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Trial record 3 of 4 for:    Novartis | Peanut Allergy
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Study of Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With an Allergy to Peanuts

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ClinicalTrials.gov Identifier: NCT05432388
Recruitment Status : Recruiting
First Posted : June 27, 2022
Last Update Posted : January 23, 2024
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Allergy, Peanut Drug: remibrutinib Drug: placebo Phase 2

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A One Month, Investigator and Participant Blinded Study to Investigate the Efficacy and Safety of Remibrutinib (LOU064) at Multiple Dose Levels in Adult Participants With Peanut Allergy
Actual Study Start Date : October 12, 2022
Estimated Primary Completion Date : April 29, 2026
Estimated Study Completion Date : April 29, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arms and Interventions
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Arm Intervention/treatment
Experimental: remibrutinib low dose
remibrutinib oral tablet
 Drug: remibrutinib
oral tablets
Other Name: (LOU064)
Experimental: remibrutinib medium dose
remibrutinib oral tablet
 Drug: remibrutinib
oral tablets
Other Name: (LOU064)
Experimental: remibrutinib high dose
remibrutinib oral tablet
 Drug: remibrutinib
oral tablets
Other Name: (LOU064)
Experimental: placebo 3 week / remibrutinib low dose 1 week
placebo oral tablet/ remibrutinib oral tablet
 Drug: remibrutinib
oral tablets
Other Name: (LOU064)

Drug: placebo
oral tablets
Placebo Comparator: placebo
oral tablet
 Drug: placebo
oral tablets


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    Responder status defined as tolerating a single dose of >=600mg of peanut protein without dose-limiting symptoms during the DBPCFC


Secondary Outcome Measures :
  1. Efficacy or oral remibrutinib compared to placebo, as measured by the proportion of participants who can tolerate a single dose of >=1000mg of peanut protein without dose-limiting symptoms during DBPCFC [ Time Frame: Baseline, Days 26 and 28 ]
    Responder status defined as tolerating a single dose of >=1000mg of peanut protein without dose-limiting symptoms during the DBPCFC

  2. Efficacy or oral remibrutinib compared to placebo, as measured by the proportion of participants who can tolerate a single dose of >=3000mg of peanut protein without dose-limiting symptoms during DBPCFC [ Time Frame: Baseline, Days 26 and 28 ]
    Responder status defined as tolerating a single dose of >=3000mg of peanut protein without dose-limiting symptoms during the DBPCFC

  3. Efficacy or oral remibrutinib compared to placebo as measured by the madimum symptoms severity at any single challenged dose up to and including 1000mg of peanut protein [ Time Frame: Baseline, Days 26 and 28 ]
    Maximum severity of symptoms occurring at any challenge dose of peanut protein up to and including 1000mg during the DBPCFC

  4. Efficacy of 3 weeks placebo treatment followed by 1 week of oral remibrutinib treatment compared to placebo as measured by the proportion of participants who can tolerate a single dose of >=600mg peanut protein during DBPCFC [ Time Frame: Baseline, Days 26 and 28 ]
    Responder status defined as tolerating a single dose of >=600mg peanut protein without dose limiting symptoms during the DBPCFC

  5. Effects of multiple doses of remibrutinib compared to placebo, as measured by multiple systemic biomarkers to inform on response to treatment or disease severity [ Time Frame: Baseline, Days 26 and 28 ]
    Change from baseline at weeks 1 and 4 of peanut specific IgE and IgG4, including peanut components

  6. Ability of remibrutinib to impact skin mast cells through the assessment of allergen-specific skin prick test [ Time Frame: Baseline and Day 26 ]
    Change from screening in skin prick test wheal diameters

  7. Cmax of remibrutinib [ Time Frame: Day 8 and Day 25 ]
    Remibrutinib concentrations in blood and PK parameter - Cmax

  8. AUClast of remibrutinib [ Time Frame: Day 8 and Day 25 ]
    Remibrutinib concentrations in blood and PK parameter - AUClast

  9. AUCtau of remibrutinib [ Time Frame: Day 8 and Day 25 ]
    Remibrutinib concentrations in blood and PK parameter - AUCtau

  10. Tmax of remibrutinib [ Time Frame: Day 8 and Day 25 ]
    Remibrutinib concentrations in blood and PK parameter - Tmax


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05432388


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
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United States, Alabama
Novartis Investigative Site Recruiting
Birmingham, Alabama, United States, 35209
United States, Arkansas
Novartis Investigative Site Recruiting
Little Rock, Arkansas, United States, 72202
United States, California
Novartis Investigative Site Recruiting
Los Angeles, California, United States, 90025
United States, Colorado
Novartis Investigative Site Recruiting
Colorado Springs, Colorado, United States, 80907
Novartis Investigative Site Completed
Denver, Colorado, United States, 80230
United States, District of Columbia
Novartis Investigative Site Recruiting
Washington, District of Columbia, United States, 20010
United States, Florida
Novartis Investigative Site Withdrawn
Greenacres City, Florida, United States, 33467
United States, Idaho
Novartis Investigative Site Recruiting
Boise, Idaho, United States, 83706
United States, Illinois
Novartis Investigative Site Recruiting
Normal, Illinois, United States, 61761
Novartis Investigative Site Recruiting
River Forest, Illinois, United States, 60305
United States, Kentucky
Novartis Investigative Site Recruiting
Lexington, Kentucky, United States, 40509
Novartis Investigative Site Recruiting
Louisville, Kentucky, United States, 40217
United States, Maryland
Novartis Investigative Site Recruiting
Baltimore, Maryland, United States, 21287
Novartis Investigative Site Recruiting
Chevy Chase, Maryland, United States, 20815
United States, Massachusetts
Novartis Investigative Site Recruiting
Boston, Massachusetts, United States, 02114
United States, New Jersey
Novartis Investigative Site Recruiting
Berlin, New Jersey, United States, 08009
United States, Ohio
Novartis Investigative Site Recruiting
Grove City, Ohio, United States, 43123
United States, Oklahoma
Novartis Investigative Site Recruiting
Tulsa, Oklahoma, United States, 74136
United States, Texas
Novartis Investigative Site Recruiting
El Paso, Texas, United States, 79924
United States, Utah
Novartis Investigative Site Recruiting
Murray, Utah, United States, 84107
United States, Washington
Novartis Investigative Site Recruiting
Seattle, Washington, United States, 98115
Spain
Novartis Investigative Site Recruiting
Malaga, Andalucia, Spain, 29009
Novartis Investigative Site Recruiting
Barcelona, Catalunya, Spain, 08035
Novartis Investigative Site Recruiting
Madrid, Spain, 28034
Sponsors and Collaborators
Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT05432388    
Other Study ID Numbers: CLOU064I12201
2021-006950-30 ( EudraCT Number )
First Posted: June 27, 2022    Key Record Dates
Last Update Posted: January 23, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Groundnut Hypersensitivity
Hypersensitivity, Peanut
Peanut Allergy
Food Allergy
 Oral food challenge
IgE
Remibrutinib
BTKi
Additional relevant MeSH terms:
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Hypersensitivity
Peanut Hypersensitivity
Immune System Diseases
Nut and Peanut Hypersensitivity
Food Hypersensitivity
 Hypersensitivity, Immediate
Remibrutinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action