Ulcerative Colitis (UC)
Conditions
Brief summary
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
DRUGHSK47388
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.
DRUGPlacebo
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.
Sponsors
Haisco Pharmaceutical Group Co., Ltd.
Haisco-USA Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with clinical response | Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients with clinical remission | Week 12 |
| The proportion of patients with symptomatic remission | Week 12 |
| The proportion of patients with endoscopic remission | Week 12 |
| Proportion of patients with Mayo endoscopic subscore 0 | Week 12 |
| Percent change from baseline in Mayo score and modified Mayo score | Week 12 |
| Percent change from baseline in partial Mayo score | Week 12 |
Countries
China
Contacts
CONTACTYongrui Wang
Outcome results
None listed