Efficacy and Safety of QAX576 in Patients With Eosinophilic Esophagitis

Phase 2

Completed

• Conditions: Eosinophilic Esophagitis
• Interventions: Drug: QAX576; Drug: QAX576 placebo

• Registration Number: NCT01022970
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-25
• Study First Submitted QC: 2009-11-30
• Study First Posted: 2009-12-01
• Primary Completion: 2012-02
• Disposition First Submitted: 2013-10-29
• Disposition First Submitted QC: 2013-10-29
• Disposition First Posted: 2013-11-21
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-09
• Last Update Posted: 2021-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
QAX576	QAX576	-
Placebo	QAX576 placebo	-

Primary Outcome Measures

Name	Time	Method
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.	13 weeks

Secondary Outcome Measures

Name	Time	Method
To investigate the safety and tolerability of QAX576 in patients with EoE.	34 weeks
To ascertain the effect of QAX576 in the frequency and severity of the symptoms of EoE.	34 weeks
To establish the duration of clinical benefit after a 12 week course of therapy.	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	34 weeks

Trial Locations

Locations (5)

Stanford Medical Center and Lucile Packard Children's Hospital; 🇺🇸 Stanford, California, United States

Northwestern University Feinberg School of Medicine; 🇺🇸 Chicago, Illinois, United States

Mayo Clinic; 🇺🇸 Minnesota, Minnesota, United States

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Oral Alpan, 6210 Old Keene Mill Court,; 🇺🇸 Springfield, Virginia, United States