Food AllergyPhase 1NCT03463135
A Study to Assess Primarily the Tolerability and Safety of SAR439794 After Repeated Sublingual Daily Administration in Peanut Allergic Adult and Adolescent Patients
A Phase 1 study testing Glucopyranosyl Lipid A (GLA) and Sublingual Immuno Therapy (SLIT) Peanut Extract (PE) in people with Food Allergy, run by Sanofi at 16 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 55 years
- Conditions the study is for
- Food Allergy
- What is being tested?
- Glucopyranosyl Lipid A (GLA) and Sublingual Immuno Therapy (SLIT) Peanut Extract (PE)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 16 sitesUnited States
- Study dates
- 7 May 2018to 10 Mar 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 21Show fewer
- 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 locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Investigational Site Number 8400002
Baltimore, Maryland, 21287
Investigational Site Number 8400001
Boston, Massachusetts, 02114
Investigational Site Number 8400010
Charleston, North Carolina, 29420
Investigational Site Number 8400011
Cincinnati, Ohio, 45229
Investigational Site Number 8400013
Denver, Colorado, 80230
Investigational Site Number 8400004
Little Rock, Arkansas, 72202
Investigational Site Number 8400014
Louisville, Kentucky, 40215
Investigational Site Number 8400017
Madison, Wisconsin, 53792
Investigational Site Number 8400012
Medford, Oregon, 97504
Investigational Site Number 8400009
Minneapolis, Minnesota, 55402
Investigational Site Number 8400016
Minneapolis, Minnesota, 55402
Investigational Site Number 8400019
Mission Viejo, California, 92691
Investigational Site Number 8400008
San Diego, California, 92123
Investigational Site Number 8400020
San Jose, California, 95117
Investigational Site Number 8400003
Seattle, Washington, 98105
Investigational Site Number 8400006
Stanford, California, 94305
About this study
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
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.
Read the 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
- Being tested
- Glucopyranosyl Lipid A (GLA), Sublingual Immuno Therapy (SLIT) Peanut Extract (PE), Placebo for GLA, Placebo for SLIT PE
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucopyranosyl Lipid A (GLA)Drug
Pharmaceutical form:Colloidal aqueous dispersion Route of administration: Sublingual
Sublingual Immuno Therapy (SLIT) Peanut Extract (PE)Drug
Pharmaceutical form:Solution Route of administration: Sublingual
Placebo for GLADrug
Pharmaceutical form:Colloidal aqueous dispersion Route of administration: Sublingual
Placebo for SLIT PEDrug
Pharmaceutical form:Solution Route of administration: Sublingual
| Study group | Role | What they receive |
|---|---|---|
| SAR439794 [PE SLIT + GLA)] | Experimental | GLA repeated doses then SLIT PE escalating doses once daily for 12 weeks Receives: 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 Receives: 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 Receives: Drug: Placebo for GLA; Drug: Placebo for SLIT PE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs)
Number of participants with AEs
Measured: Up to Week 52
Secondary outcomes (5)
Assessment of pharmacodynamic (PD) parameter: Peanut-specific serum Immunoglobulin G (IgG) levels
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
Measured: Baseline to Day 85
Assessment of PD parameter: Peanut-specific serum IgG levels
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
Measured: Baseline to Day 57
Assessment of PD parameter: Peanut-specific serum Immunoglobulin E (IgE) levels
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
Measured: Baseline to Day 57, Baseline to Day 85
Assessment of PD parameter: Skin Prick Test
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
Measured: On Day 85
Maximum SLIT PE dose
Maximum SLIT PE dose reached by patients administered with GLA + SLIT PE versus placebo GLA + SLIT PE
Measured: On Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start7 May 2018
- Primary completion8 May 2019
- Study completion10 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03463135
- Sponsor's protocol ID
- TDR14287
- Other IDs
- U1111-1200-1824
- Status last verified
- Apr 2022
- First submitted
- 2 Mar 2018
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03463135
- Acronym / sponsor ID
- TDR14287
- Conditions
- Food Allergy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 7 May 2018 (actual)
- Primary completion
- 8 May 2019 (actual)
- Study completion
- 10 Mar 2020 (actual)
- First posted
- 13 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SAR439794 [PE SLIT + GLA)] | Experimental | Drug: Glucopyranosyl Lipid A (GLA), Drug: 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 | Experimental | Drug: Sublingual Immuno Therapy (SLIT) Peanut Extract (PE), Drug: Placebo for GLAPlacebo for GLA repeated doses then SLIT PE escalating doses once daily for 12 weeks |
| Placebo for GLA + Placebo for SLIT PE | Placebo comparator | Drug: Placebo for GLA, Drug: Placebo for SLIT PEPlacebo for GLA repeated doses then Placebo for SLIT PE escalating doses once daily for 12 weeks |
Who may qualify
- Ages
- 12 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucopyranosyl Lipid A (GLA)Pharmaceutical form:Colloidal aqueous dispersion Route of administration: Sublingual | Drug | SAR439794 [PE SLIT + GLA)] |
| Sublingual Immuno Therapy (SLIT) Peanut Extract (PE)Pharmaceutical form:Solution Route of administration: Sublingual | Drug | Placebo for GLA + SLIT PE, SAR439794 [PE SLIT + GLA)] |
| Placebo for GLAPharmaceutical form:Colloidal aqueous dispersion Route of administration: Sublingual | Drug | Placebo for GLA + Placebo for SLIT PE, Placebo for GLA + SLIT PE |
| Placebo for SLIT PEPharmaceutical form:Solution Route of administration: Sublingual | Drug | Placebo for GLA + Placebo for SLIT PE |
Primary outcome
Adverse events (AEs)
Time frame: Up to Week 52
Number of participants with AEs
5 secondary outcomes
Assessment of pharmacodynamic (PD) parameter: Peanut-specific serum Immunoglobulin G (IgG) levels
Time frame: Baseline to Day 85
Assessment of PD parameter: Peanut-specific serum IgG levels
Time frame: Baseline to Day 57
Assessment of PD parameter: Peanut-specific serum Immunoglobulin E (IgE) levels
Time frame: Baseline to Day 57, Baseline to Day 85
Assessment of PD parameter: Skin Prick Test
Time frame: On Day 85
Maximum SLIT PE dose
Time frame: On Day 85
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Individual participant dataSharing planned: Yes. 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://vivli.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Glucopyranosyl Lipid A (GLA) and Sublingual Immuno Therapy (SLIT) Peanut Extract (PE) in people with Food Allergy, run by Sanofi at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AEs) (time frame: Up to Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022; AzTrials last refreshed its copy on 26 Oct 2026.