Trial record 3 of 4 for:
Novartis | Peanut Allergy
Study of Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With an Allergy to Peanuts
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| ClinicalTrials.gov Identifier: NCT05432388 |
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Recruitment Status :
Recruiting
First Posted : June 27, 2022
Last Update Posted : October 24, 2023
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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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 |
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 (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 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: remibrutinib low dose
remibrutinib oral tablet
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Drug: remibrutinib
oral tablets
Other Name: (LOU064) |
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Experimental: remibrutinib medium dose
remibrutinib oral tablet
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Drug: remibrutinib
oral tablets
Other Name: (LOU064) |
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Experimental: remibrutinib high dose
remibrutinib oral tablet
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Drug: remibrutinib
oral tablets
Other Name: (LOU064) |
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Experimental: placebo 3 week / remibrutinib low dose 1 week
placebo oral tablet/ remibrutinib oral tablet
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Drug: remibrutinib
oral tablets
Other Name: (LOU064) Drug: placebo oral tablets |
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Placebo Comparator: placebo
oral tablet
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Drug: placebo
oral tablets |
Primary Outcome Measures :
- 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 :
- 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
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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.
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
| Contact: Novartis Pharmaceuticals | 1-888-669-6682 | novartis.email@novartis.com | |
| Contact: Novartis Pharmaceuticals | +41613241111 |
Locations
| 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 | Completed |
| Denver, Colorado, United States, 80230 | |
| 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, 79912 | |
| 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
| 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: | October 24, 2023 |
| Last Verified: | October 2023 |
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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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 |