NCT07507513RecruitingPhase 2
The Purpose of This Study is to Evaluate the Efficacy and Safety of 627 in the Treatment of UC
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)
Source: ClinicalTrials.gov · Last updated 28 Jul 2026
Brief summary (registry, in English)
This study will evaluate the efficacy and safety of 627 in patients with UC.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 288 (estimated)
- First submitted
- 26 Mar 2026
- Start date
- 28 Mar 2026
- Primary completion date
- 28 Feb 2029
- Lead sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
- Diseases
- Ulcerative colitis
- NCT number
- NCT07507513
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 288
- From 28 Mar 2026 to the primary completion date, 28 Feb 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Allergy to the investigational medicinal product, any of its components, or excipients.
- Other conditions deemed unsuitable for trial participation by the investigator.
Lab values
- 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.
Other
- Pregnant or lactating female subjects.
Who the study is looking for
- 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).
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.