PouchitisPhase 2FILLMORENCT04741087
Study of the Safety and Efficacy of AMT-101 in Subjects With Pouchitis
A Phase 2 study testing AMT-101 (oral)-Dose A and AMT-101 (oral)-Dose B in people with Pouchitis, run by Applied Molecular Transport at 34 sites in 10 countries.
Trial summary
Phase 2 Study Investigating the Efficacy of AMT-101 in Subjects with Chronic Antibiotic-resistant Pouchitis Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pouchitis
- What is being tested?
- AMT-101 (oral)-Dose A and AMT-101 (oral)-Dose B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 34 sitesin 10 countries
- Study dates
- 5 Feb 2021to 22 Apr 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic or recurrent pouchitis
Who cannot join
- Known gastrologic, or systemic condition that may compromise severity or diagnosis of disease.
- History or current evidence of colonic or abdominal abnormalities.
- Previous exposure to AMT-101 or similar and known hypersensitivity to AMT-101 or its excipients.
Trial locations and contacts
34 sites in 10 countries.
34 sites in 10 countries
United States12 sites
Connecticut Clinical Research Institute
Bristol, Connecticut, 06010
University of North Carolina GI
Chapel Hill, North Carolina, 27514
Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815
University of Chicago Medical Center
Chicago, Illinois, 60637
Gastrointestinal Associates - Jackson
Flowood, Mississippi, 39232
Gastro One
Germantown, Tennessee, 38138
Gastrointestinal Asssociates- GIA Clinical Trials, LLC
Knoxville, Tennessee, 37909
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Mayo Clinic
Rochester, Minnesota, 55905
University of Utah Health Sciences Center
Salt Lake City, Utah, 84132
Washington Gastroenterology, Tacoma
Tacoma, Washington, 98405
Tyler Research Institute, LLC
Tyler, Texas, 75701
United Kingdom5 sites
MAC Clinical Research - Blackpool
Blackpool, Lancashire, FY2 0JH
MAC Clinical Research - Cannock
Cannock, South Staffordshire, WS11 0BN
MAC Clinical Research - Leeds
Leeds, West Yorkshire, LS10 1DU
MAC Clinical Research - Manchester
Manchester, M13 9NQ
MAC Clinical Research - Liverpool
Prescot, Liverpool, L34 1BH
France4 sites
CHU de Rennes - Hopital de Pontchaillou
Rennes
CHU Saint Etienne - Hopital Nord
Saint-Priest-en-Jarez, 42270
CHU de Toulouse - Hôpital Rangueil
Toulouse, 31059
CHRU Nancy - Hopital de Brabois
Vandœuvre-lès-Nancy, 54511
Germany4 sites
Praxis fur Gastroenterologie am Bayerischen Platz
Berlin, D-10825
Klinik für Innere Medizin KIM IV
Jena
UKSH Universitätsklinikum Schleswig-Holstein
Kiel, 24105
University Hospital Tübingen
Tübingen
Belgium2 sites
UZ Leuven - University Hospital Gasthuisberg
Leuven
Groupe santé CHC / Clinique du MontLégia, Liege
Liège
Hungary2 sites
Semmelweis Egyetem I. sz Belgyogyaszati Klinika
Budapest, 1083
Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar
Szeged
Switzerland2 sites
Clarunis Bauchzentrum
Basel
University Hospital of Zürich
Zurich
Spain1 site
Hospital Universitario y Politecnico La Fe de Valencia
Valencia, 46026
About this study
Official title: 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
Phase 2 Study Investigating the Efficacy of AMT-101 in Subjects with Chronic Antibiotic-resistant Pouchitis
Read the detailed description
A Phase 2 12-week, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy of AMT-101 in Subjects with Chronic Antibiotic-resistant Pouchitis
- Conditions
- Pouchitis
- Being tested
- AMT-101 (oral)-Dose A, AMT-101 (oral)-Dose B
- Keywords
- Inflammatory Bowel Disease
- Medical subject headings
- Pouchitis, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMT-101 (oral)-Dose ADrug
AMT-101 is an orally administered biologic therapeutic, taken once daily.
AMT-101 (oral)-Dose BDrug
AMT-101 is an orally administered biologic therapeutic, taken once daily.
| Study group | Role | What they receive |
|---|---|---|
| AMT-101 (Dose A) | Active comparator | Dose A: AMT-101 Tablet Receives: Drug: AMT-101 (oral)-Dose A |
| AMT-101 (Dose B) | Active comparator | Dose B: AMT-101 Tablet Receives: Drug: AMT-101 (oral)-Dose B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool Frequency Response
Measured: 12 weeks
Histologic Healing
based upon the Geboes scoring system and PDAI
Measured: 12 weeks
Secondary outcomes (3)
Histologic Response
based upon the Geboes scoring system and PDAI
Measured: 12 weeks
Change in Endoscopic Score
Measured: 12 weeks
Change in Stool Frequency
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start5 Feb 2021
- Primary completion11 Mar 2022
- Study completion22 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PouchitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Applied Molecular Transport
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04741087
- Sponsor's protocol ID
- AMT-101-201
- Acronym
- FILLMORE
- Status last verified
- Apr 2022
- First submitted
- 15 Jan 2021
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04741087
- Acronym / sponsor ID
- FILLMORE / AMT-101-201
- Conditions
- Pouchitis
- Keywords
- Inflammatory Bowel Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Applied Molecular TransportIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2021 (actual)
- Primary completion
- 11 Mar 2022 (actual)
- Study completion
- 22 Apr 2022 (actual)
- First posted
- 5 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 2 Study Investigating the Efficacy of AMT-101 in Subjects with Chronic Antibiotic-resistant Pouchitis
Detailed description
A Phase 2 12-week, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy of AMT-101 in Subjects with Chronic Antibiotic-resistant Pouchitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMT-101 (Dose A) | Active comparator | Drug: AMT-101 (oral)-Dose ADose A: AMT-101 Tablet |
| AMT-101 (Dose B) | Active comparator | Drug: AMT-101 (oral)-Dose BDose B: AMT-101 Tablet |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic or recurrent pouchitis
Key exclusion criteria (3 listed)
- Known gastrologic, or systemic condition that may compromise severity or diagnosis of disease.
- History or current evidence of colonic or abdominal abnormalities.
- Previous exposure to AMT-101 or similar and known hypersensitivity to AMT-101 or its excipients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMT-101 (oral)-Dose AAMT-101 is an orally administered biologic therapeutic, taken once daily. | Drug | AMT-101 (Dose A) |
| AMT-101 (oral)-Dose BAMT-101 is an orally administered biologic therapeutic, taken once daily. | Drug | AMT-101 (Dose B) |
Primary outcome
Stool Frequency Response
Time frame: 12 weeks
Histologic Healing
Time frame: 12 weeks
based upon the Geboes scoring system and PDAI
3 secondary outcomes
Histologic Response
Time frame: 12 weeks
Change in Endoscopic Score
Time frame: 12 weeks
Change in Stool Frequency
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
Related trials for Pouchitis
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Oral Aeromonas sp. MTB Phage Therapy for Pouchitis in Patients With Ulcerative Colitis (UC)
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Emerging Indications for Hyperbaric Oxygen Treatment
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
34 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AMT-101 (oral)-Dose A and AMT-101 (oral)-Dose B in people with Pouchitis, run by Applied Molecular Transport at 34 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, United Kingdom, France, Germany, Belgium and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stool Frequency Response (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2022.