Trial · NCT03211247
Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age
NCT03211247, Phase 3, Completed, DBV Technologies; results first posted 2024-12-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age. Trials, record NCT03211247. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03211247
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age
- NCT number
- NCT03211247
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 414 participants, actual
- Lead sponsor
- DBV Technologies
- Conditions
- Peanut Allergy
- Interventions
- Part A Viaskin Peanut 250 mcg, Part A Viaskin Peanut 100 mcg, Part A Placebo, Part B Viaskin Peanut 250 mcg, Part B Placebo
- First posted
- 2017-07-07
- Last updated
- 2024-12-16
- Results first posted
- 2024-12-16
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Treatment Responders at Month 12 | 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. |
| Secondary | Cumulative Reactive Dose (CRD) of Peanut Protein at Month 12 Using Analysis of Covariance (ANCOVA) Model | 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 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. |
| Secondary | Change From Baseline in CRD of Peanut Protein to Month 12 | Baseline (Day 1) and 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. |
| Secondary | ED of Peanut Protein at Month 12 Using ANCOVA Model | 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. The ED in each treatment group at Month 12 was compared using ANCOVA model. |
| Secondary | Change From Baseline in ED of Peanut Protein to Month 12 | Baseline (Day 1) and 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. |
| Secondary | Percentage of Participants With Severity of Objective Symptoms at Baseline and Month 12 During Double-Blind Placebo-Controlled Food Challenge | Baseline (Day 1) and Month 12 | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Treatment Responders at Month 12 | Month 12 | The FAS comprised of all participants who were randomized in the study. | Percentage of participants | NUMBER |
| SECONDARY | Cumulative Reactive Dose (CRD) of Peanut Protein at Month 12 Using Analysis of Covariance (ANCOVA) Model | Month 12 | The FAS comprised of all participants who were randomized in the study. | milligram (mg) | GEOMETRIC_LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in CRD of Peanut Protein to Month 12 | Baseline (Day 1) and Month 12 | The FAS comprised of all participants who were randomized in the study. | mg | MEDIAN |
| SECONDARY | ED of Peanut Protein at Month 12 Using ANCOVA Model | Month 12 | The FAS comprised of all participants who were randomized in the study. | mg | GEOMETRIC_LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in ED of Peanut Protein to Month 12 | Baseline (Day 1) and Month 12 | The FAS comprised of all participants who were randomized in the study. | mg | MEDIAN |
| SECONDARY | Percentage of Participants With Severity of Objective Symptoms at Baseline and Month 12 During Double-Blind Placebo-Controlled Food Challenge | Baseline (Day 1) and Month 12 | The FAS comprised of all participants who were randomized in the study. This outcome was measured on Part B subjects only. Therefore subjects from Part A are reported as zero in the outcome measure data table. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group41
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Treatment Responders at Month 12 | Part B Viaskin Peanut 250 mcg | 67.0 | 95% Confidence Interval 60.93 to 73.01 | Percentage of participants | |
| Percentage of Treatment Responders at Month 12 | Part B Placebo | 33.5 | 95% Confidence Interval 24.84 to 42.24 | Percentage of participants | |
| Percentage of Treatment Responders at Month 12 | Part A Viaskin Peanut 250 mcg | 52.4 | 95% Confidence Interval 29.8 to 74.3 | Percentage of participants | |
| Percentage of Treatment Responders at Month 12 | Part A Viaskin Peanut 100 mcg | 70.0 | 95% Confidence Interval 45.7 to 88.1 | Percentage of participants | |
| Percentage of Treatment Responders at Month 12 | Part A Placebo | 60.0 | 95% Confidence Interval 26.2 to 74.3 | Percentage of participants | |
| Cumulative Reactive Dose (CRD) of Peanut Protein at Month 12 Using Analysis of Covariance (ANCOVA) Model | Part B Viaskin Peanut 250 mcg | 1010.31 | 95% Confidence Interval 842.18 to 1212.01 | milligram (mg) | |
| Cumulative Reactive Dose (CRD) of Peanut Protein at Month 12 Using Analysis of Covariance (ANCOVA) Model | Part B Placebo | 322.57 | 95% Confidence Interval 248.37 to 418.94 | milligram (mg) | |
| Cumulative Reactive Dose (CRD) of Peanut Protein at Month 12 Using Analysis of Covariance (ANCOVA) Model | Part A Viaskin Peanut 250 mcg | 788.74 | 95% Confidence Interval 220.20 to 2825.24 | milligram (mg) | |
| Cumulative Reactive Dose (CRD) of Peanut Protein at Month 12 Using Analysis of Covariance (ANCOVA) Model | Part A Viaskin Peanut 100 mcg | 1155.90 | 95% Confidence Interval 367.53 to 3635.38 | milligram (mg) | |
| Cumulative Reactive Dose (CRD) of Peanut Protein at Month 12 Using Analysis of Covariance (ANCOVA) Model | Part A Placebo | 1153.47 | 95% Confidence Interval 474.34 to 2804.91 | milligram (mg) |
1 to 10 of 41Source ClinicalTrials.gov
See all 41 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part B Viaskin Peanut 250 mcg | 244 | |
| Overall Study | STARTED | Part B Placebo | 118 | |
| Overall Study | STARTED | Part A Viaskin Peanut 250 mcg | 21 | |
| Overall Study | STARTED | Part A Viaskin Peanut 100 mcg | 20 | |
| Overall Study | STARTED | Part A Placebo | 10 | |
| Overall Study | COMPLETED | Part B Viaskin Peanut 250 mcg | 208 | |
| Overall Study | COMPLETED | Part B Placebo | 99 | |
| Overall Study | COMPLETED | Part A Viaskin Peanut 250 mcg | 17 | |
| Overall Study | COMPLETED | Part A Viaskin Peanut 100 mcg | 16 | |
| Overall Study | COMPLETED | Part A Placebo | 9 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events720
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Application Site Erythema | General disorders | Part B Viaskin Peanut 250 mcg | 239 | 244 | 2,182 |
| other | Application Site Erythema | General disorders | Part B Placebo | 107 | 118 | 760 |
| other | Application Site Erythema | General disorders | Part A Viaskin Peanut 250 mcg | 18 | 21 | 21 |
| other | Application Site Erythema | General disorders | Part A Viaskin Peanut 100 mcg | 14 | 20 | 15 |
| other | Application Site Erythema | General disorders | Part A Placebo | 6 | 10 | 13 |
| other | Application Site Pruritus | General disorders | Part B Viaskin Peanut 250 mcg | 231 | 244 | 2,925 |
| other | Application Site Pruritus | General disorders | Part B Placebo | 72 | 118 | 523 |
| other | Application Site Pruritus | General disorders | Part A Viaskin Peanut 250 mcg | 13 | 21 | 15 |
| other | Application Site Pruritus | General disorders | Part A Viaskin Peanut 100 mcg | 11 | 20 | 29 |
| other | Application Site Pruritus | General disorders | Part A Placebo | 1 | 10 | 2 |
1 to 10 of 720Source ClinicalTrials.gov
See all 720 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part B Viaskin Peanut 250 mcg | 0 | 244 |
| Total, all-cause mortality | Part B Placebo | 0 | 118 |
| Total, all-cause mortality | Part A Viaskin Peanut 250 mcg | 0 | 21 |
| Total, all-cause mortality | Part A Viaskin Peanut 100 mcg | 0 | 20 |
| Total, all-cause mortality | Part A Placebo | 0 | 10 |
| Total, other adverse events | Part B Viaskin Peanut 250 mcg | 244 | 244 |
| Total, other adverse events | Part B Placebo | 117 | 118 |
| Total, other adverse events | Part A Viaskin Peanut 250 mcg | 21 | 21 |
| Total, other adverse events | Part A Viaskin Peanut 100 mcg | 20 | 20 |
| Total, other adverse events | Part A Placebo | 10 | 10 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03211247
GET https://conductscience.org/api/trials/v1/NCT03211247/results?page=2