A Study for HSK47388 in Participants With Ulcerative Colitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HSK47388, Placebo.
- Who it may be relevant to
- Registry conditions: Ulcerative Colitis (UC). Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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 .
Interventions
- Drug HSK47388
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. - Drug Placebo
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.
Primary outcome measures
- The proportion of patients with clinical response [Time frame: Week 12]
Secondary outcome measures (6)
- The proportion of patients with clinical remission [Time frame: Week 12]
- The proportion of patients with symptomatic remission [Time frame: Week 12]
- The proportion of patients with endoscopic remission [Time frame: Week 12]
- Proportion of patients with Mayo endoscopic subscore 0 [Time frame: Week 12]
- Percent change from baseline in Mayo score and modified Mayo score [Time frame: Week 12]
- Percent change from baseline in partial Mayo score [Time frame: Week 12]
Eligibility criteria
Inclusion 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.
Exclusion criteria
- Subjects 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
- Subjects have laboratory values meeting the criteria in protocol
- Concurrent conditions and history of other diseases as described in protocol
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sir Run Run Shaw Hospital — Hangzhou
Identifiers
NCT: NCT07335055 · HSK47388-202