Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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16 January 2017 |
Main ID: |
EUCTR2013-003254-24-NL |
Date of registration:
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20/03/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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EFFICACY AND LONG TERM SAFETY STUDY OF DUPILUMAB IN ADULT
PATIENTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS.
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Scientific title:
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A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO DEMONSTRATE THE EFFICACY AND LONG-TERM SAFETY OF DUPILUMAB IN ADULT PATIENTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS |
Date of first enrolment:
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11/07/2014 |
Target sample size:
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700 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-003254-24 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 3
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Australia
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Belgium
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Canada
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Croatia
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Czech Republic
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France
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Germany
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Hungary
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Italy
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Japan
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Korea, Republic of
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Latvia
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Netherlands
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New Zealand
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Poland
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Romania
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Russian Federation
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Spain
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Taiwan
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Ukraine
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United Kingdom
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United States
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Contacts
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Name:
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Clinical Trials information
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Address:
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777 Old Saw Mill River Road
NY 10591
Tarrytown
United States |
Telephone:
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Email:
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clinicaltrial@regeneron.com |
Affiliation:
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Regeneron Pharmaceuticals, Inc. |
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Name:
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Clinical Trials information
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Address:
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777 Old Saw Mill River Road
NY 10591
Tarrytown
United States |
Telephone:
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Email:
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clinicaltrial@regeneron.com |
Affiliation:
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Regeneron Pharmaceuticals, Inc. |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Male or female, 18 years or older
2. Chronic AD, (according to the American Academy of Dermatology
Consensus Criteria),that has been present for at least 3 years before the
screening visit.
3. Patients with documented recent history (within 6 months before the
screening visit) of inadequate response to a sufficient course of
outpatient treatment with topical AD medication(s) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 594 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 106
Exclusion criteria: 1. Prior treatment with dupilumab
2. Important side effects of topical medication (eg, intolerance to treatment, hypersensitivity reactions, significant skin atrophy, systemic effects), as assessed by the investigator or patient’s treating physician.
3. At baseline visit >= 30% of the total lesional surface located on areas of thin skin that cannot be safely treated with medium or higher potency TCS (eg, face, neck, intertriginous areas, genital areas, areas of skin atrophy)
4. Recent treatment (within specific time windows before the baseline visit) with systemic corticosteroids, immunosuppressive agents, topical corticosteroids and calcineurin inhibitors, live (attenuated) vaccine, other investigational drugs
5. History of human immunodeficiency virus (HIV) infection
6. HIV or viral hepatitis positive serology at screening
7. Known or suspected immunosuppresion
8. Recent infections requiring antiinfectious treatment
9. Recent history or high risk of clinical endoparasitoses, unless clinical and (if necessary) laboratory assessment have ruled out active infection before randomization
10. High risk populations (low life expectancy, severe concomitant diseases, etc.)
11. Pregnant or breast-feeding women
12. Patients of reproductive potential and sexually active who are unwilling to use adequate contraceptive methods.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Moderate to severe atopic dermatitis (AD). MedDRA version: 18.1
Level: LLT
Classification code 10003639
Term: Atopic dermatitis
System Organ Class: 100000004858
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Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
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Intervention(s)
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Product Name: Dupilumab Product Code: SAR231893/REGN668 Pharmaceutical Form: Solution for injection INN or Proposed INN: Dupilumab CAS Number: 1190264-60-8 Current Sponsor code: Dupilumab Other descriptive name: REGN668/SAR231893 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use
Product Name: Dupilumab Product Code: SAR231893/REGN668 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Dupilumab CAS Number: 1190264-60-8 Current Sponsor code: Dupilumab Other descriptive name: REGN668/SAR231893 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use
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Primary Outcome(s)
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Primary end point(s): -Proportion of patients with EASI-75 response (reduction of EASI score by >=75% from baseline) at week 16 -Proportion of patients with both an IGA 0 or 1 (on a 5-point scale) and a reduction from baseline of >=2 points at week 16
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Main Objective: The primary objective of the study is to demonstrate the efficacy of dupilumab administered concomitantly with TCS through week 16 in adult patients with moderate-to-severe AD.
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Secondary Objective: -Evaluate long-term efficacy of dupilumab when administered concomitantly with TCS for up to 52 weeks. -Evaluate the long-term safety of dupilumab when administered concomitantly with TCS for up to 52 weeks.
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Timepoint(s) of evaluation of this end point: Week 16
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Secondary Outcome(s)
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Secondary end point(s): Key Secondary Endpoints:
Percent change from baseline to week 16 in weekly average of peak daily Pruritus Numerical Rating Scale (NRS)
Proportion of patients with improvement (reduction) in weekly average of peak daily Pruritus NRS >=4 from baseline to week 16.
Proportion of patients with IGA 0 or 1 and a reduction from baseline of >=2 points at week 52.
Proportion of patients with EASI-75 response at week 52.
Proportion of patients with improvement (reduction) in weekly average of peak daily Pruritus NRS >=3 from baseline to week 16.
Percent change from baseline to week 52 in weekly average of peak daily Pruritus NRS.
Other Secondary Endpoints:
Percent change in EASI score from baseline to week 16.
Change from baseline to week 16 in percent BSA.
Percent change in SCORing Atopic Dermatitis (SCORAD) from baseline to week 16.
Percent change from baseline to week 16 in Global Individual Signs Score (GISS) (erythema, infiltration/papulation, excoriations, lichenification).
Change from baseline to week 16 in Dermatology Life Quality Index (DLQI).
Change from baseline to week 16 in Hospital Anxiety and Depression Scale (HADS).
Change from baseline to week 16 in Patient Oriented Eczema Measure (POEM).
Reduction in topical AD medication use through week 16 (determined by the amount of TCS and/or topical calcineurin inhibitors (TCI) used since previous visit in weight).
Proportion of patients with improvement (reduction) in weekly average of peak daily Pruritus NRS >=3 from baseline to week 52.
Proportion of patients with improvement (reduction) in weekly average of peak daily Pruritus NRS >=4 from baseline to week 52.
Percent change in EASI score from baseline to week 52.
Change from baseline to week 52 in percent BSA.
Percent Change in SCORAD from baseline to week 52.
Percent Change from baseline to week 52 in GISS (erythema, infiltration /papulation, excoriations, lichenification).
Change from baseline to week 2 in weekly average of peak daily Pruritus NRS.
Number of flares through week 52.
Change from baseline to week 52 in DLQI.
Change from baseline to week 52 in POEM.
Change from baseline to week 52 in HADS.
Incidence of skin-infection treatment-emergent adverse events (TEAEs) requiring systemic treatment from baseline through week 56.
Incidence of serious TEAEs through week 56.
Incidence of TEAEs leading to study drug discontinuation from baseline through week 56.
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Timepoint(s) of evaluation of this end point: 1), 2), 3) Week 16
4), 5) Week 52
6) Week 16
7) Week 52
8) to 15) Week 16
16) to 21) Week 52
22) Week 2
23) to 26) Week 52
27) to 29) Week 56
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Secondary ID(s)
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R668-AD-1224
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2013-003254-24-DE
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Source(s) of Monetary Support
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Regeneron Pharmaceuticals, Inc
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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