Clinical trial NCT01022970: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Eosinophilic Esophagitis
Keywords: Esophagitis
Digestive System Diseases
Esophageal disorder
Eosinophilic esophagitis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-12-01
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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.
timeFrame: 13 weeks
Secondary outcomes:
measure: To ascertain the effect of QAX576 in the frequency and severity of the symptoms of EoE.
timeFrame: 34 weeks
measure: To investigate the safety and tolerability of QAX576 in patients with EoE.
timeFrame: 34 weeks
measure: To establish the duration of clinical benefit after a 12 week course of therapy.
timeFrame: 34 weeks
measure: 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
timeFrame: 34 weeks
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Medical Center and Lucile Packard Children's Hospital
state: California
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: Minnesota
country: United States
facility: Mayo Clinic
state: Minnesota
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Springfield
country: United States
facility: Oral Alpan, 6210 Old Keene Mill Court,
state: Virginia
Study officials:
References:
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.