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Clinical Trials/NL-OMON52357
NL-OMON52357CompletedPhase 2

A Combined Phase 2/3 12-week, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy of AMT-101 in Subjects with Chronic Antibiotic-resistant Pouchitis - AMT-101-201

Applied Molecular Transport Inc.0 sites12 target enrollmentStarted: TBDLast updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
12
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 to 64 (—)

Inclusion Criteria

  • •The study will enroll male and female adult subjects with chronic
  • •antibiotic-resistant pouchitis. Inclusion criteria (subjects must meet the
  • •following criteria to be randomized into the study):
  • •1. Male and female subjects aged 18 to 75 yrs, inclusive.
  • •2. IPAA for UC completed at least 1 yr prior to screening.
  • •3. Active signs and symptoms of pouchitis, as follows:
  • •a. Modified Pouchitis Disease Activity Index (mPDAI) score >= 5, and,
  • •b. Increased stool frequency, defined as 3 more stools per day above
  • •*normal* (after IPAA) and an absolute total of >= 6 stools per day.
  • •*Increased stool frequency* is calculated as the difference between *Normal*
  • •and *Screening stool frequency.
  • •*Normal* is the stool frequency achieved post-IPAA when the subject*s bowel
  • •function was most settled. This typically occurs approximately 1 year after
  • •IPAA and should be supported by documentation in the subject*s medical records.
  • •If stool frequency never normalized after IPAA, consult with the Medical
  • •Monitor to determine if pre-IPAA stool frequency is appropriate.
  • •To be eligible for the study, subjects must experience 6 or more stools per
  • •day, and this value must be 3 or more stools per day greater than the *Normal*
  • •value, as defined above.
  • •4. Chronic or recurrent pouchitis, defined by:
  • •a. >= 2 episodes within 1 year prior to or including the screening period
  • •treated with antibiotic or other prescription therapy, or,
  • •b. Maintenance antibiotic therapy taken continuously for >=4 weeks immediately
  • •prior to the screening endoscopy.
  • •5. Antibiotic-resistant pouchitis, defined as disease remaining active despite
  • •at least 2 weeks of antibiotic therapy.
  • •6. Histologic inflammation in the pouch, defined by a Geboes score of 3.1 or
  • •7. Unlikley to conceive.
  • •8. Women of childbearing potential (WOCBP) must have a negative pregnancy test
  • •at screening and at the randomization visit prior to the first dose of study
  • •9. Able to participate fully in all aspects of this clinical trial.
  • •10. Written informed consent must be obtained and fully documented.

Exclusion Criteria

  • •Exclusion criteria (subjects who meet any of the following criteria are not
  • •eligible for participation in the study):
  • •1. Known Crohn*s disease (CD) or suspected CD of the pouch, defined as complex
  • •perianal/pouch fistula and/or extensive length of pre-pouch ileitis with deep
  • •ulceration.
  • •2. Diagnosed or suspected irritable pouch syndrome (IPS).
  • •3. Isolated or predominant cuffitis.
  • •4. Mechanical complications of the pouch such as stricture or fistula(e) that
  • •preclude evaluation of the pouch and terminal ileum.
  • •5. Fecal incontinence due to anal sphincter dysfunction.
  • •6. Pelvic sepsis within 12 months prior to screening.
  • •7. Planned surgery for UC, or any other elective surgery within the time frame
  • •of the study.
  • •8. Diverting stoma.
  • •9. Current bacterial or parasitic pathogenic enteric infection, including
  • •Clostridium difficile; known infection with hepatitis B or C virus; known
  • •infection with human immunodeficiency virus; infection requiring
  • •hospitalization or intravenous antimicrobial therapy, or opportunistic
  • •infection within 6 months prior to screening; any infection requiring
  • •antimicrobial therapy within 2 weeks prior to screening; history of more than 1
  • •episode of herpes zoster or any episode of disseminated zoster.
  • •10. A positive diagnostic tuberculosis (TB) test at screening (defined as a
  • •positive QuantiFERON test).
  • •11. Prior biologic use restrictions and exclusions:
  • •a. No more than 60% of enrolled subjects in Phase 2 and no more than 25% of
  • •enrolled subjects in Phase 3 may have prior failure of any biologics for
  • •b. Subjects who have used prior biologic therapies must have discontinued
  • •within 12 weeks or 5 half-lives of screening (or within 4 weeks if drug levels
  • •are undetectable).
  • •12. Use of any of the following prohibited therapies, except under the stated
  • •conditions (if applicable):
  • •a. Opioids within 4 weeks prior to screening.
  • •b. Chronic use (>4 weeks of continuous use prior to screening) of nonsteroidal
  • •anti-inflammatory drugs, except for chronic use of low-dose 81 mg aspirin.
  • •c. Oral 5-aminosalicylate (5-ASA), unless the dose is <= 4.8 g/day and has been
  • •stable for at least 4 weeks prior to screening.
  • •d. Oral budesonide within 6 weeks of screening.
  • •e. Other oral corticosteroids at daily doses > 20 mg prednisone or equivalent,
  • •or who started oral corticosteroids within 6 weeks prior to screening; stable
  • •doses <= 20 mg prednisone or equivalent for at least 4 weeks prior to screening
  • •are permitted.
  • •f. Any rectal compounds.
  • •g. Immunosuppresant therapy (azathioprine, 6-mercaptopurine, methotrexate,
  • •cyclosporin) within 8 weeks prior to screening.
  • •h. Fecal transplant within 12 weeks prior to screening.
  • •i. Live virus vaccination within 1 month prior to screening.
  • •j. Any investigational therapy within 4 weeks prior to screening.
  • •13. Diagnosed with any immune deficiency.
  • •14. History of malignancy, except for basal cell carcinoma, nonmetastatic
  • •squamous cell carcinoma of the skin, or prior malignancy with curative therapy
  • +5 more not shown

Investigators

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