The Impact of Dupilumab on Quality of Life in Moderate to Severe Atopic Dermatitis Patients
NCT ID: NCT03667014
Last Updated: 2024-01-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
34 participants
INTERVENTIONAL
2018-11-01
2022-12-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dupilumab treatment
30 subjects will receive dupilumab for a treatment period of 52 weeks. All patients quality of life measures will be assessed with Psychological General Well-Being scale (PGWB), Work Productivity and Activity Impairment scale (WPAI), and Dermatology Life Quality Index (DLQI). Symptom and satisfaction will be assessed with Treatment Satisfaction Questionnaire for Medication (TSQM), Itch Numerical Rating Scale, Pain Numerical Rating Scale, and Pittsburgh Sleep Quality Assessment (PSQI).
Dupilumab
Dupilumab treatment
Interventions
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Dupilumab
Dupilumab treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least 18 years of age
* Diagnosis of atopic dermatitis at least 6 months prior to enrollment, having stable (unchanged) disease for at least 2 months
* Non-immune-compromised status
* Subjects have moderate-to-severe atopic dermatitis, classified as Eczema Area and Severity Index (EASI) score greater than or equal to 6
* Subject is considered a candidate for phototherapy or systemic therapy
* Subjects of child-bearing potential must have a negative urine pregnancy test within 7 days prior to first dose of dupilumab
* Sexually active subjects of childbearing potential must agree to use medically acceptable form of contraception during screening and throughout the study
* Subject meets concomitant medication requirements (see below)
Exclusion Criteria
* Has mild atopic dermatitis, classified as EASI score less than 6
* History of known or suspected intolerance to any of the ingredients of the investigational study product
* Evidence of skin conditions other than atopic dermatitis that would interfere with study-related evaluations of atopic dermatitis.
* History of immune-compromised status \[e.g. human immunodeficiency virus (HIV) positive status or other immune suppressing drug\] or a congenital or acquired immunodeficiency or subject testing positive for HIV during screening procedures
* Has a poorly controlled medical condition including, but not limited to, unstable cardiovascular disease, poorly controlled diabetes, recent stroke, history of recurrent infections, or any other condition for which, in the opinion of the investigator, participation in the study would place the subject at risk
* Has a history of or ongoing drug or alcohol abuse
* Is not willing to comply with concomitant medication requirements
* Is known, or suspected of being unable to comply with the study protocol
* Subjects who are well controlled on current treatment for atopic dermatitis and participation in the study may worsen disease control significantly
18 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Tina Bhutani, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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UCSF Psoriasis and Skin Treatment Center
San Francisco, California, United States
Countries
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References
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Abrouk M, Nakamura M, Zhu TH, Farahnik B, Koo J, Bhutani T. The impact of PASI 75 and PASI 90 on quality of life in moderate to severe psoriasis patients. J Dermatolog Treat. 2017 Sep;28(6):488-491. doi: 10.1080/09546634.2016.1278198. Epub 2017 Jan 18.
Drucker AM, Wang AR, Qureshi AA. Research Gaps in Quality of Life and Economic Burden of Atopic Dermatitis: The National Eczema Association Burden of Disease Audit. JAMA Dermatol. 2016 Aug 1;152(8):873-4. doi: 10.1001/jamadermatol.2016.1978. No abstract available.
Nicholas MN, Gooderham MJ. Atopic Dermatitis, Depression, and Suicidality. J Cutan Med Surg. 2017 May/Jun;21(3):237-242. doi: 10.1177/1203475416685078. Epub 2017 Jan 9.
Sidbury R, Khorsand K. Evolving Concepts in Atopic Dermatitis. Curr Allergy Asthma Rep. 2017 Jul;17(7):42. doi: 10.1007/s11882-017-0710-5.
Simpson EL. Dupilumab Improves General Health-Related Quality-of-Life in Patients with Moderate-to-Severe Atopic Dermatitis: Pooled Results from Two Randomized, Controlled Phase 3 Clinical Trials. Dermatol Ther (Heidelb). 2017 Jun;7(2):243-248. doi: 10.1007/s13555-017-0181-6. Epub 2017 May 13.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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Dupilimuab Quality of Life
Identifier Type: -
Identifier Source: org_study_id
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