| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Allergic Contact Dermatitis | Drug: Dupilumab | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 20 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | The Effects of Dupilumab on Allergic Contact Dermatitis |
| Actual Study Start Date : | December 18, 2019 |
| Estimated Primary Completion Date : | December 2021 |
| Estimated Study Completion Date : | December 2021 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Subjects with Allergic Contact Dermatitis
Dupilumab 600 mg/4 mL subcutaneously once, then 300 mg/2 mL every 2 weeks for 10 weeks
|
Drug: Dupilumab
See arm/group description
|
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| Contact: Liset Chacin, BA | 617-264-5926 | lchacin@bwh.harvard.edu |
| United States, Massachusetts | |
| Brigham and Women's Hospital, Department of Dermatology | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Liset Chacin 617-264-5926 lchacin@bwh.harvard.edu | |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 23, 2019 | ||||
| First Posted Date ICMJE | May 2, 2019 | ||||
| Last Update Posted Date | March 18, 2020 | ||||
| Actual Study Start Date ICMJE | December 18, 2019 | ||||
| Estimated Primary Completion Date | December 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Change in Investigator's Global Assessment (IGA) score [ Time Frame: week 0, week 6, week 12 ] The investigator's global assessment is a physician-reported global assessment of disease activity (range 0-4) with 0 being clear and 4 being severe
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
|
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Effects of Dupilumab on Allergic Contact Dermatitis | ||||
| Official Title ICMJE | The Effects of Dupilumab on Allergic Contact Dermatitis | ||||
| Brief Summary | The aim of this study is to investigate the effects of dupilumab on allergic contact dermatitis. | ||||
| Detailed Description | The investigators will recruit 20 patients with allergic contact dermatitis who have not improved with allergen avoidance up to 6 months after patch testing, but where allergic contact dermatitis is still suspected. Subjects will receive 10 weeks of dupilumab, and both clinical data and tissue samples will be assessed. | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 4 | ||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||
| Condition ICMJE | Allergic Contact Dermatitis | ||||
| Intervention ICMJE | Drug: Dupilumab
See arm/group description
|
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| Study Arms ICMJE | Experimental: Subjects with Allergic Contact Dermatitis
Dupilumab 600 mg/4 mL subcutaneously once, then 300 mg/2 mL every 2 weeks for 10 weeks
Intervention: Drug: Dupilumab
|
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
20 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | December 2021 | ||||
| Estimated Primary Completion Date | December 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
|
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
|
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| Listed Location Countries ICMJE | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03935971 | ||||
| Other Study ID Numbers ICMJE | 2018P002882 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Ari M. Goldminz, Brigham and Women's Hospital | ||||
| Study Sponsor ICMJE | Brigham and Women's Hospital | ||||
| Collaborators ICMJE | Regeneron Pharmaceuticals | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Brigham and Women's Hospital | ||||
| Verification Date | March 2020 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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