Clinical trial NCT03667014: The Impact of Dupilumab on Quality of Life in Moderate to Severe Atopic Dermatitis Patients
Official title: The Impact of Dupilumab on Quality of Life in Moderate to Severe Atopic Dermatitis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atopic Dermatitis
Atopic Dermatitis Eczema
Keywords: atopic dermatitis
eczema
dupilumab
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2018-09-12
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single-arm, open-label study, which will examine the effect of dupilumab on quality of life in atopic dermatitis patients.

Detailed description: This is a single center, open-label study, which will examine the effect of dupilumab on quality of life in atopic dermatitis (AD). Thirty patients with moderate to severe AD will receive dupilumab for a treatment period of 52 weeks (i.e. last injection on week 48). Improvement in patient quality of life after 52 weeks of treatment with dupilumab will be evaluated using validated dermatologic and non-dermatologic psychometric instruments. The primary endpoint is the improvement in quality of life measured by change in Psychological General Well-Being scale (PGWB) at Week 16 from baseline. Additionally, patients will be given a video recording device to document their experience with the study drug at home. Video footage of patient experiences will be compiled at the end of the study. The compiled video footage will subsequently be watched and analyzed to further understand the experiences of atopic dermatitis patients, and how undergoing dupilumab treatment alters these patients' experiences and attitudes with their skin disease.

Eligibility criteria: Inclusion Criteria:

* Ability to provide written informed consent and comply with the protocol
* 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:

* Younger than 18 years of age
* 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

Primary outcomes:
measure: Psychological General Well-Being Scale (PGWB)
timeFrame: 16 weeks
Secondary outcomes:
measure: Work Productivity and Activity Impairment Scale (WPAI:SHP)
timeFrame: 16 weeks
measure: Dermatology Life Quality Index (DLQI)
timeFrame: 16 weeks
measure: Itch Numerical Rating Scale
timeFrame: 16 weeks
measure: Pain Numerical Rating Scale
timeFrame: 16 weeks
measure: PSQI
timeFrame: 16 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Psoriasis and Skin Treatment Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Tina Bhutani, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.