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NCT Number: NCT07335055

A Study for HSK47388 in Participants With Ulcerative Colitis

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 .

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sir Run Run Shaw Hospital

Hangzhou, China

Location status: Recruiting

Location contact

Qian Cao

PRINCIPAL_INVESTIGATOR

Xu

CONTACT

[email protected]

0571-86006811

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

  5. Percent change from baseline in Mayo score and modified Mayo score

    Time frame: Week 12

  6. Percent change from baseline in partial Mayo score

    Time frame: Week 12

Study contacts

Contact information is provided by the study sponsor or research team.

Yongrui Wang

CONTACT

[email protected]

028-67258840

Sponsors and collaborators

Lead sponsor

Haisco Pharmaceutical Group Co., Ltd.

Industry

Collaborators

  • Haisco-USA Pharmaceuticals, Inc.

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2029
First posted
Jan 12, 2026
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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