CompletedNCT03211247EPITOPEUpdated Dec 16, 2024Results posted

Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age

A Phase 3 interventional study of Part A Viaskin Peanut 250 mcg and Part A Viaskin Peanut 100 mcg in Peanut Allergy, sponsored by DBV Technologies. Completed at 51 sites in 8 countries. Open to participants aged 1 Year to 3 Years. Per ClinicalTrials.gov, last updated 2024-12-16.

Sponsored by DBV Technologies · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 414
Allocation: Randomized
Ages: 1 Year to 3 Years
Sex: All

Study summary

The study aims to assess the safety and efficacy of Viaskin Peanut to induce desensitization to peanut in peanut-allergic children 1 to 3 years of age after a 12-month treatment by EPicutaneous ImmunoTherapy (EPIT).

Read the detailed description

The study comprised of two parts:

In part A, subjects were randomized to receive either Viaskin Peanut 250 mcg, or Viaskin Peanut 100 mcg or the placebo in a 2:1 ratio, for 12 months. After 3 months of treatment, a data safety monitoring board had to determine the active dose to be applyed during the part B
In Part B, subjects were randomized to receive either Viaskin Peanut 250 mcg or the placebo in a 2:1 ratio, for 12 months

Conditions studied

Peanut Allergy

Browse trials for

Peanut Hypersensitivity 166

Keywords

EPIT
Epicutaneous
Immunotherapy
Viaskin

In context

Peanut Hypersensitivity

166 studies on the registry are indexed under Peanut Hypersensitivity; 27 are open to participants now.

This study's enrollment of 414 is above the median of 50 across 127 interventional studies indexed under Peanut Hypersensitivity.

Browse Peanut Hypersensitivity studies →

Lead sponsor

DBV Technologies is the lead sponsor of 16 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 1 Year to 3 Years
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Key Inclusion Criteria:

Male or female from 1-3 years of age;
Physician-diagnosed peanut allergy;
Peanut-specific IgE level > 0.7 kU/L;
Positive peanut SPT with a largest wheal diameter ≥ 6 mm;
Positive DBPCFC at ≤ 300 mg peanut protein;

Key Exclusion Criteria:

Uncontrolled asthma;
History of severe anaphylaxis to peanut;
Prior immunotherapy to any food or other immunotherapy;
Generalized severe dermatologic disease;

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 414 participants (actual)

Study arms

Experimental
Part A Viaskin Peanut 250 mcg
Biological: Part A Viaskin Peanut 250 mcg
Experimental
Part A Viaskin Peanut 100 mcg
Biological: Part A Viaskin Peanut 100 mcg
Placebo comparator
Part A Placebo
Biological: Part A Placebo
Experimental
Part B Viaskin Peanut 250 mcg
Biological: Part B Viaskin Peanut 250 mcg
Placebo comparator
Part B Placebo
Biological: Part B Placebo

Interventions

BiologicalPart A Viaskin Peanut 250 mcg
Viaskin Peanut 250 mcg, once daily
BiologicalPart A Viaskin Peanut 100 mcg
Viaskin Peanut 100 mcg, once daily
BiologicalPart A Placebo
Placebo patch, once daily
BiologicalPart B Viaskin Peanut 250 mcg
Viaskin Peanut 250 mcg, once daily
BiologicalPart B Placebo
Placebo patch, once daily

What researchers measure

Primary outcomes

Percentage of Treatment Responders at Month 12
A participant was defined as a treatment responder if the initial eliciting dose (ED) was \> 10 milligram (mg) peanut protein and the ED was ≥1000 mg peanut protein at the post-treatment double-blind placebo-controlled food challenge (DBPCFC) at Month 12 OR the initial ED at baseline was ≤10 mg peanut protein and the ED was ≥300 mg peanut protein at the post-treatment DBPCFC at Month 12.
Time frame: Month 12

Secondary outcomes

Cumulative Reactive Dose (CRD) of Peanut Protein at Month 12 Using Analysis of Covariance (ANCOVA) Model
The peanut protein CRD was defined as the sum of all peanut protein doses taken by the participant during the DBPCFC, calculated as follows: If the ED reported by the investigator in the electronic case report form (eCRF) is missing, then the CRD is missing; If the ED reported by the investigator in the eCRF was not missing then the CRD was calculated as the sum of all doses given, including also the partial doses. The CRD in each treatment group at Month 12 was compared using ANCOVA model.
Time frame: Month 12
Change From Baseline in CRD of Peanut Protein to Month 12
The peanut protein CRD was defined as the sum of all peanut protein doses taken by the participant during the DBPCFC, calculated as follows: If the ED reported by the investigator in the eCRF is missing, then the CRD is missing; If the ED reported by the investigator in the eCRF was not missing then the CRD was calculated as the sum of all doses given, including also the partial doses.
Time frame: Baseline (Day 1) and Month 12
ED of Peanut Protein at Month 12 Using ANCOVA Model
The peanut protein ED was the individual dose of peanut protein administered to participants during the food challenge procedure, which triggered objective allergic reactions, leading to stopping the challenge. The ED in each treatment group at Month 12 was compared using ANCOVA model.
Time frame: Month 12
Change From Baseline in ED of Peanut Protein to Month 12
The peanut protein ED was the individual dose of peanut protein administered to participants during the food challenge procedure, which triggered objective allergic reactions, leading to stopping the challenge.
Time frame: Baseline (Day 1) and Month 12
Percentage of Participants With Severity of Objective Symptoms at Baseline and Month 12 During Double-Blind Placebo-Controlled Food Challenge
The objective symptoms collected during the DBPCFC included skin (erythematous rash, pruritus, urticaria/angioedema, rash), upper respiratory (sneezing/itching, nasal congestion, rhinorrhea, laryngeal), lower respiratory (wheezing), gastrointestinal (diarrhea, vomiting, cardiovascular), and eyes (conjunctivitis, any other objective symptoms), with the exception of erythematous rash (recorded as Yes/No), each symptom was graded as: 0=" absent",1=" mild", 2=" moderate" or 3=" severe". For erythematous rash, the percent area involved was collected. Percentages were calculated based on the number of participants in each time point. Subjective abdominal pain (when graded 2 or 3) was also considered for this analysis.
Time frame: Baseline (Day 1) and Month 12

Results

Posted Dec 16, 2024

Participant flow

This Phase III was conducted in participants aged 1 to 3 years with peanut-allergy at 51 centers in Australia, Canada, Europe, and the United States of America. The entire duration of study was approximately 62 weeks (6-week: screening period; 12-month treatment period; and 4-week follow-up period).

Participant flow — Overall Study
Milestone	Part B Viaskin Peanut 250 mcg	Part B Placebo	Part A Viaskin Peanut 250 mcg	Part A Viaskin Peanut 100 mcg	Part A Placebo
Started	244	118	21	20	10
Completed	208	99	17	16	9
Not completed	36	19	4	4	1
Withdrew: Adverse event	8	0	1	0	0
Withdrew: Lost to follow-up	2	1	0	0	0
Withdrew: Physician decision	1	2	0	0	0
Withdrew: Non-compliance with study drug	2	0	0	0	0
Withdrew: Participant withdrawal by parent or caregiver	18	13	2	1	0
Withdrew: Participant did not want to complete oral food challenge	5	2	1	3	1
Withdrew: Protocol violation	0	1	0	0	0

Outcome measures

PrimaryPercentage of Treatment Responders at Month 12

A participant was defined as a treatment responder if the initial eliciting dose (ED) was \> 10 milligram (mg) peanut protein and the ED was ≥1000 mg peanut protein at the post-treatment double-blind placebo-controlled food challenge (DBPCFC) at Month 12 OR the initial ED at baseline was ≤10 mg peanut protein and the ED was ≥300 mg peanut protein at the post-treatment DBPCFC at Month 12.

Time frame:: Month 12
Reported as:: Number · Percentage of participants

Percentage of Treatment Responders at Month 12
Percentage of participants	Part B Viaskin Peanut 250 mcg	Part B Placebo	Part A Viaskin Peanut 250 mcg	Part A Viaskin Peanut 100 mcg	Part A Placebo
Percentage of Treatment Responders at Month 12	67.0 (60.93 to 73.01)	33.5 (24.84 to 42.24)	52.4 (29.8 to 74.3)	70.0 (45.7 to 88.1)	60.0 (26.2 to 74.3)

Statistical analysis

Part B Viaskin Peanut 250 mcg vs Part B Placebo · Wald test · p = <0.001 · Proportion difference: 33.4 · 95% CI 22.36 to 44.49The 2-sided Farrington-Manning 95% confidence interval for the difference in response rates was calculated.

SecondaryCumulative Reactive Dose (CRD) of Peanut Protein at Month 12 Using Analysis of Covariance (ANCOVA) Model

The peanut protein CRD was defined as the sum of all peanut protein doses taken by the participant during the DBPCFC, calculated as follows: If the ED reported by the investigator in the electronic case report form (eCRF) is missing, then the CRD is missing; If the ED reported by the investigator in the eCRF was not missing then the CRD was calculated as the sum of all doses given, including also the partial doses. The CRD in each treatment group at Month 12 was compared using ANCOVA model.

Time frame:: Month 12
Reported as:: Geometric least squares mean · milligram (mg)

Cumulative Reactive Dose (CRD) of Peanut Protein at Month 12 Using Analysis of Covariance (ANCOVA) Model
milligram (mg)	Part B Viaskin Peanut 250 mcg	Part B Placebo	Part A Viaskin Peanut 250 mcg	Part A Viaskin Peanut 100 mcg	Part A Placebo
Cumulative Reactive Dose (CRD) of Peanut Protein at Month 12 Using Analysis of Covariance (ANCOVA) Model	1010.31 (842.18 to 1212.01)	322.57 (248.37 to 418.94)	788.74 (220.20 to 2825.24)	1155.90 (367.53 to 3635.38)	1153.47 (474.34 to 2804.91)

SecondaryChange From Baseline in CRD of Peanut Protein to Month 12

The peanut protein CRD was defined as the sum of all peanut protein doses taken by the participant during the DBPCFC, calculated as follows: If the ED reported by the investigator in the eCRF is missing, then the CRD is missing; If the ED reported by the investigator in the eCRF was not missing then the CRD was calculated as the sum of all doses given, including also the partial doses.

Time frame:: Baseline (Day 1) and Month 12
Reported as:: Median · mg

Change From Baseline in CRD of Peanut Protein to Month 12
mg	Part B Viaskin Peanut 250 mcg	Part B Placebo	Part A Viaskin Peanut 250 mcg	Part A Viaskin Peanut 100 mcg	Part A Placebo
Change From Baseline in CRD of Peanut Protein to Month 12	1300.0 (140.0 to 3000.0)	0.0 (0.0 to 1000.0)	540.0 (0.0 to 2930.0)	1250.0 (2.5 to 3000.0)	1000.0 (300.0 to 2560.0)

SecondaryED of Peanut Protein at Month 12 Using ANCOVA Model

The peanut protein ED was the individual dose of peanut protein administered to participants during the food challenge procedure, which triggered objective allergic reactions, leading to stopping the challenge. The ED in each treatment group at Month 12 was compared using ANCOVA model.

Time frame:: Month 12
Reported as:: Geometric least squares mean · mg

ED of Peanut Protein at Month 12 Using ANCOVA Model
mg	Part B Viaskin Peanut 250 mcg	Part B Placebo	Part A Viaskin Peanut 250 mcg	Part A Viaskin Peanut 100 mcg	Part A Placebo
ED of Peanut Protein at Month 12 Using ANCOVA Model	659.36 (553.84 to 784.99)	223.12 (173.40 to 287.09)	526.31 (151.15 to 1832.58)	730.38 (254.17 to 2098.83)	760.60 (325.34 to 1778.17)

SecondaryChange From Baseline in ED of Peanut Protein to Month 12

Time frame:: Baseline (Day 1) and Month 12
Reported as:: Median · mg

Change From Baseline in ED of Peanut Protein to Month 12
mg	Part B Viaskin Peanut 250 mcg	Part B Placebo	Part A Viaskin Peanut 250 mcg	Part A Viaskin Peanut 100 mcg	Part A Placebo
Change From Baseline in ED of Peanut Protein to Month 12	900.0 (90.0 to 1700.0)	0.0 (0.0 to 700.0)	700.0 (0.0 to 1700.0)	700.0 (0.0 to 1700.0)	700.0 (200.0 to 1700.0)

SecondaryPercentage of Participants With Severity of Objective Symptoms at Baseline and Month 12 During Double-Blind Placebo-Controlled Food Challenge

The objective symptoms collected during the DBPCFC included skin (erythematous rash, pruritus, urticaria/angioedema, rash), upper respiratory (sneezing/itching, nasal congestion, rhinorrhea, laryngeal), lower respiratory (wheezing), gastrointestinal (diarrhea, vomiting, cardiovascular), and eyes (conjunctivitis, any other objective symptoms), with the exception of erythematous rash (recorded as Yes/No), each symptom was graded as: 0=" absent",1=" mild", 2=" moderate" or 3=" severe". For erythematous rash, the percent area involved was collected. Percentages were calculated based on the number of participants in each time point. Subjective abdominal pain (when graded 2 or 3) was also considered for this analysis.

Time frame:: Baseline (Day 1) and Month 12
Reported as:: Number · Percentage of participants

Percentage of Participants With Severity of Objective Symptoms at Baseline and Month 12 During Double-Blind Placebo-Controlled Food Challenge
Percentage of participants	Part B Viaskin Peanut 250 mcg	Part B Placebo	Part A Viaskin Peanut 250 mcg	Part A Viaskin Peanut 100 mcg	Part A Placebo
Baseline: Absent	0	0	—	—	—
Baseline: Mild	7.0	7.6	—	—	—
Baseline: Moderate	68.4	67.8	—	—	—
Baseline: Severe	24.6	24.6	—	—	—
Month 12: Absent	16.0	6.1	—	—	—
Month 12: Mild	20.5	14.3	—	—	—
Month 12: Moderate	51.0	51.0	—	—	—
Month 12: Severe	12.5	28.6	—	—	—

Adverse events

Collected over The TEAEs were collected from Day 1 up to Month 12. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Part B Viaskin Peanut 250 mcg	0/244 (0%)	21/244 (8.6%)	244/244 (100%)
Part B Placebo	0/118 (0%)	3/118 (2.5%)	117/118 (99.2%)
Part A Viaskin Peanut 250 mcg	0/21 (0%)	0/21 (0%)	21/21 (100%)
Part A Viaskin Peanut 100 mcg	0/20 (0%)	0/20 (0%)	20/20 (100%)
Part A Placebo	0/10 (0%)	0/10 (0%)	10/10 (100%)

Most frequent serious events

Showing 10 of 16

Most frequent serious events
Event	Part B Viaskin Peanut 250 mcg	Part B Placebo	Part A Viaskin Peanut 250 mcg	Part A Viaskin Peanut 100 mcg	Part A Placebo
WheezingRespiratory, thoracic and mediastinal disorders	6/244	1/118	0/21	0/20	0/10
Anaphylactic Reaction To FoodImmune system disorders	0/244	2/118	0/21	0/20	0/10
Bronchial HyperreactivityRespiratory, thoracic and mediastinal disorders	2/244	0/118	0/21	0/20	0/10
Medication ErrorInjury, poisoning and procedural complications	2/244	0/118	0/21	0/20	0/10
BronchitisInfections and infestations	1/244	0/118	0/21	0/20	0/10
Gastroenteritis ViralInfections and infestations	1/244	0/118	0/21	0/20	0/10
Metapneumovirus InfectionInfections and infestations	1/244	0/118	0/21	0/20	0/10
Periorbital CellulitisInfections and infestations	1/244	0/118	0/21	0/20	0/10
Respiratory Syncytial Virus BronchiolitisInfections and infestations	1/244	0/118	0/21	0/20	0/10
Respiratory Syncytial Virus InfectionInfections and infestations	1/244	0/118	0/21	0/20	0/10

Most frequent other events

Showing 10 of 128

Most frequent other events
Event	Part B Viaskin Peanut 250 mcg	Part B Placebo	Part A Viaskin Peanut 250 mcg	Part A Viaskin Peanut 100 mcg	Part A Placebo
Application Site ErythemaGeneral disorders	239/244	107/118	18/21	14/20	6/10
Application Site PruritusGeneral disorders	231/244	72/118	13/21	11/20	1/10
Application Site SwellingGeneral disorders	177/244	46/118	7/21	2/20	2/10
Upper Respiratory Tract InfectionInfections and infestations	103/244	43/118	13/21	7/20	2/10
UrticariaSkin and subcutaneous tissue disorders	85/244	44/118	4/21	4/20	5/10
PyrexiaGeneral disorders	84/244	50/118	5/21	6/20	2/10
VomitingGastrointestinal disorders	56/244	21/118	7/21	4/20	1/10
EczemaSkin and subcutaneous tissue disorders	59/244	30/118	7/21	6/20	2/10
CoughRespiratory, thoracic and mediastinal disorders	48/244	24/118	3/21	6/20	2/10
Application Site UrticariaGeneral disorders	68/244	3/118	2/21	3/20	0/10

Baseline characteristics

The Full Analysis Set (FAS) comprised of all participants who were randomized in the study.

Age, Categorical
Age, Categorical(Participants)	Part B Viaskin Peanut 250 mcg	Part B Placebo	Part A Viaskin Peanut 250 mcg	Part A Viaskin Peanut 100 mcg	Part A Placebo	Total
<=18 years	244	118	21	20	10	413
Between 18 and 65 years	0	0	0	0	0	0
>=65 years	0	0	0	0	0	0

Sex: Female, Male
Sex: Female, Male(Participants)	Part B Viaskin Peanut 250 mcg	Part B Placebo	Part A Viaskin Peanut 250 mcg	Part A Viaskin Peanut 100 mcg	Part A Placebo	Total
Female	79	34	8	5	4	130
Male	165	84	13	15	6	283

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Part B Viaskin Peanut 250 mcg	Part B Placebo	Part A Viaskin Peanut 250 mcg	Part A Viaskin Peanut 100 mcg	Part A Placebo	Total
White	159	70	15	17	7	268
Black or African American	1	1	0	0	0	2
Asian	41	24	1	2	1	69
Other	35	17	5	1	2	60
Not collected	8	6	0	0	0	14

Study locations

51 sites

University of Arizona Health Science
Tucson, Arizona 85719, United States
Arkansas Children's Hospital
Little Rock, Arkansas 72202, United States
University of California School of Medicine
Los Angeles, California 10833, United States
University of California, Rady Children's Hospital
San Diego, California 92123, United States
University of California San Francisco
San Francisco, California 94158, United States
Stanford University School of Medicine
Stanford, California 94305, United States
Children's Hospital Colorado
Aurora, Colorado 80045, United States
Children's national Health System
Washington D.C., District of Columbia 20010, United States
Emory University
Atlanta, Georgia 30329, United States
Ann & Robert H. Lurie Children's Hospital of CHicago
Chicago, Illinois 60611, United States
The Universal of Chicago Medical Center
Chicago, Illinois 60637, United States
Riley Hospital for Children at Indiana University
Indianapolis, Indiana 46202, United States
Johns Hopkins Hospital
Baltimore, Maryland 21205, United States
Boston Childrens' Hospital
Boston, Massachusetts 02115, United States
University of Michigan Health System
Ann Arbor, Michigan 48106, United States
Mount Sinai Medical Center
New York, New York 10029, United States
University of Rochester
Rochester, New York 14642, United States
The University of North Carolina - Chapell Hill
Chapel Hill, North Carolina 27599, United States
Cleveland Clinic
Cleveland, Ohio 44195, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania 15213, United States
Le Bonheur Children's Hospital
Memphis, Tennessee 38105, United States
Vanderbilt University Medical Center
Nashville, Tennessee 37232, United States
Dell Children's Medical Center
Austin, Texas 78723, United States
Children's Medical Center of Dallas
Dallas, Texas 75235, United States
Baylor College of Medicine - Texas Children's Hospital
Houston, Texas 77030, United States
ASTHMA, Inc.
Seattle, Washington 98115, United States
The Children's Hospital at Westmead
Westmead, New South Wales 2145, Australia
Sydney Children's Hospital
Randwick, NWS 2031, Australia
Queensland Children's Hospital
South Brisbane, Queensland 4101, Australia
The Women's and children's hospital
North Adelaide, South Australia 5006, Australia
The Royal Children's Hospital
Parkville, Victoria 3052, Australia
Perth Children's Hospital
Nedlands, Western Australia 6009, Australia
British Columbia Children's Hospital
Vancouver, British Columbia V5H 3V4, Canada
Hospital for Sick Children
Toronto, Ontario M5G 1X8, Canada
CHUM & CHU Sainte-Justine
Montreal, Quebec H3T 1C4, Canada
CHRU Lille
Lille, 59037, France
CHRU Metz-Thionville
Metz, 57085, France
Hopitaux Pediatriques de Nice
Nice, 06200, France
Hopital Necker
Paris, 75015, France
CHRU Nancy
Vandœuvre-lès-Nancy, 54511, France
Universitatsklinikum Carl Gustav Carus
Dresden, 01307, Germany
Universitatsklinikum Frankfurt
Frankfurt, 60590, Germany
Universitatklinikum Giessen und Marburg
Marburg, 35033, Germany
Cork University Hospital
Cork, T12YE02, Ireland
Erasmus MC Sophia Children's Hospital
Rotterdam, 3015, Netherlands
Guy's and Saint Thomas' NHS Foundation Trust
London, SE17EH, United Kingdom
St.Mary's Hospital
London, W21NY, United Kingdom
ROyal Manchester Children's Hospital
Manchester, M139WL, United Kingdom
Sheffield Children's Hospital
Sheffield, S102TH, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, SO166YD, United Kingdom

References and documents

Publications

Scurlock AM, Fleischer DM, Toit GD, Arends NJT, Pongracic JA, Trujillo J, Turner P, Vogelberg C, Bee KJ, Green TD, Meney J, Bois T, Campbell DE, Sampson HA, Burks AW. Efficacy and safety of epicutaneous immunotherapy in children with peanut allergy with atopic comorbidities. Ann Allergy Asthma Immunol. 2025 Aug;135(2):203-210. doi: 10.1016/j.anai.2025.04.002. Epub 2025 Apr 7. PubMed 40204253 ↗
Greenhawt M, Sindher SB, Wang J, O'Sullivan M, du Toit G, Kim EH, Albright D, Anvari S, Arends N, Arkwright PD, Begin P, Blumchen K, Bourrier T, Brown-Whitehorn T, Cassell H, Chan ES, Ciaccio CE, Deschildre A, Divaret-Chauveau A, Dorris SL, Dorsey MJ, Eiwegger T, Erlewyn-Lajeunesse M, Fleischer DM, Ford LS, Garcia-Lloret M, Giovannini-Chami L, Hourihane JO, Jay N, Jones SM, Kerns LA, Kloepfer KM, Leonard S, Lezmi G, Lieberman JA, Lomas J, Makhija M, Parrish C, Peake J, Perrett KP, Petroni D, Pfutzner W, Pongracic JA, Quinn P, Robison RG, Sanders G, Schneider L, Sharma HP, Trujillo J, Turner PJ, Tuttle K, Upton JE, Varshney P, Vickery BP, Vogelberg C, Wainstein B, Wood RA, Bee KJ, Campbell DE, Green TD, Rouissi R, Peillon A, Bahnson HT, Bois T, Sampson HA, Burks AW. Phase 3 Trial of Epicutaneous Immunotherapy in Toddlers with Peanut Allergy. N Engl J Med. 2023 May 11;388(19):1755-1766. doi: 10.1056/NEJMoa2212895. PubMed 37163622 ↗

Study documents

Study protocol ↗ · Nov 15, 2019
Statistical analysis plan ↗ · Mar 15, 2022

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2017 to primary completion in Aug 2019, 24 months.

Results were first posted in Dec 2024, 5 years 3 months after primary completion.

Of 15 phase 3 interventional studies under Peanut Hypersensitivity, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 42. This study's 24 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered: Jul 5, 2017
First posted: Jul 7, 2017
StartActual: Jul 31, 2017
Primary completionActual: Aug 20, 2019
CompletionActual: Apr 27, 2022
Results first posted: Dec 16, 2024
Last update: Dec 16, 2024

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Dec 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03211247
Lead sponsor: DBV Technologies
Responsible party: Sponsor
First posted: Jul 7, 2017
Start date: Jul 31, 2017
Primary completion: Aug 20, 2019
Completion: Apr 27, 2022
Results posted: Dec 16, 2024
Last update: Dec 16, 2024

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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