Clinical trial NCT03912259: Evaluation of Dupilumab in Chinese Adult Patients With Moderate to Severe Atopic Dermatitis
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dupilumab in Chinese Adult Patients With Moderate-to-severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2019-04-11
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Baseline, Week 16
Secondary outcomes:
measure: Number of Participants With Eczema Area and Severity Index (EASI) - 75 Response (>= 75% Reduction in Score From Baseline) at Week 16
timeFrame: Baseline, Week 16
measure: 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
timeFrame: Baseline, Week 16
measure: 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
timeFrame: Baseline, Week 16
measure: Percentage Change From Baseline at Week 16 in Weekly Average of Peak Daily Pruritus NRS
timeFrame: Baseline, Week 16
measure: Change From Baseline at Week 16 in Weekly Average of Peak Daily Pruritus NRS
timeFrame: Baseline, Week 16
measure: Percentage Change From Baseline to Week 16 in EASI Score
timeFrame: Baseline to Week 16
measure: Change From Baseline to Week 16 in Percent Body Surface Area (BSA) of AD Involvement
timeFrame: Baseline to Week 16
measure: Change From Baseline to Week 16 in Dermatology Life Quality Index (DLQI) Total Score
timeFrame: Baseline to Week 16
measure: Change From Baseline to Week 16 in Patient Oriented Eczema Measure (POEM)
timeFrame: Baseline to Week 16
measure: Percentage Change From Baseline to Week 2 in Weekly Average of Peak Daily Pruritus NRS
timeFrame: Baseline to Week 2
measure: Percentage Change From Baseline to Week 16 in EuroQoL Five Dimensions Questionnaire (EQ-5D) Index Scores
timeFrame: Baseline to Week 16
measure: Percentage Change From Baseline to Week 16 in EuroQoL Five Dimensions Questionnaire Visual Analog Scale Scores
timeFrame: Baseline to Week 16
measure: Absolute Change From Baseline to Week 16 in EQ-5D Index Scores
timeFrame: Baseline to Week 16
measure: Absolute Change From Baseline to Week 16 in EuroQoL Five Dimensions Questionnaire Visual Analog Scale Scores
timeFrame: Baseline to Week 16
measure: Number of Participants Who Achieve Reduction of IGA Score by >=2 From Baseline to Week 16
timeFrame: Baseline to Week 16
measure: Number of Participants Achieving IGA 0 to 1 and a Reduction of >=2 Points From Baseline Through Week 16
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16
measure: Absolute Change in EASI Score From Baseline at Weeks 2, 4, 8, 12 and 16
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16
measure: Percentage Change in EASI Score From Baseline at Weeks 2, 4, 8, 12 and 16
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16
measure: Number of Participants With EASI-50 (>=50% Improvement From Baseline) at Week 16
timeFrame: Baseline, Week 16
measure: Number of Participants With EASI-90 (>=90% Improvement From Baseline) at Week 16
timeFrame: Baseline, Week 16
measure: Absolute Change in Weekly Average of Peak Daily Pruritus NRS Score From Baseline Through Week 16
timeFrame: From Baseline Through Week 16
measure: Percentage Change in Weekly Average of Peak Daily Pruritus NRS Score From Baseline Through Week 16
timeFrame: From Baseline Through Week 16
measure: Number of Participants Who Responded "Absence of Pruritus" or "Mild Pruritus" in the Pruritus Categorical Scale at Week 16
timeFrame: Week 16
measure: Number of Days of Sick Leave/Missed School Days
timeFrame: Week 16
measure: Percentage of Participants With at Least One Day Sick Leave/Missed School Days
timeFrame: Week 16
Other outcomes:
Locations:
city: Beijing
country: China
facility: Investigational Site Number 1560019
city: Beijing
country: China
facility: Investigational Site Number 1560001
city: Beijing
country: China
facility: Investigational Site Number 1560004
city: Beijing
country: China
facility: Investigational Site Number 1560003
city: Beijing
country: China
facility: Investigational Site Number 1560010
city: Changchun
country: China
facility: Investigational Site Number 1560021
city: Changsha
country: China
facility: Investigational Site Number 1560006
city: Chongqing
country: China
facility: Investigational Site Number 1560017
city: Hangzhou
country: China
facility: Investigational Site Number 1560026
city: Hangzhou
country: China
facility: Investigational Site Number 1560007
city: Jinan
country: China
facility: Investigational Site Number 1560013
city: Kunming
country: China
facility: Investigational Site Number 1560020
city: Lianyungang
country: China
facility: Investigational Site Number 1560030
city: Nanjing
country: China
facility: Investigational Site Number 1560022
city: Ningbo
country: China
facility: Investigational Site Number 1560029
city: Shanghai
country: China
facility: Investigational Site Number 1560016
city: Shanghai
country: China
facility: Investigational Site Number 1560023
city: Shanghai
country: China
facility: Investigational Site Number 1560018
city: Shanghai
country: China
facility: Investigational Site Number 1560015
city: Shenyang
country: China
facility: Investigational Site Number 1560002
city: Shenyang
country: China
facility: Investigational Site Number 1560005
city: Shenyang
country: China
facility: Investigational Site Number 1560008
city: Shenzhen
country: China
facility: Investigational Site Number 1560024
city: Tianjin
country: China
facility: Investigational Site Number 1560027
city: Wuxi
country: China
facility: Investigational Site Number 1560028
city: Xi'An
country: China
facility: Investigational Site Number 1560012
city: Yancheng
country: China
facility: Investigational Site Number 1560025
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: