Trial · NCT01949311
Open-label Study of Dupilumab in Patients With Atopic Dermatitis
NCT01949311, Phase 3, Completed, Regeneron Pharmaceuticals; results first posted 2023-10-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Open-label Study of Dupilumab in Patients With Atopic Dermatitis. Trials, record NCT01949311. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01949311
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-label Study of Dupilumab in Patients With Atopic Dermatitis
- NCT number
- NCT01949311
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,733 participants, actual
- Lead sponsor
- Regeneron Pharmaceuticals
- Conditions
- Atopic Dermatitis
- Interventions
- Dupilumab
- First posted
- 2013-09-24
- Last updated
- 2023-10-17
- Other registries' IDs
- eudract:2013-001449-15
- Results first posted
- 2023-10-17
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Treatment Emergent Adverse Events (TEAEs) | Up to 272 weeks | |
| Primary | OPTIONAL SUB-STUDY: Number of Adverse Events of Special Interest (AESIs) Through the Last Study Visit After Switching to the New Dupilumab Drug Product | Up to 24 Weeks | Adverse events of special interest in this study include: Anaphylactic reactions, Systemic hypersensitivity reactions, Helminthic infections, Any severe type of conjunctivitis or blepharitis, Keratitis, Clinically symptomatic eosinophilia (or eosinophilia associated with clinical symptoms) |
| Secondary | Number of Serious Adverse Events (SAEs) of Special Interest | Up to 272 weeks | Adverse events of special interest in this study include: Anaphylactic reactions, Systemic hypersensitivity reactions, Helminthic infections, Any severe type of conjunctivitis or blepharitis, Keratitis, Clinically symptomatic eosinophilia (or eosinophilia associated with clinical symptoms) |
| Secondary | Rate of AESIs | Up to 272 weeks | Rate (events per patient-year) of AESIs Adverse events of special interest in this study include: Anaphylactic reactions, Systemic hypersensitivity reactions, Helminthic infections, Any severe type of conjunctivitis or blepharitis, Keratitis, Clinically symptomatic eosinophilia (or eosinophilia associated with clinical symptoms) |
| Secondary | Number of AESIs | Up to 272 weeks | Adverse events of special interest in this study include: Anaphylactic reactions, Systemic hypersensitivity reactions, Helminthic infections, Any severe type of conjunctivitis or blepharitis, Keratitis, Clinically symptomatic eosinophilia (or eosinophilia associated with clinical symptoms) |
| Secondary | Percentage of Participants With Investigator's Global Assessment (IGA) Score = 0-1 at Each Visit | Up to 272 weeks (End of Study), "Baseline, Weeks 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 272 (End of Study) | IGA is an assessment scale used to determine severity of hand and foot AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. |
| Secondary | Percentage of Participants With Eczema Area and Severity Index (EASI)-75 (≥75% Reduction in EASI Scores From Baseline of the Parent Study) at Each Visit | Up to 272 weeks (End of Study), "Baseline, Weeks 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 272 (End of Study)" | The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. |
| Secondary | Percentage of Participants With Low Disease Activity State (eg, IGA ≤2) at Each Visit | Up to 272 weeks (End of Study), "Baseline, Weeks 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 272 (End of Study)" | Low disease activity state is defined as an IGA score of ≤2 \[mild = 2, almost clear = 1, or clear = 0\] |
| Secondary | Change From Baseline in EASI Score at Each Visit | Up to 272 weeks (End of Study), "Baseline, Weeks 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 272 (End of Study)" | The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. |
| Secondary | Percent Change From Baseline in EASI Score at Each Visit | Up to 272 weeks (End of Study), "Baseline, Weeks 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 272 (End of Study)" | The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Treatment Emergent Adverse Events (TEAEs) | Up to 272 weeks | The safety analysis set (SAF) will include all patients who received any study drug; it is based on the treatment received (as treated). | Number of Events | NUMBER |
| PRIMARY | OPTIONAL SUB-STUDY: Number of Adverse Events of Special Interest (AESIs) Through the Last Study Visit After Switching to the New Dupilumab Drug Product | Up to 24 Weeks | The sub-study SAF includes all patients who receive new dupilumab drug product in the sub-study. | Events | NUMBER |
| SECONDARY | Number of Serious Adverse Events (SAEs) of Special Interest | Up to 272 weeks | The safety analysis set (SAF) will include all patients who received any study drug; it is based on the treatment received (as treated). | Events | NUMBER |
| SECONDARY | Rate of AESIs | Up to 272 weeks | The safety analysis set (SAF) will include all patients who received any study drug; it is based on the treatment received (as treated). | Events per Patient-Year | NUMBER |
| SECONDARY | Number of AESIs | Up to 272 weeks | The safety analysis set (SAF) will include all patients who received any study drug; it is based on the treatment received (as treated). | Events | NUMBER |
| SECONDARY | Percentage of Participants With Investigator's Global Assessment (IGA) Score = 0-1 at Each Visit | Up to 272 weeks (End of Study), Baseline, Weeks 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 272 (End of Study) | The safety analysis set (SAF) will include all patients who received any study drug; it is based on the treatment received (as treated). | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Eczema Area and Severity Index (EASI)-75 (≥75% Reduction in EASI Scores From Baseline of the Parent Study) at Each Visit | Up to 272 weeks (End of Study), Baseline, Weeks 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 272 (End of Study) | The safety analysis set (SAF) will include all patients who received any study drug; it is based on the treatment received (as treated). Here 'n' = number of evaluable participants at the specified timeframe | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Low Disease Activity State (eg, IGA ≤2) at Each Visit | Up to 272 weeks (End of Study), Baseline, Weeks 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 272 (End of Study) | The safety analysis set (SAF) will include all patients who received any study drug; it is based on the treatment received (as treated). Here 'n' = number of evaluable participants at the specified timeframe | Percentage of Participants | NUMBER |
| SECONDARY | Change From Baseline in EASI Score at Each Visit | Up to 272 weeks (End of Study), Baseline, Weeks 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 272 (End of Study) | The safety analysis set (SAF) will include all patients who received any study drug; it is based on the treatment received (as treated). Here 'n' = number of evaluable participants at the specified timeframe | Score on a scale | MEAN |
| SECONDARY | Percent Change From Baseline in EASI Score at Each Visit | Up to 272 weeks (End of Study), Baseline, Weeks 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 272 (End of Study) | The safety analysis set (SAF) will include all patients who received any study drug; it is based on the treatment received (as treated). Here 'n' = number of evaluable participants at the specified timeframe | Percent of Change | MEAN |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group192
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Treatment Emergent Adverse Events (TEAEs) | Dupilumab | 14717 | Number of Events | ||
| OPTIONAL SUB-STUDY: Number of Adverse Events of Special Interest (AESIs) Through the Last Study Visit After Switching to the New Dupilumab Drug Product | Dupilumab | 0 | Events | ||
| Number of Serious Adverse Events (SAEs) of Special Interest | Dupilumab | 9 | Events | ||
| Rate of AESIs | Dupilumab | 2.762 | Events per Patient-Year | ||
| Number of AESIs | Dupilumab | 161 | Events | ||
| Percentage of Participants With Investigator's Global Assessment (IGA) Score = 0-1 at Each Visit | Dupilumab | Baseline of study | 12.0 | Percentage of Participants | |
| Percentage of Participants With Investigator's Global Assessment (IGA) Score = 0-1 at Each Visit | Dupilumab | Week 4 | 31.1 | Percentage of Participants | |
| Percentage of Participants With Investigator's Global Assessment (IGA) Score = 0-1 at Each Visit | Dupilumab | Week 16 | 46.7 | Percentage of Participants | |
| Percentage of Participants With Investigator's Global Assessment (IGA) Score = 0-1 at Each Visit | Dupilumab | Week 36 | 46.2 | Percentage of Participants | |
| Percentage of Participants With Investigator's Global Assessment (IGA) Score = 0-1 at Each Visit | Dupilumab | Week 52 | 53.8 | Percentage of Participants |
1 to 10 of 192Source ClinicalTrials.gov
See all 192 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dupilumab | 2,677 | |
| Overall Study | COMPLETED | Dupilumab | 1,297 | |
| Overall Study | NOT COMPLETED | Dupilumab | 1,380 |
Source ClinicalTrials.gov
Adverse events251
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 | Nasopharyngitis | Infections and infestations | Dupilumab | 774 | 2,677 | 1,602 |
| other | Upper respiratory tract infection | Infections and infestations | Dupilumab | 365 | 2,677 | 567 |
| other | Conjunctivitis | Infections and infestations | Dupilumab | 277 | 2,677 | 417 |
| other | Oral herpes | Infections and infestations | Dupilumab | 200 | 2,677 | 463 |
| other | Dermatitis atopic | Skin and subcutaneous tissue disorders | Dupilumab | 446 | 2,677 | 787 |
| other | Conjunctivitis allergic | Eye disorders | Dupilumab | 242 | 2,677 | 329 |
| other | Headache | Nervous system disorders | Dupilumab | 218 | 2,677 | 411 |
| other | Injection site reaction | General disorders | Dupilumab | 138 | 2,677 | 506 |
| serious | Appendicitis | Infections and infestations | Dupilumab | 6 | 2,677 | 6 |
| serious | Corona virus infection | Infections and infestations | Dupilumab | 3 | 2,677 | 3 |
1 to 10 of 251Source ClinicalTrials.gov
See all 251 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dupilumab | 3 | 2,677 |
| Total, other adverse events | Dupilumab | 1,613 | 2,677 |
| Total, serious adverse events | Dupilumab | 283 | 2,677 |
Source ClinicalTrials.gov
Papers10
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/NCT01949311
GET https://conductscience.org/api/trials/v1/NCT01949311/registered?page=2