Can a new pill tame ulcerative colitis Flare-Ups?
NCT ID NCT07755241
First seen Aug 10, 2026 · Last updated Aug 18, 2026 · Updated 3 times
Summary
This clinical trial is testing an experimental oral medication called AC-101 in adults with moderately to severely active ulcerative colitis (UC), a chronic inflammatory bowel disease. The study aims to see if AC-101 can help achieve clinical remission—meaning fewer symptoms and healed intestinal lining—compared to a placebo. Participants will take either a high dose, low dose, or placebo tablet twice daily for 12 weeks, with an optional extension period. The trial is for people who have not responded well to prior treatments.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AC-101 tablets (an experimental oral drug)
- What this could lead to
- If successful, AC-101 could offer a new oral treatment option for people with ulcerative colitis who haven't responded to other therapies.
- What could go wrong
- This is an early-stage (Phase 2b) trial, so the drug may not prove effective or safe. Results from this small study will need confirmation in larger trials.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 153 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female participants aged ≥ 18 and ≤ 75 years; 2. Must sign the Informed Consent Form and be willing to participate in the study. 3. Diagnosis of UC confirmed at least 3 months prior to screening, supported by both endoscopic and histological evidence. 4. 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. 5. Documented failure to prior advanced therapies or prior conventional therapies 6. Female participants must meet either criterion a) or b), and male participants must meet criterion c) to be eligible for enrollment: 1. Female participants of non-childbearing potential; 2. 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; 3. 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. Exclusion Criteria: 1. Severe extensive colitis. 2. Hospitalization for exacerbation of UC within 12 weeks prior to screening. 3. History of gastrointestinal dysplasia, or presence of dysplasia detected in any biopsy performed during the screening colonoscopy. 4. Adenomatous colonic polyps that have not been removed prior to study enrollment. 5. Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease, or clinical findings suggestive of Crohn's disease. 6. Positive stool pathogen test or positive test for Clostridioides difficile toxin at screening. 7. Presence of an ostomy or fistula. 8. Risk of tuberculosis . 9. History of current or prior serious opportunistic infection. 10. Presence of active or chronic recurrent infection. 11. 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. 12. Current hepatitis C infection, or positive hepatitis C virus (HCV) test at screening. 13. Human immunodeficiency virus (HIV) infection/acquired immunodeficiency syndrome , or positive HIV antibody test at screening. 14. Syphilis, or positive syphilis-specific antibody test at screening. 15. Treatment with advanced therapies for UC within 8 weeks or 5 half-lives prior to randomization. 16. Treatment with intravenous corticosteroids within 2 weeks prior to randomization. 17. Treatment with leukocyte apheresis within 12 weeks prior to randomization. 18. Treatment with intravenous immunoglobulins or plasmapheresis within 12 weeks prior to randomization. 19. Treatment with lymphocyte-depleting therapy. 20. History of fecal microbiota transplantation. 21. Vaccination with live attenuated vaccines within 4 weeks prior to randomization, or a plan to receive such vaccines during the study period. 22. Requirement for parenteral nutrition. 23. 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. 24. 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. 25. Known history of immunodeficiency; other acquired or congenital immunodeficiency disorders; or history of organ transplantation. 26. 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. 27. Female patients who are pregnant, lactating, or have a positive serum pregnancy test at screening. 28. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Antiparasitic drug tested as new weapon against ulcerative colitis
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- Exercise as a potential remedy for IBD-related fatigue