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

Study 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 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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 55 Years
Gender	All

More Inclusion & Exclusion Criteria

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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05432388
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Novartis Pharmaceuticals
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Spain, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Allergy, Peanut

Additional Details

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.

Arms & Interventions

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

Interventions

Drug: - remibrutinib

oral tablets

Drug: - placebo

oral tablets

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Allervie Clinical Research, Birmingham, Alabama

Status

Recruiting

Address

Allervie Clinical Research

Birmingham, Alabama, 35209

Site Contact

Brittany Scott

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