Back to results

Study of Dupilumab (REGN668/SAR231893) Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis (SOLO 2)

Primary Purpose

Dermatitis, Atopic

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Dupilumab

Placebo (for Dupilumab)

About this trial

This is an interventional treatment trial for Dermatitis, Atopic

Eligibility Criteria

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

Inclusion Criteria:

Chronic AD that has been present for at least 3 years before the screening visit;
≥10% body surface area (BSA) of AD involvement at the screening and baseline visits;
Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks).

Exclusion Criteria:

Participation in a prior Dupilumab clinical study.
Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, before the baseline visit;
Having used any of the following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, is likely to require such treatment(s) during the first 4 weeks of study treatment:
- Immunosuppressive/ immunomodulating drugs (eg, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine, methotrexate, etc.)
- Phototherapy for AD
Regular use (more than 2 visits per week) of a tanning booth/ parlor within 4 weeks of the screening visit;
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 with hepatitis B surface antigen (HBsAg) or hepatitis C antibody at the screening visit;
Active chronic or acute infection requiring systemic treatment within 2 weeks before the baseline visit;
Known or suspected history of immunosuppression;
Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study;
Women unwilling to use adequate birth control, if of reproductive potential and sexually active.

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Dupilumab 300 mg every 2 weeks (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 once weekly (qw) from Week 1 to Week 15.

Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.

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 15.

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 of "0" or "1" and a reduction from baseline of ≥2 points at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing IGA scores at Week 16 were considered as non-responders.

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 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 16. Values after first rescue treatment use were set to missing and participants with missing EASI score at Week 16 were considered as non-responders.

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. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders.

Percentage of Participants With Improvement (Reduction ≥3 Points) in 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. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders.

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

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

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 4 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 4 were considered as non-responders.

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

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 2 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 2 were considered as non-responders.

Change From Baseline in 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

Percentage of Participants With Eczema Area and Severity Index-50 (EASI-50) (≥50% Improvement From Baseline) at Week 16

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-50 responders were the participants who achieved ≥50% overall improvement in EASI score from baseline to Week 16. Values after first rescue treatment were set to missing and participants with missing EASI-50 scores at Week 16 were considered as non-responders.

Percentage of Participants With Eczema Area and Severity Index-90 (EASI-90) (≥90% Improvement From Baseline) at Week 16

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-90 responders were the participants who achieved ≥90% overall improvement in EASI score from baseline to Week 16. Values after first rescue treatment were set to missing and participants with missing EASI-90 scores at Week 16 were considered as non-responders.

Change From Baseline in Percent Body Surface Area (BSA) 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 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).

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

The DLQI is 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 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]).

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 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.

Percent Change From Baseline in 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).

Percent Change From Baseline in Weekly Average of Peak Daily Pruritus NRS Score to Week 2

Percentage of Participants With Skin Infection Treatment Emergent Adverse Events (TEAEs) Requiring Systemic Treatment

Treatment-emergent adverse events (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 [Week 28]). 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. Statistical significance in the hierarchical testing of secondary hypotheses was broken at this endpoint. Therefore, subsequent secondary efficacy endpoints were not tested for statistical significance.

Percentage of Participants With Treatment Emergent Serious Adverse Events (TESAEs) From Baseline Through Week 16

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. Treatment-emergent adverse events (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 [Week 28]). 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 Treatment Emergent Adverse Events (TEAEs) Leading to Treatment Discontinuation From Baseline Through Week 16

Full Information

NCT ID

NCT02277769

First Posted

October 27, 2014

Last Updated

May 21, 2020

Sponsor

Regeneron Pharmaceuticals

Collaborators

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT02277769

Brief Title

Study of Dupilumab (REGN668/SAR231893) Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

Acronym

SOLO 2

Official Title

A Phase 3 Confirmatory Study Investigating the Efficacy and Safety of Dupilumab Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Completed

Study Start Date

November 30, 2014 (Actual)

Primary Completion Date

October 31, 2015 (Actual)

Study Completion Date

January 31, 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

This is a randomized, double-blind, placebo-controlled, parallel-group study to confirm the efficacy and safety of Dupilumab monotherapy in adults with moderate-to-severe atopic dermatitis (AD).

6. Conditions and Keywords

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

Dermatitis, Atopic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

708 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection once weekly (qw) from Week 1 to Week 15.

Arm Title

Dupilumab 300 mg every 2 weeks (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 15.

Intervention Type

Drug

Intervention Name(s)

Dupilumab

Other Intervention Name(s)

DUPIXENT®, REGN668, SAR231893

Intervention Description

Subcutaneous injection alternated among the different quadrants of the abdomen, upper thighs and upper arms.

Intervention Type

Drug

Intervention Name(s)

Placebo (for Dupilumab)

Intervention Description

Subcutaneous injection alternated among the different quadrants of the abdomen, upper thighs and upper arms.

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

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

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) in 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. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders.

Time Frame

Baseline to Week 16

Title

Percent Change From Baseline in Weekly Average of Peak 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 Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 4

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 ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 4 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 4 were considered as non-responders.

Time Frame

Baseline to Week 4

Title

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

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 ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 2 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 2 were considered as non-responders.

Time Frame

Baseline to Week 2

Title

Change From Baseline in 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

Percentage of Participants With Eczema Area and Severity Index-50 (EASI-50) (≥50% Improvement From Baseline) at Week 16

Description

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-50 responders were the participants who achieved ≥50% overall improvement in EASI score from baseline to Week 16. Values after first rescue treatment were set to missing and participants with missing EASI-50 scores at Week 16 were considered as non-responders.

Time Frame

Week 16

Title

Percentage of Participants With Eczema Area and Severity Index-90 (EASI-90) (≥90% Improvement From Baseline) at Week 16

Description

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-90 responders were the participants who achieved ≥90% overall improvement in EASI score from baseline to Week 16. Values after first rescue treatment were set to missing and participants with missing EASI-90 scores at Week 16 were considered as non-responders.

Time Frame

Week 16

Title

Change From Baseline in Percent Body Surface Area (BSA) 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 Global Individual Signs Score (GISS) to Week 16

Description

Time Frame

Baseline to Week 16

Title

Percent Change From Baseline in Weekly Average of Peak Daily Pruritus NRS Score to Week 2

Description

Time Frame

Baseline to Week 2

Title

Percentage of Participants With Skin Infection Treatment Emergent Adverse Events (TEAEs) Requiring Systemic Treatment

Description

Time Frame

Baseline up to Week 16

Title

Percentage of Participants With Treatment Emergent Serious Adverse Events (TESAEs) From Baseline Through Week 16

Description

Time Frame

Baseline up to Week 16

Title

Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Treatment Discontinuation From Baseline Through Week 16

Description

Time Frame

Baseline up to Week 16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Chronic AD that has been present for at least 3 years before the screening visit; ≥10% body surface area (BSA) of AD involvement at the screening and baseline visits; Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks). Exclusion Criteria: Participation in a prior Dupilumab clinical study. Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, before the baseline visit; Having used any of the following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, is likely to require such treatment(s) during the first 4 weeks of study treatment: Immunosuppressive/ immunomodulating drugs (eg, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine, methotrexate, etc.) Phototherapy for AD Regular use (more than 2 visits per week) of a tanning booth/ parlor within 4 weeks of the screening visit; 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 with hepatitis B surface antigen (HBsAg) or hepatitis C antibody at the screening visit; Active chronic or acute infection requiring systemic treatment within 2 weeks before the baseline visit; Known or suspected history of immunosuppression; Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study; Women unwilling to use adequate birth control, if of reproductive potential and sexually active. Note: The information listed above is not intended to contain all considerations relevant to a participant's potential participation in this 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

Anniston

State/Province

Alabama

Country

United States

City

Birmingham

State/Province

Alabama

Country

United States

City

Phoenix

State/Province

Arizona

Country

United States

City

Bakersfield

State/Province

California

Country

United States

City

Costa Mesa

State/Province

California

Country

United States

City

Fremont

State/Province

California

Country

United States

City

Long Beach

State/Province

California

Country

United States

City

Los Angeles

State/Province

California

Country

United States

City

Orange

State/Province

California

Country

United States

City

Roseville

State/Province

California

Country

United States

City

Temecula

State/Province

California

Country

United States

City

Trumbull

State/Province

Connecticut

Country

United States

City

Miami

State/Province

Florida

Country

United States

City

Oviedo

State/Province

Florida

Country

United States

City

Tampa

State/Province

Florida

Country

United States

City

West Palm Beach

State/Province

Florida

Country

United States

City

Alpharetta

State/Province

Georgia

Country

United States

City

Atlanta

State/Province

Georgia

Country

United States

City

Columbus

State/Province

Georgia

Country

United States

City

Buffalo Grove

State/Province

Illinois

Country

United States

City

Plainfield

State/Province

Indiana

Country

United States

City

West Des Moines

State/Province

Iowa

Country

United States

City

Overland Park

State/Province

Kansas

Country

United States

City

Rockville

State/Province

Maryland

Country

United States

City

Washington Park

State/Province

Maryland

Country

United States

City

Boston

State/Province

Massachusetts

Country

United States

City

Farmington Hills

State/Province

Michigan

Country

United States

City

Minneapolis

State/Province

Minnesota

Country

United States

City

Plymouth

State/Province

Minnesota

Country

United States

City

Saint Joseph

State/Province

Missouri

Country

United States

City

Saint Louis

State/Province

Missouri

Country

United States

City

Billings

State/Province

Montana

Country

United States

City

Bozeman

State/Province

Montana

Country

United States

City

Las Vegas

State/Province

Nevada

Country

United States

City

Verona

State/Province

New Jersey

Country

United States

City

Forest Hills

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

Chapel Hill

State/Province

North Carolina

Country

United States

City

Raleigh

State/Province

North Carolina

Country

United States

City

Wilmington

State/Province

North Carolina

Country

United States

City

Winston-Salem

State/Province

North Carolina

Country

United States

City

Tulsa

State/Province

Oklahoma

Country

United States

City

Portland

State/Province

Oregon

Country

United States

City

Jenkintown

State/Province

Pennsylvania

Country

United States

City

Greer

State/Province

South Carolina

Country

United States

City

Arlington

State/Province

Texas

Country

United States

City

Austin

State/Province

Texas

Country

United States

City

Bellaire

State/Province

Texas

Country

United States

City

Houston

State/Province

Texas

Country

United States

City

San Antonio

State/Province

Texas

Country

United States

City

Richmond

State/Province

Virginia

Country

United States

City

Seattle

State/Province

Washington

Country

United States

City

Calgary

State/Province

Alberta

Country

Canada

City

Edmonton

State/Province

Alberta

Country

Canada

City

Surrey

State/Province

British Columbia

Country

Canada

City

St. John's

State/Province

Newfoundland and Labrador

Country

Canada

City

Ajax

State/Province

Ontario

Country

Canada

City

Mississauga

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

Montreal

State/Province

Quebec

Country

Canada

City

Lille Cedex

Country

France

City

Marseille

Country

France

City

Nantes

Country

France

City

Berlin

Country

Germany

City

Bochum

Country

Germany

City

Darmstadt

Country

Germany

City

Friedrichshafen

Country

Germany

City

Hamburg

Country

Germany

City

Kiel

Country

Germany

City

Hong Kong

Country

Hong Kong

City

Lucca

Country

Italy

City

Pisa

Country

Italy

City

Roma

Country

Italy

City

Busan

Country

Korea, Republic of

City

Gyeonggi-do

Country

Korea, Republic of

City

Incheon

Country

Korea, Republic of

City

Seoul

Country

Korea, Republic of

City

Kaunas

Country

Lithuania

City

Klaipeda

Country

Lithuania

City

Vilnius

Country

Lithuania

City

Elblag

Country

Poland

City

Gdansk

Country

Poland

City

Katowice

Country

Poland

City

Poznan

Country

Poland

City

Torun

Country

Poland

City

Warsaw

Country

Poland

City

Stockholm

Country

Sweden

City

London

Country

United Kingdom

City

Plymouth

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

27690741

Citation

Simpson EL, Bieber T, Guttman-Yassky E, Beck LA, Blauvelt A, Cork MJ, Silverberg JI, Deleuran M, Kataoka Y, Lacour JP, Kingo K, Worm M, Poulin Y, Wollenberg A, Soo Y, Graham NM, Pirozzi G, Akinlade B, Staudinger H, Mastey V, Eckert L, Gadkari A, Stahl N, Yancopoulos GD, Ardeleanu M; SOLO 1 and SOLO 2 Investigators. Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis. N Engl J Med. 2016 Dec 15;375(24):2335-2348. doi: 10.1056/NEJMoa1610020. Epub 2016 Sep 30.

Results Reference

result

PubMed Identifier

36269503

Citation

Silverberg JI, Boguniewicz M, Hanifin J, Papp KA, Zhang H, Rossi AB, Levit NA. Dupilumab Treatment in Adults with Moderate-to-Severe Atopic Dermatitis is Efficacious Regardless of Age of Disease Onset: a Post Hoc Analysis of Two Phase 3 Clinical Trials. Dermatol Ther (Heidelb). 2022 Dec;12(12):2731-2746. doi: 10.1007/s13555-022-00822-x. Epub 2022 Oct 21.

Results Reference

derived

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.

Results Reference

derived

PubMed Identifier

34897582

Citation

Armstrong A, Blauvelt A, Simpson EL, Smith CH, Herranz P, Kataoka Y, Seo SJ, Ferrucci SM, Chao J, Chen Z, Rossi AB, Shumel B, Tomondy P. Continued Treatment with Dupilumab is Associated with Improved Efficacy in Adults with Moderate-to-Severe Atopic Dermatitis Not Achieving Optimal Responses with Short-Term Treatment. Dermatol Ther (Heidelb). 2022 Jan;12(1):195-202. doi: 10.1007/s13555-021-00643-4. Epub 2021 Dec 13.

Results Reference

derived

PubMed Identifier

34726270

Citation

Paller AS, Tan JKL, Bagel J, Rossi AB, Shumel B, Zhang H, Abramova A. IGAxBSA composite for assessing disease severity and response in patients with atopic dermatitis. Br J Dermatol. 2022 Mar;186(3):496-507. doi: 10.1111/bjd.20872. Epub 2022 Feb 25.

Results Reference

derived

PubMed Identifier

34142350

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.

Results Reference

derived

PubMed Identifier

34037993

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.

Results Reference

derived

PubMed Identifier

33453450

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.

Results Reference

derived

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.

Results Reference

derived

PubMed Identifier

31424712

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.

Results Reference

derived

PubMed Identifier

31407311

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.

Results Reference

derived

PubMed Identifier

30791102

Citation

Silverberg JI, Simpson EL, Ardeleanu M, Thaci D, Barbarot S, Bagel J, Chen Z, Eckert L, Chao J, Korotzer A, Rizova E, Rossi AB, Lu Y, Graham NMH, Hultsch T, Pirozzi G, Akinlade B. Dupilumab provides important clinical benefits to patients with atopic dermatitis who do not achieve clear or almost clear skin according to the Investigator's Global Assessment: a pooled analysis of data from two phase III trials. Br J Dermatol. 2019 Jul;181(1):80-87. doi: 10.1111/bjd.17791. Epub 2019 Apr 11.

Results Reference

derived

PubMed Identifier

28503712

Citation

Simpson EL. Dupilumab Improves General Health-Related Quality-of-Life in Patients with Moderate-to-Severe Atopic Dermatitis: Pooled Results from Two Randomized, Controlled Phase 3 Clinical Trials. Dermatol Ther (Heidelb). 2017 Jun;7(2):243-248. doi: 10.1007/s13555-017-0181-6. Epub 2017 May 13.

Results Reference

derived

Learn more about this trial

Study of Dupilumab (REGN668/SAR231893) Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

We'll reach out to this number within 24 hrs