A Study for HSK47388 in Participants With Ulcerative Colitis
Phase 2 · Testing HSK47388 · 1 site · Haisco Pharmaceutical Group Co., Ltd.
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing HSK47388 (a drug) as a possible treatment. Condition(s) listed: Ulcerative Colitis (UC).
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.
Who can join
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- 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.
Plus 3 more requirement(s). There are also 9 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 150 participants are expected to take part.
- Start date: 2026-02-03.
- Main results expected around 2027-10-15 (estimate from the record).
- 1 study site listed (1 marked recruiting) in China.
Main thing being measured
- The proportion of patients with clinical response (Week 12)
In the researchers’ words
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 .
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Ulcerative Colitis (UC) |
| Lead sponsor | Haisco Pharmaceutical Group Co., Ltd. |
| Collaborators | Haisco-USA Pharmaceuticals, Inc. |
| Enrollment | 150 (estimated) |
| Start date | 2026-02-03 |
| Primary completion (est.) | 2027-10-15 |
| First posted | 2026-01-12 |
| Last updated | 2026-03-05 |
| Official title | 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 |
| ClinicalTrials.gov ID | NCT07335055 |
Interventions
- HSK47388 (Drug)
Participants will be randomized to receive HSK47388, orally starting at Week 0 . At Week-12, all participants will be evaluated for clinical response and responders will enter the maintenance study. - Placebo (Drug)
Participants will be randomized to receive Placebo, orally starting at Week 0 . At Week-12, all participants will be evaluated for clinical response and responders will enter the maintenance study.
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Sir Run Run Shaw Hospital | Hangzhou | China | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.