NCT03298022

Efficacy&Safety of ALTB-168 in Patients With Moderate to Severe Active,Anti-TNF Alpha and/or Anti-integrin Refractory UC

Efficacy and Safety of ALTB-168 in Patients With Moderate to Severe Active, Anti-TNF Alpha and/or Anti-integrin Refractory Ulcerative Colitis: a 26-week, Open-label, Multi-center, Phase II Proof of Principle Trial

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: AltruBio Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of Neihulizumab (ALTB-168) 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.

Detailed 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 30 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 ≥ 3- point reduction in MCS, a 30% or greater decrease from the baseline score, and with a 1-point or greater decrease of the rectal bleeding subscore 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.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
BIOLOGICAL	ALTB-168	monoclonal antibody

Timeline

• Start date: 2018-05-04
• Primary completion: 2020-04-06
• Completion: 2020-06-01
• First posted: 2017-09-29
• Last updated: 2024-01-05
• Results posted: 2023-07-06

Locations

12 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study