Trial · NCT01675882
Efficacy and Safety of Several Doses of Viaskin Peanut in Adults and Children With Peanut Allergy
NCT01675882, Phase 2, Completed, DBV Technologies; results first posted 2021-10-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Several Doses of Viaskin Peanut in Adults and Children With Peanut Allergy. Trials, record NCT01675882. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01675882
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Several Doses of Viaskin Peanut in Adults and Children With Peanut Allergy
- NCT number
- NCT01675882
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 221 participants, actual
- Lead sponsor
- DBV Technologies
- Conditions
- Peanut Allergy
- Interventions
- Viaskin Peanut 50 mcg, Viaskin Peanut 100 mcg, Viaskin Peanut 250 mcg, Viaskin Placebo
- First posted
- 2012-08-30
- Last updated
- 2021-10-27
- Other registries' IDs
- eudract:2011-002550-32
- Results first posted
- 2021-10-27
Source ClinicalTrials.gov
Registered outcomes19
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; Analyzed in Overall Population | At Month 12 | A treatment responder was defined as a participant with a peanut protein eliciting dose equal to or greater than 1,000 mg peanut proteins based on the results of the DBPCFC after 12 months of treatment or a participant with a \>=10-fold increase of the eliciting dose at 12 months, compared to the initial eliciting dose. For participants with missing treatment response at Month 12, last observation carried forward (LOCF) imputation was used (i.e., participants were considered as non-responders). |
| Secondary | Percentage of Treatment Responders at Month 12; Analyzed in Children (6-11 Years of Age) | At Month 12 | A treatment responder was defined as a participant with a peanut protein eliciting dose equal to or greater than 1,000 mg peanut proteins based on the results of the DBPCFC after 12 months of treatment or a participant with a \>=10-fold increase of the eliciting dose at 12 months, compared to the initial eliciting dose. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders). |
| Secondary | Percentage of Treatment Responders at Month 12; Analyzed in Adolescents (12-17 Years of Age) | At Month 12 | A treatment responder was defined as a participant with a peanut protein eliciting dose equal to or greater than 1,000 mg peanut proteins based on the results of the DBPCFC after 12 months of treatment or a participant with a \>=10-fold increase of the eliciting dose at 12 months, compared to the initial eliciting dose. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders). |
| Secondary | Percentage of Treatment Responders at Month 12; Analyzed in Adults (18-55 Years of Age) | At Month 12 | A treatment responder was defined as a participant with a peanut protein eliciting dose equal to or greater than 1,000 mg peanut proteins based on the results of the DBPCFC after 12 months of treatment or a participant with a \>=10-fold increase of the eliciting dose at 12 months, compared to the initial eliciting dose. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders). |
| Secondary | Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Overall Population | At Month 12 | The peanut protein eliciting dose was defined as the first dose of peanut protein administered to the participant during the DBPCFC procedure which caused an objective allergic reaction. This was capped to 300 mg at the screening DBPCFC and to 2000 mg at the Month 12 DBPCFC. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders). |
| Secondary | Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Children (6-11 Years of Age) | At Month 12 | The peanut protein eliciting dose was defined as the first dose of peanut protein administered to the participant during the DBPCFC procedure which caused an objective allergic reaction. This was capped to 300 mg at screening DBPCFC and to 2000 mg at the Month 12 DBPCFC. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders). |
| Secondary | Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Adolescents (12-17 Years of Age) | At Month 12 | The peanut protein eliciting dose was defined as the first dose of peanut protein administered to the participant during the DBPCFC procedure which caused an objective allergic reaction. This was capped to 300 mg at screening DBPCFC and to 2000 mg at the Month 12 DBPCFC. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders). |
| Secondary | Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Adults (18-55 Years of Age) | At Month 12 | The peanut protein eliciting dose was defined as the first dose of peanut protein administered to the participant during the DBPCFC procedure which caused an objective allergic reaction. This was capped to 300 mg at screening DBPCFC and to 2000 mg at the Month 12 DBPCFC. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders). |
| Secondary | Mean Cumulative Reactive Dose of Peanut Proteins at Month 12; Analyzed in Overall Population | At Month 12 | The peanut protein cumulative reactive dose was defined as the sum of all peanut protein doses up to and including the eliciting dose ingested during the peanut challenge. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders). |
| Secondary | Change From Baseline in Severity of Symptoms Based on the Oral Food Challenge (OFC) Symptom Score Sheet at Month 12; Analyzed in Overall Population | Baseline and Month 12 | The symptoms of erythematous rash, pruritus, urticaria/angioedema, rash, sneezing/itching, nasal congestion, rhinorrhea, laryngeal symptoms (example, throat clearing, occasional cough, hoarseness, frequent dry cough, inspiratory stridor), wheezing, subjective complaints, objective complaints and cardiovascular symptoms (example, color change, weakness, dizziness, mental status change, tachycardia, decreased blood pressure, etc) were observed. The OFC score ranges from 0 to 3 for each symptom (0=Absent, 1=mild, 2=moderate or 3=severe). The total symptom score for each participant was calculated. Higher scores indicate worst outcome. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders). |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
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; Analyzed in Overall Population | At Month 12 | The full analysis set included all participants who were randomized. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Treatment Responders at Month 12; Analyzed in Children (6-11 Years of Age) | At Month 12 | The full analysis set included all participants who were randomized. Only participants in the range of 6-11 years of age are reported. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Treatment Responders at Month 12; Analyzed in Adolescents (12-17 Years of Age) | At Month 12 | The full analysis set included all participants who were randomized. Only participants in the range of 12-17 years of age are reported. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Treatment Responders at Month 12; Analyzed in Adults (18-55 Years of Age) | At Month 12 | The full analysis set included all participants who were randomized. Only participants in the range of 18-55 years of age are reported. | percentage of participants | NUMBER |
| SECONDARY | Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Overall Population | At Month 12 | The full analysis set included all participants who were randomized. | mg | MEAN |
| SECONDARY | Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Children (6-11 Years of Age) | At Month 12 | The full analysis set included all participants who were randomized. Only participants in the range of 6-11 years of age are reported. | mg | MEAN |
| SECONDARY | Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Adolescents (12-17 Years of Age) | At Month 12 | The full analysis set included all participants who were randomized. Only participants in the range of 12-17 years of age are reported. | mg | MEAN |
| SECONDARY | Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Adults (18-55 Years of Age) | At Month 12 | The full analysis set included all participants who were randomized. Only participants in the range of 18-55 years of age are reported. | mg | MEAN |
| SECONDARY | Mean Cumulative Reactive Dose of Peanut Proteins at Month 12; Analyzed in Overall Population | At Month 12 | The full analysis set included all participants who were randomized. | mg | MEAN |
| SECONDARY | Change From Baseline in Severity of Symptoms Based on the Oral Food Challenge (OFC) Symptom Score Sheet at Month 12; Analyzed in Overall Population | Baseline and Month 12 | The full analysis set included all participants who were randomized. | units on a scale | MEAN |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group256
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; Analyzed in Overall Population | Viaskin Peanut 50 μg | 45.3 | 95% Confidence Interval 31.56 to 59.55 | percentage of participants | |
| Percentage of Treatment Responders at Month 12; Analyzed in Overall Population | Viaskin Peanut 100 μg | 41.1 | 95% Confidence Interval 28.10 to 55.02 | percentage of participants | |
| Percentage of Treatment Responders at Month 12; Analyzed in Overall Population | Viaskin Peanut 250 μg | 50.0 | 95% Confidence Interval 36.34 to 63.66 | percentage of participants | |
| Percentage of Treatment Responders at Month 12; Analyzed in Overall Population | Placebo | 25.0 | 95% Confidence Interval 14.39 to 38.37 | percentage of participants | |
| Percentage of Treatment Responders at Month 12; Analyzed in Children (6-11 Years of Age) | Viaskin Peanut 50 μg | 57.1 | 95% Confidence Interval 37.18 to 75.54 | percentage of participants | |
| Percentage of Treatment Responders at Month 12; Analyzed in Children (6-11 Years of Age) | Viaskin Peanut 100 μg | 46.2 | 95% Confidence Interval 26.59 to 66.63 | percentage of participants | |
| Percentage of Treatment Responders at Month 12; Analyzed in Children (6-11 Years of Age) | Viaskin Peanut 250 μg | 53.6 | 95% Confidence Interval 33.87 to 72.49 | percentage of participants | |
| Percentage of Treatment Responders at Month 12; Analyzed in Children (6-11 Years of Age) | Placebo | 19.4 | 95% Confidence Interval 7.45 to 37.47 | percentage of participants | |
| Percentage of Treatment Responders at Month 12; Analyzed in Adolescents (12-17 Years of Age) | Viaskin Peanut 50 μg | 33.3 | 95% Confidence Interval 13.34 to 59.01 | percentage of participants | |
| Percentage of Treatment Responders at Month 12; Analyzed in Adolescents (12-17 Years of Age) | Viaskin Peanut 100 μg | 10.5 | 95% Confidence Interval 1.30 to 33.14 | percentage of participants |
1 to 10 of 256Source ClinicalTrials.gov
See all 256 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Viaskin Peanut 50 μg | 53 | |
| Overall Study | STARTED | Viaskin Peanut 100 μg | 56 | |
| Overall Study | STARTED | Viaskin Peanut 250 μg | 56 | |
| Overall Study | STARTED | Placebo | 56 | |
| Overall Study | COMPLETED | Viaskin Peanut 50 μg | 51 | |
| Overall Study | COMPLETED | Viaskin Peanut 100 μg | 49 | |
| Overall Study | COMPLETED | Viaskin Peanut 250 μg | 53 | |
| Overall Study | COMPLETED | Placebo | 54 | |
| Overall Study | NOT COMPLETED | Viaskin Peanut 50 μg | 2 | |
| Overall Study | NOT COMPLETED | Viaskin Peanut 100 μg | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events228
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 | Eye swelling | Eye disorders | Viaskin Peanut 50 μg | 1 | 53 | 1 |
| other | Eye swelling | Eye disorders | Viaskin Peanut 100 μg | 2 | 56 | 3 |
| other | Eye swelling | Eye disorders | Viaskin Peanut 250 μg | 3 | 56 | 3 |
| other | Eye swelling | Eye disorders | Placebo | 0 | 56 | 0 |
| other | Abdominal pain upper | Gastrointestinal disorders | Viaskin Peanut 50 μg | 5 | 53 | 9 |
| other | Abdominal pain upper | Gastrointestinal disorders | Viaskin Peanut 100 μg | 3 | 56 | 6 |
| other | Abdominal pain upper | Gastrointestinal disorders | Viaskin Peanut 250 μg | 2 | 56 | 2 |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 3 | 56 | 6 |
| other | Abdominal pain | Gastrointestinal disorders | Viaskin Peanut 50 μg | 2 | 53 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | Viaskin Peanut 100 μg | 4 | 56 | 4 |
1 to 10 of 228Source ClinicalTrials.gov
See all 228 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Viaskin Peanut 50 μg | 0 | 53 |
| Total, all-cause mortality | Viaskin Peanut 100 μg | 0 | 56 |
| Total, all-cause mortality | Viaskin Peanut 250 μg | 0 | 56 |
| Total, all-cause mortality | Placebo | 0 | 56 |
| Total, other adverse events | Viaskin Peanut 50 μg | 53 | 53 |
| Total, other adverse events | Viaskin Peanut 100 μg | 55 | 56 |
| Total, other adverse events | Viaskin Peanut 250 μg | 56 | 56 |
| Total, other adverse events | Placebo | 51 | 56 |
| Total, serious adverse events | Viaskin Peanut 50 μg | 2 | 53 |
| Total, serious adverse events | Viaskin Peanut 100 μg | 1 | 56 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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.
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GET https://conductscience.org/api/trials/v1/NCT01675882
GET https://conductscience.org/api/trials/v1/NCT01675882/results?page=2