NCT05372939CompletedPhase 2
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
Applied Molecular Transport18 sites in 4 countries51 target enrollmentStarted: February 5, 2021Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 51
- Locations
- 18
- Primary Endpoint
- Ulcerative Colitis disease activity as assessed by mean change in UC-100 Score from baseline
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male and female subjects aged 18 to 75 years.
- •Moderate to severe UC.
- •Eligible for Humira (adalimumab) therapy.
- •Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and at the randomization visit.
- •Written informed consent must be obtained and documented.
Exclusion Criteria
- •Known gastrologic, or systemic condition that may compromise severity or diagnosis of disease.
- •History or current evidence of colonic or abdominal abnormalities.
- •Prohibited therapies or procedures before the screening period as specified per protocol.
- •A concurrent clinically significant, serious, unstable, or uncontrolled underlying cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the investigator, might confound the study results, pose additional risk to the subject, or interfere with the subject's ability to participate fully in the study.
- •Pregnant or lactating females.
- •Current or recent history of alcohol dependence, illicit drug use, mental or legal incapacitation, or a history of clinically significant psychiatric disorders that, in the opinion of the investigator, may interfere with the subject's ability to comply with the study procedures.
- •Unable to attend study visits or comply with procedures.
- •Previous exposure to AMT-101 or similar and known hypersensitivity to AMT-101 or its excipients.
Arms & Interventions
AMT-101 and Humira (adalimumab)
Active Comparator
AMT-101 Tablet
Intervention: AMT-101 (oral) (Drug)
AMT-101 and Humira (adalimumab)
Active Comparator
AMT-101 Tablet
Intervention: Humira (adalimumab) (Combination Product)
Placebo and Humira (adalimumab)
Placebo Comparator
Placebo Tablet
Intervention: Placebo (oral) (Other)
Placebo and Humira (adalimumab)
Placebo Comparator
Placebo Tablet
Intervention: Humira (adalimumab) (Combination Product)
Outcomes
Primary Outcomes
Ulcerative Colitis disease activity as assessed by mean change in UC-100 Score from baseline
Time Frame: 8 weeks
To evaluate the effects of AMT-101 in combination with adalimumab on ulcerative colitis (UC) disease activity
Secondary Outcomes
- Clinical response rate(8 weeks)
- Mean change in high-sensitivity C-reactive protein (hs-CRP) from baseline(8 weeks)
- Proportion of subjects who achieve a significant reduction in RHI(8 weeks)
- Clinical remission rate(8 weeks)
- Mean change in Robarts Histopathology Index (RHI) from baseline(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(8 weeks)
- Mean change in fecal calprotectin from baseline(8 weeks)
Investigators
Study Sites (18)
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