Trial · NCT02636699
Efficacy and Safety of Viaskin Peanut in Children With Immunoglobulin E (IgE)-Mediated Peanut Allergy
NCT02636699, Phase 3, Completed, DBV Technologies; results first posted 2021-10-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Viaskin Peanut in Children With Immunoglobulin E (IgE)-Mediated Peanut Allergy. Trials, record NCT02636699. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02636699
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Viaskin Peanut in Children With Immunoglobulin E (IgE)-Mediated Peanut Allergy
- NCT number
- NCT02636699
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 500 participants, actual
- Lead sponsor
- DBV Technologies
- Conditions
- Peanut Allergy
- Interventions
- Viaskin Peanut 250mcg, Placebo
- First posted
- 2015-12-22
- Last updated
- 2025-06-18
- Results first posted
- 2021-10-15
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Difference in Percentages of Treatment Responders at Month 12; Analyzed in the Overall Population | At Month 12 | The Double-Blind Placebo-Controlled Food Challenges (DBPCFCs) to determine Eliciting Dose (ED) were performed at screening and Month 12, with each challenge occurring over 2 days. The participant was gradually fed increasing amounts of standardized blinded oral formulas containing either peanut protein (during 1 of the 2 days of the challenge), or without any peanut protein (during the other day of the challenge). A participant was defined as a treatment responder if: * ED was ≥300 mg peanut protein at Month 12 DBPCFC (for screening ED subgroup 1), or * ED was ≥1,000 mg peanut protein at Month 12 DBPCFC (for screening ED subgroup 2). Participants with missing treatment response at Month 12 were imputed as non-responders. The percentage of treatment responders at Month 12 is presented. Analysis of the difference in response rates between treatment groups is presented in the subsequent statistical analysis table. Analysis was performed in the overall population. |
| Secondary | Difference in Percentages of Treatment Responders at Month 12; Analyzed in Each Screening Eliciting Dose (ED) Subgroup | At Month 12 | The Double-Blind Placebo-Controlled Food Challenges (DBPCFCs) to determine Eliciting Dose (ED) were performed at screening and Month 12, with each challenge occurring over 2 days. The participant was gradually fed increasing amounts of blinded oral formulas containing either peanut protein (during 1 of the 2 days of the challenge), or without any peanut protein (during the other day of the challenge). A participant was defined as a treatment responder if: * ED was ≥300 mg peanut protein at Month 12 DBPCFC (for screening ED subgroup 1), or * ED was ≥1,000 mg peanut protein at Month 12 DBPCFC (for screening ED subgroup 2). Participants with missing treatment response at Month 12 were imputed as non-responders. The percentage of treatment responders at Month 12 is presented below. Analysis of the difference in response rates between treatment groups is presented in the subsequent statistical analysis table. Analysis was performed for each separate screening ED subgroup. |
| Secondary | Cumulative Reactive Dose (CRD) of Peanut Protein at Baseline and Month 12 | Baseline and Month 12 | The CRD was calculated as the sum of all doses given (including any repeated and partial doses). The median CRD of peanut protein at baseline and Month 12 is presented. Analysis was performed using the modified baseline observation carried forward method to impute missing data at Month 12. |
| Other | Relative Change From Baseline in Peanut-specific Immunoglobulin E (IgE) Over Time | Baseline and Months 3, 6 and 12 | Venous blood samples were drawn to assess peanut-specific IgE levels at baseline and Months 3, 6 and 12. The median relative changes from baseline in IgE levels for each timepoint are presented. Relative change from baseline=100×(value at the visit-value at baseline)/value at baseline. |
| Other | Relative Changes From Baseline in Peanut-specific Immunoglobulin G4 Subtype (IgG4) Over Time | Baseline and Months 3, 6 and 12 | Venous blood samples were drawn to assess peanut-specific IgG4 levels at baseline and Months 3, 6 and 12. The median relative changes from baseline in IgG4 levels for each timepoint are presented. Relative change from baseline=100×(value at the visit-value at baseline)/value at baseline. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Difference in Percentages of Treatment Responders at Month 12; Analyzed in the Overall Population | At Month 12 | The Intent-to-Treat (ITT) population was comprised of all participants who were randomized. | percentage of participants | NUMBER |
| SECONDARY | Difference in Percentages of Treatment Responders at Month 12; Analyzed in Each Screening Eliciting Dose (ED) Subgroup | At Month 12 | The Intent-to-Treat (ITT) population was comprised of all participants who were randomized. | percentage of participants | NUMBER |
| SECONDARY | Cumulative Reactive Dose (CRD) of Peanut Protein at Baseline and Month 12 | Baseline and Month 12 | The Intent-to-Treat (ITT) population was comprised of all participants who were randomized. | mg | MEDIAN |
| OTHER_PRE_SPECIFIED | Relative Change From Baseline in Peanut-specific Immunoglobulin E (IgE) Over Time | Baseline and Months 3, 6 and 12 | The Intent-to-Treat (ITT) population was comprised of all participants who were randomized. Only those with non-missing data were included in the analysis. | Percent of change | MEDIAN |
| OTHER_PRE_SPECIFIED | Relative Changes From Baseline in Peanut-specific Immunoglobulin G4 Subtype (IgG4) Over Time | Baseline and Months 3, 6 and 12 | The Intent-to-Treat (ITT) population was comprised of all participants who were randomized. Only those with non-missing data were included in the analysis. | Percent of change | MEDIAN |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Difference in Percentages of Treatment Responders at Month 12; Analyzed in the Overall Population | DBV712 250 μg | 35.3 | 95% Confidence Interval 29.5 to 41.6 | percentage of participants | |
| Difference in Percentages of Treatment Responders at Month 12; Analyzed in the Overall Population | Placebo | 13.6 | 95% Confidence Interval 8.5 to 20.9 | percentage of participants | |
| Difference in Percentages of Treatment Responders at Month 12; Analyzed in Each Screening Eliciting Dose (ED) Subgroup | DBV712 250 μg | Screening ED subgroup 1 | 39.0 | 95% Confidence Interval 25.7 to 54.3 | percentage of participants |
| Difference in Percentages of Treatment Responders at Month 12; Analyzed in Each Screening Eliciting Dose (ED) Subgroup | Placebo | Screening ED subgroup 1 | 20.0 | 95% Confidence Interval 8.1 to 41.6 | percentage of participants |
| Difference in Percentages of Treatment Responders at Month 12; Analyzed in Each Screening Eliciting Dose (ED) Subgroup | DBV712 250 μg | Screening ED subgroup 2 | 34.5 | 95% Confidence Interval 28.2 to 41.4 | percentage of participants |
| Difference in Percentages of Treatment Responders at Month 12; Analyzed in Each Screening Eliciting Dose (ED) Subgroup | Placebo | Screening ED subgroup 2 | 12.2 | 95% Confidence Interval 7.1 to 20.2 | percentage of participants |
| Cumulative Reactive Dose (CRD) of Peanut Protein at Baseline and Month 12 | DBV712 250 μg | Baseline | 144.0 | Inter-Quartile Range 44.0 to 444.0 | mg |
| Cumulative Reactive Dose (CRD) of Peanut Protein at Baseline and Month 12 | Placebo | Baseline | 144.0 | Inter-Quartile Range 44.0 to 444.0 | mg |
| Cumulative Reactive Dose (CRD) of Peanut Protein at Baseline and Month 12 | DBV712 250 μg | Month 12 | 444.0 | Inter-Quartile Range 144.0 to 1444.0 | mg |
| Cumulative Reactive Dose (CRD) of Peanut Protein at Baseline and Month 12 | Placebo | Month 12 | 144.0 | Inter-Quartile Range 44.0 to 444.0 | mg |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Screening Period | STARTED | DBV712 250 μg | 0 | |
| Screening Period | STARTED | Placebo | 0 | |
| Screening Period | STARTED | Screened | 500 | |
| Screening Period | COMPLETED | DBV712 250 μg | 0 | |
| Screening Period | COMPLETED | Placebo | 0 | |
| Screening Period | COMPLETED | Screened | 356 | |
| Screening Period | NOT COMPLETED | DBV712 250 μg | 0 | |
| Screening Period | NOT COMPLETED | Placebo | 0 | |
| Screening Period | NOT COMPLETED | Screened | 144 | |
| Treatment and Follow-up Periods | STARTED | DBV712 250 μg | 238 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events135
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 | Upper respiratory tract infection | Infections and infestations | DBV712 250 μg | 73 | 238 | 134 |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 30 | 118 | 48 |
| other | Upper respiratory tract infection | Infections and infestations | Screened | 16 | 500 | 16 |
| other | Viral upper respiratory tract infection | Infections and infestations | DBV712 250 μg | 42 | 238 | 82 |
| other | Viral upper respiratory tract infection | Infections and infestations | Placebo | 20 | 118 | 40 |
| other | Viral upper respiratory tract infection | Infections and infestations | Screened | 8 | 500 | 8 |
| other | Gastroenteritis | Infections and infestations | DBV712 250 μg | 20 | 238 | 23 |
| other | Gastroenteritis | Infections and infestations | Placebo | 10 | 118 | 11 |
| other | Gastroenteritis | Infections and infestations | Screened | 2 | 500 | 2 |
| other | Viral infection | Infections and infestations | DBV712 250 μg | 19 | 238 | 21 |
1 to 10 of 135Source ClinicalTrials.gov
See all 135 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DBV712 250 μg | 0 | 238 |
| Total, all-cause mortality | Placebo | 0 | 118 |
| Total, all-cause mortality | Screened | 0 | 500 |
| Total, other adverse events | DBV712 250 μg | 222 | 238 |
| Total, other adverse events | Placebo | 96 | 118 |
| Total, other adverse events | Screened | 83 | 500 |
| Total, serious adverse events | DBV712 250 μg | 10 | 238 |
| Total, serious adverse events | Placebo | 6 | 118 |
| Total, serious adverse events | Screened | 9 | 500 |
Source ClinicalTrials.gov
Papers4
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/NCT02636699
GET https://conductscience.org/api/trials/v1/NCT02636699/results?page=2