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

Phase 3

Active, not recruiting

• Conditions: Atopic Dermatitis

• Registration Number: 2023-509425-53-00
• Lead Sponsor: Regeneron Pharmaceuticals Inc.

Brief Summary

To assess the long-term safety of dupilumab in pediatric patients with Atopic Dermatitis (AD).

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

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-09-30
• Last Update Posted: 2024-10-02

Recruitment & Eligibility

• Status: Ongoing, recruitment ended
• Sex: Not specified
• Target Recruitment: 201

Inclusion Criteria

Male or female, ≥6 months to <18 years of age at the time of screening

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

PFP Sub-study only: Body weight ≥5 kg and <60 kg at time of screening

PFP Sub-study only: 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

Note: Other Protocol Defined Inclusion Criteria Apply

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

PFP Sub-study Only: 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 Exclusion Criteria Apply

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

PFP Sub-study Only: Switched dupilumab doses within the past 12 weeks

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of treatment-emergent adverse events (TEAEs) per participant year from baseline through the last study visit		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		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)		OPTIONAL SUB-STUDY: Pharmacokinetic (PK) of dupilumab: Peak concentration (Cmax)
OPTIONAL SUB-STUDY: PK of dupilumab: Trough concentration (Ctrough)		OPTIONAL SUB-STUDY: PK of dupilumab: Trough concentration (Ctrough)
OPTIONAL SUB-STUDY: Incidence of TEAEs during the 12-week PFP treatment period and during entire sub-study		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		OPTIONAL SUB-STUDY: Incidence of SAEs during the 12-week PFP treatment period and during entire sub-study

Secondary Outcome Measures

Name	Time	Method
Percent change from baseline in SCORing Atopic Dermatitis (SCORAD) 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 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		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
Number of treatment-emergent serious adverse events (SAEs) from baseline through the last study visit		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		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 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		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		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		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		Change from baseline in Body Surface Area (BSA) affected by AD (BSA) at all in-clinic visits post-baseline
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		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
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		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
Number of AD flares during the study		Number of AD flares during the study
Annualize event rate of AD flares during the study		Annualize event rate of AD flares during the study
Proportion of participants with at least one flare during the study		Proportion of participants with at least one flare during the study
Proportion of well-controlled weeks		Proportion of well-controlled weeks
OPTIONAL SUB-STUDY: Incidence and titer of treatment-emergent anti-drug antibodies (ADA) (PFP Sub-Study)		OPTIONAL SUB-STUDY: Incidence and titer of treatment-emergent anti-drug antibodies (ADA) (PFP Sub-Study)

Trial Locations

Locations (21)

Kozni ambulance Kutna Hora s.r.o.; 🇨🇿 Kutna Hora, Czechia

Krajska zdravotni a.s.; 🇨🇿 Usti Nad Labem, Czechia

Universitaetsklinikum Schleswig-Holstein AöR; 🇩🇪 Luebeck, Germany

Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR; 🇩🇪 Dresden, Germany

Universitaetsklinikum Muenster AöR; 🇩🇪 Muenster, Germany

Klinikum rechts der Isar der TU Muenchen AöR; 🇩🇪 Munich, Germany

Universitaetsklinikum Frankfurt AöR; 🇩🇪 Frankfurt Am Main, Germany

Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.; 🇵🇱 Cracow, Poland

Klinika Ambroziak Sp. z o.o.; 🇵🇱 Warsaw, Poland

Pro Familia Altera Sp. z o.o.; 🇵🇱 Katowice, Poland

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Kozni ambulance Kutna Hora s.r.o.

🇨🇿Kutna Hora, Czechia

Lucie Petru

Site contact

00420327503202

petru.l@seznam.cz