Efficacy and Safety of QAX576 in Patients With Eosinophilic Esophagitis

• Register: ClinicalTrials.gov
• Last refreshed on: 22 March 2021
• Main ID: NCT01022970
• Date of registration: 25/11/2009
• Prospective Registration: No
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Efficacy and Safety of QAX576 in Patients With Eosinophilic Esophagitis
• Scientific title: A Double Blinded Randomized Placebo-controlled Trial of Intravenous QAX576 in the Treatment of Eosinophilic Esophagitis (EoE)
• Date of first enrolment: November 2009
• Target sample size: 25
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01022970
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2

Countries of recruitment

United States

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 50 Years
Gender: All

Health Condition(s) or Problem(s) studied

Eosinophilic Esophagitis

Intervention(s)

Drug: QAX576 placebo

Drug: QAX576

Primary Outcome(s)

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. [Time Frame: 13 weeks]

Secondary Outcome(s)

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 [Time Frame: 34 weeks]

To investigate the safety and tolerability of QAX576 in patients with EoE. [Time Frame: 34 weeks]

To ascertain the effect of QAX576 in the frequency and severity of the symptoms of EoE. [Time Frame: 34 weeks]

To establish the duration of clinical benefit after a 12 week course of therapy. [Time Frame: 34 weeks]

Secondary ID(s)

CQAX576A2205

Source(s) of Monetary Support

Please refer to primary and secondary sponsors