Efficacy and Safety of QAX576 in Patients With Eosinophilic Esophagitis

Eosinophilic Esophagitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01022970
• Other study ID #: CQAX576A2205
• Status: Completed
• Phase: Phase 2
• Start date: November 2009

Study information

• Verified date: March 2021
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis

Intervention

Drug:
• QAX576 placebo

• QAX576

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Mayo Clinic	Minnesota	Minnesota
United States	Oral Alpan, 6210 Old Keene Mill Court,	Springfield	Virginia
United States	Stanford Medical Center and Lucile Packard Children's Hospital	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To ascertain the effect of QAX576 in the frequency and severity of the symptoms of EoE.		34 weeks
Secondary	To investigate the safety and tolerability of QAX576 in patients with EoE.		34 weeks
Secondary	To establish the duration of clinical benefit after a 12 week course of therapy.		34 weeks
Secondary	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

External Links

•   Results for CQAX576A2205 from the Novartis Clinical Trials website