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New treatment option for Ulcerative Colitis (UC)
Official title A Study for HSK47388 in Participants With Ulcerative Colitis
ClinicalTrials.gov ID: NCT07335055
What this study is testing
What is HSK47388?
HSK47388 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for ulcerative colitis (uc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 .
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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
You likely can't join if
- people have used treatments within the time frame specified in protocol prior to the baseline visit
- Diagnosis of indeterminate colitis, ischemic colitis, Crohn's colitis or clinical findings suggestive of Crohn's disease
- Participants with current or prior diagnosis of fulminant colitis and/or toxic megacolon
- Presence of a stoma
- Presence or history of a fistula
- Intra-abdominal or other major surgery performed within 12 weeks before baseline
See the full eligibility criteria
- 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.
- people have used treatments within the time frame specified in protocol prior to the baseline visit
- Diagnosis of indeterminate colitis, ischemic colitis, Crohn's colitis or clinical findings suggestive of Crohn's disease
- Participants with current or prior diagnosis of fulminant colitis and/or toxic megacolon
- Presence of a stoma
- Presence or history of a fistula
- Intra-abdominal or other major surgery performed within 12 weeks before baseline
- History of extensive colonic resection
- people have laboratory values meeting the criteria in protocol
- Concurrent conditions and history of other diseases as described in protocol
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.