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

NCT03667014 | Completed Phase 4 Results FDA Drug

• 1 other identifier: Dupilimuab Quality of Life
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis; Atopic Dermatitis Eczema

Keywords

atopic dermatitis; eczema; dupilumab

Outcome Measures

Primary Outcomes (1)

• Psychological General Well-Being Scale (PGWB)

  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.

  16 weeks

Secondary Outcomes (5)

• Work Productivity and Activity Impairment Scale (WPAI:SHP)

  16 weeks

• Dermatology Life Quality Index (DLQI)

  16 weeks

• Itch Numerical Rating Scale

  16 weeks

• Pain Numerical Rating Scale

  16 weeks

• PSQI

  16 weeks

Study Arms (1)

Dupilumab treatment

EXPERIMENTAL

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

Interventions

Dupilumab DRUG

Dupilumab treatment

Also known as: Dupixent

Dupilumab treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (1)

UCSF Psoriasis and Skin Treatment Center

San Francisco, California, 94118, United States

Location

Related Publications (5)

• 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.

  PMID: 28042711 BACKGROUND

• 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.

  PMID: 27305113 BACKGROUND

• 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.

  PMID: 28300443 BACKGROUND

• 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.

  PMID: 28555328 BACKGROUND

• 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.

  PMID: 28503712 BACKGROUND

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Tina Bhutani
• Organization: UCSF

tina.bhutani@ucsf.edu

4153537800

Study Officials

• Tina Bhutani, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: September 12, 2018
• Study Start: November 1, 2018
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: January 9, 2024
• Results First Posted: January 9, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)