FARE Clinical Trial Finder

Simplify your search for a clinical trial and help researchers discover new therapies. The FARE Clinical Trial Finder links patients with food allergy and healthy, non-patient volunteers to actively recruiting food allergy studies.

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

Study Purpose

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.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Interventional
Eligible Ages 12 Years - 55 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03463135

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
Phase 1

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Sanofi

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Clinical Sciences & Operations
Principal Investigator Affiliation Sanofi

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Industry
Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Food Allergy
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Investigational Site Number 8400004, Little Rock, Arkansas

Status

Recruiting

Address

Investigational Site Number 8400004

Little Rock, Arkansas, 72202

Site Contact

800-633-1610

Investigational Site Number 8400019, Mission Viejo, California

Status

Recruiting

Address

Investigational Site Number 8400019

Mission Viejo, California, 92691

Site Contact

800-633-1610

Investigational Site Number 8400008, San Diego, California

Status

Recruiting

Address

Investigational Site Number 8400008

San Diego, California, 92123

Site Contact

800-633-1610

Investigational Site Number 8400020, San Jose, California

Status

Recruiting

Address

Investigational Site Number 8400020

San Jose, California, 95117

Site Contact

800-633-1610

Investigational Site Number 8400006, Stanford, California

Status

Recruiting

Address

Investigational Site Number 8400006

Stanford, California, 94305

Site Contact

800-633-1610

Investigational Site Number 8400013, Denver, Colorado

Status

Recruiting

Address

Investigational Site Number 8400013

Denver, Colorado, 80230

Site Contact

800-633-1610

Investigational Site Number 8400014, Louisville, Kentucky

Status

Recruiting

Address

Investigational Site Number 8400014

Louisville, Kentucky, 40215

Site Contact

800-633-1610

Investigational Site Number 8400002, Baltimore, Maryland

Status

Recruiting

Address

Investigational Site Number 8400002

Baltimore, Maryland, 21287

Site Contact

800-633-1610

Investigational Site Number 8400001, Boston, Massachusetts

Status

Recruiting

Address

Investigational Site Number 8400001

Boston, Massachusetts, 02114

Site Contact

800-633-1610

Investigational Site Number 8400007, Ann Arbor, Michigan

Status

Recruiting

Address

Investigational Site Number 8400007

Ann Arbor, Michigan, 48106

Site Contact

800-633-1610

Investigational Site Number 8400009, Minneapolis, Minnesota

Status

Recruiting

Address

Investigational Site Number 8400009

Minneapolis, Minnesota, 55402

Site Contact

800-633-1610

Investigational Site Number 8400016, Minneapolis, Minnesota

Status

Recruiting

Address

Investigational Site Number 8400016

Minneapolis, Minnesota, 55402

Site Contact

800-633-1610

Investigational Site Number 8400011, Cincinnati, Ohio

Status

Recruiting

Address

Investigational Site Number 8400011

Cincinnati, Ohio, 45229

Site Contact

800-633-1610

Investigational Site Number 8400012, Medford, Oregon

Status

Recruiting

Address

Investigational Site Number 8400012

Medford, Oregon, 97504

Site Contact

800-633-1610

Investigational Site Number 8400010, Charleston, South Carolina

Status

Recruiting

Address

Investigational Site Number 8400010

Charleston, South Carolina, 29407

Site Contact

800-633-1610

Investigational Site Number 8400003, Seattle, Washington

Status

Recruiting

Address

Investigational Site Number 8400003

Seattle, Washington, 98105

Site Contact

800-633-1610

Investigational Site Number 8400017, Madison, Wisconsin

Status

Recruiting

Address

Investigational Site Number 8400017

Madison, Wisconsin, 53792

Site Contact

800-633-1610

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.