part it lasts up to 4 weeks. After that, participants will continue in the study and receive the investigational treatment (without placebo) until Week 52. The study includes food allergy challenge testing (called a double-blind, placebo-controlled food challenge), and participants must be willing to keep avoiding their allergy foods during the study.

This study may be an option for
Adolescents and adults with peanut, milk, or egg IgE-mediated food allergy may be able to participate if they:

Are 12 to 65 years old
Have positive allergy blood testing (IgE) for peanut, milk, or egg
Have a positive skin prick test for peanut, milk, or egg
Have a positive double-blind, placebo-controlled food challenge at the start of the study
Are willing to take part in the food challenge testing and keep avoiding peanut, milk, or egg (and any other foods they are allergic to) during the study

Study timeline and visits:
Participation lasts 52 weeks of treatment. Some participants may have an additional 4-week safety follow-up period off treatment. Eligible participants may be able to join a separate study to continue receiving the investigational treatment longer term.

Interventions

DRUG: Remibrutinib|DRUG: Placebo

Official title

A 52-week Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess Efficacy and Safety of Remibrutinib (LOU064) in Adult and Adolescent Participants With IgE-mediated Food Allergy

Who can take part?

This text was simplified by AI to make it easier to read. It may contain mistakes. Switch to Original information for the official version.

You might be able to join if

Sign the study consent form and/or assent form (if applicable) before joining the study
Be able to understand and sign consent/assent (for adolescents, a parent or legal guardian must also be able to understand and sign); if an adolescent reaches the legal adult age during the study, they must sign an adult consent form at the next study visit
Be male or female and be 12 to 65 years old at the time of signing consent/assent
Have a positive allergen-specific IgE blood test for peanut, milk, or egg at the first screening visit
Have a positive skin prick test for peanut, milk, or egg at the first screening visit
Have a positive double-blind, placebo-controlled food challenge at the baseline visit (second screening visit), meaning they develop dose-limiting symptoms at a single dose of:
- 100 mg or less of peanut allergen protein, or
- 300 mg or less of milk or egg allergen protein
Be able and willing to take part in the double-blind, placebo-controlled food challenge and be willing to continue avoiding peanut, milk (cooked and uncooked), or egg (cooked and uncooked), and any other foods they are allergic to, throughout the study

You might not be able to join if

Have used the study treatment before, or have used other Bruton tyrosine kinase (BTK) inhibitors before
Have a history of allergy (hypersensitivity) to the study drug, its ingredients, or drugs with a similar chemical structure
Have allergy (hypersensitivity) or intolerance to any of the food “matrix” ingredients used for the double-blind, placebo-controlled food challenge materials
Have any dose-limiting symptoms to the placebo allergen during the baseline double-blind, placebo-controlled food challenge (screening visit part 1 and/or part 2)
Have medical exam results, medical conditions, or lab results that, in the study doctor’s opinion, make the person not suitable for the study

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