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Efficacy and Safety of QAX576 in Patients With Eosinophilic Esophagitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01022970
First received: November 25, 2009
Last updated: June 27, 2012
Last verified: June 2012
History of Changes
  Purpose

This study is designed to investigate the effects of a 12 week course of intravenous QAX576 6mg/kg every 4 weeks in reducing the number of eosinophils in the esophagus of EoE patients by 75% or greater when compared with baseline.


Condition Intervention Phase
Eosinophilic Esophagitis
 Drug: QAX576 placebo
Drug: QAX576
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Double Blinded Randomized Placebo-controlled Trial of Intravenous QAX576 in the Treatment of Eosinophilic Esophagitis (EoE)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • The primary endpoint in this study is the number of patients (responder) with a reduction of 75% or more in eosinophils per HPF (distal or proximal esophagus) from baseline to week 13. [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To ascertain the effect of QAX576 in the frequency and severity of the symptoms of EoE. [ Time Frame: 34 weeks ] [ Designated as safety issue: No ]
  • To investigate the safety and tolerability of QAX576 in patients with EoE. [ Time Frame: 34 weeks ] [ Designated as safety issue: No ]
  • To establish the duration of clinical benefit after a 12 week course of therapy. [ Time Frame: 34 weeks ] [ Designated as safety issue: No ]
  • PK/PD relationship between blood levels of QAX576 and IL- 13 dependent gene expression in esophageal biopsies and soluble biomarkers, inflammatory and fibrotic markers within esophageal biopsies and activation markers expressed on peripheral [ Time Frame: 34 weeks ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: November 2009
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: QAX576 placebo
Active Comparator: QAX576 Drug: QAX576

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females aged 18-50 with symptomatic eosinophilic esophagitis
  • Female subjects must be women of non child bearing potential.
  • Elimination diet must have been tried.
  • Treatment for at least two months prior to enrollment on a protocol pump inhibitor .
  • Appropriate contraception must be used by males, (e.g., spermicidal gel plus condom)
  • Must be able to communicate well with the investigator, to understand and comply with the requirements of the study.
  • Understand and sign the written informed consent.

Exclusion criteria:

  • Have received corticosteroids within 3 months before starting the study for any symptoms.
  • Any other eosinophilic disorders.
  • History of clinical schistosomiasis, or having travelled within the preceding 6 months to an area with endemic schistosomiasis, including but not limited to Southeast and Southwest Asia, South America and Africa. Travel to these areas must not be planned for at least 6 months after the last dose.
  • Donation or loss of 400 ml or more of blood within eight (8) weeks prior to initial dosing.
  • History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
  • History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during the screening.

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01022970

Locations
United States, California
Stanford Medical Center and Lucile Packard Children's Hospital
Stanford, California, United States, 94305
United States, Illinois
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
United States, Minnesota
Mayo Clinic
Minnesota, Minnesota, United States, 55905
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
United States, Virginia
Oral Alpan, 6210 Old Keene Mill Court,
Springfield, Virginia, United States, 22152
Sponsors and Collaborators
Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01022970     History of Changes
Other Study ID Numbers: CQAX576A2205
Study First Received: November 25, 2009
Last Updated: June 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Esophagitis
Digestive System Diseases
Esophageal disorder
Eosinophilic esophagitis

Additional relevant MeSH terms:
Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
 Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013