Primary Objective: To assess tolerability and safety of SAR439794 \[peanut extract (PE) sublingual immunotherapy (SLIT) adjuvanted with Glucopyranosyl Lipid A (GLA)\] after repeated sublingual (SL) daily administration in peanut allergic adult and adolescent patients. Secondary Objective: To assess pharmacodynamics of SAR439794 after repeated SL daily administration in peanut allergic adult and adolescent patients.
The total study duration per participant is approximately from 15 to 18 weeks (core study) from screening until end-of-study visit, and 2 phone calls at Week 26 and Week 52 after the last Investigational Medicinal Product (IMP) dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
27
Pharmaceutical form:Colloidal aqueous dispersion Route of administration: Sublingual
Pharmaceutical form:Solution Route of administration: Sublingual
Pharmaceutical form:Colloidal aqueous dispersion Route of administration: Sublingual
Investigational Site Number 8400004
Little Rock, Arkansas, United States
Investigational Site Number 8400019
Mission Viejo, California, United States
Adverse events (AEs)
Number of participants with AEs
Time frame: Up to Week 52
Assessment of pharmacodynamic (PD) parameter: Peanut-specific serum Immunoglobulin G (IgG) levels
Change from baseline to Day 85 in peanut-specific serum IgGs levels in patients administered with Glucopyranosyl Lipid A (GLA) + Sublingual Immuno Therapy Peanut Extract (SLIT PE) versus placebo for GLA + SLIT PE
Time frame: Baseline to Day 85
Assessment of PD parameter: Peanut-specific serum IgG levels
Change from baseline to Day 57 in peanut-specific serum IgGs levels (total P-sIgGs, P-sIgG4 and P-sIgG1) in patients administered with GLA + SLIT PE versus placebo for GLA + SLIT PE
Time frame: Baseline to Day 57
Assessment of PD parameter: Peanut-specific serum Immunoglobulin E (IgE) levels
Change from baseline to Day 57 and Day 85 in peanut-specific IgE in patients administered with GLA + SLIT PE versus placebo for GLA + SLIT PE
Time frame: Baseline to Day 57, Baseline to Day 85
Assessment of PD parameter: Skin Prick Test
Absolute change from baseline in Skin Prick Test (SPT) to peanut allergen at Day 85 only in patients administered with GLA + SLIT PE versus placebo for GLA + SLIT PE
Time frame: On Day 85
Maximum SLIT PE dose
Maximum SLIT PE dose reached by patients administered with GLA + SLIT PE versus placebo GLA + SLIT PE
Time frame: On Day 85
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Pharmaceutical form:Solution Route of administration: Sublingual
Investigational Site Number 8400008
San Diego, California, United States
Investigational Site Number 8400020
San Jose, California, United States
Investigational Site Number 8400006
Stanford, California, United States
Investigational Site Number 8400013
Denver, Colorado, United States
Investigational Site Number 8400014
Louisville, Kentucky, United States
Investigational Site Number 8400002
Baltimore, Maryland, United States
Investigational Site Number 8400001
Boston, Massachusetts, United States
Investigational Site Number 8400009
Minneapolis, Minnesota, United States
...and 6 more locations