NCT07335055RecruitingPhase 2
A Study for HSK47388 in Participants With 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
Source: ClinicalTrials.gov · Last updated 5 Mar 2026
Brief summary (registry, in English)
The purpose of this protocol is to evaluate the efficacy and safety of HSK47388 as therapy in participants with moderately to severely active ulcerative colitis .
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 4 Jan 2026
- Start date
- 3 Feb 2026
- Primary completion date
- 15 Oct 2027
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Diseases
- Ulcerative colitis
- NCT number
- NCT07335055
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 150
- From 3 Feb 2026 to the primary completion date, 15 Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects have used treatments within the time frame specified in protocol prior to the baseline visit
- Participants with current or prior diagnosis of fulminant colitis and/or toxic megacolon
- Intra-abdominal or other major surgery performed within 12 weeks before baseline
Other illness
- Diagnosis of indeterminate colitis, ischemic colitis, Crohn's colitis or clinical findings suggestive of Crohn's disease
- Presence or history of a fistula
- History of extensive colonic resection
- Concurrent conditions and history of other diseases as described in protocol
Lab values
- Subjects have laboratory values meeting the criteria in protocol
Other
- Presence of a stoma
Who the study is looking for
- Written informed consent must be obtained
- Male or female, ≥18 years old and ≤75 years old
- Willing and able to comply with study-specific procedures and the requirements of study protocol.
- Diagnosis of ulcerative colitis (UC)
- Baseline modified Mayo score of 5 to 9 and the endoscopy subscore 2 to 3
- Demonstrated an inadequate response, loss of response, or failure to tolerate previous conventional therapy or advanced therapy.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sir Run Run Shaw Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.