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

NCT05372939 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2022-09-14

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Applied Molecular Transport

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-05
Primary Completion
2022-06-01
Completion
2022-07-13
FDA Drug
Yes

Countries

  • Georgia
  • Netherlands
  • Poland
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05372939 on ClinicalTrials.gov