Evaluation of Dupilumab in Chinese Adult Patients With Moderate to Severe Atopic Dermatitis

Sanofi165 enrolled

Overview

Primary Objective: To evaluate the efficacy of dupilumab monotherapy compared to placebo treatment in adult participants with moderate-to-severe atopic dermatitis (AD). Secondary Objectives: * To evaluate the safety of dupilumab monotherapy compared to placebo treatment in adult participants with moderate-to-severe AD. * To evaluate the effect of dupilumab on improving patient reported outcomes (PROs). * To evaluate dupilumab immunogenicity.

The maximum study duration was 33 weeks per participants, including a screening period of up to 5 weeks, a 16-week randomized treatment period, and a 12-week follow-up period.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

165

Conditions

Atopic Dermatitis

Interventions

DupilumabDRUG

Pharmaceutical form: solution, Route of administration: SC

PlaceboDRUG

Pharmaceutical form: solution, Route of administration: SC

Emollient (moisturizer)DRUG

Pharmaceutical form: cream, Route of administration: topical use

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria: * Male or female, 18 years or older. * AD (according to American Academy of Dermatology Consensus Criteria, 2014) that had been present for at least 3 years before the screening visit. * Eczema Area and Severity Index (EASI) score greater than or equal to (\>=) 16 at the screening and baseline visits. * Investigator's Global Assessment (IGA) score \>=3 (on the 0 to 4 IGA scale, in which 3 was moderate and 4 was severe) at the screening and baseline visits. * Participants with \>=10 percent (%) body surface area (BSA) of AD involvement at the screening and baseline visits. * Baseline Pruritus Numerical Rating Scale (NRS) average score for maximum itch intensity \>=4. * Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments were otherwise medically inadvisable (e.g., because of important side effects or safety risks). Exclusion criteria: * Had used any of the following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, was likely to require such treatment(s) during the first 4 weeks of study treatment: * Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, interferon-gamma \[IFN-γ\], Janus kinase inhibitors, azathioprine, methotrexate); * Phototherapy for AD. * Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within 1 week before the baseline visit. * Treatment with systemic Traditional Chinese Medicine (TCM) within 4 weeks before the baseline visit or treatment with topical TCM within 1 week before the baseline visit. * Treatment with biologics as follows: * Any cell-depleting agents including but not limited to rituximab: within 6 months before the baseline visit, or until lymphocyte count returns to normal, whichever is longer; * Other biologics: within 5 half-lives (if known) or 16 weeks prior to baseline visit, whichever was longer. * Initiation of treatment of AD with prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea, or filaggrin degradation products during the screening period (participants may continue using stable doses of such moisturizers if initiated before the screening visit). * Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the baseline visit. * Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit. * Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit, or superficial skin infections within 1 week before the baseline visit. NOTE: participants may be rescreened after infection resolves. * Known or suspected history of immunosuppression, including history of invasive opportunistic infections (e.g., tuberculosis \[TB\], histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution: or unusually frequent, recurrent, or prolonged infections, per investigator judgment. * Active TB, latent untreated TB or a history of incompletely treated TB or non-tuberculous mycobacterial infection were excluded from the study unless that was well documented by a specialist that the participants had adequately treated and could then start treatment with a biologic agent, in the medical judgment of the Investigator and/or infectious disease specialist. TB testing would be performed according to local guidelines if required by regulatory authorities or ethics committees. The above information was not intended to contain all considerations relevant to a participants potential participation in a clinical trial.

Locations (27)

Investigational Site Number 1560019

Beijing, China

Outcomes

Primary Outcomes

Number of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of Greater Than or Equal to (>=) 2 Points at Week 16

The IGA is an assessment instrument used to rate the severity of AD globally based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity.

Time frame: Baseline, Week 16

Secondary Outcomes

Number of Participants With Eczema Area and Severity Index (EASI) - 75 Response (>= 75% Reduction in Score From Baseline) at Week 16

EASI: Measure to assess severity and extent of AD based on 4 AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\] and lichenification). Each characteristic was assessed for severity by Investigator/designee on scale of "0" (absent) through "3" (severe) and scored separately for each of 4 body regions (head, trunk, upper and lower extremities). Total score range from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD.

Time frame: Baseline, Week 16

Number of Participants Who Achieved >=4 Points With Reduction From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score at Week 16

Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \[0 = no itch; 10 = worst itch imaginable\]), higher scores indicated greater severity.

Time frame: Baseline, Week 16

Number of Participants Who Achieved >=3 Points With Reduction From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale Score at Week 16

Data from ClinicalTrials.gov

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Investigational Site Number 1560001

Beijing, China

Investigational Site Number 1560004

Beijing, China

Investigational Site Number 1560003

Beijing, China

Investigational Site Number 1560010

Beijing, China

Investigational Site Number 1560021

Changchun, China

Investigational Site Number 1560006

Changsha, China

Investigational Site Number 1560017

Chongqing, China

Investigational Site Number 1560026

Hangzhou, China

Investigational Site Number 1560007

Hangzhou, China

...and 17 more locations

Time frame: Baseline, Week 16

Percentage Change From Baseline at Week 16 in Weekly Average of Peak Daily Pruritus NRS

Time frame: Baseline, Week 16

Change From Baseline at Week 16 in Weekly Average of Peak Daily Pruritus NRS

Time frame: Baseline, Week 16

Percentage Change From Baseline to Week 16 in EASI Score

EASI: Measure to assess severity \& extent of AD based on 4 AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\] \& lichenification). Each characteristic was assessed for severity by Investigator/designee on scale of "0" (absent) through "3"(severe) \& scored separately for each of 4 body regions (head, trunk, upper \& lower extremities). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD.