NCT07507513
The Purpose of This Study is to Evaluate the Efficacy and Safety of 627 in the Treatment of UC
Recruiting · Phase 2 · Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. · registry updated 2026-07-28
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
This study will evaluate the efficacy and safety of 627 in patients with UC.
Inclusion
- 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).
Exclusion
- 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.