Study of REGN668 in Adult Patients With Extrinsic Moderate-to-Severe Atopic Dermatitis
This study is ongoing, but not recruiting participants.
Sponsor:
Regeneron Pharmaceuticals
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01548404
First received: March 5, 2012
Last updated: April 15, 2013
Last verified: April 2013
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Purpose
To assess the clinical efficacy of repeated subcutaneous (SC) doses of REGN668 in adult patients with moderate-to-severe atopic dermatitis (AD).
| Condition | Intervention | Phase |
|---|---|---|
|
Atopic Dermatitis |
Drug: REGN668 Other: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Repeat-Dose Study of the Efficacy, Safety, Tolerability, and Pharmacodynamics of Subcutaneously-Administered REGN668 in Adult Patients With Extrinsic Moderate-to-Severe Atopic Dermatitis |
Further study details as provided by Regeneron Pharmaceuticals:
Primary Outcome Measures:
- Percent change in EASI score [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ]The primary endpoint is the percent change in Eczema Area and Severity Index (EASI) score from baseline to week 12.
Secondary Outcome Measures:
- IGA Score [ Time Frame: Week 12 ] [ Designated as safety issue: No ]Proportion of patients who achieve an Investigator's Global Assessment (IGA) score of 0 or 1 at week 12
- Change in EASI score [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
| Enrollment: | 109 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1
REGN668
|
Drug: REGN668
REGN668 for SC dosing will be evaluated in this study.
|
|
Experimental: Group 2
Placebo matching REGN668
|
Other: Placebo
Placebo matching REGN668
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
The inclusion criteria include, but are not limited to, the following:
- Male or female, 18 years or older
- Chronic Atopic Dermatitis for at least 3 years
- 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
Exclusion Criteria:
- Prior treatment with REGN668
- Presence of certain laboratory abnormalities at the screening visit
- Treatment with an investigational drug within 8 weeks
- Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit
- Certain treatments and medical procedures, undertaken within a particular timeframe prior to the baseline visit, preclude eligibility for participation in the study:
- Known history of human immunodeficiency virus (HIV) infection
- History of malignancy within 5 years before the baseline visit, with certain exceptions
- Planned surgical procedure during the length of the patient's participation in this study
- History of clinical parasite infection.
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01548404
Locations
| Czech Republic | |
| Nachod, Czech Republic | |
| Svitavy, Czech Republic | |
| Usti nad Labem, Czech Republic | |
| France | |
| Nice, France | |
| Pierre Bénite, France | |
| Toulouse, France | |
| Germany | |
| Berlin, Germany | |
| Bonn, Germany | |
| Frankfurt, Germany | |
| Gera, Germany | |
| Heidelberg, Germany | |
| Kiel, Germany | |
| Münster, Germany | |
| Hungary | |
| Kaposvar, Hungary | |
| Szeged, Hungary | |
| Szekszard, 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: | NCT01548404 History of Changes |
| Other Study ID Numbers: | R668-AD-1117 |
| Study First Received: | March 5, 2012 |
| Last Updated: | April 15, 2013 |
| Health Authority: | Czech Republic: State Institute for Drug Control France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Ethics Commission Hungary: National Institute of Pharmacy Poland: Ministry of Health |
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 19, 2013