NCT05372939

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

A Randomized, Placebo-controlled, Double-blind, Parallel-group, Exploratory, Phase 2 Study of the Efficacy and Safety of Oral AMT-101 in Combination With Adalimumab in Subjects With Moderate to Severe Ulcerative Colitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Applied Molecular Transport · Industry
• Sex: All
• Age: 18 Years – 75 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 Combination With Adalimumab 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 Combination with Adalimumab 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
COMBINATION_PRODUCT	Humira (adalimumab)	Humira comparator is administered subcutaneously, on Humira frequency schedule.

Timeline

• Start date: 2021-02-05
• Primary completion: 2022-06-01
• Completion: 2022-07-13
• First posted: 2022-05-13
• Last updated: 2022-09-14

Locations

18 sites across 4 countries: Georgia, Netherlands, Poland, Ukraine

Regulatory

• FDA-regulated drug study