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

NCT03912259 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: EFC15116U1111-1190-7728
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 27

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Week 16

Secondary Outcomes (25)

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

  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

  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

  Baseline, Week 16

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

  Baseline, Week 16

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

  Baseline, Week 16

Study Arms (2)

Placebo Q2W

PLACEBO COMPARATOR

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.

Drug: Placebo; Drug: Emollient (moisturizer)

Dupilumab 300 mg Q2W

EXPERIMENTAL

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

Drug: Dupilumab; Drug: Emollient (moisturizer)

Interventions

Dupilumab DRUG

Pharmaceutical form: solution, Route of administration: SC

Also known as: Dupixent, SAR231893

Dupilumab 300 mg Q2W

Placebo DRUG

Pharmaceutical form: solution, Route of administration: SC

Placebo Q2W

Emollient (moisturizer) DRUG

Pharmaceutical form: cream, Route of administration: topical use

Dupilumab 300 mg Q2W; Placebo Q2W

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (27)

Investigational Site Number 1560019

Beijing, 100034, China

Location

Investigational Site Number 1560001

Beijing, 100044, China

Location

Investigational Site Number 1560004

Beijing, 100050, China

Location

Investigational Site Number 1560003

Beijing, 100191, China

Location

Investigational Site Number 1560010

Beijing, 100730, China

Location

Investigational Site Number 1560021

Changchun, 130021, China

Location

Investigational Site Number 1560006

Changsha, 410011, China

Location

Investigational Site Number 1560017

Chongqing, 400038, China

Location

Investigational Site Number 1560026

Hangzhou, 310006, China

Location

Investigational Site Number 1560007

Hangzhou, 310009, China

Location

Investigational Site Number 1560013

Jinan, 250013, China

Location

Investigational Site Number 1560020

Kunming, China

Location

Investigational Site Number 1560030

Lianyungang, 222002, China

Location

Investigational Site Number 1560022

Nanjing, 210042, China

Location

Investigational Site Number 1560029

Ningbo, China

Location

Investigational Site Number 1560016

Shanghai, 200040, China

Location

Investigational Site Number 1560023

Shanghai, 200092, China

Location

Investigational Site Number 1560018

Shanghai, 200433, China

Location

Investigational Site Number 1560015

Shanghai, 200443, China

Location

Investigational Site Number 1560002

Shenyang, 110001, China

Location

Investigational Site Number 1560005

Shenyang, 110001, China

Location

Investigational Site Number 1560008

Shenyang, 110004, China

Location

Investigational Site Number 1560024

Shenzhen, China

Location

Investigational Site Number 1560027

Tianjin, 300052, China

Location

Investigational Site Number 1560028

Wuxi, 214002, China

Location

Investigational Site Number 1560012

Xi'an, 710004, China

Location

Investigational Site Number 1560025

Yancheng, China

Location

Related Publications (1)

• 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.

  PMID: 36525340 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

dupilumab; Emollients

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

Intervention Hierarchy (Ancestors)

Dermatologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi

Contact-US@sanofi.com

800-633-1610

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: April 11, 2019
• Study Start: December 19, 2018
• Primary Completion: February 14, 2020
• Study Completion: February 14, 2020
• Last Updated: December 19, 2023
• Results First Posted: April 5, 2021

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share

Locations

CN (27)