Allergy, Peanut
Conditions
Keywords
Groundnut Hypersensitivity, Hypersensitivity, Peanut, Peanut Allergy, Food Allergy, Oral food challenge, IgE, Remibrutinib, BTKi
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.
Interventions
DRUGremibrutinib
oral tablets
DRUGplacebo
oral tablets
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | 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 | 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 | 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 | 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 | Baseline and Day 26 | Change from screening in skin prick test wheal diameters |
| Cmax of remibrutinib | Day 8 and Day 25 | Remibrutinib concentrations in blood and PK parameter - Cmax |
| AUClast of remibrutinib | Day 8 and Day 25 | Remibrutinib concentrations in blood and PK parameter - AUClast |
| AUCtau of remibrutinib | Day 8 and Day 25 | Remibrutinib concentrations in blood and PK parameter - AUCtau |
| Tmax of remibrutinib | Day 8 and Day 25 | Remibrutinib concentrations in blood and PK parameter - Tmax |
Countries
United States
Outcome results
None listed