Study of Dupilumab (REGN668/SAR231893) Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study Investigating the Efficacy, Safety, Pharmacokinetic and Biomarker Profiles of Dupilumab (REGN668) Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01859988
• Other study ID #: R668-AD-1021
• Status: Completed
• Phase: Phase 2
• First received: May 20, 2013
• Last updated: August 10, 2015
• Start date: May 2013
• Est. completion date: September 2014

Study information

• Verified date: August 2015
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCzech Republic: State Institute for Drug ControlCanada: Health CanadaGermany: Paul-Ehrlich-InstitutHungary: National Institute of PharmacyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsJapan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

To assess the efficacy of multiple dupilumab (REGN668/SAR231893) dose-regimens, compared to placebo, in adult patients with moderate-to-severe atopic dermatitis (AD).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: September 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

The inclusion criteria include, but are not limited to, the following:

1. Chronic Atopic Dermatitis that has been present for at least 3 years

2. History of inadequate response to outpatient treatment with topical medications, or for whom topical treatments are otherwise inadvisable (eg, because of important side effects or safety risks)

3. Willing and able to comply with all clinic visits and study-related procedures

The exclusion criteria include, but are not limited to, the following:

1. Prior treatment with dupilumab (REGN668/ SAR231893)

2. Presence of certain laboratory abnormalities at the screening visit

3. Treatment with an investigational drug within 8 weeks of baseline visit

4. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit

5. Certain other treatments and medical procedures undertaken within a particular timeframe prior to the baseline visit

6. Known history of human immunodeficiency virus (HIV) infection

7. History of malignancy within 5 years before the baseline visit (with certain exceptions)

8. Planned surgical procedure during the length of the study

9. High risk of parasite infection

10. Any other medical or psychological condition that, in the opinion of the investigator or the sponsor's medical monitor, would place the patient at risk, interfere with participation in the study or interfere with interpretation of study results.

11. Pregnant or breast-feeding women

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Dupilumab (REGN668/SAR231893)

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals	Sanofi

Countries where clinical trial is conducted

United States,  Canada,  Czech Republic,  Germany,  Hungary,  Japan,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change in Eczema Area and Severity Index score	Percent change in Eczema Area and Severity Index (EASI) score from baseline to week 16.	Baseline to week 16	No
Secondary	Investigator's Global Assessment score	Proportion of participants achieving Investigator's Global Assessment (IGA) score 0 (clear) or 1 (almost clear) at week 16	At week 16	No
Secondary	Absolute change in EASI score	Absolute change in EASI scores from baseline to week 16	Baseline to week 16	No