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Efficacy and Safety of QAX576 in Patients With Eosinophilic Esophagitis

Primary Purpose

Eosinophilic Esophagitis

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

QAX576 placebo

QAX576

About this trial

This is an interventional treatment trial for Eosinophilic Esophagitis focused on measuring Esophagitis, Digestive System Diseases, Esophageal disorder, Eosinophilic esophagitis

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Stanford Medical Center and Lucile Packard Children's Hospital
Northwestern University Feinberg School of Medicine
Mayo Clinic
Cincinnati Children's Hospital Medical Center
Oral Alpan, 6210 Old Keene Mill Court,

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

QAX576

Arm Description

Outcomes

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.

Secondary Outcome Measures

To ascertain the effect of QAX576 in the frequency and severity of the symptoms of EoE.

To investigate the safety and tolerability of QAX576 in patients with EoE.

To establish the duration of clinical benefit after a 12 week course of therapy.

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

Full Information

NCT ID

NCT01022970

First Posted

November 25, 2009

Last Updated

March 9, 2021

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01022970

Brief Title

Efficacy and Safety of QAX576 in Patients With Eosinophilic Esophagitis

Official Title

A Double Blinded Randomized Placebo-controlled Trial of Intravenous QAX576 in the Treatment of Eosinophilic Esophagitis (EoE)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

November 2009 (undefined)

Primary Completion Date

February 2012 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Eosinophilic Esophagitis

Keywords

Esophagitis, Digestive System Diseases, Esophageal disorder, Eosinophilic esophagitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Title

QAX576

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

QAX576 placebo

Intervention Type

Drug

Intervention Name(s)

QAX576

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

To ascertain the effect of QAX576 in the frequency and severity of the symptoms of EoE.

Time Frame

34 weeks

Title

To investigate the safety and tolerability of QAX576 in patients with EoE.

Time Frame

34 weeks

Title

To establish the duration of clinical benefit after a 12 week course of therapy.

Time Frame

34 weeks

Title

Time Frame

34 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Stanford Medical Center and Lucile Packard Children's Hospital

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

Northwestern University Feinberg School of Medicine

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Mayo Clinic

City

Minnesota

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Cincinnati Children's Hospital Medical Center

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45229

Country

United States

Facility Name

Oral Alpan, 6210 Old Keene Mill Court,

City

Springfield

State/Province

Virginia

ZIP/Postal Code

22152

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

25226850

Citation

Rothenberg ME, Wen T, Greenberg A, Alpan O, Enav B, Hirano I, Nadeau K, Kaiser S, Peters T, Perez A, Jones I, Arm JP, Strieter RM, Sabo R, Gunawardena KA. Intravenous anti-IL-13 mAb QAX576 for the treatment of eosinophilic esophagitis. J Allergy Clin Immunol. 2015 Feb;135(2):500-7. doi: 10.1016/j.jaci.2014.07.049. Epub 2014 Sep 13.

Results Reference

derived

Links:

URL

https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=8985

Description

Results for CQAX576A2205 from the Novartis Clinical Trials website

Learn more about this trial

Efficacy and Safety of QAX576 in Patients With Eosinophilic Esophagitis

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