NCT04583358

Study of the Efficacy and Safety of AMT-101 in Subjects With Ulcerative Colitis (LOMBARD)

A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects With Moderate to Severe Ulcerative Colitis (LOMBARD)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Applied Molecular Transport · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis.

Detailed description

This is a Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study to evaluate the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	AMT-101 (oral)	AMT 101 is orally administered biological therapeutic taken once daily
OTHER	Placebo (oral)	Orally administered placebo comparator taken once daily

Timeline

• Start date: 2020-08-26
• Primary completion: 2022-11-30
• Completion: 2022-12-31
• First posted: 2020-10-12
• Last updated: 2022-11-07

Locations

59 sites across 14 countries: United States, Belarus, Bulgaria, Canada, France, Georgia, Germany, Hungary, Moldova, Poland, Russia, Switzerland, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study