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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18-75 with moderate to severe active ulcerative colitis, diagnosed at least 3 months ago, who did not respond well to earlier treatment.
- Age
- 18-75 years
- Sex
- Men and women
- Disease stage
- Moderate to severe active ulcerative colitis (UC), diagnosed for at least 3 months before randomization.
- Earlier treatment
- Inadequate or lost response, intolerance to one or more therapies, or dependence on corticosteroids.
Main reasons for not taking part
- Severe opportunistic infection within 2 months before screening that is not well controlled
- Positive test for hepatitis B, hepatitis C, HIV or syphilis during screening
- Any cancer within 5 years before screening, or active cancer now
- Major surgery within 6 months before screening, or planned during the study
- Pregnant or breastfeeding women
Read by machine on 9 November 2026.
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.