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

Conditions

• Allergy, Peanut

Eligibility Criteria

Sex

ALL

Age

18 Years - 55 Years

Healthy Volunteers

Not accepted

Interventions

• LOU064 — DRUG
  oral tablets
• placebo — DRUG
  oral tablets

Study Details

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.

Key Dates

First listed

Jun 27, 2022

Start date

Oct 12, 2022

Status verified

May 2026

Primary completion

Mar 11, 2025

Completion

Mar 11, 2025

Study Design

Enrollment

76 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: LOU064 10 mg
  LOU064 10 mg was administered orally twice per day, on Days 1 through 28.
• Experimental: LOU064 25 mg
  LOU064 25 mg was administered orally twice per day, on Days 1 through 28.
• Experimental: LOU064 100 mg
  LOU064 100 mg was administered orally twice per day, on Days 1 through 28.
• 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.
• Placebo Comparator: Placebo
  Placebo was administered orally twice per day, on Days 1 through 28.

Primary Outcome Measure

Percentage of Participants Who Tolerated a Single Dose of >= 600 mg (1044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms [ Time Frame: Week 4 ]

Locations (24)

Find similar trials in Birmingham, AL

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