Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: HSK47388-Dose level 1Experimental treatment 1 intervention
Group B: HSK47388-Dose level 2Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

The proportion of patients with clinical response

Time frame
Week 12

Secondary outcomes

1

The proportion of patients with clinical remission

Time frame
Week 12
2

The proportion of patients with symptomatic remission

Time frame
Week 12
3

The proportion of patients with endoscopic remission

Time frame
Week 12
4

Proportion of patients with Mayo endoscopic subscore 0

Time frame
Week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Haisco Pharmaceutical Group Co., Ltd.

Lead sponsor

Haisco-USA Pharmaceuticals, Inc.

Collaborator

Source ClinicalTrials.gov
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