Study of Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With an Allergy to Peanuts

Novartis

Status and phase: Completed; Phase 2

Conditions: Allergy, Peanut

Treatments: Drug: placebo; Drug: remibrutinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT05432388

CLOU064I12201

2021-006950-30 (EudraCT Number)

Details and patient eligibility

About

A study to evaluate the safety, efficacy and tolerability of remibrutinib at three doses versus placebo in adult participants who have a confirmed allergy to peanuts. The efficacy will be measured by the ability of participants to tolerate increasing doses of peanut protein during an oral food challenge after 1 month of study treatment.

Full description

This is a one month, phase 2, multi-center, randomized, investigator- and participant-blinded, placebo controlled study to assess the safety, efficacy and tolerability of remibrutinib (LOU064) in 3 doses of oral tablet twice a day in participants with a medically confirmed diagnosis of IgE-mediated peanut allergy. Participants will be randomized to remibrutinib low, medium or high dose for one-month treatment period (up to 5 weeks). Participants will have oral food challenges at the beginning of the study and at the end of the treatment period to assess their symptoms from increasing doses of peanut allergen.

Enrollment: 76 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Medical History of allergy to peanuts
• Positive peanut IgE >= 0.35 kUA/L
• Positive Skin Prick test for peanut allergen during screening for study
• Positive Oral Food Challenge to peanut during screening for study
• Willingness to comply with study schedule and procedures and avoid other allergens during study period

Exclusion criteria

• History of severe or life-threatening hypersensitivity event leading to ICU admission or intubation within 60 days of screening
• Uncontrolled asthma
• Bleeding risk or coagulation disorder(s)
• Use of anticoagulants or anti-platelets (aspirin or clopidogrel may be permitted)
• History of splenectomy
• Any significant disease that would put the safety of the patient at risk. This includes, but is not limited to: history of cancer, significant cardiac disease/history, hematology disorders, history of GI bleeding, active infectious process, liver disease, renal disease, immunologic disease (stable diabetes and thyroid disease may be permitted), alcohol or drug abuse, etc.

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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76 participants in 5 patient groups, including a placebo group

remibrutinib low dose

Experimental group

Description:

remibrutinib oral tablet

Treatment:

Drug: remibrutinib

remibrutinib medium dose

Experimental group

Description:

remibrutinib oral tablet

Treatment:

Drug: remibrutinib

remibrutinib high dose

Experimental group

Description:

remibrutinib oral tablet

Treatment:

Drug: remibrutinib

placebo 3 week / remibrutinib low dose 1 week

Experimental group

Description:

placebo oral tablet/ remibrutinib oral tablet

Treatment:

Drug: remibrutinib

Drug: placebo

placebo

Placebo Comparator group

Description:

oral tablet

Treatment:

Drug: placebo