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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
51
AMT 101 is orally administered biological therapeutic taken once daily
Orally administered placebo comparator taken once daily
Humira comparator is administered subcutaneously, on Humira frequency schedule.
Arensia Exploratory Medicine GmbH Georgia
Tbilisi, Georgia
Ulcerative Colitis disease activity as assessed by mean change in UC-100 Score from baseline
To evaluate the effects of AMT-101 in combination with adalimumab on ulcerative colitis (UC) disease activity
Time frame: 8 weeks
Mean change in Robarts Histopathology Index (RHI) from baseline
Time frame: 8 weeks
Mean change in total Mayo Clinic Score (MCS) and component scores (Mayo Endoscopic Subscore [MES], partial MCS, rectal bleeding and stool frequency) from baseline
Time frame: 8 weeks
Mean change in fecal calprotectin from baseline
Time frame: 8 weeks
Mean change in high-sensitivity C-reactive protein (hs-CRP) from baseline
Time frame: 8 weeks
Proportion of subjects who achieve a significant reduction in RHI
Time frame: 8 weeks
Clinical remission rate
Time frame: 8 weeks
Clinical response rate
Time frame: 8 weeks
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