A Study for HSK47388 in Participants With Ulcerative Colitis
ConditionUlcerative Colitis (UC)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHaisco Pharmaceutical Group Co., Ltd.
About this trial
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 .
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- HSK47388
- Placebo
Treatment groups
150 Participants
are divided into 3 treatment groupsSponsors and collaborators
Haisco Pharmaceutical Group Co., Ltd.
Lead sponsor
Haisco-USA Pharmaceuticals, Inc.
Collaborator
Source ClinicalTrials.gov