Ulcerative Colitis Chronic MildPhase 1NCT03923478
ABI-M201 in Adult Subjects With Mildly-to-Moderately Active Ulcerative Colitis
A Phase 1 study testing ABI-M201 in people with Ulcerative Colitis Chronic Mild and Ulcerative Colitis Chronic Moderate, run by Assembly Biosciences at 11 sites in 2 countries.
Trial summary
Phase 1B randomized, double-blind, placebo-controlled, two-cohort clinical trial of ABI-M201 in adult subjects with mildly-to-moderately active Ulcerative Colitis(UC) and ongoing treatment with mesalamine. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ulcerative Colitis Chronic Mild, Ulcerative Colitis Chronic Moderate
- What is being tested?
- ABI-M201
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 24 Jun 2019to 20 Jan 2021
- Phase
- Phase 1
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Established diagnosis of UC for at least 3 months prior to screening, with minimum disease extent of 15 cm from the anal verge
- Mildly to moderately active UC
- Inadequate response to ongoing treatment with oral mesalamine ≥2.4 g/day for ≥4 weeks from screening visit
Who cannot join
- Possible or confirmed diagnosis of Crohn's Disease or other forms of inflammatory bowel disorders
- Ongoing or failed prior treatment for UC with methotrexate, azathioprine, 6-mercaptopurine, cyclosporine, tofacitinib, mycophenolate mofetil, sirolimus (rapamycin), thalidomide, tacrolimus (FK-506), or biologics (e.g., TNF-alpha-antagonists, anti-integrin therapies, or agents targeting IL-12 or IL-23, etc.)
- Any immunosuppressive condition or treatment with immunosuppressive medications
- History of prior surgical intervention in any region of the gastrointestinal tract (excluding minor surgery)
- Prior diagnosis of any cardiovascular, renal, hepatic, endocrine, infectious, hematological, oncologic, neuro-psychiatric or immune-mediated disorder, which in the opinion of the Principal Investigator might impact the subject's safety or compliance, or the interpretation of results
- Treatment with any other investigational drugs ≤12 weeks prior to baseline visit
- The participant has a condition or is in a situation which, in the Principal Investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States10 sites
(Investigator Site)
Bellevue, Washington, 98004
(Investigator Site)
Chesterfield, Michigan, 48047
(Investigator Site)
Decatur, Georgia, 30033
(Investigator Site)
Jackson, Tennessee, 38305
(Investigator Site)
Milwaukee, Wisconsin, 53226
(Investigator site)
Oakland, California, 94612
(Investigator Site)
Rochester, Minnesota, 55905
(Investigator Site)
San Carlos, California, 94070
(Investigator Site)
Shreveport, Louisiana, 71105
(Investigator Site)
Ypsilanti, Michigan, 48197
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 1b Study to Evaluate the Safety, Efficacy and Mircobiological Response of Oral ABI-M201 in Subjects With Mildly-to-Moderately Active UC With Ongoing Mesalamine Treatment
Phase 1B randomized, double-blind, placebo-controlled, two-cohort clinical trial of ABI-M201 in adult subjects with mildly-to-moderately active Ulcerative Colitis(UC) and ongoing treatment with mesalamine.
Read the detailed description
This multi-center randomized, double-blind, placebo-controlled study will evaluate the safety of ABI-M201 and its effects on disease activity measures in men and women with mildly-to-moderately active UC and ongoing treatment with mesalamine. The study will consist of 2 sequential, non-overlapping participant cohorts, separated by intervening interim analysis (IA). Both cohorts will involve 8-weeks of study drug treatment. Interim data from the initial treatment cohort (Cohort A) will inform decision to advance to the subsequent second cohort (Cohort B) and its dose selection. 20 subjects will be randomized to cohort A (1:1 allocation) and receive treatment with 1 capsule per day of ABI-M201 versus Placebo. 24 subjects will be randomized to cohort B (3:1 allocation) and receive treatment with up to 5 capsules one time a day of ABI-M201 versus Placebo.
- Being tested
- ABI-M201, Placebo
- Keywords
- Phase 1B, Randomized, Placebo Controlled
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABI-M201Drug
Active Treatment
PlaceboDrug
Control Treatment
| Study group | Role | What they receive |
|---|---|---|
| ABI-M201 | Experimental | Cohort A: 1 capsule one time a day
Cohort B: 1- 5 capsules one time a day Receives: Drug: ABI-M201 |
| Placebo | Placebo comparator | Cohort A: 1 capsule one time a day
Cohort B: 1-5 capsules one time a day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
[Safety]
Measured: 8-weeks
Incidence of Treatment-Emergent Laboratory Abnormalities
[Safety]
Measured: 8-weeks
Secondary outcomes (2)
Clinical Remission
[UC Disease Activity]
Measured: 8-weeks
Endoscopic Improvement
[UC Disease Activity]
Measured: 8-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2019
- Study start24 Jun 2019
- Primary completion20 Jan 2021
- Study completion20 Jan 2021
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis Chronic MildStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind, placebo-controlled trial involving two sequential non-overlapping cohorts, with intervening interim analysis
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assembly Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03923478
- Sponsor's protocol ID
- ABI-M201-101
- Status last verified
- Mar 2021
- First submitted
- 15 Apr 2019
- Last updated
- 19 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 1b Study to Evaluate the Safety, Efficacy and Mircobiological Response of Oral ABI-M201 in Subjects With Mildly-to-Moderately Active UC With Ongoing Mesalamine Treatment
- ClinicalTrials.gov ID
- NCT03923478
- Acronym / sponsor ID
- ABI-M201-101
- Keywords
- Phase 1B, Randomized, Placebo Controlled
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Assembly BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- 20 Jan 2021 (actual)
- Study completion
- 20 Jan 2021 (actual)
- First posted
- 22 Apr 2019 (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 1B randomized, double-blind, placebo-controlled, two-cohort clinical trial of ABI-M201 in adult subjects with mildly-to-moderately active Ulcerative Colitis(UC) and ongoing treatment with mesalamine.
Detailed description
This multi-center randomized, double-blind, placebo-controlled study will evaluate the safety of ABI-M201 and its effects on disease activity measures in men and women with mildly-to-moderately active UC and ongoing treatment with mesalamine. The study will consist of 2 sequential, non-overlapping participant cohorts, separated by intervening interim analysis (IA). Both cohorts will involve 8-weeks of study drug treatment. Interim data from the initial treatment cohort (Cohort A) will inform decision to advance to the subsequent second cohort (Cohort B) and its dose selection. 20 subjects will be randomized to cohort A (1:1 allocation) and receive treatment with 1 capsule per day of ABI-M201 versus Placebo. 24 subjects will be randomized to cohort B (3:1 allocation) and receive treatment with up to 5 capsules one time a day of ABI-M201 versus Placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blind, placebo-controlled trial involving two sequential non-overlapping cohorts, with intervening interim analysis
| Arm | Type | Receives |
|---|---|---|
| ABI-M201 | Experimental | Drug: ABI-M201Cohort A: 1 capsule one time a day Cohort B: 1- 5 capsules one time a day |
| Placebo | Placebo comparator | Drug: PlaceboCohort A: 1 capsule one time a day Cohort B: 1-5 capsules one time a day |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Established diagnosis of UC for at least 3 months prior to screening, with minimum disease extent of 15 cm from the anal verge
- Mildly to moderately active UC
- Inadequate response to ongoing treatment with oral mesalamine ≥2.4 g/day for ≥4 weeks from screening visit
Key exclusion criteria (7 listed)
- Possible or confirmed diagnosis of Crohn's Disease or other forms of inflammatory bowel disorders
- Ongoing or failed prior treatment for UC with methotrexate, azathioprine, 6-mercaptopurine, cyclosporine, tofacitinib, mycophenolate mofetil, sirolimus (rapamycin), thalidomide, tacrolimus (FK-506), or biologics (e.g., TNF-alpha-antagonists, anti-integrin therapies, or agents targeting IL-12 or IL-23, etc.)
- Any immunosuppressive condition or treatment with immunosuppressive medications
- History of prior surgical intervention in any region of the gastrointestinal tract (excluding minor surgery)
- Prior diagnosis of any cardiovascular, renal, hepatic, endocrine, infectious, hematological, oncologic, neuro-psychiatric or immune-mediated disorder, which in the opinion of the Principal Investigator might impact the subject's safety or compliance, or the interpretation of results
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 |
|---|---|---|
| ABI-M201Active Treatment | Drug | ABI-M201 |
| PlaceboControl Treatment | Drug | Placebo |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: 8-weeks
[Safety]
Incidence of Treatment-Emergent Laboratory Abnormalities
Time frame: 8-weeks
[Safety]
2 secondary outcomes
Clinical Remission
Time frame: 8-weeks
Endoscopic Improvement
Time frame: 8-weeks
Results and safety
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Ulcerative Colitis Chronic Mild
RecruitingPhase 1
R-3750 in Patients With Mild to Moderate Ulcerative Colitis
Ulcerative Colitis Chronic Mild, Ulcerative Colitis Chronic Moderate
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.
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABI-M201 in people with Ulcerative Colitis Chronic Mild and Ulcerative Colitis Chronic Moderate, run by Assembly Biosciences at 11 sites in 2 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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Canada. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: Sponsor Decision). 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?
Incidence of Treatment-Emergent Adverse Events (time frame: 8-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 19 Mar 2021.