NCT01022970

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

November 25, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 1, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Last Updated

March 11, 2021

Status Verified

March 1, 2021

Enrollment Period

2.3 years

First QC Date

November 25, 2009

Last Update Submit

March 9, 2021

Conditions

Eosinophilic Esophagitis

Keywords

EsophagitisDigestive System DiseasesEsophageal disorderEosinophilic esophagitis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

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

    34 weeks

  • To investigate the safety and tolerability of QAX576 in patients with 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: QAX576 placebo

QAX576

ACTIVE COMPARATOR
Drug: QAX576

Interventions

QAX576 placeboDRUG
Placebo
QAX576DRUG
QAX576

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Stanford Medical Center and Lucile Packard Children's Hospital

Stanford, California, 94305, United States

Location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Mayo Clinic

Minneota, Minnesota, 55905, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Oral Alpan, 6210 Old Keene Mill Court,

Springfield, Virginia, 22152, United States

Location

Related Publications (1)

  • 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.

    PMID: 25226850DERIVED

Related Links

MeSH Terms

Conditions

Eosinophilic EsophagitisEsophagitisDigestive System DiseasesEsophageal Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesGastroenteritisEosinophiliaLeukocyte DisordersHematologic DiseasesHemic and Lymphatic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2009

First Posted

December 1, 2009

Study Start

November 1, 2009

Primary Completion

February 1, 2012

Last Updated

March 11, 2021

Record last verified: 2021-03

Locations

US(5)