A Study to Assess Primarily the Tolerability and Safety of SAR439794 After Repeated Sublingual Daily Administration in Peanut Allergic Adult and Adolescent Patients
- Conditions
- Food Allergy
- Interventions
- Drug: Glucopyranosyl Lipid A (GLA)Drug: Placebo for GLADrug: Sublingual Immuno Therapy (SLIT) Peanut Extract (PE)Drug: Placebo for SLIT PE
- Registration Number
- NCT03463135
- Lead Sponsor
- Sanofi
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SAR439794 [PE SLIT + GLA)] Glucopyranosyl Lipid A (GLA) GLA repeated doses then SLIT PE escalating doses once daily for 12 weeks Placebo for GLA + SLIT PE Placebo for GLA Placebo for GLA repeated doses then SLIT PE escalating doses once daily for 12 weeks SAR439794 [PE SLIT + GLA)] Sublingual Immuno Therapy (SLIT) Peanut Extract (PE) GLA repeated doses then SLIT PE escalating doses once daily for 12 weeks Placebo for GLA + SLIT PE Sublingual Immuno Therapy (SLIT) Peanut Extract (PE) Placebo for GLA repeated doses then SLIT PE escalating doses once daily for 12 weeks Placebo for GLA + Placebo for SLIT PE Placebo for GLA Placebo for GLA repeated doses then Placebo for SLIT PE escalating doses once daily for 12 weeks Placebo for GLA + Placebo for SLIT PE Placebo for SLIT PE Placebo for GLA repeated doses then Placebo for SLIT PE escalating doses once daily for 12 weeks
- Primary Outcome Measures
Name Time Method Adverse events (AEs) Up to Week 52 Number of participants with AEs
- Secondary Outcome Measures
Name Time Method Assessment of pharmacodynamic (PD) parameter: Peanut-specific serum Immunoglobulin G (IgG) levels Baseline to Day 85 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
Maximum SLIT PE dose On Day 85 Maximum SLIT PE dose reached by patients administered with GLA + SLIT PE versus placebo GLA + SLIT PE
Assessment of PD parameter: Skin Prick Test On Day 85 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
Assessment of PD parameter: Peanut-specific serum IgG levels Baseline to Day 57 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
Assessment of PD parameter: Peanut-specific serum Immunoglobulin E (IgE) levels Baseline to Day 57, Baseline to Day 85 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
Trial Locations
- Locations (16)
Investigational Site Number 8400004
๐บ๐ธLittle Rock, Arkansas, United States
Investigational Site Number 8400019
๐บ๐ธMission Viejo, California, United States
Investigational Site Number 8400008
๐บ๐ธSan Diego, California, United States
Investigational Site Number 8400020
๐บ๐ธSan Jose, California, United States
Investigational Site Number 8400006
๐บ๐ธStanford, California, United States
Investigational Site Number 8400013
๐บ๐ธDenver, Colorado, United States
Investigational Site Number 8400014
๐บ๐ธLouisville, Kentucky, United States
Investigational Site Number 8400002
๐บ๐ธBaltimore, Maryland, United States
Investigational Site Number 8400001
๐บ๐ธBoston, Massachusetts, United States
Investigational Site Number 8400009
๐บ๐ธMinneapolis, Minnesota, United States
Investigational Site Number 8400016
๐บ๐ธMinneapolis, Minnesota, United States
Investigational Site Number 8400010
๐บ๐ธCharleston, North Carolina, United States
Investigational Site Number 8400011
๐บ๐ธCincinnati, Ohio, United States
Investigational Site Number 8400012
๐บ๐ธMedford, Oregon, United States
Investigational Site Number 8400003
๐บ๐ธSeattle, Washington, United States
Investigational Site Number 8400017
๐บ๐ธMadison, Wisconsin, United States