Can a new pill tame ulcerative colitis when others fail?
NCT ID NCT07747155
First seen Aug 05, 2026 · Last updated Aug 07, 2026 · Updated 2 times
Summary
This trial is testing an experimental oral drug called PTT-621 in adults aged 18-70 with moderate-to-severe ulcerative colitis who haven't responded well to standard treatments. Participants will take PTT-621 tablets for 12 weeks. The main goal is to see if the drug can improve the lining of the colon, with secondary goals of assessing safety, symptom relief, and how the drug behaves in the body.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PTT-621 tablets (an experimental oral drug)
- What this could lead to
- If successful, PTT-621 could offer a new oral treatment option for people with moderate-to-severe ulcerative colitis who haven't found relief from current therapies.
- What could go wrong
- This is an early-stage (Phase IIa) study with only 40 participants, so results may not apply to everyone. The drug's safety and effectiveness are not yet proven, and side effects are possible.
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 40 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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Jun 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 70 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 18-70 years inclusive at screening. 2. Diagnosed with ulcerative colitis (UC) at least 60 days prior to the first dose of IP. 3\. Participants have active UC at screening, defined as a modified Mayo score of 5-9. 4\. Endoscopic evidence of UC extending ≥15 cm from the anal verge during the screening period. 5\. Participants have had inadequate/loss of response or intolerance to at least one of the following: 5-aminosalicylic acid, glucocorticoids, immunosuppressants, biologics, and/or small-molecule targeted therapies. 6\. Participants currently receiving the following UC therapies are eligible if they meet stability requirements: Oral glucocorticoids: with stable dosing for ≥2 weeks prior to screening endoscopy;Oral 5-ASA: Stable dose for at least 2 weeks prior to the endoscopic assessment during the screening period. 7\. Female participants of childbearing potential must have a negative serum/urine pregnancy test at screening. 8\. Willing to use at least one highly effective contraceptive method during sexual intercourse throughout the study and until 1 month after the last dose of IP. 9\. Willing to refrain from sperm/ova donation throughout the study and until 1 month after the last dose of IP. 10\. Able and willing to provide written informed consent and comply with all protocol-specified procedures and visit schedules. Exclusion Criteria: * 1\. A current diagnosis of Crohn's disease (CD), indeterminate colitis, infectious colitis, or any other colitis/enteritis that could interfere with efficacy evaluation; 2. Has UC complications (e.g., fulminant colitis, toxic megacolon, prior total or partial colectomy, or other conditions requiring surgery); 3. Prior or current gastrointestinal dysplasia; 4. History of gastrointestinal malignancy, or any current evidence of gastrointestinal cancer.
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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 places running it
1 site. The list below names each one and where it is.
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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.
Contacts and locations
Locations
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Renji Hospital-Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Triple-Pronged attack on gut inflammation put to the test
- Two biologics go head to head in ulcerative colitis
- New drug ATTO-1091 put to the test for safety in ulcerative colitis
- Antiparasitic drug tested as new weapon against ulcerative colitis
- Could your Donor's gut bacteria decide whether a stool transplant works?
- Exercise as a potential remedy for IBD-related fatigue