Ulcerative ColitisPhase 2NCT04583358
Study of the Efficacy and Safety of AMT-101 in Subjects With Ulcerative Colitis (LOMBARD)
A Phase 2 study testing AMT-101 (oral) in people with Ulcerative Colitis, run by Applied Molecular Transport at 59 sites in 14 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- AMT-101 (oral)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 59 sitesin 14 countries
- Study dates
- 26 Aug 2020to 31 Dec 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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.
- 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.
Trial locations and contacts
59 sites in 14 countries.
59 sites in 14 countries
United States15 sites
Washington Gastroenterology
Bellevue, Washington, 38004
Gwinnett Research Institute, LLC
Buford, Georgia, 30519
Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815
Gastro One
Germantown, Tennessee, 38138
Carolina Research
Greenville, North Carolina, 27834
GIA Clinical Trials, LLC
Knoxville, Tennessee, 37909
Caprock Gastro Research
Lubbock, Texas, 79424
Vanderbilt University Medical Center
Nashville, Tennessee, 37212-1375
AdventHealth - Florida Hospital
Orlando, Florida, 32803
Advanced Medical Research Center
Port Orange, Florida, 32127
Inland Empire Clinical Trials, LLC
Rialto, California, 92377
University of Utah Hospitals and Clinics
Salt Lake City, Utah, 84112
Washington Gastroenterology, PLLC
Tacoma, Washington, 98405
Tyler Research Institute, LLC
Tyler, Texas, 75701
Huron Gastroenterology Associates
Ypsilanti, Michigan, 48197
Poland12 sites
Vitamed Gałaj i Cichomski S.J.
Bydgoszcz, 85079
Centrum Medyczne LUKAMED Joanna Luka-Wendrowska
Chojnice, Pomeranian, 89-600
Centrum Medyczne CLW-MED
Grudziądz, Kuyavian-Pomeranian Voivodeship, 86-300
Indywidualna Praktyka Lekarska Maciej Zymła
Knurów, Silesian, 44190
Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska S.J.
Ksawerów, Łódź Voivodeship, 95054
Centrum Medyczne Medyk
Rzeszów, 35326
Endoskopia Sp. z o.o.
Sopot, Pomeranian Voivodeship, 81756
Nowe Zdrowie CK Kieltucki I Wspólnicy sp.j.
Staszów, Świętokrzyskie Voivodeship, 28200
Gastromed Kopon, Zmudziski I Wspolnicy Sp.j.
Torun, Kuyavian-Pomeranian Voivodeship, 87100
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, Masovia, 00728
Nzoz Vivamed
Warsaw, Masovia, 03-580
Vistamed & Vertigo Sp. z o.o
Wroclaw, Lower Silesian Voivodeship, 54-144
Ukraine10 sites
Regional Hospital of War Veterans
Kharkiv, 61019
Medical and Diagnostic Centre of Private Enterprise of Private Manufacturing Company "Acinus"
Kropyvnytskyi, 25006
Medical center limited liability Harmoniya Krasy
Kyiv, 01135
Medical Center Ok!Clinic+ International Institute
Kyiv, 02091
CI of Kyiv RC Regional Clinical Hospital No 2
Kyiv, 04073
Lviv Regional Clinical Hospital
Lviv, 79010
Uzhgorod National University
Uzhhorod, 88009
Vinnytsya City Clinical Hospital No 1
Vinnytsia, 21029
Medical Center of Limited Liability Co
Zaporizhzhya, 69076
Limited Liability Company Medibor
Zhytomyr, 10003
Hungary5 sites
Clinexpert Kft.
Budapest, 1033
Semmelweis Egyetem Altalanos Orvostudomanyi Kar
Budapest, 1083
Mohacsi Korhaz
Mohács, Baranya, 7700
Szegedi Tudomanyegyetem
Szeged, Csongrád megye, 6725
Javorszky Odon Korhaz, Gasztroenterologiai Osztaly
Vác, Pest County, 2600
Germany4 sites
Universitätsklinikum Jena Klinik fuer Innere Medizin IV
Jena, Thuringia, 7747
University Hospital Schleswig-Holstein
Kiel, 24105
Staedtisches Klinikum Lueneburg
Lüneburg, 21339
Universitätsklinikum Tübingen
Tübingen, Baden-Wurttemberg, 72076
Canada3 sites
London Health Sciences Centre - Victoria Hospital
London, Ontario, N6A5W9
GI Research Institute
Vancouver, British Columbia, V6Z2K5
Toronto Digestive Disease Associates Specialty Research
Vaughan, Ontario, L4L4Y7
Bulgaria2 sites
MHAT Blagoevgrad AD
Blagoevgrad, 2700
MHAT Lyulin EAD
Sofia, 1336
Russia2 sites
Novosibirsk GastroCenter LLC
Novosibirsk, Novosibirsk Oblast, 630007
Medical Diagnostics Center, LLC
Yaroslavl, Yaroslavl Oblast, 150000
Belarus1 site
Vitebsk Regional Clinical Hospital
Vitebsk, Vitebsk Oblast, 210037
France1 site
CHU Saint-Etienne - Hospital Nord Gastroenteroloy
Saint-Priest-en-Jarez, 42270
Moldova1 site
Clinical Republican Hospital "Timofei Mosneaga", ARENSIA E.M.
Chisinau, Municipality of Chisinau, MD-2025
United Kingdom1 site
Barnsley Hospital NHS Foundation Trust
Barnsley, Yorkshire, S75 2EP
About this study
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)
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.
Read the 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.
- Conditions
- Ulcerative Colitis
- Being tested
- AMT-101 (oral), Placebo (oral)
- Keywords
- Inflammatory Bowel Diseases
- Medical subject headings
- Colitis, Ulcerative, 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)Drug
AMT 101 is orally administered biological therapeutic taken once daily
Placebo (oral)Other
Orally administered placebo comparator taken once daily
| Study group | Role | What they receive |
|---|---|---|
| AMT-101 | Active comparator | AMT-101 Tablet Receives: Drug: AMT-101 (oral) |
| Placebo | Placebo comparator | Placebo Tablet Receives: Other: Placebo (oral) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mayo Score
Measured: 12 weeks
Secondary outcomes (4)
Endoscopic Remission Rate
Measured: 12 weeks
Mucosal Healing Rate
Measured: 12 weeks
Histologic Remission Rate
Measured: 12 weeks
Clinical Remission Rate
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 posted12 Oct 2020
- Study start26 Aug 2020
- Primary completion30 Nov 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies 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
- 105 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
- NCT04583358
- Sponsor's protocol ID
- AMT-101-202
- Status last verified
- Nov 2022
- First submitted
- 16 Sep 2020
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04583358
- Acronym / sponsor ID
- AMT-101-202
- Conditions
- Ulcerative Colitis
- Keywords
- Inflammatory Bowel Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Applied Molecular TransportIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2020 (actual)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 12 Oct 2020 (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.
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.
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
- 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 | Active comparator | Drug: AMT-101 (oral)AMT-101 Tablet |
| Placebo | Placebo comparator | Other: Placebo (oral)Placebo Tablet |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
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)AMT 101 is orally administered biological therapeutic taken once daily | Drug | AMT-101 |
| Placebo (oral)Orally administered placebo comparator taken once daily | Other | Placebo |
Primary outcome
Change in Mayo Score
Time frame: 12 weeks
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
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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.
59 sites in 14 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) in people with Ulcerative Colitis, run by Applied Molecular Transport at 59 sites in 14 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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites in United States, Poland, Ukraine, Hungary, Germany and 9 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Change in Mayo Score (time frame: 12 weeks). 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 7 Nov 2022.