Study of the Efficacy and Safety of AMT-101 in Subjects With Ulcerative Colitis (LOMBARD)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04583358 |
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Recruitment Status :
Recruiting
First Posted : October 12, 2020
Last Update Posted : November 11, 2021
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Sponsor:
Applied Molecular Transport
Information provided by (Responsible Party):
Applied Molecular Transport
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Brief Summary:
Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Ulcerative Colitis | Drug: AMT-101 (oral) Other: Placebo (oral) | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 102 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects With Moderate to Severe Ulcerative Colitis (LOMBARD) |
| Actual Study Start Date : | August 26, 2020 |
| Estimated Primary Completion Date : | June 2022 |
| Estimated Study Completion Date : | June 2022 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Ulcerative colitis
MedlinePlus related topics:
Ulcerative Colitis
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: AMT-101
AMT-101 Tablet
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Drug: AMT-101 (oral)
AMT 101 is orally administered biological therapeutic taken once daily |
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Placebo Comparator: Placebo
Placebo Tablet
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Other: Placebo (oral)
Orally administered placebo comparator taken once daily |
Primary Outcome Measures :
- Change in Mayo Score [ Time Frame: 12 weeks ]
Secondary Outcome Measures :
- Endoscopic Remission Rate [ Time Frame: 12 weeks ]
- Mucosal Healing Rate [ Time Frame: 12 weeks ]
- Histologic Remission Rate [ Time Frame: 12 weeks ]
- Clinical Remission Rate [ Time Frame: 12 weeks ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male and female subjects aged 18 to 75 years, inclusive.
- Diagnosis of moderate to severe UC.
- Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and at the randomization visit.
- Able to participate fully in all aspects of this clinical trial.
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04583358
Contacts
| Contact: AMT Administrator | 650-392-0420 | LombardStudy@appliedmt.com |
Locations
Show 51 study locations
Sponsors and Collaborators
Applied Molecular Transport
| Responsible Party: | Applied Molecular Transport |
| ClinicalTrials.gov Identifier: | NCT04583358 |
| Other Study ID Numbers: |
AMT-101-202 |
| First Posted: | October 12, 2020 Key Record Dates |
| Last Update Posted: | November 11, 2021 |
| Last Verified: | November 2021 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Applied Molecular Transport:
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Inflammatory Bowel Diseases |
Additional relevant MeSH terms:
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Colitis Colitis, Ulcerative Ulcer Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Colonic Diseases Intestinal Diseases Pathologic Processes Inflammatory Bowel Diseases |