Study to Assess the Safety of REGN668 (SAR231893) Administered Concomitantly With Topical Corticosteroids (TCS) in Patients With Moderate-to-severe Atopic Dermatitis (AD)
This study has been completed.
Sponsor:
Regeneron Pharmaceuticals
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01639040
First received: July 9, 2012
Last updated: February 6, 2013
Last verified: February 2013
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Purpose
The purpose of this study is to assess the safety of REGN668 (SAR231893) administered concomitantly with topical corticosteroids (TCS) in patients with moderate-to-severe atopic dermatitis (AD).
| Condition | Intervention | Phase |
|---|---|---|
|
Atopic Dermatitis |
Drug: REGN668 (SAR231893) Other: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Assess the Safety of REGN668 Administered Concomitantly With Topical Corticosteroids to Patients With Moderate-to-Severe Atopic Dermatitis |
Resource links provided by NLM:
Further study details as provided by Regeneron Pharmaceuticals:
Primary Outcome Measures:
- Safety [ Time Frame: Day 1 to Day 78 ] [ Designated as safety issue: Yes ]Assessed by evaluating the incidence of AEs from day 1 to day 78
| Enrollment: | 31 |
| Study Start Date: | July 2012 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Regimen 1 |
Drug: REGN668 (SAR231893)
A total of 4 doses will be administered
|
| Placebo Comparator: Regimen 2 |
Other: Placebo
A total of 4 doses will be administered
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male and female patients aged 18 years or older
- Chronic AD that has been present for at least 2 years
Exclusion Criteria:
- Prior treatment with REGN668 (SAR231893)
- Hypersensitivity to corticosteroids or to any other ingredients contained by the TCS product used in the study
- AD lesions located on face, flexural, and genital areas
- Certain treatments and medical procedures, undertaken within a particular time frame prior to the baseline visit, preclude eligibility for participation in the study
- Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit
- Treatment with an investigational drug within 8 weeks
- Known history of human immunodeficiency virus (HIV) infection
- Presence of certain laboratory abnormalities at the screening visit
- History of certain opportunistic infections or certain clinical parasite infections
- History of malignancy within 5 years before the baseline visit, with certain exceptions
- Pregnant or breast-feeding women
- Travel within 12 months of study start to areas endemic for parasitic infections, such as developing countries in Africa and the tropical and subtropical regions of Asia
- History of alcohol or drug abuse within 2 years of the screening visit
- Any medical or psychiatric condition which, 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 the interpretation of study results
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01639040
Locations
| Germany | |
| Berlin, Germany | |
| Dresden, Germany | |
| Duelmen, Germany | |
| Frankfurt, Germany | |
| Gera, Germany | |
| Langenau, Germany | |
| Munster, Germany | |
| Hungary | |
| Szeged-Hungary, Hungary | |
| Szolnok, Hungary | |
| Poland | |
| Gdansk, Poland | |
| Lodz, Poland | |
| Lublin, Poland | |
| Warszawa, Poland | |
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
| Study Director: | Clinical Trial Management | Regeneron Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Regeneron Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01639040 History of Changes |
| Other Study ID Numbers: | R668-AD-1121 |
| Study First Received: | July 9, 2012 |
| Last Updated: | February 6, 2013 |
| Health Authority: | Hungary: National Institute of Pharmacy Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Germany: Paul-Ehrlich-Institut |
Additional relevant MeSH terms:
|
Dermatitis Dermatitis, Atopic Skin Diseases Skin Diseases, Genetic Genetic Diseases, Inborn |
Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013