Trial record 1 of 1 for:
R668-AD-0914
Sequential Ascending Dose Study to Assess the Safety and Tolerability of REGN668 (SAR231893) in Patients With Atopic Dermatitis
This study has been completed.
Sponsor:
Regeneron Pharmaceuticals
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01259323
First received: December 10, 2010
Last updated: October 2, 2012
Last verified: October 2012
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Purpose
The purpose of this study is to assess the Safety and Tolerability of REGN668 (how the body reacts to the drug) compared to placebo (an inert substance) in patients with moderate-to-severe extrinsic Atopic Dermatitis.
| Condition | Intervention | Phase |
|---|---|---|
|
Dermatitis |
Biological: REGN668 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Sequential Ascending, Repeated-Dose Study of the Safety and Pharmacokinetics of Subcutaneous REGN668 in Patients With Moderate-to-Severe Extrinsic Atopic Dermatitis |
Further study details as provided by Regeneron Pharmaceuticals:
Primary Outcome Measures:
- The primary endpoint in the study is the incidence of treatment-emergent adverse events (TEAEs) in patients treated with REGN668 or Placebo from baseline through week 12. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- The secondary endpoint is to characterize PK profile of study drug REGN668 from baseline through week 12. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 30 |
| Study Start Date: | December 2010 |
| Study Completion Date: | July 2012 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Cohort 1 |
Biological: REGN668
Dose 1: REGN668 or placebo
|
| Experimental: Cohort 2 |
Biological: REGN668
Dose 2: REGN668 or placebo
|
| Experimental: Cohort 3 |
Biological: REGN668
Dose 3: REGN668 or placebo
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Clinical diagnosis of atopic dermatitis that has been present for at least 3 years before the screening visit
- Investigator's Global Assessment (IGA) score of >/= 3 at the screening and baseline visits
- >/= 15% body surface area (BSA) of AD involvement at the screening and baseline visits
- History of inadequate response to a stable (>/= 1 month) regimen of topical corticosteroids or calcineurin inhibitors as treatment for AD within 3 months before the screening visit
- Willing and able to comply with clinic visits and study-related procedures
- Patient able to read and understand, and willing to sign the informed consent form
Exclusion Criteria:
- A positive QuantiFERON® - TB (tuberculosis) Gold Test at the screening visit
- Known history of Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C and/or positive Hepatitis B surface antigen (HBsAg), positive Hepatitis C antibody (HCV)
- Treatment with an investigational drug within 8 weeks before the baseline visit
- Treatment with leukotriene inhibitors within 4 weeks before the baseline visit
- Treatment with systemic corticosteroids within 4 weeks before the baseline visit
- Treatment with topical corticosteroids, tacrolimus, and/or pimecrolimus within 1 week before the baseline visit
- Systemic treatment for AD with an immunosuppressive/immunomodulating substance within 4 weeks before the baseline visit
- Chronic or acute infection requiring treatment
- History of clinical parasite infection, other than treated trichomoniasis
- History of malignancy within 5 years before the baseline 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
- Pregnant or breast-feeding women
- Unwilling to use adequate birth control, if of reproductive potential and sexually active
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01259323
Locations
| United States, California | |
| Los Angeles, California, United States | |
| Riverside, California, United States | |
| United States, Florida | |
| Miami, Florida, United States | |
| United States, Illinois | |
| Chicago, Illinois, United States | |
| United States, Michigan | |
| Troy, Michigan, United States | |
| United States, New York | |
| New York, New York, United States | |
| Rochester, New York, United States | |
| United States, Oregon | |
| Portland, Oregon, United States | |
| United States, Pennsylvania | |
| Philadelphia, Pennsylvania, United States | |
| United States, Texas | |
| Dallas, Texas, United States | |
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: | NCT01259323 History of Changes |
| Other Study ID Numbers: | R668-AD-0914 |
| Study First Received: | December 10, 2010 |
| Last Updated: | October 2, 2012 |
| Health Authority: | United States: Food and Drug Administration |
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 23, 2013