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Study to Assess the Efficacy and Long-term Safety of Dupilumab (REGN668/SAR231893) in Adult Participants With Moderate-to-Severe Atopic Dermatitis (CHRONOS)

Primary Purpose

Atopic Dermatitis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Dupilumab

Placebo (for Dupilumab)

Topical Corticosteroid (TCS)

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

Chronic AD that had been present for at least 3 years before the screening visit;
Documented recent history (within 6 months before the screening visit) of inadequate response to a sufficient course of out-patient treatment with topical AD medication(s).

Key Exclusion Criteria:

Participation in a prior Dupilumab clinical trial;
Important side effects of topical medication (e.g. intolerance to treatment, hypersensitivity reactions, significant skin atrophy, systemic effects), as assessed by the investigator or treating physician;
Having 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 2 weeks of study treatment:
1. Immunosuppressive/immunomodulating drugs (e.g, systemic steroids, cyclosporine, mycophenolate-mofetil, Janus kinase inhibitors, interferon-gamma [IFN-γ], azathioprine, methotrexate, etc.);
2. Phototherapy for AD;
Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit;
History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening;
Positive hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody at the screening visit;
Active or acute infection requiring systemic treatment within 2 weeks before baseline visit;
Known or suspected history of immunosuppression;
Pregnant or breastfeeding women, or planning to become pregnant or breastfeed during the participant's participation in this study.

Note: The eligibility criteria listed above is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial therefore not all inclusion/ exclusion criteria are listed.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Placebo qw

Dupilumab 300 mg q2w

Dupilumab 300 mg qw

Arm Description

Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection weekly (qw) from Week 1 to Week 51.

Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab every 2 weeks (q2w) from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.

Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.

Outcomes

Primary Outcome Measures

Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of ≥2 Points at 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 response is an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score "0" or "1" and a reduction from baseline of ≥2 points at Week 16 were reported.

Secondary Outcome Measures

Percentage of Participants With Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) at 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 ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline to Week 16.

Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16

Pruritus NRS was an assessment tool that was used to report the intensity of a 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]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported.

Percentage of Participants With Improvement (Reduction ≥3 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16

Pruritus NRS was an assessment tool that was used to report the intensity of a 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]). Participants achieving a reduction of ≥3 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported.

Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of ≥2 Points at Week 52

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 response is an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score of "0" or "1" and a reduction from baseline of ≥2 points at Week 52 were reported.

Percentage of Participants With Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) at Week 52

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. EASI-75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline to Week 52.

Percent Change From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 16

Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 52

Percentage of Participants With Improvement (Reduction ≥3 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 52

Pruritus NRS was an assessment tool that was used to report the intensity of a 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]). Participants achieving a reduction of ≥3 points from baseline in weekly average of peak daily pruritus NRS score at Week 52 were reported.

Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 24

Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 4

Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 2

Change From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 16

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

Change From Baseline in Percent Body Surface Area (BSA) Affected by Atopic Dermatitis to Week 16

BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]). It was reported as a percentage of all major body sections combined.

Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Score to Week 16

SCORAD was 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.) were assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).

Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 16

The DLQI was a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL). The 10 questions assessed QOL over the past week, with an overall scoring of 0 (absent disease) to 30 (severe disease); a high score was indicative of a poor QOL.

Change From Baseline in Patient Oriented Eczema Measure (POEM) to Week 16

The POEM was a 7-item questionnaire that assessed 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]).

Change From Baseline in Hospital Anxiety Depression Scale (HADS) to Week 16

HADS is a fourteen item scale. Seven of the items relate to anxiety and seven items relate to depression. Each item on the questionnaire scored from 0 (minimum score) - 3 (maximum score) and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported as 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe anxiety or depression.

Percent Change From Baseline in Total Global Individual Signs Score (GISS) 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).

Proportion of Topical Atopic Dermatitis Medication-Free Days Through Week 52

Proportion of topical AD medication-free days through Week 52 was calculated as the number of days that a participant used neither topical corticosteroid (TCS)/ topical calcineurin inhibitors (TCI) nor system rescue therapy divided by the study days of each period.

Percent Change From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 2

Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score to Week 52

Change From Baseline in Percent Body Surface Area (BSA) Affected by Atopic Dermatitis to Week 52

Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Score to Week 52

Percent Change From Baseline in Global Individual Signs Score (GISS) to Week 52

Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 52

Change From Baseline in Patient Oriented Eczema Measure (POEM) to Week 52

The POEM was 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]).

Change From Baseline in Hospital Anxiety Depression Scale (HADS) to Week 52

HADS is a fourteen item scale. Seven of the items relate to anxiety and seven items relate to depression. Each item on the questionnaire is scored from 0 (minimum score) - 3 (maximum score) and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported as 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe anxiety or depression.

Number of Flares Through Week 52

Atopic dermatitis (AD) flares were defined as worsening of the disease that required escalation/intensification of AD treatment. Number of flares occurred in the participants starting from first dose through Week 52 were reported.

Number of Serious Treatment Emergent Adverse Events (TEAEs) Leading to Study Drug Discontinuation Through Week 52

Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. A Serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.

Percentage of Participants With Skin Infection Treatment Emergent Adverse Events (TEAEs) (Excluding Herpetic Infections) From Baseline Through Week 52

Any untoward medical occurrence in a participants who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. 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 end of treatment at Week 52). Any TEAE included participants with both serious and non-serious AEs. Skin infection TEAEs were identified based on blinded adjudication of all reported TEAEs under the 2 primary System Organ Classes (SOC): SOC = "Infection and Infestations" or SOC = "Skin and Subcutaneous Tissue Disorders". Blinded adjudication was performed and finalized by the study medical monitor before database lock.

Number of Skin Infection TEAEs (Excluding Herpetic Infections) From Baseline Through Week 52

Any untoward medical occurrence in a participant who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. 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 end of treatment at Week 52). Any TEAE included participants with both serious and non-serious AEs. Skin infection TEAEs were identified based on blinded adjudication of all reported TEAEs under the 2 primary System Organ Classes (SOC): SOC = "Infection and Infestations" or SOC = "Skin and Subcutaneous Tissue Disorders". Blinded adjudication was performed and finalized by the study medical monitor before database lock.

Percentage of Participants With Skin Infection Treatment Emergent Adverse Events (TEAEs) (Excluding Herpetic Infections) Requiring Systemic Treatment From Baseline Through Week 52

Number of Skin Infection Treatment Emergent Adverse Events (TEAEs) (Excluding Herpetic Infections) Requiring Systemic Treatment From Baseline Through Week 52

Full Information

NCT ID

NCT02260986

First Posted

October 6, 2014

Last Updated

October 12, 2017

Sponsor

Regeneron Pharmaceuticals

Collaborators

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT02260986

Brief Title

Study to Assess the Efficacy and Long-term Safety of Dupilumab (REGN668/SAR231893) in Adult Participants With Moderate-to-Severe Atopic Dermatitis

Acronym

CHRONOS

Official Title

A Randomized, Double-Blind, Placebo-Controlled Study to Demonstrate the Efficacy and Long-Term Safety of Dupilumab in Adult Patients With Moderate-to-Severe Atopic Dermatitis

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

September 2014 (undefined)

Primary Completion Date

August 2015 (Actual)

Study Completion Date

October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Regeneron Pharmaceuticals

Collaborators

Sanofi

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The primary objective of the study was to demonstrate the efficacy of Dupilumab administered concomitantly with topical corticosteroid (TCS) through Week 16 in adult participants with moderate-to-severe atopic dermatitis (AD) compared to placebo administered concomitantly with TCS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atopic Dermatitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

740 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo qw

Arm Type

Experimental

Arm Description

Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection weekly (qw) from Week 1 to Week 51.

Arm Title

Dupilumab 300 mg q2w

Arm Type

Experimental

Arm Description

Arm Title

Dupilumab 300 mg qw

Arm Type

Experimental

Arm Description

Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.

Intervention Type

Drug

Intervention Name(s)

Dupilumab

Other Intervention Name(s)

REGN668, SAR231893, Dupixent

Intervention Description

Subcutaneous injection in the different quadrants of the abdomen (avoiding navel and waist areas) and upper thighs

Intervention Type

Drug

Intervention Name(s)

Placebo (for Dupilumab)

Intervention Description

Subcutaneous injection in the different quadrants of the abdomen (avoiding navel and waist areas) and upper thighs

Intervention Type

Other

Intervention Name(s)

Topical Corticosteroid (TCS)

Intervention Description

All participants were required to treatment with a (TCS) using a standardized regimen. It was recommended that participants use triamcinolone acetonide 0.1% cream or fluocinolone acetonide 0.025% ointment for medium potency, and hydrocortisone 1% cream for low potency.

Primary Outcome Measure Information:

Title

Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of ≥2 Points at Week 16

Description

Time Frame

Baseline to Week 16

Secondary Outcome Measure Information:

Title

Percentage of Participants With Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) at Week 16

Description

Time Frame

Baseline to Week 16

Title

Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16

Description

Time Frame

Baseline to Week 16

Title

Percentage of Participants With Improvement (Reduction ≥3 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16

Description

Pruritus NRS was an assessment tool that was used to report the intensity of a 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]). Participants achieving a reduction of ≥3 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported.

Time Frame

Baseline to Week 16

Title

Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of ≥2 Points at Week 52

Description

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 response is an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score of "0" or "1" and a reduction from baseline of ≥2 points at Week 52 were reported.

Time Frame

Baseline to Week 52

Title

Percentage of Participants With Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) at Week 52

Description

Time Frame

Baseline to Week 52

Title

Percent Change From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 16

Description

Time Frame

Baseline to Week 16

Title

Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 52

Description

Time Frame

Baseline to Week 52

Title

Percentage of Participants With Improvement (Reduction ≥3 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 52

Description

Pruritus NRS was an assessment tool that was used to report the intensity of a 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]). Participants achieving a reduction of ≥3 points from baseline in weekly average of peak daily pruritus NRS score at Week 52 were reported.

Time Frame

Baseline to Week 52

Title

Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 24

Description

Time Frame

Baseline to Week 24

Title

Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 4

Description

Time Frame

Baseline to Week 4

Title

Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 2

Description

Time Frame

Baseline to Week 2

Title

Change From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 16

Description

Time Frame

Baseline to Week 16

Title

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

Description

Time Frame

Baseline to Week 16

Title

Change From Baseline in Percent Body Surface Area (BSA) Affected by Atopic Dermatitis to Week 16

Description

Time Frame

Baseline to Week 16

Title

Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Score to Week 16

Description

Time Frame

Baseline to Week 16

Title

Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 16

Description

Time Frame

Baseline to Week 16

Title

Change From Baseline in Patient Oriented Eczema Measure (POEM) to Week 16

Description

Time Frame

Baseline to Week 16

Title

Change From Baseline in Hospital Anxiety Depression Scale (HADS) to Week 16

Description

Time Frame

Baseline to Week 16

Title

Percent Change From Baseline in Total Global Individual Signs Score (GISS) to Week 16

Description

Time Frame

Baseline to Week 16

Title

Proportion of Topical Atopic Dermatitis Medication-Free Days Through Week 52

Description

Time Frame

Baseline to Week 52

Title

Percent Change From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 2

Description

Time Frame

Baseline to Week 2

Title

Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score to Week 52

Description

Time Frame

Baseline to Week 52

Title

Change From Baseline in Percent Body Surface Area (BSA) Affected by Atopic Dermatitis to Week 52

Description

Time Frame

Baseline to Week 52

Title

Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Score to Week 52

Description

Time Frame

Baseline to Week 52

Title

Percent Change From Baseline in Global Individual Signs Score (GISS) to Week 52

Description

Time Frame

Baseline to Week 52

Title

Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 52

Description

Time Frame

Baseline to Week 52

Title

Change From Baseline in Patient Oriented Eczema Measure (POEM) to Week 52

Description

Time Frame

Baseline to Week 52

Title

Change From Baseline in Hospital Anxiety Depression Scale (HADS) to Week 52

Description

Time Frame

Baseline to Week 52

Title

Number of Flares Through Week 52

Description

Time Frame

Baseline up to Week 52

Title

Number of Serious Treatment Emergent Adverse Events (TEAEs) Leading to Study Drug Discontinuation Through Week 52

Description

Time Frame

Baseline up to Week 52

Title

Percentage of Participants With Skin Infection Treatment Emergent Adverse Events (TEAEs) (Excluding Herpetic Infections) From Baseline Through Week 52

Description

Time Frame

Baseline up to Week 52

Title

Number of Skin Infection TEAEs (Excluding Herpetic Infections) From Baseline Through Week 52

Description

Time Frame

Baseline up to Week 52

Title

Percentage of Participants With Skin Infection Treatment Emergent Adverse Events (TEAEs) (Excluding Herpetic Infections) Requiring Systemic Treatment From Baseline Through Week 52

Description

Time Frame

Baseline up to Week 52

Title

Number of Skin Infection Treatment Emergent Adverse Events (TEAEs) (Excluding Herpetic Infections) Requiring Systemic Treatment From Baseline Through Week 52

Description

Time Frame

Baseline up to Week 52

Other Pre-specified Outcome Measures:

Title

Change From Baseline in Sinonasal Outcome Test (SNOT-22) Score to Week 16

Description

The SNOT 22 was a validated measure of health related quality of life in sinonasal disease. It was a 22 item questionnaire with each item assigned a score ranging from 0-5. The total score may range from 0 (no disease) -110 (worst disease) (lower scores represent better health related quality of life). The SNOT-22 was administered only to participants with chronic inflammatory conditions of the nasal mucosa and/or paranasal sinuses.

Time Frame

Baseline to Week 16

Title

Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score to Week 16

Description

ACQ-5 questionnaire was a validated questionnaire comprising of 5 questions for asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath, and wheeze. Participants were asked to rate their asthma symptoms during the previous week on a 7-point scale as 0=no impairment, 6=maximum impairment. ACQ-5 score was the mean of the 5 questions and range between 0 (totally controlled) and 6 (severely uncontrolled) (a higher score indicated lower asthma control). The ACQ-5 questionnaire was administered only to the participants with a medical history of asthma.

Time Frame

Baseline to Week 16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: Chronic AD that had been present for at least 3 years before the screening visit; Documented recent history (within 6 months before the screening visit) of inadequate response to a sufficient course of out-patient treatment with topical AD medication(s). Key Exclusion Criteria: Participation in a prior Dupilumab clinical trial; Important side effects of topical medication (e.g. intolerance to treatment, hypersensitivity reactions, significant skin atrophy, systemic effects), as assessed by the investigator or treating physician; Having 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 2 weeks of study treatment: Immunosuppressive/immunomodulating drugs (e.g, systemic steroids, cyclosporine, mycophenolate-mofetil, Janus kinase inhibitors, interferon-gamma [IFN-γ], azathioprine, methotrexate, etc.); Phototherapy for AD; Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit; History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening; Positive hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody at the screening visit; Active or acute infection requiring systemic treatment within 2 weeks before baseline visit; Known or suspected history of immunosuppression; Pregnant or breastfeeding women, or planning to become pregnant or breastfeed during the participant's participation in this study. Note: The eligibility criteria listed above is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial therefore not all inclusion/ exclusion criteria are listed.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trial Management

Organizational Affiliation

Regeneron Pharmaceuticals

Official's Role

Study Director

Facility Information:

City

Phoenix

State/Province

Arizona

Country

United States

City

Hot Springs

State/Province

Arkansas

Country

United States

City

Little Rock

State/Province

Arkansas

Country

United States

City

Encinitas

State/Province

California

Country

United States

City

Oceanside

State/Province

California

Country

United States

City

Palmdale

State/Province

California

Country

United States

City

San Diego

State/Province

California

Country

United States

City

New Haven

State/Province

Connecticut

Country

United States

City

Trumbull

State/Province

Connecticut

Country

United States

City

Edgewater

State/Province

Florida

Country

United States

City

Lake Worth

State/Province

Florida

Country

United States

City

Miami Lakes

State/Province

Florida

Country

United States

City

Orlando

State/Province

Florida

Country

United States

City

Tampa

State/Province

Florida

Country

United States

City

Alpharetta

State/Province

Georgia

Country

United States

City

Columbus

State/Province

Georgia

Country

United States

City

Savannah

State/Province

Georgia

Country

United States

City

West Dundee

State/Province

Illinois

Country

United States

City

Carmel

State/Province

Indiana

Country

United States

City

New Albany

State/Province

Indiana

Country

United States

City

Rockville

State/Province

Maryland

Country

United States

City

Ann Arbor

State/Province

Michigan

Country

United States

City

Bay City

State/Province

Michigan

Country

United States

City

Edina

State/Province

Minnesota

Country

United States

City

Fridley

State/Province

Minnesota

Country

United States

City

Saint Louis

State/Province

Missouri

Country

United States

City

Omaha

State/Province

Nebraska

Country

United States

City

Henderson

State/Province

Nevada

Country

United States

City

Verona

State/Province

New Jersey

Country

United States

City

Albuquerque

State/Province

New Mexico

Country

United States

City

Corning

State/Province

New York

Country

United States

City

New York

State/Province

New York

Country

United States

City

Smithtown

State/Province

New York

Country

United States

City

Stony Brook

State/Province

New York

Country

United States

City

Cincinnati

State/Province

Ohio

Country

United States

City

Norman

State/Province

Oklahoma

Country

United States

City

Oklahoma City

State/Province

Oklahoma

Country

United States

City

Lake Oswego

State/Province

Oregon

Country

United States

City

Portland

State/Province

Oregon

Country

United States

City

Exton

State/Province

Pennsylvania

Country

United States

City

Hazleton

State/Province

Pennsylvania

Country

United States

City

Philadelphia

State/Province

Pennsylvania

Country

United States

City

Austin

State/Province

Texas

Country

United States

City

Dallas

State/Province

Texas

Country

United States

City

West Jordan

State/Province

Utah

Country

United States

City

South Burlington

State/Province

Vermont

Country

United States

City

Henrico

State/Province

Virginia

Country

United States

City

Norfolk

State/Province

Virginia

Country

United States

City

Richmond

State/Province

Virginia

Country

United States

City

Spokane

State/Province

Washington

Country

United States

City

Phillip

State/Province

Australian Capital Territory

Country

Australia

City

Kogarah

State/Province

New South Wales

Country

Australia

City

Benowa

State/Province

Queensland

Country

Australia

City

Dulwich

State/Province

Queensland

Country

Australia

City

Hectorville

State/Province

South Australia

Country

Australia

City

Carlton

State/Province

Victoria

Country

Australia

City

Surrey

State/Province

British Columbia

Country

Canada

City

Vancouver

State/Province

British Columbia

Country

Canada

City

Ajax

State/Province

Ontario

Country

Canada

City

Barrie

State/Province

Ontario

Country

Canada

City

Hamilton

State/Province

Ontario

Country

Canada

City

Markham

State/Province

Ontario

Country

Canada

City

North Bay

State/Province

Ontario

Country

Canada

City

Oakville

State/Province

Ontario

Country

Canada

City

Ottawa

State/Province

Ontario

Country

Canada

City

Peterborough

State/Province

Ontario

Country

Canada

City

Richmond Hill

State/Province

Ontario

Country

Canada

City

Toronto

State/Province

Ontario

Country

Canada

City

Waterloo

State/Province

Ontario

Country

Canada

City

Windsor

State/Province

Ontario

Country

Canada

City

Drummondville

State/Province

Quebec

Country

Canada

City

Quebec

Country

Canada

City

Hradec Kralove

Country

Czechia

City

Nachod

Country

Czechia

City

Praha 10

Country

Czechia

City

Praha 5

Country

Czechia

City

Svitavy

Country

Czechia

City

Usti nad Labem

Country

Czechia

City

Oroshaza

State/Province

Békés

Country

Hungary

City

Szolnok

State/Province

Jász-Nagykun-Szolnok

Country

Hungary

City

Veszprem

State/Province

Veszprém

Country

Hungary

City

Budapest

Country

Hungary

City

Ancona

Country

Italy

City

Bologna

Country

Italy

City

Brescia

Country

Italy

City

Novara

Country

Italy

City

Pavia

Country

Italy

City

Perugia

Country

Italy

City

Roma

Country

Italy

City

Kitakyushu

State/Province

Fukuoka

Country

Japan

City

Amagasaki

State/Province

Hyôgo

Country

Japan

City

Yokohama

State/Province

Kanagawa

Country

Japan

City

Kamimashiki-gun

State/Province

Kumamoto

Country

Japan

City

Saitama-shi

State/Province

Saitama

Country

Japan

City

Yaizu

State/Province

Shizuoka

Country

Japan

City

Koto-ku

State/Province

Tokyo

Country

Japan

City

Setagaya-ku

State/Province

Tokyo

Country

Japan

City

Adachi-ku

State/Province

Tôkyô

Country

Japan

City

Chiyoda-ku

State/Province

Tôkyô

Country

Japan

City

Nakano-ku

State/Province

Tôkyô

Country

Japan

City

Nerima-ku

State/Province

Tôkyô

Country

Japan

City

Shibuya-ku

State/Province

Tôkyô

Country

Japan

City

Shinagawa-ku

State/Province

Tôkyô

Country

Japan

City

Shinjuku-ku

State/Province

Tôkyô

Country

Japan

City

Suginami-ku

State/Province

Tôkyô

Country

Japan

City

Fukuoka

Country

Japan

City

Bucheon-si

State/Province

Gyeonggido

Country

Korea, Republic of

City

Suwon

State/Province

Gyeonggido

Country

Korea, Republic of

City

Seoul

State/Province

Seoul Teugbyeolsi

Country

Korea, Republic of

City

Seodaemun-gu

Country

Korea, Republic of

City

Uijeongbu-si

Country

Korea, Republic of

City

Breda

State/Province

Noord-Brabant

Country

Netherlands

City

Amsterdam

State/Province

Noord-Holland

Country

Netherlands

City

Rotterdam

State/Province

Zuid-Holland

Country

Netherlands

City

Groningen

Country

Netherlands

City

Utrecht

Country

Netherlands

City

Dunedin

State/Province

South Island

Country

New Zealand

City

Auckland

Country

New Zealand

City

Wroclaw

State/Province

Dolnośląskie

Country

Poland

City

Lublin

State/Province

Lubelskie

Country

Poland

City

Warszawa

State/Province

Mazowieckie

Country

Poland

City

Krakow

State/Province

Małopolskie

Country

Poland

City

Strzelce Opolskie

State/Province

Opolskie

Country

Poland

City

Iwonicz Zdroj

State/Province

Podkarpackie

Country

Poland

City

Bialystok

State/Province

Podlaskie

Country

Poland

City

Gdansk

State/Province

Pomorskie

Country

Poland

City

Poznan

State/Province

Wielkopolskie

Country

Poland

City

Szczecin

State/Province

Zachodniopomorskie

Country

Poland

City

Gdynia

Country

Poland

City

Łódź

State/Province

Łódzkie

Country

Poland

City

Katowice

State/Province

Śląskie

Country

Poland

City

Skarzysko-Kamienna

State/Province

Świętokrzyskie

Country

Poland

City

Brasov

State/Province

Braşov

Country

Romania

City

Bucuresti

State/Province

Bucureşti

Country

Romania

City

Cluj-Napoca

State/Province

Cluj

Country

Romania

City

Craiova

State/Province

Dolj

Country

Romania

City

Targu Mures

State/Province

Mureş

Country

Romania

City

Barcelona

State/Province

Cataluña

Country

Spain

City

Alicante

Country

Spain

City

Madrid

Country

Spain

City

Dundee

State/Province

Angus

Country

United Kingdom

City

Edgbaston

State/Province

Birmingham

Country

United Kingdom

City

Glasgow

State/Province

Glasgow City

Country

United Kingdom

City

Sidcup

State/Province

Kent

Country

United Kingdom

City

Northwood

State/Province

Middlesex

Country

United Kingdom

City

Liverpool

Country

United Kingdom

City

Manchester

Country

United Kingdom

City

Reading

Country

United Kingdom

City

Salford

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

35636689

Citation

Wechsler ME, Klion AD, Paggiaro P, Nair P, Staumont-Salle D, Radwan A, Johnson RR, Kapoor U, Khokhar FA, Daizadeh N, Chen Z, Laws E, Ortiz B, Jacob-Nara JA, Mannent LP, Rowe PJ, Deniz Y. Effect of Dupilumab on Blood Eosinophil Counts in Patients With Asthma, Chronic Rhinosinusitis With Nasal Polyps, Atopic Dermatitis, or Eosinophilic Esophagitis. J Allergy Clin Immunol Pract. 2022 Oct;10(10):2695-2709. doi: 10.1016/j.jaip.2022.05.019. Epub 2022 May 28.

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Blauvelt A, de Bruin-Weller M, Simpson EL, Chen Z, Ardeleanu M, Rossi AB. Consistency of Response to Dupilumab in Adults with Moderate-to-Severe Atopic Dermatitis Over 1 Year. Dermatol Ther (Heidelb). 2022 Jan;12(1):9-13. doi: 10.1007/s13555-021-00657-y. Epub 2022 Jan 7.

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Blauvelt A, de Bruin-Weller M, Simpson EL, Chen Z, Zhang A, Shumel B. Dupilumab with Topical Corticosteroids Provides Rapid and Sustained Improvement in Adults with Moderate-to-Severe Atopic Dermatitis Across Anatomic Regions Over 52 Weeks. Dermatol Ther (Heidelb). 2022 Jan;12(1):223-231. doi: 10.1007/s13555-021-00638-1. Epub 2021 Nov 22.

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PubMed Identifier

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Citation

Griffiths C, de Bruin-Weller M, Deleuran M, Fargnoli MC, Staumont-Salle D, Hong CH, Sanchez-Carazo J, Foley P, Seo SJ, Msihid J, Chen Z, Cyr SL, Rossi AB. Dupilumab in Adults with Moderate-to-Severe Atopic Dermatitis and Prior Use of Systemic Non-Steroidal Immunosuppressants: Analysis of Four Phase 3 Trials. Dermatol Ther (Heidelb). 2021 Aug;11(4):1357-1372. doi: 10.1007/s13555-021-00558-0. Epub 2021 Jun 18.

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PubMed Identifier

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Citation

Hamilton JD, Harel S, Swanson BN, Brian W, Chen Z, Rice MS, Amin N, Ardeleanu M, Radin A, Shumel B, Ruddy M, Patel N, Pirozzi G, Mannent L, Graham NMH. Dupilumab suppresses type 2 inflammatory biomarkers across multiple atopic, allergic diseases. Clin Exp Allergy. 2021 Jul;51(7):915-931. doi: 10.1111/cea.13954. Epub 2021 Jun 26.

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PubMed Identifier

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Citation

Wu JJ, Spelman L, Tan JL, Etoh T, Zhang H, Shumel B, Rossi AB. Dupilumab Maintains Long-Term Disease Control in Adults with Moderate-to-Severe Atopic Dermatitis as Measured by Well-Controlled Weeks: Results From the LIBERTY AD CHRONOS Clinical Trial. Dermatol Ther (Heidelb). 2021 Apr;11(2):327-330. doi: 10.1007/s13555-021-00487-y. Epub 2021 Jan 28. No abstract available.

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PubMed Identifier

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Citation

Boguniewicz M, Beck LA, Sher L, Guttman-Yassky E, Thaci D, Blauvelt A, Worm M, Corren J, Soong W, Lio P, Rossi AB, Lu Y, Chao J, Eckert L, Gadkari A, Hultsch T, Ruddy M, Mannent LP, Graham NMH, Pirozzi G, Chen Z, Ardeleanu M. Dupilumab Improves Asthma and Sinonasal Outcomes in Adults with Moderate to Severe Atopic Dermatitis. J Allergy Clin Immunol Pract. 2021 Mar;9(3):1212-1223.e6. doi: 10.1016/j.jaip.2020.12.059. Epub 2021 Jan 13.

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PubMed Identifier

33165005

Citation

Silverberg JI, Simpson EL, Guttman-Yassky E, Cork MJ, de Bruin-Weller M, Yosipovitch G, Eckert L, Chen Z, Ardeleanu M, Shumel B, Hultsch T, Rossi AB, Hamilton JD, Orengo JM, Ruddy M, Graham NMH, Pirozzi G, Gadkari A. Dupilumab Significantly Modulates Pain and Discomfort in Patients With Atopic Dermatitis: A Post Hoc Analysis of 5 Randomized Clinical Trials. Dermatitis. 2021 Oct 1;32(1S):S81-S91. doi: 10.1097/DER.0000000000000698.

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PubMed Identifier

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Citation

Weyne J, Blauvelt A, de Bruin-Weller M, Prens E, Asbell P, Sierka D, Chen Z, Shumel B. Patient-Reported Ocular Disorders and Symptoms in Adults with Moderate-to-Severe Atopic Dermatitis: Screening and Baseline Survey Data from a Clinical Trial. Dermatol Ther (Heidelb). 2020 Dec;10(6):1415-1421. doi: 10.1007/s13555-020-00456-x. Epub 2020 Oct 12.

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PubMed Identifier

31564057

Citation

Katoh N, Kataoka Y, Saeki H, Hide M, Kabashima K, Etoh T, Igarashi A, Imafuku S, Kawashima M, Ohtsuki M, Fujita H, Arima K, Takagi H, Chen Z, Shumel B, Ardeleanu M. Efficacy and safety of dupilumab in Japanese adults with moderate-to-severe atopic dermatitis: a subanalysis of three clinical trials. Br J Dermatol. 2020 Jul;183(1):39-51. doi: 10.1111/bjd.18565. Epub 2019 Nov 28.

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PubMed Identifier

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Citation

Alexis AF, Rendon M, Silverberg JI, Pariser DM, Lockshin B, Griffiths CE, Weisman J, Wollenberg A, Chen Z, Davis JD, Li M, Eckert L, Gadkari A, Shumel B, Rossi AB, Graham NM, Ardeleanu M. Efficacy of Dupilumab in Different Racial Subgroups of Adults With Moderate-to-Severe Atopic Dermatitis in Three Randomized, Placebo-Controlled Phase 3 Trials. J Drugs Dermatol. 2019 Aug 1;18(8):804-813.

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Citation

Wollenberg A, Beck LA, Blauvelt A, Simpson EL, Chen Z, Chen Q, Shumel B, Khokhar FA, Hultsch T, Rizova E, Rossi AB, Graham NMH, Pirozzi G, Lu Y, Ardeleanu M. Laboratory safety of dupilumab in moderate-to-severe atopic dermatitis: results from three phase III trials (LIBERTY AD SOLO 1, LIBERTY AD SOLO 2, LIBERTY AD CHRONOS). Br J Dermatol. 2020 May;182(5):1120-1135. doi: 10.1111/bjd.18434. Epub 2019 Dec 1.

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Blauvelt A, de Bruin-Weller M, Gooderham M, Cather JC, Weisman J, Pariser D, Simpson EL, Papp KA, Hong HC, Rubel D, Foley P, Prens E, Griffiths CEM, Etoh T, Pinto PH, Pujol RM, Szepietowski JC, Ettler K, Kemeny L, Zhu X, Akinlade B, Hultsch T, Mastey V, Gadkari A, Eckert L, Amin N, Graham NMH, Pirozzi G, Stahl N, Yancopoulos GD, Shumel B. Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial. Lancet. 2017 Jun 10;389(10086):2287-2303. doi: 10.1016/S0140-6736(17)31191-1. Epub 2017 May 4.

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Learn more about this trial

Study to Assess the Efficacy and Long-term Safety of Dupilumab (REGN668/SAR231893) in Adult Participants With Moderate-to-Severe Atopic Dermatitis

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