DUPILUMAB for Atopic dermatitis

Inclusion criteria

• {"criterion_text":"- Male or female, ≥6 months to <18 years of age at the time of screening\n- 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\n- PFP Sub-study Only: Age ≥2 to <12 years at time of screening\n- PFP Sub-study only: Body weight ≥5 kg and <60 kg at time of screening\n- 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\n- Note: Other Protocol Defined Inclusion Criteria Apply"}

Exclusion criteria

• {"criterion_text":"- 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\n- 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.\n- Note: Other Protocol Defined Exclusion Criteria Apply\n- 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\n- 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\n- Having used immunosuppressive/immunomodulating drugs within 4 weeks before the baseline visit\n- Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit\n- Diagnosed active endoparasitic infections or at high risk of these infections\n- Severe concomitant illness(es) that, in the investigator's judgment, would adversely affect the participant's participation in the study\n- 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\n- PFP Sub-study Only: Switched dupilumab doses within the past 12 weeks"}

Primary endpoints

• {"endpoint_text":"- Rate of treatment-emergent adverse events (TEAEs) per participant year from baseline through the last study visit","definition_or_measurement_approach":"TEAEs counted and expressed per participant-year from baseline through last study visit."}
• {"endpoint_text":"- Number of participants with at least one TEAE per participant year from baseline through the last study visit","definition_or_measurement_approach":"Number/proportion of participants with ≥1 TEAE expressed per participant-year from baseline through last study visit."}
• {"endpoint_text":"- OPTIONAL SUB-STUDY: Pharmacokinetic (PK) of dupilumab: Peak concentration (Cmax)","definition_or_measurement_approach":"PK measurement of dupilumab peak serum concentration (Cmax) in PFP sub-study participants."}
• {"endpoint_text":"- OPTIONAL SUB-STUDY: PK of dupilumab: Trough concentration (Ctrough)","definition_or_measurement_approach":"PK measurement of dupilumab trough serum concentration (Ctrough) in PFP sub-study participants."}
• {"endpoint_text":"- OPTIONAL SUB-STUDY: Incidence of TEAEs during the 12-week PFP treatment period and during entire sub-study","definition_or_measurement_approach":"Incidence of TEAEs during specified 12-week PFP treatment window and across the full PFP sub-study period."}
• {"endpoint_text":"- OPTIONAL SUB-STUDY: Incidence of SAEs during the 12-week PFP treatment period and during entire sub-study","definition_or_measurement_approach":"Incidence of SAEs during specified 12-week PFP treatment window and across the full PFP sub-study period."}

Secondary endpoints

• {"endpoint_text":"- Number of treatment-emergent serious adverse events (SAEs) from baseline through the last study visit","definition_or_measurement_approach":"Counting SAEs from baseline through last study visit."}
• {"endpoint_text":"- Incidence of TEAEs of special interest from baseline through the last study visit","definition_or_measurement_approach":"Incidence of pre-defined TEAEs of special interest assessed from baseline through last visit."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Proportion of participants achieving IGA 0 or 1 at scheduled in-clinic visits post-baseline."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Proportion achieving ≥75% reduction in EASI from parent-study baseline at scheduled in-clinic visits post-baseline."}
• {"endpoint_text":"- Change from baseline in EASI score at all in-clinic visits post-baseline","definition_or_measurement_approach":"Absolute change in EASI score from baseline at each scheduled in-clinic visit post-baseline."}
• {"endpoint_text":"- Percent change from baseline in EASI at all in-clinic visits post-baseline","definition_or_measurement_approach":"Percent change in EASI from baseline at each scheduled in-clinic visit."}
• {"endpoint_text":"- Change from baseline in Body Surface Area (BSA) affected by AD (BSA) at all in-clinic visits post-baseline","definition_or_measurement_approach":"Change in BSA affected by AD from baseline at scheduled in-clinic visits."}
• {"endpoint_text":"- Percent change from baseline in SCORing Atopic Dermatitis (SCORAD) at all in-clinic visits post-baseline","definition_or_measurement_approach":"Percent change in SCORAD from baseline at scheduled in-clinic visits."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Change from baseline in CDLQI for participants ≥4 years at scheduled visits where assessed."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Change from baseline in IDQOL for participants <4 years at scheduled visits where assessed."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Proportion of initial responders (IGA 0/1) maintaining IGA 0/1 for ≥75% of subsequent visits during treatment."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Median percent of subsequent visits with maintained IGA 0/1 among responders."}
• {"endpoint_text":"- Number of AD flares during the study","definition_or_measurement_approach":"Count of atopic dermatitis flares occurring during study period."}
• {"endpoint_text":"- Annualize event rate of AD flares during the study","definition_or_measurement_approach":"Annualized rate of AD flares during the study."}
• {"endpoint_text":"- Proportion of participants with at least one flare during the study","definition_or_measurement_approach":"Proportion of participants experiencing ≥1 AD flare during study."}
• {"endpoint_text":"- Proportion of well-controlled weeks","definition_or_measurement_approach":"Proportion of weeks classified as well-controlled during study period (as defined in protocol)."}
• {"endpoint_text":"- OPTIONAL SUB-STUDY: Incidence and titer of treatment-emergent anti-drug antibodies (ADA) (PFP Sub-Study)","definition_or_measurement_approach":"Incidence and titers of treatment-emergent ADA measured in PFP sub-study participants."}

Czechia

Earliest CTIS Part Ii Submission Date

27-08-2024

Latest Decision Or Authorization Date

01-10-2024

Processing Time Days

35

Number Of Sites

2

Number Of Participants

13

Germany

Earliest CTIS Part Ii Submission Date

27-08-2024

Latest Decision Or Authorization Date

30-09-2024

Processing Time Days

34

Number Of Sites

5

Number Of Participants

33

Poland

Earliest CTIS Part Ii Submission Date

27-08-2024

Latest Decision Or Authorization Date

03-07-2025

Processing Time Days

310

Number Of Sites

11

Number Of Participants

155

Primary sponsor

Full Name

Regeneron Pharmaceuticals Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Icon Clinical Research Limited

Responsibilities

Contract Research Organisation

Third parties

• {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"sponsorDuties code 3","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medpace Reference Laboratories LLC","duties_or_roles":"sponsorDuties code 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Cytel Inc.","duties_or_roles":"IDMC","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Contract Research Organisation","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"sponsorDuties code 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Fisher Clinical Services Inc.","duties_or_roles":"Clinical Supply","organisation_type":"Pharmaceutical company"}