Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01022970
Other study ID # CQAX576A2205
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date November 2009

Study information

Verified date March 2021
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
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. completion date
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT03382678 - CEGIR 7807: Validation of Online Cohort of EGID Patients Enrolled in RDCRN CEGIR Contact Registry
Completed NCT05083312 - Efficacy and Safety APT-1011 in Adolescent Subjects With Eosinophilic Esophagitis (EoE) - A Sub-Study of the FLUTE-2 Trial Phase 3
Completed NCT04593251 - Dose Escalation Study to Evaluate an Experimental New Treatment (CALY-002) in Healthy Subjects and Subjects With Celiac Disease and Eosinophilic Esophagitis Phase 1
Completed NCT03633617 - Study to Determine the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE) Phase 3
Completed NCT04941742 - The Use of Fractionated Exhaled Nitric Oxide in the Diagnosis and Assessment of Disease Activity of Eosinophilic Esophagitis (Validation Phase)
Terminated NCT04543409 - A Study of Benralizumab in Patients With Eosinophilic Esophagitis Phase 3
Terminated NCT02314455 - Esophageal Absorption in EoE N/A
Completed NCT01953575 - Mucosal Impedance and Eosinophilic Esophagitis N/A
Completed NCT01386112 - Safety and Tolerability Study of Oral EUR-1100 to Treat Eosinophilic Esophagitis Phase 1/Phase 2
Recruiting NCT04991935 - Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis Phase 3
Not yet recruiting NCT05896891 - San Raffaele EoE Biobank
Active, not recruiting NCT05482256 - A Study of Detergents in the Pathogenesis of Eosinophilic Esophagitis N/A
Recruiting NCT05485155 - Zemaira Eosinophilic Esophagitis Pilot Study Phase 2
Recruiting NCT04149470 - Proton Pump Inhibitor (PPI) Response in Eosinophilic Esophagitis Assessed by Transnasal Endoscopy (TNE) Phase 4
Recruiting NCT04416217 - Eosinophilic Esophagitis Steroid Safety Study
Completed NCT05084963 - A Study to Assess the Efficacy, Safety and Tolerability of IRL201104 in Adults With Active Eosinophilic Esophagitis Phase 2
Completed NCT02579876 - Milk Patch for Eosinophilic Esophagitis Phase 2
Recruiting NCT02331849 - Esophageal Motility in Eosinophilic Esophagitis Evaluated by High Resolution Manometry. N/A
Active, not recruiting NCT02202590 - Using Spectrally Encoded Confocal Microscopy (SECM) to Image the Esophagus N/A
Active, not recruiting NCT05176249 - Prospective Database for Eosinophilic Esophagitis (EoE) of Pediatric Population