Ulcerative Colitis
Conditions
Keywords
Inflammatory Bowel Diseases
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.
Interventions
DRUGAMT-101 (oral)
AMT 101 is orally administered biological therapeutic taken once daily
OTHERPlacebo (oral)
Orally administered placebo comparator taken once daily
COMBINATION_PRODUCTHumira (adalimumab)
Humira comparator is administered subcutaneously, on Humira frequency schedule.
Sponsors
Applied Molecular Transport
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ulcerative Colitis disease activity as assessed by mean change in UC-100 Score from baseline | 8 weeks | To evaluate the effects of AMT-101 in combination with adalimumab on ulcerative colitis (UC) disease activity |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Mean change in high-sensitivity C-reactive protein (hs-CRP) from baseline | 8 weeks |
| Mean change in Robarts Histopathology Index (RHI) from baseline | 8 weeks |
| Clinical remission rate | 8 weeks |
| Clinical response rate | 8 weeks |
| Proportion of subjects who achieve a significant reduction in RHI | 8 weeks |
Countries
Georgia, Netherlands, Poland, Ukraine
Outcome results
None listed