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

NCT ID: NCT03463135

Last Updated: 2022-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-07
• Study Completion Date: 2020-03-10

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.

Conditions

Food Allergy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SAR439794 [PE SLIT + GLA)]

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

Group Type: EXPERIMENTAL

Glucopyranosyl Lipid A (GLA)

Intervention Type: DRUG

Pharmaceutical form:Colloidal aqueous dispersion Route of administration: Sublingual

Sublingual Immuno Therapy (SLIT) Peanut Extract (PE)

Intervention Type: DRUG

Pharmaceutical form:Solution Route of administration: Sublingual

Placebo for GLA + SLIT PE

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

Group Type: EXPERIMENTAL

Sublingual Immuno Therapy (SLIT) Peanut Extract (PE)

Intervention Type: DRUG

Pharmaceutical form:Solution Route of administration: Sublingual

Placebo for GLA

Intervention Type: DRUG

Pharmaceutical form:Colloidal aqueous dispersion Route of administration: Sublingual

Placebo for GLA + Placebo for SLIT PE

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

Group Type: PLACEBO_COMPARATOR

Placebo for GLA

Intervention Type: DRUG

Pharmaceutical form:Colloidal aqueous dispersion Route of administration: Sublingual

Placebo for SLIT PE

Intervention Type: DRUG

Pharmaceutical form:Solution Route of administration: Sublingual

Interventions

Glucopyranosyl Lipid A (GLA)

Pharmaceutical form:Colloidal aqueous dispersion Route of administration: Sublingual

Intervention Type: DRUG

Sublingual Immuno Therapy (SLIT) Peanut Extract (PE)

Pharmaceutical form:Solution Route of administration: Sublingual

Intervention Type: DRUG

Placebo for GLA

Pharmaceutical form:Colloidal aqueous dispersion Route of administration: Sublingual

Intervention Type: DRUG

Placebo for SLIT PE

Pharmaceutical form:Solution Route of administration: Sublingual

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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).
• Presence of sublingual epithelium and oral mucosa wound or infection (abcess, ulcer, candidiasis, gingivitis, etc.) or painful tooth decay.
• Participation in any food immunotherapy interventional study within the past 6 months.
• Patients who had received any monophosphoryl lipid (MPL)- or glucopyranosyl lipid A (GLA)-containing products within the last 6 months.
• Patients who experienced a Grade 3 or higher treatment emergent adverse event following administration of a MPL- or GLA-containing product.
• Use within the past 6 months of systemic immunomodulatory treatment and biologics with an immune target, including Xolair®.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 8400004

Little Rock, Arkansas, United States

Investigational Site Number 8400019

Mission Viejo, California, United States

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

Investigational Site Number 8400016

Minneapolis, Minnesota, United States

Investigational Site Number 8400010

Charleston, North Carolina, United States

Investigational Site Number 8400011

Cincinnati, Ohio, United States

Investigational Site Number 8400012

Medford, Oregon, United States

Investigational Site Number 8400003

Seattle, Washington, United States

Investigational Site Number 8400017

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

U1111-1200-1824

Identifier Type: OTHER

Identifier Source: secondary_id

TDR14287

Identifier Type: -

Identifier Source: org_study_id