Testing the drug 627 in adults with moderate to severe ulcerative colitis
Tests 627 against a placebo in adults with active ulcerative colitis.
Plain-language title generated from the registry record
Registry title: The Purpose of This Study is to Evaluate the Efficacy and Safety of 627 in the Treatment of UC
Key facts
- Where
- Guangzhou, ChinaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07507513, who can take part
Where in China
- The First Affiliated Hospital, Sun Yat-sen UniversityGuangzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
- Trial code
- NCT07507513
- Record updated
- 28 July 2026
- Original description
This study will evaluate the efficacy and safety of 627 in patients with UC.Read full original descriptionShow less
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Immunogenicity of SSGJ-627 in Subjects With Moderate to Severe Active Ulcerative Colitis (UC)
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; 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; History of alcohol or substance abuse within 6 months prior to screening; Undergone major surgery within 6 months prior to screening or planned major surgery during the study period; Blood donation or significant blood loss within 4 weeks prior to screening; Participation in any drug clinical trial within 3 months prior to screening or within 5 half-lives of the investigational drug (whichever is longer); Vaccination with live/attenuated live vaccines within 4 weeks prior to screening or planned vaccination during the study period; Allergy to the investigational medicinal product, any of its components, or excipients; Other conditions deemed unsuitable for trial participation by the investigator; 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; Pregnant or lactating female subjects.