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Efficacy and Safety of QAX576 in Patients With Eosinophilic Esophagitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01022970
First Posted: December 1, 2009
Last Update Posted: December 16, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  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: Triple (Participant, Care Provider, 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:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

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 ]

Secondary Outcome Measures:
  • To ascertain the effect of QAX576 in the frequency and severity of the symptoms of EoE. [ Time Frame: 34 weeks ]
  • To investigate the safety and tolerability of QAX576 in patients with EoE. [ Time Frame: 34 weeks ]
  • To establish the duration of clinical benefit after a 12 week course of therapy. [ Time Frame: 34 weeks ]
  • 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01022970     History of Changes
Other Study ID Numbers: CQAX576A2205
First Submitted: November 25, 2009
First Posted: December 1, 2009
Last Update Posted: December 16, 2013
Last Verified: November 2013

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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