- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02407756
A Study to Determine the Safety and Tolerability of Dupilumab (REGN668/SAR231893) in Patients Aged ≥6 to <18 Years With Atopic Dermatitis (Eczema)
A Phase 2a Study Investigating the Safety, Pharmacokinetics, Immunogenicity, and Exploratory Efficacy of Dupilumab in Patients Aged ≥6 to <18 Years With Atopic Dermatitis
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).
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Ontario
-
Markham, Ontario, Canada
-
Peterborough, Ontario, Canada
-
Waterloo, Ontario, Canada
-
Windsor, Ontario, Canada
-
-
-
-
-
Kutna Hora, Czechia
-
Prague, Czechia
-
-
-
-
-
Dresden, Germany
-
Frankfurt, Germany
-
Gera, Germany
-
Hamburg, Germany
-
Kiel, Germany
-
Luebeck, Germany
-
Muenster, Germany
-
Munich, Germany
-
Tuebingen, Germany
-
-
-
-
-
Kaposvar, Hungary
-
Miskolc, Hungary
-
Szeged, Hungary
-
Szolnok, Hungary
-
-
-
-
-
Katowice, Poland
-
Krakow, Poland
-
Lodz, Poland
-
Warszawa, Poland
-
Wroclaw, Poland
-
-
-
-
-
Manchester, United Kingdom
-
Sheffield, United Kingdom
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Key Inclusion Criteria:
- 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
Key Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort 1
Cohort 1 will receive dupilumab dosing regimen 1
|
Other Names:
|
Experimental: Cohort 2
Cohort 2 will receive dupilumab dosing regimen 2
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics (PK) of Dupilumab: Maximum Plasma Concentration Observed (Cmax) After Single Administration
Time Frame: Day 2, 4, 8, 15, 22, 29, 36, 43, and 50
|
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
Time Frame: Day 2, 4, 8, 15, 22, 29, 36, 43, and 50
|
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
Time Frame: Pre-dose on Day 71 and Day 85
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Reduction From Baseline in Eczema Area and Severity Index (EASI) at Week 12
Time Frame: Baseline to Week 12 (one week after last dose)
|
The EASI score was used to measure the severity and extent of atopic dermatitis (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 to 72 points, with the higher scores reflecting the worse severity of AD.
Analysis was performed on safety analysis set (SAF) that included all subjects who received any study drug.
Data after rescue treatment use during the Part B period were set to missing, then missing values were imputed by last observation carried forward (LOCF).
|
Baseline to Week 12 (one week after last dose)
|
Percent Reduction From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Week 12
Time Frame: Baseline to Week 12 (one week after last dose)
|
SCORAD is a clinical tool for assessing the severity of atopic dermatitis developed by the European Task Force on Atopic Dermatitis ("Severity scoring of atopic dermatitis: the SCORAD index.
Consensus Report of the European Task Force on Atopic Dermatitis".
Dermatology (Basel) 186 (1): 23-31.
1993).
Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored.
Total score ranges from 0 [absent disease] to 103 [severe disease]).
Analysis was performed on SAF.
Data after rescue treatment use during the Part B period were set to missing, then missing values were imputed by LOCF.
|
Baseline to Week 12 (one week after last dose)
|
Percent Reduction From Baseline in Pruritus Numerical Rating Scale (NRS) at Week 12
Time Frame: Baseline to Week 12 (one week after last dose)
|
Pruritus NRS scale is an assessment tool that is used to report the intensity of subject's pruritus (itch), both maximum and average intensity, during a 24-hour recall period.
Subjects were asked the following question: how would a subject rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]).
Analysis was performed on SAF.
Data after rescue treatment use during the Part B period were set to missing, then missing values were imputed by LOCF.
|
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
Time Frame: Week 12
|
IGA is an assessment scale used to determine severity of 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 is an IGA score of 0 (clear) or 1 (almost clear).
Analysis was performed on SAF.
Subjects with rescue treatment usage during the Part B period were specified as non-responders from the time the rescue was used.
|
Week 12
|
Percent Reduction From Baseline in Body Surface Area (BSA) at Week 12
Time Frame: Baseline to Week 12
|
Body surface area affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]).
It was reported as a percentage of all major body sections combined.
Analysis was performed on SAF.
|
Baseline to Week 12
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R668-AD-1412
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Atopic Dermatitis
-
Catalysis SLCompletedAtopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis and Related Conditions | Atopic Dermatitis \(AD\)Serbia
-
Jacob Pontoppidan ThyssenThe Novo Nordic FoundationRecruitingAtopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis FlareDenmark
-
ShaperonRecruitingAtopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis of ScalpUnited States
-
University of California, San FranciscoSanofi; Regeneron PharmaceuticalsRecruitingEczema | Atopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis and Related ConditionsUnited States
-
PfizerActive, not recruitingEczema | Atopic Dermatitis | Eczema, Atopic | Atopic Dermatitis, UnspecifiedUnited States, Canada, Czechia, Poland
-
AmgenCompletedDermatitis, Atopic DermatitisCanada, United States, Japan
-
SanofiCompletedAtopic Dermatitis | Dermatitis AtopicChina
-
SanofiCompletedDermatitis AtopicSaudi Arabia, Kuwait, United Arab Emirates
-
Hadassah Medical OrganizationUnknownATOPIC DERMATITIS
-
Regeneron PharmaceuticalsSanofiRecruitingModerate-to-Severe Atopic Dermatitis | Atopic EczemaUnited States
Clinical Trials on Dupilumab
-
Brigham and Women's HospitalRegeneron PharmaceuticalsRecruiting
-
Akron Children's HospitalRegeneron Pharmaceuticals; Ohio State UniversityNot yet recruiting
-
University of MichiganRegeneron PharmaceuticalsRecruiting
-
Northwestern UniversityRecruitingSkin DiseasesUnited States
-
University of California, San FranciscoRecruiting
-
Fundació Institut de Recerca de l'Hospital de la...RecruitingAsthma; EosinophilicSpain
-
Montefiore Medical CenterRegeneron PharmaceuticalsRecruitingChronic Rhinosinusitis With Nasal PolypsUnited States
-
University of RochesterNot yet recruiting
-
Academisch Medisch Centrum - Universiteit van Amsterdam...Erasmus Medical Center; Prothya BiosolutionsRecruitingAtopic Dermatitis | Atopic Dermatitis EczemaNetherlands