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-ES
• Date of registration: 22/05/2014
• 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: 30/06/2014
• Target sample size: 450
• 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, Korea, Republic of, Latvia, Netherlands, New Zealand, Poland, Romania, Russian Federation, Spain, Taiwan, United Kingdom

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 382
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 68

Exclusion criteria:
1. Prior treatment with dupilumab
2. 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
3. History of human immunodeficiency virus (HIV) infection
4. HIV or viral hepatitis seropositivity at screening
5. Known or suspected immunosuppresion
6. Recent infections requiring antiinfectious treatment
7. Recent history or high risk of clinical endoparasitoses
8. High risk populations (low life expectancy, severe concomitant
diseases, etc.)
9. Pregnant or breast-feeding women
10. Patients of reproductive potential and sexually active who are
unwilling to use adequate contracepcion.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Moderate to severe atopic dermatitis (AD).
MedDRA version: 17.0 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: 100-
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
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)

Main Objective: Assess the efficacy of dupilumab over 12 weeks of treatment in adult
patients with moderate-to-severe atopic dermatitis (AD) who have failed or are intolerant to topical steroids with or without topical calcineurin inhibitors.

Primary end point(s): - Percentage of patients with EASI-50 response (reduction of EASI score by at least 50% from baseline) at week 12.
- Percentage of patients with IGA 0 or 1 at week 12

Secondary Objective: -Evaluate efficacy over time of dupilumab when administered for up to 52 weeks.
-Evaluate the long-term safety of dupilumab administered for up to 52 weeks.

Timepoint(s) of evaluation of this end point: Week 12

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1) Week 12
2) Week 12.
3) Week 12.
4) Week 12.
5) Week 12.
6) Week 12.
7) Week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and week 52.
8) Week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and week 52.
9) Week 12.
10) Week 56
11) Week 56
12) Week 56
10) Week 56
11) Week 56
12) Week 56.

Secondary end point(s): - The change from baseline in maximum itch intensity (NRS) at week 12
- The change from baseline in BSA at week 12
- The change from baseline in the erythema of GISS at week 12
- The change from baseline in the infiltration/papulation of GISS at week 12
- The change from baseline in the excoriations of GISS at week 12
- The change from baseline in the lichenification of GISS at week 12
- Percentage of patients achieving EASI-50 response (reduction of EASI
score by at least 50% from baseline) at week 12 and maintaining EASI-50 response on at least 6 of the10 subsequent every 4 weeks (q4w) visits (from visits at weeks 16, 20, 24, 28, 32, 36, 40, 44, 48, and week 52); 1 of the 6 must be in the last 4 visits (weeks 40, 44,
48 and 52).
- Percentage of patients with IGA 0 to 1 at week 12 and maintaining IGA 0 to 2 on at least 6 of the10 subsequent q4w visits (from visits at weeks 16, 20, 24, 28, 32, 36, 40, 44, 48, and week 52); 1 of the 6 must be in the last 4 visits (weeks 40, 44, 48 and 52).
- The change from baseline in oozing/crusting at week 12
- Incidence of serious treatment-emergent adverse events (TEAEs)
through week 56
- Incidence of study drug discontinuation due to an AE through week 56.
- Incidence of skin-infections through week 56

Secondary ID(s)

R668-AD-1224

2013-003254-24-DE

Source(s) of Monetary Support

Regeneron Pharmaceuticals, Inc