NCT03054428|CompletedPhase 3ResultsDMCFDA Drug

Efficacy and Safety of Dupilumab in Participants ≥12 to <18 Years of Age, With Moderate-to-severe Atopic Dermatitis

A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Dupilumab Monotherapy in Patients ≥12 to <18 Years of Age, With Moderate-to-severe Atopic Dermatitis

Regeneron Pharmaceuticals ClinicalTrials.gov

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2 other identifiers

R668-AD-15262015-004458-16

Study Type

interventional

Target

251

Locations

2 countries

Sites

Timeline

RegisteredFeb 2017

StartedMar 2017

CompletionJun 2018

Brief Summary

The primary objective of the study was to demonstrate the efficacy of dupilumab as a monotherapy in participants ≥12 years to \<18 years of age with moderate-to-severe atopic dermatitis (AD). The secondary objective of the study was to assess the safety of dupilumab as a monotherapy in participants ≥12 years to \<18 years of age with moderate-to-severe AD.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

251

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Mar 2017

Shorter than P25 for phase_3

Geographic Reach

2 countries

45 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.2 years study duration

First Submitted

Initial submission to the registry

February 13, 2017

Completed

2 days until next milestone

First Posted

Study publicly available on registry

February 15, 2017

Completed

1 month until next milestone

Study Start

First participant enrolled

March 21, 2017

Completed

1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2018

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2018

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

July 23, 2019

Completed

Last Updated

July 23, 2019

Status Verified

July 1, 2019

Enrollment Period

1 year

First QC Date

February 13, 2017

Results QC Date

April 4, 2019

Last Update Submit

July 16, 2019

Conditions

Moderate-to-Severe Atopic Dermatitis Dermatitis, Dermatitis Atopic Eczema, Skin Diseases, Skin Diseases Genetic, Genetic Diseases Inborn, Skin Disease, Eczematous Skin Hypersensitivity, Immediate Hypersensitivity, Immune System Diseases Dermatitis, Atopic

Outcome Measures

Primary Outcomes (2)

Percentage of Participants With Investigator's Global Assessment (IGA) 0 or 1 (and Reduction From Baseline of ≥2 Points) at Week 16
IGA is an assessment scale used to determine severity of atopic dermatitis (AD) and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA "0" or "1" and a reduction from baseline of ≥2 points at Week 16 were reported. \[Values after first rescue treatment used were set to missing. Participants with missing score at week 16 were considered as a non-responder. Participant considered non-responder after rescue treatment use. Efficacy analyses were based on the treatment allocated at randomization (as randomized).\]
Baseline and Week 16
Percentage of Participants With Eczema Area and Severity Index (EASI)-75 (≥75% Improvement From Baseline) at Week 16
The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI--75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline to Week 16. \[Values after first rescue treatment used were set to missing. Participants with missing score at week 16 were considered as a non-responder. Participant considered nonresponder after rescue treatment use. Efficacy analyses were based on the treatment allocated at randomization (as randomized).\]
Baseline and Week 16

Secondary Outcomes (18)

Percent Change From Baseline in EASI Score at Week 16
Baseline and Week 16
Percent Change From Baseline in Weekly Average of Daily Peak Pruritus Numerical Rating Scale (NRS) Score at Week 16
Baseline and Week 16
Percentage of Participants With Improvement (Reduction ≥3 Points) of Weekly Average of Daily Peak Pruritus NRS From Baseline to Week 16
Baseline to Week 16
Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Daily Peak Pruritus NRS From Baseline to Week 16
Baseline to Week 16
Percentage of Participants With EASI-50 (≥50% Improvement From Baseline) at Week 16
Baseline and Week 16
+13 more secondary outcomes

Study Arms (3)

Placebo

EXPERIMENTAL

Participants received placebo matching dupilumab once every 2 weeks (Q2W) (including doubling the amount of placebo on day 1 to match the loading dose). In order to maintain blinding for the study, participants in the \<60 kilogram (kg) weight stratum received, in a 1:1 ratio, either placebo matching 200 milligram (mg) dupilumab (including doubling the amount of placebo on day 1 to match the loading dose) or placebo matching 300 milligram (mg) dupilumab (including doubling the amount of placebo on day 1 to match the loading dose). In the ≥60 kg weight stratum, the participants randomized to the placebo group received placebo matching 300 mg dupilumab (including doubling the amount of placebo on day 1 to match the loading dose).

Drug: Placebo

Dupilumab 300 mg Q4W

EXPERIMENTAL

Participants received once every 4 weeks (Q4W) subcutaneous (SC) injections of 300 milligrams (mg) dupilumab following a loading dose of 600 mg on day 1. In order to maintain blinding, all participants received an injection once every 2 weeks (Q2W) from day 1 to week 14. Participants received placebo 2 milliliter (mL) injection at the weeks dupilumab was not given.

Drug: Dupilumab

Dupilumab 200 mg or 300 mg Q2W

EXPERIMENTAL

Participants with baseline weight \<60 kg received once every 2 weeks (Q2W) subcutaneous (SC) injections of 200 milligrams (mg) dupilumab following a loading dose of 400 mg on day 1. Participants with baseline weight ≥60 kg received Q2W SC injections of 300 mg dupilumab following a loading dose of 600 mg on day 1.

Drug: Dupilumab

Interventions

DupilumabDRUG

Subcutaneous injection among the different quadrants of the abdomen (avoiding navel and waist areas), upper thighs, and upper arms.

Also known as: REGN668

Dupilumab 200 mg or 300 mg Q2WDupilumab 300 mg Q4W

PlaceboDRUG

Subcutaneous injection among the different quadrants of the abdomen (avoiding navel and waist areas), upper thighs, and upper arms.

Placebo

Eligibility Criteria

Age12 Years - 17 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

Male or female ≥12 to \<18 years of age at time of screening visit
Diagnosis of AD according to the American Academy of Dermatology consensus criteria at screening visit
IGA ≥3 at screening and baseline visit
EASI ≥16 at the screening and baseline visit
Baseline Pruritus NRS average score for maximum itch intensity ≥4
≥10% BSA of AD involvement at the screening and baseline visits
With documented recent history (within 6 months before the screening visit) of inadequate response to topical AD medication(s) or for whom topical treatments is medically inadvisable

You may not qualify if:

Participation in a prior dupilumab clinical study
Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within 2 weeks before the baseline visit
Having used immunosuppressive/immunomodulating drugs within 4 weeks before the baseline visit
Body weight \<30 kg at baseline
Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before the baseline visit
Known or suspected immunodeficiency, known history of human immunodeficiency virus (HIV) infection or HIV seropositivity at the screening visit, established diagnosis of HBV infection or HBV seropositivity at screening, established diagnosis of HCV infection or HCV seropositivity at screening
History of malignancy before the baseline visit
Diagnosed active endoparasitic infections or at high risk of these infections
Patient is female who is pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
Patient is female of childbearing potential and sexually active, who is unwilling to use adequate methods of contraception throughout the duration of the study and for 120 days after the last dose of study drug

Contact the study team to confirm eligibility.