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

• Register: EUCTR
• Last refreshed on: 28 November 2016
• Main ID: EUCTR2013-003254-24-LV
• Date of registration: 21/03/2014
• Prospective Registration: Yes
• Primary sponsor: Regeneron Pharmaceuticals, Inc.
• Public title: EFFICACY AND LONG TERM SAFETY STUDY OF DUPILUMAB IN ADULT PATIENTS WITH MODERATE-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: 13/06/2014
• 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, Canada, Croatia, Czech Republic, France, Germany, 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 thescreening 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

Health Condition(s) or Problem(s) studied

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

Moderate to severe atopic dermatitis (AD).
MedDRA version: 17.0 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858

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

Primary Outcome(s)

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

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.

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)

Timepoint(s) of evaluation of this end point: 1) Week 16
2) Week 16
3) Week 52
4) Week 52
5) Week 16
6) Week 16
7) Week 16
8) Week 16
9) Week 16
10) Week 16
11) Week 52
12) Week 52
13) Week 52
14) Week 52
15) Week 52
16) Week 2
17) Week 56
18) Week 52
19) Week 56
20) Week 56

Secondary end point(s): Percent change from baseline to week 16 in Pruritus NRS
Proportion of patients with improvement (reduction) of Pruritus NRS >=3 from baseline to week 16
Proportion of patients with an IGA 0-1at week 52
Proportion of patients with an EASI-75 response at week 52
Change from baseline to week 16 in percent BSA
Change in SCORAD from baseline to week 16
Change from baseline to week 16 in global individual AD signs (erythema, infiltration/papulation, excoriations, lichenification)
Change from baseline to week 16 in DLQI
Change from baseline to week 16 in HADS
Reduction in topical AD medication use through week 16
Proportion of patients with improvement (reduction) of Pruritus NRS =3 from baseline to week 52
Percent change from baseline to week 52 in Pruritus NRS
Change from baseline to week 52 in percent BSA
Change in SCORAD from baseline to week 52
Change from baseline to week 52 in global individual AD signs (erythema, infiltration/papulation, excoriations, lichenification)
Change from baseline to week 2 in pruritus NRS
Incidence of skin-infections requiring systemic treatment from baseline through week 56
Number of flares through week 52
Incidence of serious treatment-emergent adverse events (TEAEs) from baseline through week 56
Incidence of TEAEs leading to study drug discontinuation from baseline through week 56

Secondary ID(s)

R668-AD-1224

2013-003254-24-DE

Source(s) of Monetary Support

Regeneron Pharmaceuticals, Inc