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The Impact of Dupilumab on Quality of Life in Moderate to Severe Atopic Dermatitis Patients

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ClinicalTrials.gov Identifier: NCT03667014
Recruitment Status : Recruiting
First Posted : September 12, 2018
Last Update Posted : November 20, 2020
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Atopic Dermatitis Eczema Drug: Dupilumab Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Impact of Dupilumab on Quality of Life in Moderate to Severe Atopic Dermatitis Patients
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Dupilumab

Arm Intervention/treatment
Experimental: 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).
Drug: Dupilumab
Dupilumab treatment
Other Name: Dupixent




Primary Outcome Measures :
  1. Psychological General Well-Being scale (PGWB) [ Time Frame: 16 weeks ]
    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. It is a self-reported, 22 item questionnaire, scored 0-5 and summed. PGWB will be administered at every study visit.


Secondary Outcome Measures :
  1. Work Productivity and Activity Impairment scale (WPAI:SHP) [ Time Frame: 16 weeks ]

    Improvement in work productivity measured by change in Work Productivity and Activity Impairment scale (WPAI) at Week 16 from baseline. It measures the effect of health and symptom severity on work productivity and nonwork activities by assessing absenteeism, presenteeism, and impairment of daily activities. There are 6 questions, each with unique answers. WPAI outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity.

    Scoring equations:

    1. Percent work time missed due to problem: Q2/(Q2+Q4)
    2. Percent impairment while working due to problem: Q5/10
    3. Percent overall work impairment due to problem:

      Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4)))x(Q5/10)]

    4. Percent activity impairment due to problem: Q6/10

  2. Dermatology Life Quality Index (DLQI) [ Time Frame: 16 weeks ]
    Improvement in quality of life measured by change in Dermatology Life Quality Index (DLQI) at Week 16 from baseline. It is a 10 item questionnaire with a final score calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.

  3. Treatment Satisfaction Questionnaire for Medication (TSQM) [ Time Frame: 16 weeks ]
    Assessment of patient satisfaction with treatment measured by change in Treatment Satisfaction Questionnaire for Medication (TSQM) at Week 16 from baseline. TSQM is a 14-item questionnaire with 4 domains: effectiveness, convenience, global satisfaction, and side effects. Item scores are summed to give four domain scores, which are in turn transformed to a scale of 0-100, with higher scores indicating greater satisfaction.

  4. Itch Numerical Rating Scale [ Time Frame: 16 weeks ]
    Improvement in itch scores using numerical rating scales at Week 16 from baseline. This is a 0-10 scale with 0 equaling No itch, and 10 being Worst imaginable itch. Patients will circle number that describes the itch experienced from atopic dermatitis.

  5. Pain Numerical Rating Scale [ Time Frame: 16 weeks ]
    Improvement in pain scores using numerical rating scales at Week 16 from baseline. This is a 0-10 numerical scale with 10 as the worst imaginable itch. Patients circle the number that best describes the pain experienced from atopic dermatitis.

  6. PSQI [ Time Frame: 16 weeks ]
    Improvement in sleep quality measured by the Pittsburgh Sleep Quality Assessment (PSQI) at Week 16 from baseline. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03667014


Contacts
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Contact: Quinn Thibodeaux, MD 415-944-7618 psoriasis@ucsf.edu
Contact: Kristen Beck, MD 415-944-7618 psoriasis@ucsf.edu

Locations
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United States, California
UCSF Psoriasis and Skin Treatment Center Recruiting
San Francisco, California, United States, 94118
Contact: Quinn Thibodeaux, MD    415-944-7618    psoriasis@ucsf.edu   
Principal Investigator: Tina Bhutani, MD         
Sponsors and Collaborators
University of California, San Francisco
Regeneron Pharmaceuticals
Investigators
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Principal Investigator: Tina Bhutani, MD University of California, San Francisco
Publications:
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03667014    
Other Study ID Numbers: Dupilimuab Quality of Life
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: November 20, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
atopic dermatitis
eczema
dupilumab
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases