A Study to Assess Primarily the Tolerability and Safety of SAR439794 After Repeated Sublingual Daily Administration in Peanut Allergic Adult and Adolescent Patients

NCT03463135 | Completed Phase 1 FDA Drug

• 2 other identifiers: TDR14287U1111-1200-1824
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 16

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.

Conditions

Food Allergy

Outcome Measures

Primary Outcomes (1)

• Adverse events (AEs)

  Number of participants with AEs

  Up to Week 52

Secondary Outcomes (5)

• Assessment of pharmacodynamic (PD) parameter: Peanut-specific serum Immunoglobulin G (IgG) levels

  Baseline to Day 85

• Assessment of PD parameter: Peanut-specific serum IgG levels

  Baseline to Day 57

• Assessment of PD parameter: Peanut-specific serum Immunoglobulin E (IgE) levels

  Baseline to Day 57, Baseline to Day 85

• Assessment of PD parameter: Skin Prick Test

  On Day 85

• Maximum SLIT PE dose

  On Day 85

Study Arms (3)

SAR439794 [PE SLIT + GLA)]

EXPERIMENTAL

GLA repeated doses then SLIT PE escalating doses once daily for 12 weeks

Drug: Glucopyranosyl Lipid A (GLA); Drug: Sublingual Immuno Therapy (SLIT) Peanut Extract (PE)

Placebo for GLA + SLIT PE

EXPERIMENTAL

Placebo for GLA repeated doses then SLIT PE escalating doses once daily for 12 weeks

Drug: Sublingual Immuno Therapy (SLIT) Peanut Extract (PE); Drug: Placebo for GLA

Placebo for GLA + Placebo for SLIT PE

PLACEBO COMPARATOR

Placebo for GLA repeated doses then Placebo for SLIT PE escalating doses once daily for 12 weeks

Drug: Placebo for GLA; Drug: Placebo for SLIT PE

Interventions

Glucopyranosyl Lipid A (GLA) DRUG

Pharmaceutical form:Colloidal aqueous dispersion Route of administration: Sublingual

SAR439794 [PE SLIT + GLA)]

Sublingual Immuno Therapy (SLIT) Peanut Extract (PE) DRUG

Pharmaceutical form:Solution Route of administration: Sublingual

Placebo for GLA + SLIT PE; SAR439794 [PE SLIT + GLA)]

Placebo for GLA DRUG

Pharmaceutical form:Colloidal aqueous dispersion Route of administration: Sublingual

Placebo for GLA + Placebo for SLIT PE; Placebo for GLA + SLIT PE

Placebo for SLIT PE DRUG

Pharmaceutical form:Solution Route of administration: Sublingual

Placebo for GLA + Placebo for SLIT PE

Eligibility Criteria

• Age: 12 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male or female patients, between 18 and 55 years of age, inclusive and adolescents between 12 and 17 years of age (after enrollment of 20 adult patients completed the 6 weeks dose escalation period and the safety and tolerability is deemed acceptable).
• Physician-diagnosed peanut allergy OR convincing history of objective clinical symptoms consistent with immediate hypersensitivity within 4 hours following known ingestion of peanuts or peanut-containing food AND by the following combined criteria:
• Peanut-specific IgE (P-sIgE) \>5 kUA/L and Arah2-specific IgE (Arah2-sIgE) \>2 kUA/L,
• Skin Prick Test (SPT) to peanut allergen ≥5 mm compared to saline control.
• High-sensitivity C reactive protein (hs-CRP), fibrinogen and neutrophil count within laboratory normal range unless the Investigator considers an abnormality to be clinically irrelevant.
• Ability to perform spirometry based on the American Thoracic Society guidelines.
• Patient must be trained on the proper use of an injectable epinephrine device and should be able to use it.

You may not qualify if:

• Any history or presence of autoimmune, cardiovascular disease, chronic lung disease, malignancy, psychiatric illness, or gastrointestinal inflammatory conditions, including celiac disease, inflammatory bowel disease and eosinophilic gastrointestinal disorders.
• History of severe anaphylaxis, documented hypotension, neurological compromise (confusion, loss of consciousness), or incontinence known or suspected to be caused by ingestion of peanut or that required treatment with 2 or more administrations of epinephrine or hospitalization.
• Daily oral steroid use for \>1 month during the past year, burst oral steroid course in the past 6 months, or \>1 burst oral steroid course in the past year.
• Asthma requiring \>1 hospitalization in the past year or \>1 emergency department visit in the past 6 months.
• Severe or poorly controlled atopic dermatitis.
• Diagnosis of eosinophilic esophagitis.
• Diagnosis of other severe or complicating medical problems.
• Primary immune deficiency.
• If female, pregnancy (defined as positive β-HCG \[human chorionic gonadotropin\] blood test), breastfeeding.
• If female of childbearing potential, unable to use an effective method of contraception to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of their participation in the study.
• Use of beta blockers, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, or monoamine oxidase inhibitors.
• Any patient who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.
• Any patient who cannot be contacted in case of emergency.
• Any patient who is the Investigator or any subinvestigator, research assistant, pharmacist, study coordinator, or other staff thereof, directly involved in conducting the study.
• Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti-hepatitis B virus core antibodies (anti-HBc Ab), anti-hepatitis C virus antibodies (anti-HCV Ab), anti-human immunodeficiency Virus 1 and 2 antibodies (anti-HIV1 and anti- HIV2 Ab).

Sponsors & Collaborators

• Sanofi: lead

Study Sites (16)

Investigational Site Number 8400004

Little Rock, Arkansas, 72202, United States

Location

Investigational Site Number 8400019

Mission Viejo, California, 92691, United States

Location

Investigational Site Number 8400008

San Diego, California, 92123, United States

Location

Investigational Site Number 8400020

San Jose, California, 95117, United States

Location

Investigational Site Number 8400006

Stanford, California, 94305, United States

Location

Investigational Site Number 8400013

Denver, Colorado, 80230, United States

Location

Investigational Site Number 8400014

Louisville, Kentucky, 40215, United States

Location

Investigational Site Number 8400002

Baltimore, Maryland, 21287, United States

Location

Investigational Site Number 8400001

Boston, Massachusetts, 02114, United States

Location

Investigational Site Number 8400009

Minneapolis, Minnesota, 55402, United States

Location

Investigational Site Number 8400016

Minneapolis, Minnesota, 55402, United States

Location

Investigational Site Number 8400010

Charleston, North Carolina, 29420, United States

Location

Investigational Site Number 8400011

Cincinnati, Ohio, 45229, United States

Location

Investigational Site Number 8400012

Medford, Oregon, 97504, United States

Location

Investigational Site Number 8400003

Seattle, Washington, 98105, United States

Location

Investigational Site Number 8400017

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Food Hypersensitivity

Interventions

glucopyranosyl lipid-A; gamma-carboxyglutamyl-gamma-carboxyglutamic acid

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2018
• First Posted: March 13, 2018
• Study Start: May 7, 2018
• Primary Completion: May 8, 2019
• Study Completion: March 10, 2020
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

US (16)