Ulcerative Colitis (UC)Phase 2NCT07755241
A Study of AC-101 Tablets in Patients With Ulcerative Colitis
A Phase 2 study testing AC-101 in people with Ulcerative Colitis (UC), run by Accro Bioscience (Suzhou) Limited at 1 site in China.
Trial summary
This is a Phase Ⅱb, multicenter, randomized, parallel-group, double-blind, placebo-controlled, dose-finding study of AC-101 tablets in patients with moderately to severely active ulcerative colitis (UC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis (UC)
- What is being tested?
- AC-101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 153 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2026to 28 Feb 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Male or female participants aged ≥ 18 and ≤ 75 years；
- Must sign the Informed Consent Form and be willing to participate in the study.
- Diagnosis of UC confirmed at least 3 months prior to screening, supported by both endoscopic and histological evidence.
- Evidence of UC extending ≥ 15 cm from the anal verge as assessed by colonoscopy. Moderately to severely active UC, defined as a modified Mayo Score of 5 to 9, with an Endoscopic Subscore ≥ 2.
- Documented failure to prior advanced therapies or prior conventional therapies
- Female participants must meet either criterion a) or b), and male participants must meet criterion c) to be eligible for enrollment:
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- Female participants of non-childbearing potential;
- Female participants of childbearing potential who are not pregnant must agree to use highly effective contraception during the treatment period and for at least 1 month after the last dose of study treatment;
- Male participants with a pregnant or non-pregnant female partner of childbearing potential must agree to use contraception during the treatment period and for at least 1 month after the last dose of study treatment.
Who cannot join
- Severe extensive colitis.
- Hospitalization for exacerbation of UC within 12 weeks prior to screening.
- History of gastrointestinal dysplasia, or presence of dysplasia detected in any biopsy performed during the screening colonoscopy.
- Adenomatous colonic polyps that have not been removed prior to study enrollment.
- Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease, or clinical findings suggestive of Crohn's disease.
- Positive stool pathogen test or positive test for Clostridioides difficile toxin at screening.
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- Presence of an ostomy or fistula.
- Risk of tuberculosis .
- History of current or prior serious opportunistic infection.
- Presence of active or chronic recurrent infection.
- Patients with any of the following hepatitis B screening results:
- Acute or chronic hepatitis B infection; or Positive hepatitis B virus (HBV) test at screening (HBsAg positive); or HBsAg negative, hepatitis B core antibody (HBcAb) positive, with detectable HBV-DNA.
- Current hepatitis C infection, or positive hepatitis C virus (HCV) test at screening.
- Human immunodeficiency virus (HIV) infection/acquired immunodeficiency syndrome , or positive HIV antibody test at screening.
- Syphilis, or positive syphilis-specific antibody test at screening.
- Treatment with advanced therapies for UC within 8 weeks or 5 half-lives prior to randomization.
- Treatment with intravenous corticosteroids within 2 weeks prior to randomization.
- Treatment with leukocyte apheresis within 12 weeks prior to randomization.
- Treatment with intravenous immunoglobulins or plasmapheresis within 12 weeks prior to randomization.
- Treatment with lymphocyte-depleting therapy.
- History of fecal microbiota transplantation.
- Vaccination with live attenuated vaccines within 4 weeks prior to randomization, or a plan to receive such vaccines during the study period.
- Requirement for parenteral nutrition.
- History of myocardial infarction, acute stroke, transient ischemic attack, thromboembolic events, clinically significant arrhythmia, unstable angina, coronary artery bypass grafting, or severe pulmonary heart disease/pulmonary hypertension within 3 months prior to randomization, which, in the investigator's judgment, may affect the evaluation of study results.
- Presence of any other unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, neurological/psychiatric, or other medical condition that, in the investigator's judgment, may interfere with the study results.
- Known history of immunodeficiency; other acquired or congenital immunodeficiency disorders; or history of organ transplantation.
- History of malignancy within 5 years prior to screening, with the exception of adequately treated carcinoma in situ of the cervix, or basal cell or squamous cell carcinoma of the skin.
- Female patients who are pregnant, lactating, or have a positive serum pregnancy test at screening.
- Any other condition that, in the investigator's opinion, may affect the patient's safety or compliance, or preclude the patient from completing the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080
Minhu Chen, 020-8708185, chenminhu@vip.163.com
About this study
Official title: A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Dose-finding Study to Evaluate the Efficacy and Safety of AC-101 Tablets in Patients With Moderately to Severely Active Ulcerative Colitis
This is a Phase Ⅱb, multicenter, randomized, parallel-group, double-blind, placebo-controlled, dose-finding study of AC-101 tablets in patients with moderately to severely active ulcerative colitis (UC). The study will evaluate the efficacy, safety, and pharmacokinetics of AC-101 compared with placebo in patients who have had an inadequate response, loss of response, or intolerance to prior advanced therapies or to prior conventional therapies. The study consists of a screening period (up to 4 weeks), a 12-week induction period, a 40-week extension period, and a 4-week safety follow-up period.
- Conditions
- Ulcerative Colitis (UC)
- Being tested
- AC-101, Placebo
- Keywords
- IBD, AC-101, dose finding
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AC-101Drug
AC-101 tablets at the high dose will be administered orally twice daily
AC-101Drug
AC-101 tablets at the low dose will be administered orally twice daily.
PlaceboDrug
Placebo tablets will be administered orally twice daily.
| Study group | Role | What they receive |
|---|---|---|
| AC-101 cohort 1 | Experimental | Patients will receive AC-101 Dose 1 as tablets orally twice daily Receives: Drug: AC-101 |
| AC-101 cohort 2 | Experimental | Patients will receive AC-101 Dose 2 as tablets orally twice daily Receives: Drug: AC-101 |
| Placebo | Placebo comparator | Patients will receive oral placebo tablets twice daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Remission
Clinical remission at Week 12, defined as stool frequency subscore of 0 or 1, rectal bleeding subscore of 0, AND centrally read endoscopy subscore of 0 or 1
Measured: Week 12
Secondary outcomes (3)
Clinical response
Clinical response at Week 12, defined as a decrease from baseline in the modified Mayo Score of greater than or equal to 2 points AND at least a 30 percent reduction from baseline, AND a decrease in RB of greater than or equal to 1 or an absolute rectal bleeding subscore of 0 or 1
Measured: Week 12
Symptomatic remission
Symptomatic remission at Week 12, defined as RB=0 and SF=0, OR RB=0, SF≤1 and at least 1 point reduction from baseline
Measured: Week 12
Adverse Events
Adverse events during the study
Measured: Up to 56 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start10 Sep 2026
- Primary completion30 Nov 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis (UC)Studies 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
- 153 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Accro Bioscience (Suzhou) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07755241
- Sponsor's protocol ID
- AC-101-UC-Ⅱ-01
- Status last verified
- Oct 2026
- First submitted
- 5 Aug 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Dose-finding Study to Evaluate the Efficacy and Safety of AC-101 Tablets in Patients With Moderately to Severely Active Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT07755241
- Acronym / sponsor ID
- AC-101-UC-Ⅱ-01
- Conditions
- Ulcerative Colitis (UC)
- Keywords
- IBD, AC-101, dose finding
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 153 participants (estimated)
- Lead sponsor
- Accro Bioscience (Suzhou) LimitedIndustry (pharma, biotech, devices)
- Study start
- 10 Sep 2026 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 10 Aug 2026 (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.
This is a Phase Ⅱb, multicenter, randomized, parallel-group, double-blind, placebo-controlled, dose-finding study of AC-101 tablets in patients with moderately to severely active ulcerative colitis (UC). The study will evaluate the efficacy, safety, and pharmacokinetics of AC-101 compared with placebo in patients who have had an inadequate response, loss of response, or intolerance to prior advanced therapies or to prior conventional therapies. The study consists of a screening period (up to 4 weeks), a 12-week induction period, a 40-week extension period, and a 4-week safety follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AC-101 cohort 1 | Experimental | Drug: AC-101Patients will receive AC-101 Dose 1 as tablets orally twice daily |
| AC-101 cohort 2 | Experimental | Drug: AC-101Patients will receive AC-101 Dose 2 as tablets orally twice daily |
| Placebo | Placebo comparator | Drug: PlaceboPatients will receive oral placebo tablets twice daily |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female participants aged ≥ 18 and ≤ 75 years；
- Must sign the Informed Consent Form and be willing to participate in the study.
- Diagnosis of UC confirmed at least 3 months prior to screening, supported by both endoscopic and histological evidence.
- Evidence of UC extending ≥ 15 cm from the anal verge as assessed by colonoscopy. Moderately to severely active UC, defined as a modified Mayo Score of 5 to 9, with an Endoscopic Subscore ≥ 2.
- Documented failure to prior advanced therapies or prior conventional therapies
Key exclusion criteria (29 listed)
- Severe extensive colitis.
- Hospitalization for exacerbation of UC within 12 weeks prior to screening.
- History of gastrointestinal dysplasia, or presence of dysplasia detected in any biopsy performed during the screening colonoscopy.
- Adenomatous colonic polyps that have not been removed prior to study enrollment.
- Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease, or clinical findings suggestive of Crohn's disease.
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 |
|---|---|---|
| AC-101AC-101 tablets at the high dose will be administered orally twice daily | Drug | AC-101 cohort 1 |
| AC-101AC-101 tablets at the low dose will be administered orally twice daily. | Drug | AC-101 cohort 2 |
| PlaceboPlacebo tablets will be administered orally twice daily. | Drug | Placebo |
Primary outcome
Clinical Remission
Time frame: Week 12
Clinical remission at Week 12, defined as stool frequency subscore of 0 or 1, rectal bleeding subscore of 0, AND centrally read endoscopy subscore of 0 or 1
3 secondary outcomes
Clinical response
Time frame: Week 12
Symptomatic remission
Time frame: Week 12
Adverse Events
Time frame: Up to 56 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AC-101 in people with Ulcerative Colitis (UC), run by Accro Bioscience (Suzhou) Limited at 1 site in China.
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 9 inclusion and 29 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: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yin Lin (86-020-87330631, zsyyiec2020@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Remission (time frame: Week 12). 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 28 Oct 2026.