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

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

Tracking Information

• First Submitted Date: May 31, 2022
• First Posted Date: June 27, 2022
• Last Update Posted Date: January 23, 2024
• Actual Study Start Date: October 12, 2022
• Estimated Primary Completion Date: April 29, 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 20, 2022)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 20, 2022)

• 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
• 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
• 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
• 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
• 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
• 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
• Cmax of remibrutinib [ Time Frame: Day 8 and Day 25 ]
  Remibrutinib concentrations in blood and PK parameter - Cmax
• AUClast of remibrutinib [ Time Frame: Day 8 and Day 25 ]
  Remibrutinib concentrations in blood and PK parameter - AUClast
• AUCtau of remibrutinib [ Time Frame: Day 8 and Day 25 ]
  Remibrutinib concentrations in blood and PK parameter - AUCtau
• Tmax of remibrutinib [ Time Frame: Day 8 and Day 25 ]
  Remibrutinib concentrations in blood and PK parameter - Tmax

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study of Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With an Allergy to Peanuts
• 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
• 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.
• 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 Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Allergy, Peanut

Intervention

• Drug: remibrutinib
  oral tablets
  Other Name: (LOU064)
• Drug: placebo
  oral tablets

Study Arms

• Experimental: remibrutinib low dose
  remibrutinib oral tablet
  Intervention: Drug: remibrutinib
• Experimental: remibrutinib medium dose
  remibrutinib oral tablet
  Intervention: Drug: remibrutinib
• Experimental: remibrutinib high dose
  remibrutinib oral tablet
  Intervention: Drug: remibrutinib
• Experimental: placebo 3 week / remibrutinib low dose 1 week
  placebo oral tablet/ remibrutinib oral tablet
  Interventions:

  • Drug: remibrutinib
  • Drug: placebo
• Placebo Comparator: placebo
  oral tablet
  Intervention: Drug: placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 20, 2022): 110
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 29, 2026
• Estimated Primary Completion Date: April 29, 2026 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Novartis Pharmaceuticals; 1-888-669-6682; novartis.email@novartis.com

Contact: Novartis Pharmaceuticals; +41613241111

• Listed Location Countries: Spain, United States

Administrative Information

• NCT Number: NCT05432388
• Other Study ID Numbers: CLOU064I12201; 2021-006950-30 ( EudraCT Number )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

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

• Current Responsible Party: Novartis ( Novartis Pharmaceuticals )
• Original Responsible Party: Same as current
• Current Study Sponsor: Novartis Pharmaceuticals
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Novartis
• Verification Date: January 2024