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Study to Assess the Long-term Safety of Dupilumab Administered in Participants ≥6 Months to <18 Years of Age With Atopic Dermatitis (AD)

Primary Purpose

Atopic Dermatitis

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Dupilumab

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Eczema

Eligibility Criteria

6 Months - 17 Years (Child)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

Participated in a prior dupilumab study in pediatric participants with AD and adequately completed the visits and assessments required for both the treatment and follow-up periods, as defined in the prior study protocol
PFP Sub-Study Only:
Age ≥2 to <12 years at time of screening
Body weight ≥5 kg and <60 kg at time of screening
Must have received the same dupilumab dose regimen to be used in the PFP sub-study during the previous 12 weeks in the main OLE study using the prefilled syringe, as defined in the protocol

Key Exclusion Criteria:

Participants who, during their participation in a prior dupilumab study developed an adverse event (AE) or serious adverse event (SAE) deemed related to study drug which could indicate that continued treatment with study drug may present an unreasonable risk for the patient
Participants, who during the participation in a prior Dupilumab study, developed an AE that was deemed related to study drug and led to study treatment discontinuation, which in the opinion of the investigator or medical monitor could indicate that continued treatment with study drug may present an unreasonable risk for the patient
Treatment with an investigational drug, other than dupilumab, within 8 weeks or within 5 half-lives (if known), whichever is longer, before the baseline visit
Having used immunosuppressive/immunomodulating drugs within 4 weeks before the baseline visit
Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit
Diagnosed active endoparasitic infections or at high risk of these infections
Severe concomitant illness(es) that, in the investigator's judgment, would adversely affect the participant's participation in the study
PFP Sub-study Only:
Poor compliance as defined by having missed 1 or more of the planned last 3 injections in the main OLE study prior to entering the sub-study
Switched dupilumab doses within the past 12 weeks
Meet criteria for temporary/permanent discontinuation of study drug at time of screening into PFP sub-study, as defined in the protocol.

Note: Other protocol defined Inclusion / Exclusion criteria may apply

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Body weight ≥60 kg

Body weight 30 kg to <60 kg

Body weight 15 kg to <30 kg

Body weight 5 kg to <15 kg

Arm Description

Administered every two weeks (Q2W)

Administered Q2W

Administered every 4 weeks (Q4W)

Administered Q4W

Outcomes

Primary Outcome Measures

Rate of treatment-emergent adverse events (TEAEs) per participant year from baseline through the last study visit

Number of participants with at least one TEAE per participant year from baseline through the last study visit

OPTIONAL SUB-STUDY: Pharmacokinetic (PK) of dupilumab: Peak concentration (Cmax)

Peak serum concentration after multiple doses of dupilumab administered using the PFP (test) relative to the prefilled syringe (reference)

OPTIONAL SUB-STUDY: PK of dupilumab: Trough concentration (Ctrough)

Drug concentration in serum after multiple doses of dupilumab administered using the PFP (test) relative to the prefilled syringe (reference)

OPTIONAL SUB-STUDY: Incidence of TEAEs during the 12-week PFP treatment period and during entire sub-study

OPTIONAL SUB-STUDY: Incidence of SAEs during the 12-week PFP treatment period and during entire sub-study

Secondary Outcome Measures

Number of treatment-emergent serious adverse events (SAEs) from baseline through the last study visit

Incidence of TEAEs of special interest from baseline through the last study visit

Proportion of participants with an Investigator Global Assessment (IGA) score of 0 or 1 (clear or almost clear) at all in-clinic visits post-baseline

Proportion of participants with Eczema Area and Severity Index (EASI)-75 (≥75% reduction in EASI from baseline of parent study) response at all in-clinic visits post-baseline

Change from baseline in EASI score at all in-clinic visits post-baseline

Percent change from baseline in EASI at all in-clinic visits post-baseline

Change from baseline in Body Surface Area (BSA) affected by AD (BSA) at all in-clinic visits post-baseline

Percent change from baseline in SCORing Atopic Dermatitis (SCORAD) at all in-clinic visits post-baseline

Change from baseline in Children's Dermatology Life Quality Index (CDLQI) for participants ≥4 years of age at all in-clinic visits post-baseline in which the assessments are planned to be performed

Change from baseline in Infants' Dermatology Quality of Life Index (IDQOL) for participants <4 years of age at all in-clinic visits post-baseline in which the assessments are planned to be performed

Proportion of responders (defined as participants with IGA 0 or 1) who maintain IGA 0 or 1 during at least 75% of the subsequent* visits during the treatment period

*Subsequent refers to the visits following the first visit at which IGA 0 or 1 is achieved.

For responders (defined as participants with IGA 0 or 1), median percentage of subsequent* visits during the treatment period, at which IGA 0 or 1 is maintained

*Subsequent refers to the visits following the first visit at which IGA 0 or 1 is achieved.

Number of AD flares during the study

AD flares are defined as worsening of the disease that requires escalation/intensification of AD treatment

Annualize event rate of AD flares during the study

AD flares are defined as worsening of the disease that requires escalation/intensification of AD treatment

Proportion of participants with at least one flare during the study

AD flares are defined as worsening of the disease that requires escalation/intensification of AD treatment

Proportion of well-controlled weeks

Well-controlled weeks are those for which participants or parents/caregivers answer "Yes" AND during which no rescue treatments were administered

OPTIONAL SUB-STUDY: Incidence and titer of treatment-emergent anti-drug antibodies (ADA) (PFP Sub-Study)

Full Information

NCT ID

NCT02612454

First Posted

November 11, 2015

Last Updated

May 4, 2023

Sponsor

Regeneron Pharmaceuticals

Collaborators

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT02612454

Brief Title

Study to Assess the Long-term Safety of Dupilumab Administered in Participants ≥6 Months to <18 Years of Age With Atopic Dermatitis (AD)

Official Title

An Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Dupilumab in Patients ≥6 Months to <18 Years of Age With Atopic Dermatitis

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 15, 2015 (Actual)

Primary Completion Date

August 19, 2026 (Anticipated)

Study Completion Date

August 19, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Regeneron Pharmaceuticals

Collaborators

Sanofi

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The primary objective of the study is to assess the long-term safety of dupilumab in pediatric participants with AD. The secondary objectives of the study are: To assess the long-term efficacy of dupilumab in pediatric participants with AD To assess the trough concentrations of functional dupilumab in serum and the immunogenicity in pediatric participants with AD after re-treatment with dupilumab Optional Pre-filled Pen (PFP) Sub-Study in pediatric patients ≥2 to <12 years of age with AD Co-Primary Objectives are: To evaluate the pharmacokinetic (PK) of dupilumab PFPs To evaluate the safety of dupilumab PFPs Secondary Objective is: - To evaluate the immunogenicity of dupilumab PFPs

6. Conditions and Keywords

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

Atopic Dermatitis

Keywords

Eczema

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

880 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Body weight ≥60 kg

Arm Type

Experimental

Arm Description

Administered every two weeks (Q2W)

Arm Title

Body weight 30 kg to <60 kg

Arm Type

Experimental

Arm Description

Administered Q2W

Arm Title

Body weight 15 kg to <30 kg

Arm Type

Experimental

Arm Description

Administered every 4 weeks (Q4W)

Arm Title

Body weight 5 kg to <15 kg

Arm Type

Experimental

Arm Description

Administered Q4W

Intervention Type

Drug

Intervention Name(s)

Dupilumab

Other Intervention Name(s)

DUPIXENT®, REGN668, SAR231893

Intervention Description

Weight-tiered dosing administered subcutaneous (SC)

Primary Outcome Measure Information:

Title

Rate of treatment-emergent adverse events (TEAEs) per participant year from baseline through the last study visit

Time Frame

Baseline up to week 272

Title

Number of participants with at least one TEAE per participant year from baseline through the last study visit

Time Frame

Baseline up to week 272

Title

OPTIONAL SUB-STUDY: Pharmacokinetic (PK) of dupilumab: Peak concentration (Cmax)

Description

Peak serum concentration after multiple doses of dupilumab administered using the PFP (test) relative to the prefilled syringe (reference)

Time Frame

Up to week 16

Title

OPTIONAL SUB-STUDY: PK of dupilumab: Trough concentration (Ctrough)

Description

Drug concentration in serum after multiple doses of dupilumab administered using the PFP (test) relative to the prefilled syringe (reference)

Time Frame

Up to week 16

Title

OPTIONAL SUB-STUDY: Incidence of TEAEs during the 12-week PFP treatment period and during entire sub-study

Time Frame

Up to week 16

Title

OPTIONAL SUB-STUDY: Incidence of SAEs during the 12-week PFP treatment period and during entire sub-study

Time Frame

Up to week 16

Secondary Outcome Measure Information:

Title

Number of treatment-emergent serious adverse events (SAEs) from baseline through the last study visit

Time Frame

Baseline up to week 272

Title

Incidence of TEAEs of special interest from baseline through the last study visit

Time Frame

Baseline up to week 272

Title

Proportion of participants with an Investigator Global Assessment (IGA) score of 0 or 1 (clear or almost clear) at all in-clinic visits post-baseline

Time Frame

Baseline up to week 272

Title

Proportion of participants with Eczema Area and Severity Index (EASI)-75 (≥75% reduction in EASI from baseline of parent study) response at all in-clinic visits post-baseline

Time Frame

Baseline up to week 272

Title

Change from baseline in EASI score at all in-clinic visits post-baseline

Time Frame

Baseline up to week 272

Title

Percent change from baseline in EASI at all in-clinic visits post-baseline

Time Frame

Baseline up to week 272

Title

Change from baseline in Body Surface Area (BSA) affected by AD (BSA) at all in-clinic visits post-baseline

Time Frame

Baseline up to week 272

Title

Percent change from baseline in SCORing Atopic Dermatitis (SCORAD) at all in-clinic visits post-baseline

Time Frame

Baseline up to week 272

Title

Change from baseline in Children's Dermatology Life Quality Index (CDLQI) for participants ≥4 years of age at all in-clinic visits post-baseline in which the assessments are planned to be performed

Time Frame

Baseline up to week 272

Title

Change from baseline in Infants' Dermatology Quality of Life Index (IDQOL) for participants <4 years of age at all in-clinic visits post-baseline in which the assessments are planned to be performed

Time Frame

Baseline up to week 272

Title

Proportion of responders (defined as participants with IGA 0 or 1) who maintain IGA 0 or 1 during at least 75% of the subsequent* visits during the treatment period

Description

*Subsequent refers to the visits following the first visit at which IGA 0 or 1 is achieved.

Time Frame

Baseline to week 260

Title

For responders (defined as participants with IGA 0 or 1), median percentage of subsequent* visits during the treatment period, at which IGA 0 or 1 is maintained

Description

*Subsequent refers to the visits following the first visit at which IGA 0 or 1 is achieved.

Time Frame

Baseline to week 260

Title

Number of AD flares during the study

Description

AD flares are defined as worsening of the disease that requires escalation/intensification of AD treatment

Time Frame

Baseline to week 272

Title

Annualize event rate of AD flares during the study

Description

AD flares are defined as worsening of the disease that requires escalation/intensification of AD treatment

Time Frame

Baseline to week 272

Title

Proportion of participants with at least one flare during the study

Description

AD flares are defined as worsening of the disease that requires escalation/intensification of AD treatment

Time Frame

Baseline to week 272

Title

Proportion of well-controlled weeks

Description

Well-controlled weeks are those for which participants or parents/caregivers answer "Yes" AND during which no rescue treatments were administered

Time Frame

Baseline to week 272

Title

OPTIONAL SUB-STUDY: Incidence and titer of treatment-emergent anti-drug antibodies (ADA) (PFP Sub-Study)

Time Frame

Up to 16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: Participated in a prior dupilumab study in pediatric participants with AD and adequately completed the visits and assessments required for both the treatment and follow-up periods, as defined in the prior study protocol PFP Sub-Study Only: Age ≥2 to <12 years at time of screening Body weight ≥5 kg and <60 kg at time of screening Must have received the same dupilumab dose regimen to be used in the PFP sub-study during the previous 12 weeks in the main OLE study using the prefilled syringe, as defined in the protocol Key Exclusion Criteria: Participants who, during their participation in a prior dupilumab study developed an adverse event (AE) or serious adverse event (SAE) deemed related to study drug which could indicate that continued treatment with study drug may present an unreasonable risk for the patient Participants, who during the participation in a prior Dupilumab study, developed an AE that was deemed related to study drug and led to study treatment discontinuation, which in the opinion of the investigator or medical monitor could indicate that continued treatment with study drug may present an unreasonable risk for the patient Treatment with an investigational drug, other than dupilumab, within 8 weeks or within 5 half-lives (if known), whichever is longer, before the baseline visit Having used immunosuppressive/immunomodulating drugs within 4 weeks before the baseline visit Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit Diagnosed active endoparasitic infections or at high risk of these infections Severe concomitant illness(es) that, in the investigator's judgment, would adversely affect the participant's participation in the study PFP Sub-study Only: Poor compliance as defined by having missed 1 or more of the planned last 3 injections in the main OLE study prior to entering the sub-study Switched dupilumab doses within the past 12 weeks Meet criteria for temporary/permanent discontinuation of study drug at time of screening into PFP sub-study, as defined in the protocol. Note: Other protocol defined Inclusion / Exclusion criteria may apply

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trial Management

Organizational Affiliation

Regeneron Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Regeneron Investigational Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35209

Country

United States

Facility Name

Regeneron Investigational Site

City

Gilbert

State/Province

Arizona

ZIP/Postal Code

85234

Country

United States

Facility Name

Regeneron Investigational Site

City

Bakersfield

State/Province

California

ZIP/Postal Code

93309

Country

United States

Facility Name

Regeneron Investigational Site

City

Long Beach

State/Province

California

ZIP/Postal Code

90808

Country

United States

Facility Name

Regeneron Investigational Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90027

Country

United States

Facility Name

Regeneron Investigational site

City

Mission Viejo

State/Province

California

ZIP/Postal Code

92691

Country

United States

Facility Name

Regeneron Investigational Site

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

Regeneron Investigational Site

City

Palo Alto

State/Province

California

ZIP/Postal Code

92304

Country

United States

Facility Name

Regeneron Investigational Site

City

Rolling Hills Estates

State/Province

California

ZIP/Postal Code

90274

Country

United States

Facility Name

Regeneron Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

Regeneron Investigational Site

City

Centennial

State/Province

Colorado

ZIP/Postal Code

80112

Country

United States

Facility Name

Regeneron Investigational Site

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20016

Country

United States

Facility Name

Regeneron Investigational Site

City

Coral Gables

State/Province

Florida

ZIP/Postal Code

33146

Country

United States

Facility Name

Regeneron Investigational Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33613

Country

United States

Facility Name

Regeneron Investigational Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33624

Country

United States

Facility Name

Regeneron Investigational Site

City

Columbus

State/Province

Georgia

ZIP/Postal Code

31904

Country

United States

Facility Name

Regeneron Investigational Site

City

Macon

State/Province

Georgia

ZIP/Postal Code

31217

Country

United States

Facility Name

Regeneron Investigational Site

City

Sandy Springs

State/Province

Georgia

ZIP/Postal Code

30328

Country

United States

Facility Name

Regeneron Investigational Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Regeneron Investigational Site

City

Skokie

State/Province

Illinois

ZIP/Postal Code

60077

Country

United States

Facility Name

Regeneron Investigational site

City

Plainfield

State/Province

Indiana

ZIP/Postal Code

46168

Country

United States

Facility Name

Regeneron Investigational Site

City

Rockville

State/Province

Maryland

ZIP/Postal Code

20850

Country

United States

Facility Name

Regeneron Investigational Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Regeneron Investigational Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02116

Country

United States

Facility Name

Regeneron Investigational Site

City

Ypsilanti

State/Province

Michigan

ZIP/Postal Code

48197

Country

United States

Facility Name

Regeneron Investigational Site

City

Plymouth

State/Province

Minnesota

ZIP/Postal Code

55441

Country

United States

Facility Name

Regeneron Investigational Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63104

Country

United States

Facility Name

Regeneron Investigational Site

City

Forest Hills

State/Province

New York

ZIP/Postal Code

11375

Country

United States

Facility Name

Regeneron Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

Regeneron Investigational Site

City

Rochester

State/Province

New York

ZIP/Postal Code

14642

Country

United States

Facility Name

Regeneron Investigational Site

City

Gahanna

State/Province

Ohio

ZIP/Postal Code

43230

Country

United States

Facility Name

Regeneron Investigational Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Regeneron Investigational site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Regeneron Investigational Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

Regeneron Investigational Site

City

North Charleston

State/Province

South Carolina

ZIP/Postal Code

29420

Country

United States

Facility Name

Regeneron Investigational Site

City

Bellaire

State/Province

Texas

ZIP/Postal Code

77401-3505

Country

United States

Facility Name

Regeneron Investigational Site

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76244

Country

United States

Facility Name

Regeneron Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78218

Country

United States

Facility Name

Regeneron Investigational Site

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23502

Country

United States

Facility Name

Regeneron Investigational Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98105

Country

United States

Facility Name

Regeneron Investigational Site

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2G 1B1

Country

Canada

Facility Name

Regeneron Investigational Site

City

Surrey

State/Province

British Columbia

ZIP/Postal Code

V3R 6A7

Country

Canada

Facility Name

Regeneron Investigational Site

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3C 0N2

Country

Canada

Facility Name

Regeneron Investigational Site

City

Markham

State/Province

Ontario

ZIP/Postal Code

L3P 1X2

Country

Canada

Facility Name

Regeneron Investigational Site

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K2C 2N3

Country

Canada

Facility Name

Regeneron Investigational Site

City

Peterborough

State/Province

Ontario

ZIP/Postal Code

K9J 5K2

Country

Canada

Facility Name

Regeneron Investigational Site

City

Waterloo

State/Province

Ontario

ZIP/Postal Code

N2J 1C4

Country

Canada

Facility Name

Regeneron Investigational Site

City

Windsor

State/Province

Ontario

ZIP/Postal Code

N8W 1E6

Country

Canada

Facility Name

Regeneron Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3T 1C5

Country

Canada

Facility Name

Regeneron Investigational Site

City

Kutna Hora

ZIP/Postal Code

28401

Country

Czechia

Facility Name

Regeneron Investigational Site

City

Prague

ZIP/Postal Code

10034

Country

Czechia

Facility Name

Regeneron Investigational Site

City

Ústí Nad Labem

ZIP/Postal Code

40113

Country

Czechia

Facility Name

Regeneron Study Site

City

Tuebingen

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

72076

Country

Germany

Facility Name

Regeneron Investigational Site

City

Frankfurt

State/Province

Hessen

ZIP/Postal Code

60590

Country

Germany

Facility Name

Regeneron Investigational Site

City

Muenster

State/Province

North Rhine-Westphal

ZIP/Postal Code

48149

Country

Germany

Facility Name

Regeneron Investigational Site

City

Dresden

State/Province

Sachsen

ZIP/Postal Code

01307

Country

Germany

Facility Name

Regeneron Investigational Site

City

Gera

ZIP/Postal Code

07548

Country

Germany

Facility Name

Regeneron Investigational Site

City

Hamburg

ZIP/Postal Code

22149

Country

Germany

Facility Name

Regeneron Study Site

City

Muenchen

ZIP/Postal Code

80802

Country

Germany

Facility Name

Regeneron Investigational Site

City

Munich

ZIP/Postal Code

80337

Country

Germany

Facility Name

Regeneron Investigational Site

City

Szolnok

State/Province

Jasz-Nagykun-Szolnok

ZIP/Postal Code

5000

Country

Hungary

Facility Name

Regeneron Investigational Site

City

Kaposvar

ZIP/Postal Code

7400

Country

Hungary

Facility Name

Regeneron Investigational Site

City

Miskolc

ZIP/Postal Code

3526

Country

Hungary

Facility Name

Regeneron Investigational Site

City

Szeged

ZIP/Postal Code

6720

Country

Hungary

Facility Name

Regeneron Investigational Site

City

Wroclaw

State/Province

Dolnoslaskie

ZIP/Postal Code

50368

Country

Poland

Facility Name

Regeneron Investigational Site

City

Wrocław

State/Province

Dolnoslaskie

ZIP/Postal Code

50-381

Country

Poland

Facility Name

Regeneron Investigational Site

City

Ostrowiec Świętokrzyski

State/Province

Kielce

ZIP/Postal Code

27-400

Country

Poland

Facility Name

Regeneron Investigational Site

City

Krakow

State/Province

Malopolska

ZIP/Postal Code

31-011

Country

Poland

Facility Name

Regeneron Investigational Site

City

Kraków

State/Province

Malopolska

ZIP/Postal Code

30 363

Country

Poland

Facility Name

Regeneron Investigational Site

City

Katowice

State/Province

Slaskie

ZIP/Postal Code

40-648

Country

Poland

Facility Name

Regeneron Investigational Site

City

Białystok

ZIP/Postal Code

15 453

Country

Poland

Facility Name

Regeneron Investigational Site

City

Bydgoszcz

ZIP/Postal Code

85-065

Country

Poland

Facility Name

Regeneron Investigational Site

City

Chorzow

ZIP/Postal Code

41-500

Country

Poland

Facility Name

Regeneron Investigational Site

City

Gdańsk

ZIP/Postal Code

80-152

Country

Poland

Facility Name

Regeneron Investigational Site

City

Katowice

ZIP/Postal Code

40 611

Country

Poland

Facility Name

Regeneron Investigational Site

City

Kraków

ZIP/Postal Code

30 363

Country

Poland

Facility Name

Regeneron Investigational Site

City

Lodz

ZIP/Postal Code

90-265

Country

Poland

Facility Name

Regeneron Investigational Site

City

Warszawa

ZIP/Postal Code

01-142

Country

Poland

Facility Name

Regeneron Investigational Site

City

Warszawa

ZIP/Postal Code

01-817

Country

Poland

Facility Name

Regeneron Investigational Site

City

Warszawa

ZIP/Postal Code

02-758

Country

Poland

Facility Name

Regeneron Investigational Site

City

Warszawa

ZIP/Postal Code

91-142

Country

Poland

Facility Name

Regeneron Investigational Site

City

London

State/Province

Greater London

ZIP/Postal Code

SE1 7EH

Country

United Kingdom

Facility Name

Regeneron Investigational Site

City

Manchester

State/Province

Lancashire

ZIP/Postal Code

M13 9WL

Country

United Kingdom

Facility Name

Regeneron Investigational Site

City

Sheffield

State/Province

South Yorkshire

ZIP/Postal Code

S10 2TH

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

35567671

Citation

Blauvelt A, Guttman-Yassky E, Paller AS, Simpson EL, Cork MJ, Weisman J, Browning J, Soong W, Sun X, Chen Z, Kosloski MP, Kamal MA, Delevry D, Chuang CC, O'Malley JT, Bansal A. Long-Term Efficacy and Safety of Dupilumab in Adolescents with Moderate-to-Severe Atopic Dermatitis: Results Through Week 52 from a Phase III Open-Label Extension Trial (LIBERTY AD PED-OLE). Am J Clin Dermatol. 2022 May;23(3):365-383. doi: 10.1007/s40257-022-00683-2. Epub 2022 May 14.

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

33481203

Citation

Bansal A, Simpson EL, Paller AS, Siegfried EC, Blauvelt A, de Bruin-Weller M, Corren J, Sher L, Guttman-Yassky E, Chen Z, Daizadeh N, Kamal MA, Shumel B, Mina-Osorio P, Mannent L, Patel N, Graham NMH, Khokhar FA, Ardeleanu M. Conjunctivitis in Dupilumab Clinical Trials for Adolescents with Atopic Dermatitis or Asthma. Am J Clin Dermatol. 2021 Jan;22(1):101-115. doi: 10.1007/s40257-020-00577-1.

Results Reference

derived

Learn more about this trial

Study to Assess the Long-term Safety of Dupilumab Administered in Participants ≥6 Months to <18 Years of Age With Atopic Dermatitis (AD)

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Study to Assess the Long-term Safety of Dupilumab Administered in Participants ≥6 Months to <18 Years of Age With Atopic Dermatitis (AD)

Atopic Dermatitis

About this trial

Eligibility Criteria

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Arm 1

Arm 2

Arm 3

Arm 4

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Secondary Outcome Measures

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4. Oversight

5. Study Description

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10. Eligibility

12. IPD Sharing Statement

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