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

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ClinicalTrials.gov Identifier: NCT03463135
Recruitment Status : Recruiting
First Posted : March 13, 2018
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Food Allergy Drug: Glucopyranosyl Lipid A (GLA) Drug: Sublingual Immuno Therapy (SLIT) Peanut Extract (PE) Drug: Placebo for GLA Drug: Placebo for SLIT PE Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, 3-arm, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacodynamics of Repeated Sublingual Daily Administration of SAR439794 in Peanut Allergic Adult and Adolescent Patients
Actual Study Start Date : May 7, 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : May 7, 2020

Arm Intervention/treatment
Experimental: SAR439794 [PE SLIT + GLA)]
GLA repeated doses then SLIT PE escalating doses once daily for 12 weeks
Drug: Glucopyranosyl Lipid A (GLA)
Pharmaceutical form:Colloidal aqueous dispersion Route of administration: Sublingual

Drug: Sublingual Immuno Therapy (SLIT) Peanut Extract (PE)
Pharmaceutical form:Solution Route of administration: Sublingual

Experimental: Placebo for GLA + SLIT PE
Placebo for GLA repeated doses then SLIT PE escalating doses once daily for 12 weeks
Drug: Sublingual Immuno Therapy (SLIT) Peanut Extract (PE)
Pharmaceutical form:Solution Route of administration: Sublingual

Drug: Placebo for GLA
Pharmaceutical form:Colloidal aqueous dispersion Route of administration: Sublingual

Placebo Comparator: Placebo for GLA + Placebo for SLIT PE
Placebo for GLA repeated doses then Placebo for SLIT PE escalating doses once daily for 12 weeks
Drug: Placebo for GLA
Pharmaceutical form:Colloidal aqueous dispersion Route of administration: Sublingual

Drug: Placebo for SLIT PE
Pharmaceutical form:Solution Route of administration: Sublingual




Primary Outcome Measures :
  1. Adverse events (AEs) [ Time Frame: Up to Week 52 ]
    Number of participants with AEs


Secondary Outcome Measures :
  1. Assessment of pharmacodynamic (PD) parameter: Peanut-specific serum Immunoglobulin G (IgG) levels [ Time Frame: 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

  2. Assessment of PD parameter: Peanut-specific serum IgG levels [ Time Frame: 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

  3. Assessment of PD parameter: Peanut-specific serum Immunoglobulin E (IgE) levels [ Time Frame: 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

  4. Assessment of PD parameter: Skin Prick Test [ Time Frame: 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

  5. Maximum SLIT PE dose [ Time Frame: On Day 85 ]
    Maximum SLIT PE dose reached by patients administered with GLA + SLIT PE versus placebo GLA + SLIT PE



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Ages Eligible for Study:   12 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03463135


Contacts
Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext 1 then # Contact-Us@sanofi.com

Locations
United States, Arkansas
Investigational Site Number 8400004 Recruiting
Little Rock, Arkansas, United States, 72202
United States, California
Investigational Site Number 8400019 Recruiting
Mission Viejo, California, United States, 92691
Investigational Site Number 8400008 Recruiting
San Diego, California, United States, 92123
Investigational Site Number 8400020 Recruiting
San Jose, California, United States, 95117
Investigational Site Number 8400006 Recruiting
Stanford, California, United States, 94305
United States, Colorado
Investigational Site Number 8400013 Recruiting
Denver, Colorado, United States, 80230
United States, Kentucky
Investigational Site Number 8400014 Recruiting
Louisville, Kentucky, United States, 40215
United States, Maryland
Investigational Site Number 8400002 Recruiting
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Investigational Site Number 8400001 Recruiting
Boston, Massachusetts, United States, 02114
United States, Minnesota
Investigational Site Number 8400009 Recruiting
Minneapolis, Minnesota, United States, 55402
Investigational Site Number 8400016 Recruiting
Minneapolis, Minnesota, United States, 55402
United States, Oregon
Investigational Site Number 8400012 Recruiting
Medford, Oregon, United States, 97504
United States, South Carolina
Investigational Site Number 8400010 Recruiting
Charleston, South Carolina, United States, 29407
United States, Washington
Investigational Site Number 8400003 Recruiting
Seattle, Washington, United States, 98105
United States, Wisconsin
Investigational Site Number 8400017 Recruiting
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT03463135     History of Changes
Other Study ID Numbers: TDR14287
U1111-1200-1824 ( Other Identifier: UTN )
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Food Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases