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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT05432388
Phase
PHASE2
Status
Completed

Conditions

  • Allergy, Peanut

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • remibrutinib — 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 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.

Key Dates

Start date
Oct 12, 2022
Status verified
May 2025
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: remibrutinib low dose
    remibrutinib oral tablet
  • Experimental: remibrutinib medium dose
    remibrutinib oral tablet
  • Experimental: remibrutinib high dose
    remibrutinib oral tablet
  • Experimental: placebo 3 week / remibrutinib low dose 1 week
    placebo oral tablet/ remibrutinib oral tablet
  • Placebo Comparator: placebo
    oral tablet

Primary Outcome Measure

Efficacy or oral remibrutinib compared to placebo, as measured by the proportion of participants who can tolerate a single dose of >=600mg of peanut protein without dose-limiting symptoms during DBPCFC [ Time Frame: Baseline and Day 26 ]

Locations (23)

FacilityCityStateZIPSite coordinators
Allervie Clinical ResearchBirminghamAlabama35209-
Arkansas Children's HospitalLittle RockArkansas72202-
California Allergy and Asthma Medical GroupLos AngelesCalifornia90025-
Allergy and Asthma Clin Res IncWalnut CreekCalifornia94598-
Asthma and Allergy Associates P CColorado SpringsColorado80907-
Colorado Allergy and Asthma Ctr PCDenverColorado80230-
Childrens National HospitalWashington D.C.District of Columbia20010-
Treasure Valley Medical ResearchBoiseIdaho83706-
Midwest Allergy Sinus Asthma SCNormalIllinois61761-
Asthma and Allergy Center of Chicago S CRiver ForestIllinois60305-
Bluegrass Allergy Research .LexingtonKentucky40509-
Family Allergy and AsthmaLouisvilleKentucky40217-
Johns Hopkins HospitalBaltimoreMaryland21287-
Institute for Asthma and Allergy PCChevy ChaseMaryland20815-
Massachusetts General HospitalBostonMassachusetts02114-
University of Michigan Clinical Trials OfficeAnn ArborMichigan48109-
CenExel HRIBerlinNew Jersey08009-
Columbia University Irving MedicalNew YorkNew York10032-
CR Services Acquisition US Main centerColumbusOhio43213-
Vital Prospects Clinical Research InstituteTulsaOklahoma74136-
Western Sky Medical ResearchEl PasoTexas79924-
Allergy Associates of UtahSandy CityUtah84093-
Seattle Allergy and Asthma RschSeattleWashington98115-

Find similar trials in Birmingham, AL

By research site
Allervie Clinical Research· Birmingham, ALArkansas Children's Hospital· Little Rock, ARCalifornia Allergy and Asthma Medical Group· Los Angeles, CAAllergy and Asthma Clin Res Inc· Walnut Creek, CAAsthma and Allergy Associates P C· Colorado Springs, COColorado Allergy and Asthma Ctr PC· Denver, CO

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