Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03667014
Other study ID # Dupilimuab Quality of Life
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date November 1, 2018
Est. completion date December 15, 2022

Study information

Verified date December 2023
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date December 15, 2022
Est. primary completion date December 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
Dupilumab
Dupilumab treatment

Locations

Country Name City State
United States UCSF Psoriasis and Skin Treatment Center San Francisco California

Sponsors (2)

Lead Sponsor Collaborator
University of California, San Francisco Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Work Productivity and Activity Impairment Scale (WPAI:SHP) 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:
Percent work time missed due to problem: Q2/(Q2+Q4)
Percent impairment while working due to problem: Q5/10
Percent overall work impairment due to problem:
Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4)))x(Q5/10)]
Percent activity impairment due to problem: Q6/10
16 weeks
Secondary Dermatology Life Quality Index (DLQI) 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. 16 weeks
Secondary Itch Numerical Rating Scale 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. 16 weeks
Secondary Pain Numerical Rating Scale 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. 16 weeks
Secondary PSQI 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. 16 weeks
See also
  Status Clinical Trial Phase
Completed NCT05018806 - Proof of Concept Study of Rilzabrutinib in Adult Patients With Moderate-to-severe Atopic Dermatitis Phase 2
Terminated NCT03847389 - Clobetasol Topical Oil for Children With Moderate to Severe Atopic Dermatitis Phase 1/Phase 2
Completed NCT04090229 - A Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneously Delivered ASLAN004 in Adults With Moderate-Severe Atopic Dermatitis Phase 1
Active, not recruiting NCT05388760 - Tralokinumab Monotherapy for Children With Moderate-to-severe Atopic Dermatitis - TRAPEDS 1 (TRAlokinumab PEDiatric Trial no. 1) Phase 2
Completed NCT05530707 - Evaluation of Acceptability, Skin Barrier Restoration and Balance of Atopic Skin Using Moisturizer N/A
Completed NCT02595073 - Clinical Study to Evaluate the Efficacy and Safety of Desoximetasone (DSXS) With Atopic Dermatitis Phase 3
Recruiting NCT05509023 - Evaluating Safety and Efficacy of ADX-914 in Patients With Moderate to Severe Atopic Dermatitis (SIGNAL-AD) Phase 2
Recruiting NCT05048056 - Phase 2 Study of Efficacy and Safety of AK120, in Subjects With Moderate-to-Severe Atopic Dermatitis Phase 2
Completed NCT04598269 - Study of ATI-1777 in Adult Patients With Moderate or Severe Atopic Dermatitis Phase 2
Recruiting NCT03936335 - An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis (AD)
Withdrawn NCT03089476 - Evaluating Skin Barrier Dysfunction in Infants at High Risk of Atopy N/A
Recruiting NCT05029895 - A Study to Evaluate Adverse Events and Change in Disease State of Oral Upadacitinib in Adolescent Participants Ages 12 to <18 Years Old Diagnosed With Atopic Dermatitis (AD)
Terminated NCT03654755 - Study to Evaluate Long-Term Safety of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis Phase 2
Completed NCT04556461 - Effects of Tralokinumab Treatment of Atopic Dermatitis on Skin Barrier Function Phase 2
Recruiting NCT04818138 - BROadband vs Narrowband photoTherapy for Eczema Trial Nested in the CACTI Cohort N/A
Completed NCT03719742 - A Clinical Study to Evaluate the Safety and Efficacy of a Baby Cleanser and a Moisturizer N/A
Completed NCT05375955 - A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis. Phase 2
Completed NCT03441568 - In-home Use Test of the New Modified Diprobase Formulation to Assess the Safety and Tolerability in Infants and Children Under Physician's Control N/A
Recruiting NCT06366932 - Optimization of Atopic Dermatitis Treatment That Requires Second-line Systemic Therapy Through Predictive Models Phase 4
Completed NCT03304470 - A Study to Evaluate the Safety and Efficacy of ATx201 in Subjects With Moderate Atopic Dermatitis Phase 2