NCT01548404

Brief Summary

The primary objective was to assess the clinical efficacy of repeated subcutaneous (SC) doses of Dupilumab in adult participants with moderate-to-severe atopic dermatitis (AD).

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2012

Shorter than P25 for phase_2

Geographic Reach
5 countries

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 8, 2012

Completed
24 days until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
5.2 years until next milestone

Results Posted

Study results publicly available

August 10, 2018

Completed
Last Updated

August 10, 2018

Status Verified

November 1, 2017

Enrollment Period

11 months

First QC Date

March 5, 2012

Results QC Date

May 22, 2017

Last Update Submit

November 13, 2017

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

  • Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 12- Last Observation Carried Forward (LOCF)

    The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. The efficacy data were set to be missing after use of rescue medication and after early termination visit for participants who prematurely discontinued study treatment. All missing values were imputed by LOCF.

    Baseline to Week 12

Secondary Outcomes (8)

  • Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" at Week 12- LOCF

    Week 12

  • Percentage of Participants Who Achieved at Least a 50% Reduction From Baseline in the EASI Score (EASI-50) at Week 12- LOCF

    Week 12

  • Change From Baseline in EASI Score at Week 12- LOCF

    Baseline to Week 12

  • Percent Change From Baseline in IGA Score at Week 12- LOCF

    Baseline to Week 12

  • Change From Baseline in Percent Body Surface Area (BSA) Affected by Atopic Dermatitis (AD) at Week 12 - LOCF

    Baseline to Week 12

  • +3 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo (for Dupilumab) once weekly for 12 weeks by subcutaneous (SC) injection.

Drug: Placebo

Dupilumab 300 mg

EXPERIMENTAL

Dupilumab 300 mg once weekly for 12 weeks by SC injection.

Drug: Dupilumab

Interventions

PlaceboDRUG

Subcutaneous injection altered between back of arms, abdomen and upper thighs.

Placebo
DupilumabDRUG

Subcutaneous injection altered between back of arms, abdomen and upper thighs.

Also known as: REGN668/SAR231893, Dupixent
Dupilumab 300 mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, 18 years or older;
  • Chronic Atopic Dermatitis (AD) for at least 3 years;
  • History of inadequate response to a stable (\>/= 1 month) regimen of topical corticosteroids or calcineurin inhibitors as treatment for AD within 3 months before the screening visit.

You may not qualify if:

  • Prior treatment with REGN668;
  • Presence of certain laboratory abnormalities at the screening visit;
  • Treatment with an investigational drug within 8 weeks ;
  • Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit;
  • Certain treatments and medical procedures, undertaken within a particular time-frame prior to the baseline visit, preclude eligibility for participation in the study;
  • Known history of human immunodeficiency virus (HIV) infection;
  • History of malignancy within 5 years before the baseline visit, with certain exceptions;
  • Planned surgical procedure during the length of the patient's participation in this study;
  • History of clinical parasite infection;
  • Any medical or psychiatric condition which in the opinion of the investigator or the sponsor's medical monitor, would place the participant at risk, interfere with participation in the study, or interfere with the interpretation of study results;
  • Pregnant or breast-feeding women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Unknown Facility

Náchod, Czechia

Location

Unknown Facility

Svitavy, Czechia

Location

Unknown Facility

Ústí nad Labem, Czechia

Location

Unknown Facility

Nice, France

Location

Unknown Facility

Pierre-Bénite, France

Location

Unknown Facility

Toulouse, France

Location

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Bonn, Germany

Location

Unknown Facility

Frankfurt, Germany

Location

Unknown Facility

Gera, Germany

Location

Unknown Facility

Heidelberg, Germany

Location

Unknown Facility

Kiel, Germany

Location

Unknown Facility

Münster, Germany

Location

Unknown Facility

Kaposvár, Hungary

Location

Unknown Facility

Szeged, Hungary

Location

Unknown Facility

Szekszárd, Hungary

Location

Unknown Facility

Szolnok, Hungary

Location

Unknown Facility

Gdansk, Poland

Location

Unknown Facility

Lodz, Poland

Location

Unknown Facility

Lublin, Poland

Location

Unknown Facility

Warsaw, Poland

Location

Related Publications (2)

  • Beck LA, Thaci D, Hamilton JD, Graham NM, Bieber T, Rocklin R, Ming JE, Ren H, Kao R, Simpson E, Ardeleanu M, Weinstein SP, Pirozzi G, Guttman-Yassky E, Suarez-Farinas M, Hager MD, Stahl N, Yancopoulos GD, Radin AR. Dupilumab treatment in adults with moderate-to-severe atopic dermatitis. N Engl J Med. 2014 Jul 10;371(2):130-9. doi: 10.1056/NEJMoa1314768.

    PMID: 25006719RESULT

  • Tsianakas A, Luger TA, Radin A. Dupilumab treatment improves quality of life in adult patients with moderate-to-severe atopic dermatitis: results from a randomized, placebo-controlled clinical trial. Br J Dermatol. 2018 Feb;178(2):406-414. doi: 10.1111/bjd.15905. Epub 2018 Jan 11.

    PMID: 28845523DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Results Point of Contact

Title
Clinical Trial Management
Organization
Regeneron Pharmaceuticals, Inc.
clinicaltrials@regeneron.com

Study Officials

  • Clinical Trial Management

    Regeneron Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2012

First Posted

March 8, 2012

Study Start

April 1, 2012

Primary Completion

March 1, 2013

Study Completion

June 1, 2013

Last Updated

August 10, 2018

Results First Posted

August 10, 2018

Record last verified: 2017-11

Locations

CZ(3)DE(7)HU(4)PL(4)FR(3)