NCT01385657

Brief Summary

The purpose of this study is to assess the safety and tolerability of repeated subcutaneous (SC) doses of Dupilumab in participants with moderate-to-severe atopic dermatitis (AD).

Trial Health

90
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2011

Shorter than P25 for phase_1

Geographic Reach
3 countries

13 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

June 9, 2011

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 30, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

July 31, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2012

Completed
Last Updated

February 26, 2020

Status Verified

February 1, 2020

Enrollment Period

8 months

First QC Date

June 9, 2011

Last Update Submit

February 24, 2020

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)

    An adverse event (AE) was defined as any untoward medical occurrence in a participant who received investigational medicinal product (IMP) without regard to possibility of causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a study drug, whether or not considered related to the study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was considered as medically important event. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to the end of study visit \[Day 85\]). Any TEAE included participants with both serious and non-serious AEs.

    Baseline up to end of study (up to Day 85)

Secondary Outcomes (3)

  • Pharmacokinetics of Dupilumab: Peak Plasma Concentration (Cmax)

    Day 22 (pre-dose), 25, 29, 36, 43, 50, 57, 64, 71 and Day 85

  • Pharmacokinetics of Dupilumab: Last Positive (Quantifiable) Concentration (Clast)

    Day 22 (pre-dose), 25, 29, 36, 43, 50, 57, 64, 71 and Day 85

  • Pharmacokinetics of Dupilumab: Time of the Last Positive (Quantifiable) Concentration (Tlast)

    Day 22 (pre-dose), 25, 29, 36, 43, 50, 57, 64, 71 and Day 85

Other Outcomes (6)

  • Percentage of Participants with Investigator's Global Assessment (IGA) Score of "0" or "1" at Day 29/ Week 4 (End of Treatment Period)

    At Day 29/ Week 4

  • Percent Change From Baseline in Body Surface Area (BSA) Affected by Atopic Dermatitis to Week 4

    Baseline to Day 29/ Week 4

  • Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score to Week 4

    Baseline to Day 29/ Week 4

  • +3 more other outcomes

Study Arms (3)

Placebo

EXPERIMENTAL

Placebo (for Dupilumab) as a single subcutaneous (SC) injection on Day 1, 8, 15, and 22

Drug: PlaceboOther: Background treatment

Dupilumab 150 mg

EXPERIMENTAL

Dupilumab 150 mg as a single SC injection on Day 1, 8, 15, and 22

Drug: DupilumabOther: Background treatment

Dupilumab 300 mg

EXPERIMENTAL

Dupilumab 300 mg as a single SC injection on Day 1, 8, 15, and 22

Drug: DupilumabOther: Background treatment

Interventions

PlaceboDRUG

A total of 4 doses were administered.

Placebo
DupilumabDRUG

A total of 4 doses were administered.

Also known as: REGN668, SAR231893, Dupixent
Dupilumab 150 mgDupilumab 300 mg
Background treatmentOTHER

Participants were required to apply stable doses of an additive-free, basic bland emollient on the affected areas of the skin twice daily throughout the study.

Dupilumab 150 mgDupilumab 300 mgPlacebo

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 AD diagnosed by the Eichenfield revised criteria of Hannifin and Rajka that had been present for at least 3 years before the screening visit;
  • Eczema Area and Severity Index (EASI) score ≥ 12 at the screening and baseline visits;
  • Investigator's Global Assessment (IGA) score ≥ 3 at the screening and baseline visits;
  • ≥ 10% body surface area (BSA) of AD involvement at the screening and baseline visits;
  • 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:

  • Positive Hepatitis B surface antigen, and/or positive Hepatitis C antibody at the screening visit;
  • Treatment with an investigational drug within 8 weeks or within 5 half-lives, if known, whichever is longer, before the baseline visit;
  • Treatment with leukotriene inhibitors within 4 weeks before the baseline visit;
  • Treatment with systemic corticosteroids within 4 weeks before the baseline visit;
  • Treatment with topical corticosteroids, tacrolimus, and/or pimecrolimus within 1 week before the baseline visit;
  • Systemic treatment for AD with an immunosuppressive/immunomodulating substance within 4 weeks before the baseline visit;
  • Chronic or acute infection requiring treatment with oral or IV antibiotics, antivirals, or antifungals within 4 weeks before the screening visit or superficial skin infections within 1 week before the screening visit;
  • Known history of human immunodeficiency virus (HIV) infection;
  • History of clinical parasite infection, other than treated trichomoniasis;
  • History of malignancy within 5 years before the baseline visit, with the following exceptions: participants with a history of completely treated carcinoma in-situ of cervix, and non-metastatic squamous or basal cell carcinoma of the skin were allowed;
  • 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;
  • Unwilling to use adequate birth control, if of reproductive potential and sexually active.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Unknown Facility

Kogarah, New South Wales, Australia

Location

Unknown Facility

Woolloongabba, Queensland, Australia

Location

Unknown Facility

Carlton, Victoria, Australia

Location

Unknown Facility

Nedlands, Western Australia, Australia

Location

Unknown Facility

Hanover, Lower Saxony, Germany

Location

Unknown Facility

Bonn, North Rhine-Westphalia, Germany

Location

Unknown Facility

Berlin, 10117, Germany

Location

Unknown Facility

Berlin, 10827, Germany

Location

Unknown Facility

Gera, Germany

Location

Unknown Facility

Münster, Germany

Location

Unknown Facility

Sydenham, Christchurch, New Zealand

Location

Unknown Facility

Caversham, Dunedin, New Zealand

Location

Unknown Facility

Auckland, New Zealand

Location

Related Publications (2)

  • Hamilton JD, Suarez-Farinas M, Dhingra N, Cardinale I, Li X, Kostic A, Ming JE, Radin AR, Krueger JG, Graham N, Yancopoulos GD, Pirozzi G, Guttman-Yassky E. Dupilumab improves the molecular signature in skin of patients with moderate-to-severe atopic dermatitis. J Allergy Clin Immunol. 2014 Dec;134(6):1293-1300. doi: 10.1016/j.jaci.2014.10.013.

    PMID: 25482871RESULT

  • 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

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

Study Officials

  • Clinical Trial Management

    Regeneron Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
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

June 9, 2011

First Posted

June 30, 2011

Study Start

July 31, 2011

Primary Completion

March 31, 2012

Study Completion

March 31, 2012

Last Updated

February 26, 2020

Record last verified: 2020-02

Locations

NZ(3)AU(4)DE(6)