Study of REGN668(SAR231893) in Adult Patients With Extrinsic Moderate-to-Severe Atopic Dermatitis

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01548404
First received: March 5, 2012
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

To assess the clinical efficacy of repeated subcutaneous (SC) doses of REGN668 (SAR231893) in adult patients with moderate-to-severe atopic dermatitis (AD).


Condition Intervention Phase
Atopic Dermatitis
Drug: REGN668(SAR231893)
Drug: 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:
  • Proportion of patients who achieve an IGA score of 0 or 1 [ Time Frame: at 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

  • Proportion of patients who achieve ≥50% overall improvement in EASI score [ Time Frame: baseline to week 12 ] [ Designated as safety issue: No ]
    Proportion of patients who achieve ≥50% overall improvement in EASI score from baseline to week 12

  • Change in EASI score [ Time Frame: baseline to week 12 ] [ Designated as safety issue: No ]
    Change (or percent change) in EASI score from baseline to week 12

  • Change in IGA score [ Time Frame: baseline to week 12 ] [ Designated as safety issue: No ]
    Change in IGA score from baseline to week 12

  • Change in % BSA, SCORAD score, Pruritus NRS, and 5-D Pruritus Scale [ Time Frame: baseline to week 12 ] [ Designated as safety issue: No ]
    Change in % BSA, SCORAD score, Pruritus NRS, and 5-D Pruritus Scale from baseline to week 12

  • Incidence of TEAEs [ Time Frame: baseline through week 28 ] [ Designated as safety issue: Yes ]
    Incidence of treatment emergent adverse events (TEAEs) from baseline through week 28


Enrollment: 109
Study Start Date: April 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
REGN668(SAR231893)
Drug: REGN668(SAR231893)
REGN668(SAR231893) for SC dosing will be evaluated in this study.
Experimental: Group 2
Placebo matching REGN668(SAR231893)
Drug: Placebo
Placebo matching REGN668(SAR231893)

  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:

  1. Male or female, 18 years or older
  2. Chronic Atopic Dermatitis for at least 3 years
  3. 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:

  1. Prior treatment with REGN668
  2. Presence of certain laboratory abnormalities at the screening visit
  3. Treatment with an investigational drug within 8 weeks
  4. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit
  5. Certain treatments and medical procedures, undertaken within a particular timeframe prior to the baseline visit, preclude eligibility for participation in the study:
  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 patient's participation in this study
  9. History of clinical parasite infection.
  10. 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
  11. Pregnant or breast-feeding women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Regeneron Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: November 19, 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 October 01, 2014