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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02612454
Other study ID # R668-AD-1434
Secondary ID 2015-001396-40
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date October 15, 2015
Est. completion date October 7, 2026

Study information

Verified date June 2024
Source Regeneron Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 880
Est. completion date October 7, 2026
Est. primary completion date October 7, 2026
Accepts healthy volunteers No
Gender All
Age group 6 Months to 17 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dupilumab
Weight-tiered dosing administered subcutaneous (SC)

Locations

Country Name City State
Canada Regeneron Investigational Site Calgary Alberta
Canada Regeneron Investigational Site Markham Ontario
Canada Regeneron Investigational Site Montreal Quebec
Canada Regeneron Investigational Site Ottawa Ontario
Canada Regeneron Investigational Site Peterborough Ontario
Canada Regeneron Investigational Site Surrey British Columbia
Canada Regeneron Investigational Site Waterloo Ontario
Canada Regeneron Investigational Site Windsor Ontario
Canada Regeneron Investigational Site Winnipeg Manitoba
Czechia Regeneron Investigational Site Kutna Hora
Czechia Regeneron Investigational Site Prague
Czechia Regeneron Investigational Site Ústí Nad Labem
Germany Regeneron Investigational Site Dresden Sachsen
Germany Regeneron Investigational Site Frankfurt Hessen
Germany Regeneron Investigational Site Gera
Germany Regeneron Investigational Site Hamburg
Germany Regeneron Study Site Muenchen
Germany Regeneron Investigational Site Muenster North Rhine-Westphal
Germany Regeneron Investigational Site Munich
Germany Regeneron Study Site Tuebingen Baden-Wuerttemberg
Hungary Regeneron Investigational Site Kaposvar
Hungary Regeneron Investigational Site Miskolc
Hungary Regeneron Investigational Site Szeged
Hungary Regeneron Investigational Site Szolnok Jasz-Nagykun-Szolnok
Poland Regeneron Investigational Site Bialystok
Poland Regeneron Investigational Site Bydgoszcz
Poland Regeneron Investigational Site Chorzow
Poland Regeneron Investigational Site Gdansk
Poland Regeneron Investigational Site Katowice
Poland Regeneron Investigational Site Katowice Slaskie
Poland Regeneron Investigational Site Krakow Malopolska
Poland Regeneron Investigational Site Kraków Malopolska
Poland Regeneron Investigational Site Kraków
Poland Regeneron Investigational Site Lodz
Poland Regeneron Investigational Site Ostrowiec Swietokrzyski Kielce
Poland Regeneron Investigational Site Warszawa
Poland Regeneron Investigational Site Warszawa
Poland Regeneron Investigational Site Warszawa
Poland Regeneron Investigational Site Warszawa
Poland Regeneron Investigational Site Wroclaw Dolnoslaskie
Poland Regeneron Investigational Site Wroclaw Dolnoslaskie
United Kingdom Regeneron Investigational Site London Greater London
United Kingdom Regeneron Investigational Site Manchester Lancashire
United Kingdom Regeneron Investigational Site Sheffield South Yorkshire
United States Regeneron Investigational Site Bakersfield California
United States Regeneron Investigational Site Bellaire Texas
United States Regeneron Investigational Site Birmingham Alabama
United States Regeneron Investigational Site Boston Massachusetts
United States Regeneron Investigational Site Boston Massachusetts
United States Regeneron Investigational Site Centennial Colorado
United States Regeneron Investigational Site Charleston South Carolina
United States Regeneron Investigational Site Chicago Illinois
United States Regeneron Investigational Site Columbus Georgia
United States Regeneron Investigational Site Coral Gables Florida
United States Regeneron Investigational Site Forest Hills New York
United States Regeneron Investigational Site Fort Worth Texas
United States Regeneron Investigational Site Gahanna Ohio
United States Regeneron Investigational Site Gilbert Arizona
United States Regeneron Investigational Site Long Beach California
United States Regeneron Investigational Site Los Angeles California
United States Regeneron Investigational Site Macon Georgia
United States Regeneron Investigational site Mission Viejo California
United States Regeneron Investigational Site New York New York
United States Regeneron Investigational Site Norfolk Virginia
United States Regeneron Investigational Site North Charleston South Carolina
United States Regeneron Investigational Site Orange California
United States Regeneron Investigational Site Palo Alto California
United States Regeneron Investigational site Philadelphia Pennsylvania
United States Regeneron Investigational site Plainfield Indiana
United States Regeneron Investigational Site Plymouth Minnesota
United States Regeneron Investigational Site Portland Oregon
United States Regeneron Investigational Site Rochester New York
United States Regeneron Investigational Site Rockville Maryland
United States Regeneron Investigational Site Rolling Hills Estates California
United States Regeneron Investigational Site Saint Louis Missouri
United States Regeneron Investigational Site San Antonio Texas
United States Regeneron Investigational Site San Diego California
United States Regeneron Investigational Site Sandy Springs Georgia
United States Regeneron Investigational Site Seattle Washington
United States Regeneron Investigational Site Skokie Illinois
United States Regeneron Investigational Site Tampa Florida
United States Regeneron Investigational Site Tampa Florida
United States Regeneron Investigational Site Washington District of Columbia
United States Regeneron Investigational Site Ypsilanti Michigan

Sponsors (2)

Lead Sponsor Collaborator
Regeneron Pharmaceuticals Sanofi

Countries where clinical trial is conducted

United States,  Canada,  Czechia,  Germany,  Hungary,  Poland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of treatment-emergent adverse events (TEAEs) per participant year from baseline through the last study visit Baseline up to week 272
Primary Number of participants with at least one TEAE per participant year from baseline through the last study visit Baseline up to week 272
Primary 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) Up to week 16
Primary 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) Up to week 16
Primary OPTIONAL SUB-STUDY: Incidence of TEAEs during the 12-week PFP treatment period and during entire sub-study Up to week 16
Primary OPTIONAL SUB-STUDY: Incidence of SAEs during the 12-week PFP treatment period and during entire sub-study Up to week 16
Secondary Number of treatment-emergent serious adverse events (SAEs) from baseline through the last study visit Baseline up to week 272
Secondary Incidence of TEAEs of special interest from baseline through the last study visit Baseline up to week 272
Secondary 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 Baseline up to week 272
Secondary 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 Baseline up to week 272
Secondary Change from baseline in EASI score at all in-clinic visits post-baseline Baseline up to week 272
Secondary Percent change from baseline in EASI at all in-clinic visits post-baseline Baseline up to week 272
Secondary Change from baseline in Body Surface Area (BSA) affected by AD (BSA) at all in-clinic visits post-baseline Baseline up to week 272
Secondary Percent change from baseline in SCORing Atopic Dermatitis (SCORAD) at all in-clinic visits post-baseline Baseline up to week 272
Secondary 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 Baseline up to week 272
Secondary 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 Baseline up to week 272
Secondary 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. Baseline to week 260
Secondary 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. Baseline to week 260
Secondary Number of AD flares during the study AD flares are defined as worsening of the disease that requires escalation/intensification of AD treatment Baseline to week 272
Secondary 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 Baseline to week 272
Secondary 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 Baseline to week 272
Secondary 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 Baseline to week 272
Secondary OPTIONAL SUB-STUDY: Incidence and titer of treatment-emergent anti-drug antibodies (ADA) (PFP Sub-Study) Up to 16 weeks
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