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

NCT ID: NCT03912259

Last Updated: 2023-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 165 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-19
• Study Completion Date: 2020-02-14

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo Q2W

Placebo matched to dupilumab 600 milligrams (mg) (loading dose), subcutaneously (SC) on Day 1 followed by placebo matched to dupilumab 300 mg once every 2 weeks (Q2W) for 16 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Pharmaceutical form: solution,

Route of administration: SC

Emollient (moisturizer)

Intervention Type: DRUG

Pharmaceutical form: cream,

Route of administration: topical use

Dupilumab 300 mg Q2W

Dupilumab at a loading dose of 600 mg, SC on Day 1 followed by 300 mg, Q2W for 16 weeks.

Group Type: EXPERIMENTAL

Dupilumab

Intervention Type: DRUG

Pharmaceutical form: solution,

Route of administration: SC

Emollient (moisturizer)

Intervention Type: DRUG

Pharmaceutical form: cream,

Route of administration: topical use

Interventions

Dupilumab

Pharmaceutical form: solution,

Route of administration: SC

Intervention Type: DRUG

Placebo

Pharmaceutical form: solution,

Route of administration: SC

Intervention Type: DRUG

Emollient (moisturizer)

Pharmaceutical form: cream,

Route of administration: topical use

Intervention Type: DRUG

Other Intervention Names

Dupixent; SAR231893

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 1560019

Beijing, , China

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

Investigational Site Number 1560013

Jinan, , China

Investigational Site Number 1560020

Kunming, , China

Investigational Site Number 1560030

Lianyungang, , China

Investigational Site Number 1560022

Nanjing, , China

Investigational Site Number 1560029

Ningbo, , China

Investigational Site Number 1560016

Shanghai, , China

Investigational Site Number 1560023

Shanghai, , China

Investigational Site Number 1560018

Shanghai, , China

Investigational Site Number 1560015

Shanghai, , China

Investigational Site Number 1560002

Shenyang, , China

Investigational Site Number 1560005

Shenyang, , China

Investigational Site Number 1560008

Shenyang, , China

Investigational Site Number 1560024

Shenzhen, , China

Investigational Site Number 1560027

Tianjin, , China

Investigational Site Number 1560028

Wuxi, , China

Investigational Site Number 1560012

Xi'an, , China

Investigational Site Number 1560025

Yancheng, , China

Countries

China

References

Mickevicius T, Pink AE, Bhogal M, O'Brart D, Robbie SJ. Dupilumab-Induced, Tralokinumab-Induced, and Belantamab Mafodotin-Induced Adverse Ocular Events-Incidence, Etiology, and Management. Cornea. 2023 Apr 1;42(4):507-519. doi: 10.1097/ICO.0000000000003162. Epub 2022 Dec 15.

Reference Type: DERIVED

PMID: 36525340 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

U1111-1190-7728

Identifier Type: OTHER

Identifier Source: secondary_id

EFC15116

Identifier Type: -

Identifier Source: org_study_id