NCT02407756

Brief Summary

The primary objective of the study is to characterize the safety and pharmacokinetics (PK) of dupilumab in pediatric patients with moderate-to-severe atopic dermatitis (AD) (for adolescents ≥12 to \<18 years of age) or severe AD (for children ≥6 to \<12 years of age). The secondary objective of the study is to explore the immunogenicity and efficacy of dupilumab in pediatric patients with moderate-to-severe AD (for adolescents ≥12 to \<18 years of age) or severe AD (for children ≥6 to \<12 years of age).

Trial Health

93
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2015

Shorter than P25 for phase_2

Geographic Reach
6 countries

26 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

First Submitted

Initial submission to the registry

March 31, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

March 31, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 3, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2016

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

October 5, 2020

Completed
Last Updated

November 27, 2020

Status Verified

November 1, 2020

Enrollment Period

1 year

First QC Date

March 31, 2015

Results QC Date

September 10, 2020

Last Update Submit

November 24, 2020

Conditions

Atopic Dermatitis

Keywords

Eczema

Outcome Measures

Primary Outcomes (3)

  • Pharmacokinetics (PK) of Dupilumab: Maximum Plasma Concentration Observed (Cmax) After Single Administration

    Peak dupilumab concentration in serum following single dose administration. Analysis was performed on PK analysis set that included all treated subjects who received the study medication and had at least 1 quantified (non-missing) result for dupilumab concentration following the first dose of the study drug.

    Day 2, 4, 8, 15, 22, 29, 36, 43, and 50

  • PK of Dupilumab: Area Under the Plasma Concentration Versus Time Curve (AUClast) After Single Administration

    Mean AUC estimates were calculated using mean concentration data at each time point, using a non-compartmental approach (NCA). Calculated AUClast (computed from time zero to the time of the last positive concentration) are presented. Analysis was performed on PK analysis set that included all treated subjects who received the study medication and had at least 1 quantified (non-missing) result for dupilumab concentration following the first dose of the study drug.

    Day 2, 4, 8, 15, 22, 29, 36, 43, and 50

  • PK of Dupilumab: Trough Dupilumab Concentration in Serum (Ctrough) Before 3rd and 4th Repeated Dose

    Analysis was performed on PK analysis set that included all treated subjects who received the study medication and had at least 1 quantified (non-missing) result for dupilumab concentration following the first dose of study drug.

    Pre-dose on Day 71 and Day 85

Secondary Outcomes (5)

  • Percent Reduction From Baseline in Eczema Area and Severity Index (EASI) at Week 12

    Baseline to Week 12 (one week after last dose)

  • Percent Reduction From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Week 12

    Baseline to Week 12 (one week after last dose)

  • Percent Reduction From Baseline in Pruritus Numerical Rating Scale (NRS) at Week 12

    Baseline to Week 12 (one week after last dose)

  • Percentage of Subjects With Investigator Global Assessment (IGA) Score of "0" or "1" (Clear or Almost Clear) at Week 12

    Week 12

  • Percent Reduction From Baseline in Body Surface Area (BSA) at Week 12

    Baseline to Week 12

Study Arms (2)

Cohort 1

EXPERIMENTAL

Cohort 1 will receive dupilumab dosing regimen 1

Drug: Dupilumab

Cohort 2

EXPERIMENTAL

Cohort 2 will receive dupilumab dosing regimen 2

Drug: Dupilumab

Interventions

DupilumabDRUG
Also known as: REGN668(SAR231893)
Cohort 1Cohort 2

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Male or female patients ≥6 to \<18 years of age with a diagnosis of 1. Atopic Dermatitis whose disease cannot be adequately controlled with topical medications
  • Minimum disease severity, as defined by Investigator's Global Assessment (IGA)
  • IGA = 3 or 4 in adolescents ≥12 to \<18 year of age
  • IGA = 4 in children ≥6 to \<12 years of age

You may not qualify if:

  • Recent treatment (within specific time windows before the baseline visit) with systemic immunosuppressive agents for eg. Systemic corticosteroids, live (attenuated) vaccines and other investigational drugs including biologics
  • History of any of the following infections:
  • Any systemic infection requiring treatment within 4 weeks before the baseline visit
  • Superficial skin infections within 1 week before the baseline visit
  • Known history of HIV infection
  • History of seropositivity to hepatitis B or C screening tests
  • History of clinical endoparasitosis (ie, helminthic infection) within 12 months before the baseline visit, or high risk of helminthic infection, unless subsequent medical assessments (e.g. stool exam, blood tests, etc.) have ruled out the possibility of parasite infection/infestation
  • History of malignancy within 5 years before the baseline visit
  • Persistent (confirmed by repeated tests ≥2 weeks apart) elevated transaminases (alanine aminotransferase \[ALT\] and/or aspartate aminotransferase \[AST\]) more than 3 times the upper limit of normal (ULN) during the screening period
  • Presence of any severe concomitant illness(es) that, in the investigator's judgment, would adversely affect the patient's participation in the study
  • Presence of skin comorbidities that may interfere with study assessments
  • Females patients who are pregnant or breastfeeding
  • Female patients who are of reproductive potential and are sexually active, who are unwilling to use adequate methods of contraception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Unknown Facility

Markham, Ontario, Canada

Location

Unknown Facility

Peterborough, Ontario, Canada

Location

Unknown Facility

Waterloo, Ontario, Canada

Location

Unknown Facility

Windsor, Ontario, Canada

Location

Unknown Facility

Kutná Hora, Czechia

Location

Unknown Facility

Prague, Czechia

Location

Unknown Facility

Dresden, Germany

Location

Unknown Facility

Frankfurt, Germany

Location

Unknown Facility

Gera, Germany

Location

Unknown Facility

Hamburg, Germany

Location

Unknown Facility

Kiel, Germany

Location

Unknown Facility

Lübeck, Germany

Location

Unknown Facility

Munich, Germany

Location

Unknown Facility

Münster, Germany

Location

Unknown Facility

Tübingen, Germany

Location

Unknown Facility

Kaposvár, Hungary

Location

Unknown Facility

Miskolc, Hungary

Location

Unknown Facility

Szeged, Hungary

Location

Unknown Facility

Szolnok, Hungary

Location

Unknown Facility

Katowice, Poland

Location

Unknown Facility

Krakow, Poland

Location

Unknown Facility

Lodz, Poland

Location

Unknown Facility

Warsaw, Poland

Location

Unknown Facility

Wroclaw, Poland

Location

Unknown Facility

Manchester, United Kingdom

Location

Unknown Facility

Sheffield, United Kingdom

Location

Related Publications (2)

  • Blauvelt A, Guttman-Yassky E, Paller AS, Simpson EL, Cork MJ, Weisman J, Browning J, Soong W, Sun X, Chen Z, Kosloski MP, Kamal MA, Delevry D, Chuang CC, O'Malley JT, Bansal A. Long-Term Efficacy and Safety of Dupilumab in Adolescents with Moderate-to-Severe Atopic Dermatitis: Results Through Week 52 from a Phase III Open-Label Extension Trial (LIBERTY AD PED-OLE). Am J Clin Dermatol. 2022 May;23(3):365-383. doi: 10.1007/s40257-022-00683-2. Epub 2022 May 14.

    PMID: 35567671DERIVED

  • Cork MJ, Thaci D, Eichenfield LF, Arkwright PD, Hultsch T, Davis JD, Zhang Y, Zhu X, Chen Z, Li M, Ardeleanu M, Teper A, Akinlade B, Gadkari A, Eckert L, Kamal MA, Ruddy M, Graham NMH, Pirozzi G, Stahl N, DiCioccio AT, Bansal A. Dupilumab in adolescents with uncontrolled moderate-to-severe atopic dermatitis: results from a phase IIa open-label trial and subsequent phase III open-label extension. Br J Dermatol. 2020 Jan;182(1):85-96. doi: 10.1111/bjd.18476. Epub 2019 Oct 8.

    PMID: 31595499DERIVED

MeSH Terms

Conditions

Dermatitis, AtopicEczema

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Results Point of Contact

Title
Clinical Trial Administrator
Organization
Regeneron Pharmaceuticals, Inc.
clinicaltrials@regeneron.com
844-734-6643

Study Officials

  • Clinical Trial Management

    Regeneron Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2015

First Posted

April 3, 2015

Study Start

March 31, 2015

Primary Completion

March 31, 2016

Study Completion

March 31, 2016

Last Updated

November 27, 2020

Results First Posted

October 5, 2020

Record last verified: 2020-11

Locations

HU(4)CZ(2)PL(5)GB(2)CA(4)DE(9)