Not Yet RecruitingPhase 2

The Purpose of This Study is to Evaluate the Efficacy and Safety of 627 in the Treatment of UC

China288 participantsStarted 2026-03-31

Plain-language summary

This study will evaluate the efficacy and safety of 627 in patients with UC.

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Able to understand and comply with the requirements of the study protocol, and sign the written informed consent form (ICF).
✓. Male or female subjects aged 18-75 years old when signing the ICF.
✓. Subjects must have been diagnosed with UC for at least 3 months prior to randomization.
✓. Moderate to Severe Active Ulcerative Colitis (UC).
✓. Inadequate or lost response, intolerance to one or more therapies, or corticosteroid dependence.
✓. Female subjects of childbearing potential and male subjects (and their female partners) must use highly effective contraception from the screening period through at least 6 months after the last dose. The subjects must have no plans for pregnancy, sperm donation, or oocyte donation during the same period (from screening through at least 6 months post-last dose).

✕. History of severe opportunistic infection within 2 months prior to screening or randomization that remains not adequately controlled.
✕. Receiving protocol-prohibited treatments prior to screening or randomization.
✕. Presence of any laboratory test abnormalities during screening and/or determination by the investigator that enrollment in the study may pose uncontrollable safety risks to the subject.
✕. Positive hepatitis B test result, positive hepatitis C virus antibody (HCV Ab), positive human immunodeficiency virus antibody (HIV Ab), or positive serum Treponema pallidum antibody (TP Ab) during screening, as specified in the protocol.
✕. History of clinically significant cardiovascular and cerebrovascular diseases within 6 months prior to screening.
✕. History of any malignancy within 5 years prior to screening or currently active malignancy.
✕. Allergy to the investigational medicinal product, any of its components, or excipients.
✕. History of alcohol or substance abuse within 6 months prior to screening.

Number of participants with Adverse Events

Timeframe: During the 36-week study period

NCT IDNCT07507513

SponsorSunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-02-28

Qinghong Zhou

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Able to understand and comply with the requirements of the study protocol, and sign the written informed consent form (ICF).
✓. Male or female subjects aged 18-75 years old when signing the ICF.
✓. Subjects must have been diagnosed with UC for at least 3 months prior to randomization.
✓. Moderate to Severe Active Ulcerative Colitis (UC).
✓. Inadequate or lost response, intolerance to one or more therapies, or corticosteroid dependence.
✓. Female subjects of childbearing potential and male subjects (and their female partners) must use highly effective contraception from the screening period through at least 6 months after the last dose. The subjects must have no plans for pregnancy, sperm donation, or oocyte donation during the same period (from screening through at least 6 months post-last dose).

✕. History of severe opportunistic infection within 2 months prior to screening or randomization that remains not adequately controlled.
✕. Receiving protocol-prohibited treatments prior to screening or randomization.
✕. Presence of any laboratory test abnormalities during screening and/or determination by the investigator that enrollment in the study may pose uncontrollable safety risks to the subject.
✕. Positive hepatitis B test result, positive hepatitis C virus antibody (HCV Ab), positive human immunodeficiency virus antibody (HIV Ab), or positive serum Treponema pallidum antibody (TP Ab) during screening, as specified in the protocol.
✕. History of clinically significant cardiovascular and cerebrovascular diseases within 6 months prior to screening.
✕. History of any malignancy within 5 years prior to screening or currently active malignancy.
✕. Allergy to the investigational medicinal product, any of its components, or excipients.
✕. History of alcohol or substance abuse within 6 months prior to screening.