A Study to Determine the Safety and Tolerability of Dupilumab (REGN668/SAR231893) in Patients Aged ≥6 to <18 Years With Atopic Dermatitis (Eczema)

NCT ID: NCT02407756

Last Updated: 2020-11-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-03-31

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).

Conditions

Atopic Dermatitis

Keywords

Eczema

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1

Cohort 1 will receive dupilumab dosing regimen 1

Group Type: EXPERIMENTAL

Dupilumab

Intervention Type: DRUG

Cohort 2

Cohort 2 will receive dupilumab dosing regimen 2

Group Type: EXPERIMENTAL

Dupilumab

Intervention Type: DRUG

Interventions

Dupilumab

Intervention Type: DRUG

Other Intervention Names

REGN668(SAR231893)

Eligibility Criteria

Inclusion Criteria

1. 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

2. Minimum disease severity, as defined by Investigator's Global Assessment (IGA)

1. IGA = 3 or 4 in adolescents ≥12 to <18 year of age

2. IGA = 4 in children ≥6 to <12 years of age

Exclusion Criteria

1. 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

2. History of any of the following infections:

1. Any systemic infection requiring treatment within 4 weeks before the baseline visit

2. Superficial skin infections within 1 week before the baseline visit

3. Known history of HIV infection

4. History of seropositivity to hepatitis B or C screening tests

5. 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

3. History of malignancy within 5 years before the baseline visit

4. 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

5. Presence of any severe concomitant illness(es) that, in the investigator's judgment, would adversely affect the patient's participation in the study

6. Presence of skin comorbidities that may interfere with study assessments

7. Females patients who are pregnant or breastfeeding

8. Female patients who are of reproductive potential and are sexually active, who are unwilling to use adequate methods of contraception

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

Markham, Ontario, Canada

Peterborough, Ontario, Canada

Waterloo, Ontario, Canada

Windsor, Ontario, Canada

Kutná Hora, , Czechia

Prague, , Czechia

Dresden, , Germany

Frankfurt, , Germany

Gera, , Germany

Hamburg, , Germany

Kiel, , Germany

Lübeck, , Germany

Munich, , Germany

Münster, , Germany

Tübingen, , Germany

Kaposvár, , Hungary

Miskolc, , Hungary

Szeged, , Hungary

Szolnok, , Hungary

Katowice, , Poland

Krakow, , Poland

Lodz, , Poland

Warsaw, , Poland

Wroclaw, , Poland

Manchester, , United Kingdom

Sheffield, , United Kingdom

Countries

Canada; Czechia; Germany; Hungary; Poland; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 35567671 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31595499 (View on PubMed)

Other Identifiers

R668-AD-1412

Identifier Type: -

Identifier Source: org_study_id