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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)

StatusActive, Not Recruiting
PhasePhase 3
Started2015-10-15
View on ClinicalTrials.gov ↗

Amendment history

2026-05-26
2 amendments v15-v16
2 re-verifications since 2025-06-24, no change to tracked fields
2024-06-07
Study Status v14
Primary completion date2026-08-19→2026-10-07
Completion date2026-08-19→2026-10-07
2023-05-04
Study Status v13
Re-verified, no change to tracked fields
2022-07-26
Enrolling by Invitation→Active, Not Recruiting Study Status, Study Design v12
Trial statusEnrolling by Invitation→Active, Not Recruiting
Primary completion date2026-11-03→2026-08-19
Completion date2026-11-03→2026-08-19
Enrollment targetestimated 800→confirmed 880
2021-06-30
Study Status, Study Description, Outcome Measures, Eligibility v11
Primary completion date2026-12-17→2026-11-03
Completion date2026-12-17→2026-11-03
Eligibility criteria+646 characters
Key Inclusion Criteria: - Participated in a prior dupilumab study in pediatric partici [...] d 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 parti [...] dversely affect the participant's participation in the study PFP Sub-study Only: Poor complian [...] [...]
Secondary endpoints16 to 17 entries
OPTIONAL SUB-STUDY: Incidence and titer of treatment-emergent anti-drug antibodies (ADA) (PFP Sub-Study)
Primary endpoints2 to 6 entries
OPTIONAL SUB-STUDY: Incidence of SAEs 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: PK of dupilumab: Trough concentration (Ctrough) OPTIONAL SUB-STUDY: [...]
Show 10 earlier versions
2021-04-06
Study Status, Contacts/Locations v10
Study sites102→84
2020-05-20
Study Identification, Study Status, Study Design, Arms and Interventions, Eligibility, Contacts/Locations v9
Primary completion date2023-11-16→2026-12-17
Completion date2023-11-16→2026-12-17
Enrollment target765→800
Study sites97→102
Study arms1→4
Eligibility criteria+15 characters
Key Inclusion Criteria: 1.- Participated in a prior dupilumab study in pediatric patientsparticipants with AD and adequately completed the visits and assessments [...] defined in the prior study protocol Key Exclusion Criteria: PatientsParticipants who, during their participation in a prior dupilumab study [...] study drug may present an unreasonable risk for the patient PatientsParticipants, who during the participation in a prior Dupilumab study, d [...] in the investigator's judgment, would adversely affect the patientparticipant's participation in the study. Note: Other protocol defined Inclusion / Exclusion [...]
2019-07-30
Study Status, Contacts/Locations v8
Study sites95→97
2019-03-21
Study Status, Oversight, Contacts/Locations v7
Primary completion date2024-01-25→2023-11-16
Completion date2024-01-25→2023-11-16
Study sites92→95
2019-01-15
Study Status, Contacts/Locations v6
Study sites90→92
2019-01-07
Study Status, Contacts/Locations v5
Primary completion date2023-10-16→2024-01-25
Completion date2023-10-16→2024-01-25
Start date2015-10-22→2015-10-15
Study sites78→90
2018-08-21
Study Status, Contacts/Locations v4
Study sites72→78
2018-05-01
Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v3
Study sites25→72
Study arms2→1
Eligibility criteria+236 characters
[...] study drug may present an unreasonable risk for the patient HavingPatients, usedwho immunosuppressive/immunomodulating drugs within 4 weeks beforeduring the baselineparticipation visitin 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 dupiluma [...]
Secondary endpoints16 entries, revised
Incidence (number)Number of treatment-emergent serious adverse events (SAEs) from baseline through the last study visit Change from baseline in Eczema Area and Severity Index (EASI) score at all in-clinic visits post-baseline Assessment of maintenance of treatment effect: Proportion of responders (defined as patientsparticipants with IGA 0 or 1) who maintain IGA 0 or 1 during at least 75% of the subsequent* visits during the treatment period Assessment of maintenance of treatment effect: For responders (defined as patientsparticipants with IGA 0 or 1), median percentage of subsequent* visits d [...] [...]
Primary endpoints2 entries, revised
Incidence (number)Number of patientsparticipants with at least 1one TEAE per participant year from baseline through the last study visit
Study title-20 characters
Study to Assess the Long-term Safety of Dupilumab (REGN668/SAR231893) Administered in Participants ≥6 Months to <18 Years of Age With Atopic Dermatitis (AD)
2017-11-27
Study Identification, Study Status, Oversight, Study Design, Arms and Interventions, Outcome Measures, Eligibility v2
Primary completion date2018-10→2023-10-16
Completion date2018-10→2023-10-16
Start date2015-10→2015-10-22
Enrollment target69→765
Eligibility criteria-465 characters
Key Inclusion Criteria: Male1. or female, ≥6 to <18 years of age at the time of screening Participated in a prior dupilumab study in pediatric patient [...] who, during their participation in a prior dupilumab study in pediatric patients with AD, developed aan adverse event (AE) or serious adverse event (SAE) potentially related to the study drug any adverse event (AE) that led to permanent study drug discontinuation in the prior dupilumab study, except if the AE was worsening AD, or if the patient received placebo (if known) Patients, who during their participation in a prior dupilumab study in ped [...] [...]
Secondary endpoints4 to 16 entries
Incidence and rate (events per patient-yearnumber) of treatment-emergent SAEs andfrom AEsbaseline through the last study visit Incidence of TEAEs of special interest from baseline through the last study visit Proportion of patientsparticipants whowith achievean and maintain remission [(Investigator's Global Assessment (IGA) score of 0 or 1 (clear or almost clear) at all in-1)]clinic overvisits timepost-baseline Proportion of participants with Eczema Area and Severity Index (EASI)-75: Proportion of patients achieving and maintaining at least (≥75% reduction in EASI from baseline of parent study [...] [...]
Primary endpoints1 to 2 entries
Incidence and(number) rateof patients with at least 1 TEAE 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
Study title+11 characters
A Study to Assess the Long-term Safety of Dupilumab (REGN668/SAR231893) Administered in PatientsParticipants ≥6 Months to <18 YearYears of Age With Atopic Dermatitis (AD)
2016-10-26
Study Status, Study Design, Eligibility v1
Primary completion date2018-07→2018-10
Completion date2018-07→2018-10
Enrollment target80→69
2015-11-19
Original filing
Regeneron
148 trials monitored
See 16 trials at risk
Atopic Dermatitis
489 trials monitored
See 14 trials at risk
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
Trial Details
NCT Number NCT02612454
Lead Sponsor Regeneron Pharmaceuticals
Collaborators: Sanofi
Conditions Atopic Dermatitis
Enrollment 880 participants
Start Date 2015-10-15
Primary Completion 2026-10-07 (estimated)
Study Completion 2026-10-07 (estimated)
Updated on ClinicalTrials.gov 2026-05-29