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

ConditionsIgE-Mediated Food AllergyPeanut AllergyCow Milk AllergyEgg Allergy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12-65
SponsorNovartis Pharmaceuticals

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Remibrutinib

    Drug

    Oral administration of remibrutinib.

  • Placebo

    Drug

    Oral administration of placebo.

Treatment groups

576 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Sub-study 1- LOU064Experimental treatment 2 interventions
Group B: Sub-study 1- PlaceboPlacebo comparator 1 intervention
Group C: Sub-study 2- LOU064Experimental treatment 2 interventions
Group D: Sub-study 2- PlaceboPlacebo comparator 1 intervention
Group E: Sub-study 3- LOU064Experimental treatment 2 interventions
Group F: Sub-study 3- PlaceboPlacebo comparator 1 intervention
Group G: Sub-study 4- LOU064Experimental treatment 2 interventions
Group H: Sub-study 4- PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Novartis Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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