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 Clinical Trial

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

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
• 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
• 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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

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