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New pill could tame Flare-Ups for ulcerative colitis patients

NCT ID NCT07335055

Disease control Sponsor: Haisco Pharmaceutical Group Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an experimental drug called HSK47388 in 150 adults with moderately to severely active ulcerative colitis, a chronic bowel disease causing inflammation and sores. Participants will receive either the drug or a placebo to see if it improves symptoms and helps heal the gut lining. The goal is to find a new treatment option for people who haven't responded well to other therapies.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Written informed consent must be obtained 2. Male or female, ≥18 years old and ≤75 years old 3. Willing and able to comply with study-specific procedures and the requirements of study protocol. 4. Diagnosis of ulcerative colitis (UC) 5. Baseline modified Mayo score of 5 to 9 and the endoscopy subscore 2 to 3 6. Demonstrated an inadequate response, loss of response, or failure to tolerate previous conventional therapy or advanced therapy. Exclusion Criteria: 1. Subjects have used treatments within the time frame specified in protocol prior to the baseline visit 2. Diagnosis of indeterminate colitis, ischemic colitis, Crohn's colitis or clinical findings suggestive of Crohn's disease 3. Participants with current or prior diagnosis of fulminant colitis and/or toxic megacolon 4. Presence of a stoma 5. Presence or history of a fistula 6. Intra-abdominal or other major surgery performed within 12 weeks before baseline 7. History of extensive colonic resection 8. Subjects have laboratory values meeting the criteria in protocol 9. Concurrent conditions and history of other diseases as described in protocol

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Conditions

The condition(s) this trial relates to.

ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ulcerative colitis (UC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Sir Run Run Shaw Hospital

    RECRUITING

    Hangzhou, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.