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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04583358
Recruitment Status : Active, not recruiting
First Posted : October 12, 2020
Last Update Posted : November 7, 2022
Sponsor:
Information provided by (Responsible Party):
Applied Molecular Transport

Study Description
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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

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 Subjects with Moderate to Severe Ulcerative Colitis.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 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 : November 30, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: AMT-101
AMT-101 Tablet
 Drug: AMT-101 (oral)
AMT 101 is orally administered biological therapeutic taken once daily
Placebo Comparator: Placebo
Placebo Tablet
 Other: Placebo (oral)
Orally administered placebo comparator taken once daily


Outcome Measures
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Primary Outcome Measures :
  1. Change in Mayo Score [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Endoscopic Remission Rate [ Time Frame: 12 weeks ]
  2. Mucosal Healing Rate [ Time Frame: 12 weeks ]
  3. Histologic Remission Rate [ Time Frame: 12 weeks ]
  4. Clinical Remission Rate [ Time Frame: 12 weeks ]

Eligibility Criteria
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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.
Contacts and Locations
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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


Locations
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Sponsors and Collaborators
Applied Molecular Transport
More Information
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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 7, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Applied Molecular Transport:
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