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Safety and Tolerability of REGN668 (SAR231893) in Patients With Moderate to Severe Atopic Dermatitis

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01385657
First received: June 9, 2011
Last updated: September 27, 2013
Last verified: April 2012
  Purpose

The purpose of this study is to assess the safety and tolerability of repeated subcutaneous (SC) doses of REGN668 in patients with moderate-to-severe atopic dermatitis (AD).


Condition Intervention Phase
Atopic Dermatitis
Drug: REGN668 (SAR231893)
Phase 1
Phase 2

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, Tolerability, and Pharmacokinetics of Subcutaneous REGN668 in Patients With Moderate-to-Severe 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: Baseline through week 12 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The secondary endpoint in the study is to characterize PK profile of study drug REGN668 from baseline through Week 12. [ Time Frame: Baseline through week 12 ] [ Designated as safety issue: No ]

    PK profile includes, but is not limited to, the following:

    • AUC: Area Under the concentration Curve computed from time zero to the time of last concentration of study drug
    • Cmax: the peak concentration of study drug
    • Tmax: time to peak concentration of study drug


Enrollment: 37
Study Start Date: July 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1 Drug: REGN668 (SAR231893)
Dose 1 or placebo
Experimental: Cohort 2 Drug: REGN668 (SAR231893)
Dose 2 or placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female, 18 years or older
  2. Chronic AD diagnosed by the Eichenfield revised criteria of Hannifin and Rajka that has been present for at least 3 years before the screening visit
  3. Eczema Area and Severity Index (EASI) score >/= 12 at the screening and baseline visits
  4. Investigator's Global Assessment (IGA) score >/= 3 at the screening and baseline visits
  5. >/= 10% body surface area (BSA) of AD involvement at the screening and baseline visits
  6. 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. Positive Hepatitis B surface antigen, and/or positive Hepatitis C antibody at the screening visit
  2. Treatment with an investigational drug within 8 weeks or within 5 half-lives, if known, whichever is longer, before the baseline visit
  3. Treatment with leukotriene inhibitors within 4 weeks before the baseline visit
  4. Treatment with systemic corticosteroids within 4 weeks before the baseline visit
  5. Treatment with topical corticosteroids, tacrolimus, and/or pimecrolimus within 1 week before the baseline visit
  6. Systemic treatment for AD with an immunosuppressive/immunomodulating substance within 4 weeks before the baseline visit
  7. Chronic or acute infection requiring treatment with oral or IV antibiotics, antivirals, or antifungals within 4 weeks before the screening visit or superficial skin infections within 1 week before the screening visit
  8. Known history of human immunodeficiency virus (HIV) infection
  9. History of clinical parasite infection, other than treated trichomoniasis
  10. History of malignancy within 5 years before the baseline visit, with the following exceptions: patients with a history of completely treated carcinoma in situ of cervix, and non-metastatic squamous or basal cell carcinoma of the skin are allowed
  11. 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
  12. Pregnant or breast-feeding women
  13. Unwilling to use adequate birth control, if of reproductive potential and sexually active
  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: NCT01385657

Locations
Australia, New South Wales
Kogarah, New South Wales, Australia
Australia, Queensland
Woolloongabba, Queensland, Australia
Australia, Victoria
Carlton, Victoria, Australia
Australia, Western Australia
Nedlands, Western Australia, Australia
Germany
Hannover, Niedersachsen, Germany
Bonn, Nordrhein-Westfalen, Germany
Berlin, Germany, 10117
Berlin, Germany, 10827
Gera, Germany
Munster, Germany
New Zealand
Syndenham, Christchurch, New Zealand
Caversham, Dunedin, New Zealand
Auckland, New Zealand
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: NCT01385657     History of Changes
Other Study ID Numbers: R668-AD-1026
Study First Received: June 9, 2011
Last Updated: September 27, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Germany: Paul-Ehrlich-Institut
New Zealand: Medsafe

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Genetic Diseases, Inborn
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic

ClinicalTrials.gov processed this record on November 27, 2014