EFFICACY AND LONG TERM SAFETY STUDY OF DUPILUMAB IN ADULT PATIENTS WITH MODERATE0-TO-SEVERE ATOPIC DERMATITIS.

• Register: EUCTR
• Last refreshed on: 23 January 2017
• Main ID: EUCTR2013-003254-24-PL
• Date of registration: 29/04/2014
• Prospective Registration: Yes
• Primary sponsor: Regeneron Pharmaceuticals, Inc.
• Public title: EFFICACY AND LONG TERM SAFETY STUDY OF DUPILUMAB IN ADULT PATIENTS WITH MODERATE0-TO-SEVERE ATOPIC DERMATITIS.
• Scientific title: 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: 02/06/2014
• Target sample size: 700
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-003254-24
• Study type: Interventional clinical trial of medicinal product
• Study design: 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
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Denmark, France, Germany, Greece, Hungary, Italy, Japan, Korea, Republic of, Latvia, Netherlands, New Zealand, Poland, Romania, Russian Federation, Spain, Taiwan, Ukraine, United Kingdom, United States

Contacts

• Name: Clinical Trials information
• Affiliation: Regeneron Pharmaceuticals, Inc.

• Name: Clinical Trials information
• Affiliation: Regeneron Pharmaceuticals, Inc.

Key inclusion & exclusion criteria

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), or for whom topical AD therapies are medically inadvisable.
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

Health Condition(s) or Problem(s) studied

Moderate to severe atopic dermatitis (AD).
MedDRA version: 19.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858

Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Intervention(s)

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

Primary Outcome(s)

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.

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

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.

Timepoint(s) of evaluation of this end point: Week 16

Secondary Outcome(s)

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.

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

Secondary ID(s)

2013-003254-24-DE

R668-AD-1224

Source(s) of Monetary Support

Regeneron Pharmaceuticals, Inc