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Efficacy and Safety of AbGn-168H in Patients With Moderate to Severe Active, Anti-TNF Alpha and/or Anti-integrin Refractory Ulcerative Colitis

2017-10-03 05:44:51 | BioPortfolio

Summary

To evaluate the efficacy and safety of Neihulizumab (AbGn-168H) administered intravenously in patients with moderate to severe active ulcerative colitis who are refractory or intolerant to anti-Tumor Necrosis Factor α and/or anti-integrin treatments.

Description

This is a Phase II, open label, single arm, multiple dose proof of principle study to test the efficacy and safety of Neihulizumab in patients with moderate to severe active ulcerative colitis and who has failed or are intolerant to anti-TNFα and/or anti-integrin therapy. A minimum of 35 patients and a maximum of 40 will be recruited in 1 dosing group. For efficacy evaluation, the primary endpoint is the proportion of patients with clinical response, defined as defined as a ≥ 3-point reduction in complete Mayo score, a 30% or greater decrease from the baseline score, and with a 1-point or greater decrease of the rectal bleeding subscale or an absolute rectal bleeding score of 0 or 1 at Week 12. Safety assessments will consist of evaluating physical examination, vital signs (blood pressure, heart rate, respiratory rate, body temperature and oxygen saturation), safety laboratory tests, adverse events and tolerability.

Study Design

Conditions

Ulcerative Colitis

Intervention

AbGn-168H

Status

Not yet recruiting

Source

AbGenomics International, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2017-10-03T05:44:51-0400

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