UCRecruiting
The Purpose of This Study is to Evaluate the Efficacy and Safety of 627 in the Treatment of UC
Phase 2 · Testing 627 · 1 site · Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing 627 (a drug) as a possible treatment. Condition(s) listed: Ulcerative Colitis (UC).
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.
Who can join
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- 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.
Plus 3 more requirement(s). There are also 14 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 288 participants are expected to take part.
- Start date: 2026-03-28.
- Main results expected around 2029-02-28 (estimate from the record).
- 1 study site listed (1 marked recruiting) in China.
Main thing being measured
- Number of participants with Adverse Events (During the 36-week study period)
In the researchers’ words
This study will evaluate the efficacy and safety of 627 in patients with UC.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Ulcerative Colitis (UC) |
| Lead sponsor | Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. |
| Enrollment | 288 (estimated) |
| Start date | 2026-03-28 |
| Primary completion (est.) | 2029-02-28 |
| First posted | 2026-04-02 |
| Last updated | 2026-07-28 |
| Official title | 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) |
| ClinicalTrials.gov ID | NCT07507513 |
Interventions
- 627 (Drug)
627 subcutaneous (SC) injection. - Placebo (Drug)
Placebo subcutaneous (SC) injection.
Full eligibility criteria (from the record)
Inclusion Criteria: 1. Able to understand and comply with the requirements of the study protocol, and sign the written informed consent form (ICF). 2. Male or female subjects aged 18-75 years old when signing the ICF. 3. Subjects must have been diagnosed with UC for at least 3 months prior to randomization. 4. Moderate to Severe Active Ulcerative Colitis (UC). 5. Inadequate or lost response, intolerance to one or more therapies, or corticosteroid dependence. 6. 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 Criteria: 1. History of severe opportunistic infection within 2 months prior to screening or randomization that remains not adequately controlled. 2. Receiving protocol-prohibited treatments prior to screening or randomization. 3. 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. 4. 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. 5. History of clinically significant cardiovascular and cerebrovascular diseases within 6 months prior to screening. 6. History of any malignancy within 5 years prior to screening or currently active malignancy. 7. Allergy to the investigational medicinal product, any of its components, or excipients. 8. History of alcohol or substance abuse within 6 months prior to screening. 9. Undergone major surgery within 6 months prior to screening or planned major surgery during the study period. 10. Blood donation or significant blood loss within 4 weeks prior to screening. 11. Participation in any drug clinical trial within 3 months prior to screening or within 5 half-lives of the investigational drug (whichever is longer). 12. Vaccination with live/attenuated live vaccines within 4 weeks prior to screening or planned vaccination during the study period. 13. Pregnant or lactating female subjects. 14. Other conditions deemed unsuitable for trial participation by the investigator.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital, Sun Yat-sen University | Guangzhou, Guangdong | China | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.