HSK47388 for adults with moderately to severely active ulcerative colitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2, interventional, placebo-controlled trial of HSK47388 in adults (18–75) with moderately to severely active ulcerative colitis and baseline modified Mayo scores of 5–9 with endoscopy subscore 2–3. Eligible participants must have shown inadequate response, loss of response, or intolerance to conventional or advanced therapies. Participants will receive HSK47388 or placebo and be monitored for clinical improvement, endoscopic findings, and safety including adverse events. The trial is sponsored by Haisco Pharmaceutical and is being conducted at Sir Run Run Shaw Hospital in Hangzhou.

Why it matters

Who can join: the full rules

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

Where it's running

• Sir Run Run Shaw Hospital
  Hangzhou, China Recruiting

Study contacts

• Study coordinator: Yongrui Wang
• Email: wangyr@haisco.com
• Phone: 028-67258840

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.