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

Sponsor
Applied Molecular Transport
Study ID
NCT05372939
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • AMT-101 (oral) — DRUG
    AMT 101 is orally administered biological therapeutic taken once daily
  • Placebo (oral) — OTHER
    Orally administered placebo comparator taken once daily
  • Humira (adalimumab) — COMBINATION_PRODUCT
    Humira comparator is administered subcutaneously, on Humira frequency schedule.

Study Details

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.

Key Dates

Start date
Feb 5, 2021
Status verified
Sep 2022
Primary completion
Jun 1, 2022
Completion
Jul 13, 2022

Study Design

Enrollment
51 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: AMT-101 and Humira (adalimumab)
    AMT-101 Tablet
  • Placebo Comparator: Placebo and Humira (adalimumab)
    Placebo Tablet

Primary Outcome Measure

Ulcerative Colitis disease activity as assessed by mean change in UC-100 Score from baseline [ Time Frame: 8 weeks ]

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