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Completed

NCT Number: NCT01859988

Study of Dupilumab Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

To assess the efficacy of multiple dupilumab dose-regimens, compared to placebo, in adult participants with moderate-to-severe atopic dermatitis (AD).

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Eczema Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Vancouver (2 Locations), British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

The inclusion criteria included, but were not limited to, the following:

  • Chronic Atopic Dermatitis that had been present for at least 3 years
  • History of inadequate response to out-patient treatment with topical medications, or for whom topical treatments were otherwise inadvisable (e.g, because of important side effects or safety risks)
  • Willing and able to comply with all clinic visits and study-related procedures

The exclusion criteria included, but were not limited to, the following:

  • Prior treatment with dupilumab (REGN668/SAR231893)
  • Presence of certain laboratory abnormalities at the screening visit
  • Treatment with an investigational drug within 8 weeks of baseline visit
  • Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit
  • Certain other treatments and medical procedures undertaken within a particular time frame prior to the baseline visit
  • 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 study
  • High risk of parasite infection
  • Any other medical or psychological condition that in the opinion of the investigator or the sponsor's medical monitor, would place the participants at risk, interfere with participation in the study or interfere with interpretation of study results
  • Pregnant or breast-feeding women

Treatment and study plan

Dupilumab

Drug

Other names: REGN668, SAR231893, Dupixent

Placebo

Drug

Primary outcomes

  1. Percent Change in Eczema Area and Severity Index Score (EASI) From Baseline to Week 16

    Time frame: Baseline to Week 16

    The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.

Secondary outcomes

  1. Percentage of Participants Who Achieved Investigator's Global Assessment (IGA) Response at Week 16

    Time frame: Week 16

    IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a static 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). Values after first rescue medication were set to missing and participants with missing IGA score at Week 16 were treated as a non-responders.

  2. Percentage of Participants Who Achieved IGA Score Reduction of ≥2 at Week 16

    Time frame: Week 16

    IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic success is an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score reduction from baseline of ≥2 points at Week 16 were reported. Values after first rescue medication were set to missing and participants with missing IGA score at Week 16 were treated as a non-responders.

  3. Percent Change in Peak Weekly Averaged Pruritus Numerical Rating Scores (NRS) From Baseline to Week 16

    Time frame: Baseline to Week 16

    Pruritus NRS is an assessment tool that is used to report the intensity of participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]).

  4. Absolute Change in Peak Weekly Averaged Pruritus NRS From Baseline to Week 16

    Time frame: Baseline to Week 16

    Pruritus NRS is an assessment tool that is used to report the intensity of participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]).

  5. Absolute Change in EASI Score From Baseline to Week 16

    Time frame: Baseline to Week 16

    The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.

  6. Percent Change in SCORing Atopic Dermatitis (SCORAD) Scores From Baseline to Week 16

    Time frame: Baseline to Week 16

    SCORAD is a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).

  7. Absolute Change in SCORAD Scores From Baseline to Week 16

    Time frame: Baseline to Week 16

    SCORAD is a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).

  8. Percentage of Participants Who Achieved 50%, 75% and 90% Reduction From Baseline in EASI Score (EASI-50, EASI-75 and EASI-90 Respectively) at Week 16

    Time frame: Week 16

    The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-50, EASI-75 and EASI-90 responders were the participants who achieved ≥50%, ≥75% and ≥90% overall improvement in EASI score respectively from baseline to Week 16.

  9. Percentage of Participants Who Achieved 50%, 75% and 90% Reduction From Baseline in SCORAD Score (SCORAD-50, SCORAD-75 and SCORAD-90 Respectively) at Week 16

    Time frame: Week 16

    SCORAD is a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease). SCORAD-50, SCORAD-75 and SCORAD-90 responders were the participants who achieved ≥50%, ≥75% and ≥90% overall improvement in SCORAD score respectively from baseline to Week 16.

  10. Percent Change in Patient Oriented Eczema Measure (POEM) Scores From Baseline to Week 16

    Time frame: Baseline to Week 16

    POEM is a 7-item questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life [QOL]).

  11. Absolute Change in POEM Scores From Baseline to Week 16

    Time frame: Baseline to Week 16

    POEM is a 7-item questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life [QOL]).

  12. Changes in Global Individual Signs Score (GISS) Components (Erythema, Infiltration/Papulation, Excoriations, and Lichenification) From Baseline to Week 16

    Time frame: Baseline to Week 16

    Individual components of the AD lesions (erythema, infiltration/papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0=none, 1=mild, 2=moderate and 3=severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease).

  13. Changes in GISS Cumulative Score From Baseline to Week 16

    Time frame: Baseline to Week 16

    Individual components of the AD lesions (erythema, infiltration/papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0 = none,1 = mild, 2 = moderate and 3 = severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease).

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Collaborators

  • Sanofi

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study Investigating the Efficacy, Safety, Pharmacokinetic and Biomarker Profiles of Dupilumab (REGN668) Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 22, 2013
Registry last updated
Aug 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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