HSK47388 for adults with moderately to severely active ulcerative colitis

A Phase 2 Randomized, Double-blind, Placebo-Controlled, Multicenter Clinical Study to Evaluate the Efficacy and Safety of HSK47388 in Participants With Moderately to Severely Active Ulcerative Colitis

This trial will test whether HSK47388 helps adults with moderately to severely active ulcerative colitis control inflammation and symptoms better than a placebo.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Hangzhou)
• Trial ID: NCT07335055 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–75 with moderately to severely active ulcerative colitis (modified Mayo 5–9, endoscopy 2–3) who have had inadequate response, loss of response, or intolerance to conventional or advanced therapies.

Not a fit: People with Crohn's disease, indeterminate colitis, fulminant colitis or toxic megacolon, history of fistula or stoma, recent major abdominal surgery, extensive colonic resection, or those who used disallowed treatments within the protocol timeframe are unlikely to be eligible or benefit.

Why it matters

Potential benefit: If successful, HSK47388 could provide a new treatment option to help induce remission and reduce symptoms in people with moderate-to-severe ulcerative colitis.

How similar studies have performed: Other targeted therapies for moderate-to-severe ulcerative colitis have shown mixed but sometimes meaningful results in phase 2 trials, so the approach has precedent but is not yet proven.

Eligibility criteria

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 this trial is running

Hangzhou

• Sir Run Run Shaw Hospital — Hangzhou, China (Recruiting)

Study contacts

• Study coordinator: Yongrui Wang

Conditions Ulcerative Colitis