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

Purpose

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 was measured by the ability of participants to tolerate increasing doses of peanut protein during an oral food challenge after 1 month of study treatment.

Condition

  • Allergy, Peanut

Eligibility

Eligible Ages
Between 18 Years and 55 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
LOU064 10 mg 		LOU064 10 mg was administered orally twice per day, on Days 1 through 28.
  • Drug: LOU064
    oral tablets
    Other names:
    • remibrutinib
Experimental
LOU064 25 mg 		LOU064 25 mg was administered orally twice per day, on Days 1 through 28.
  • Drug: LOU064
    oral tablets
    Other names:
    • remibrutinib
Experimental
LOU064 100 mg 		LOU064 100 mg was administered orally twice per day, on Days 1 through 28.
  • Drug: LOU064
    oral tablets
    Other names:
    • remibrutinib
Experimental
Placebo + LOU064 25 mg 		Placebo was administered orally twice per day, on Days 1 through 21 followed by LOU064 25 mg twice per day, on Days 22 through 28.
  • Drug: LOU064
    oral tablets
    Other names:
    • remibrutinib
  • Drug: placebo
    oral tablets
Placebo Comparator
Placebo 		Placebo was administered orally twice per day, on Days 1 through 28.
  • Drug: placebo
    oral tablets

More Details

Status
Completed
Sponsor
Novartis Pharmaceuticals

Study Contact

Detailed Description

This was a randomized, participant- and investigator-blinded, placebo-controlled study to assess the safety and clinical efficacy of oral LOU064 versus placebo across five treatment arms in participants with a medically confirmed diagnosis of IgE-mediated peanut allergy for one-month treatment period (up to 5 weeks). Participants had 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.