Ulcerative Colitis (UC)Phase 2NCT07507513
The Purpose of This Study is to Evaluate the Efficacy and Safety of 627 in the Treatment of UC
A Phase 2 study testing 627 in people with Ulcerative Colitis (UC), run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 1 site in China.
Trial summary
This study will evaluate the efficacy and safety of 627 in patients with UC. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis (UC)
- What is being tested?
- 627
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 288 participants
- Where
- 1 siteChina
- Study dates
- 28 Mar 2026to 30 Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- Allergy to the investigational medicinal product, any of its components, or excipients.
- 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.
- Pregnant or lactating female subjects.
- Other conditions deemed unsuitable for trial participation by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080
Minhu Chen, +86 020-87332916, chenminhu@vip.163.com
About this study
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)
This study will evaluate the efficacy and safety of 627 in patients with UC.
Read the detailed description
Ulcerative colitis (UC) is a chronic non-specific intestinal disease characterized by continuous and diffuse inflammatory changes in the colorectal mucosa. Despite the availability of advanced therapies, there remains a significant unmet medical need, such as inadequate or loss of response to one or more of the following therapies, corticosteroid dependence, or intolerance to one or more therapies. The purpose of this study is to evaluate the efficacy and safety of 627 in patients with moderate to severe UC.
- Conditions
- Ulcerative Colitis (UC)
- Being tested
- 627, Placebo
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
627Drug
627 subcutaneous (SC) injection.
PlaceboDrug
Placebo subcutaneous (SC) injection.
| Study group | Role | What they receive |
|---|---|---|
| Group M1 | Experimental | dose level 1 of 627 Receives: Drug: 627; Drug: Placebo |
| Group M2 | Experimental | dose level 2 of 627 Receives: Drug: 627; Drug: Placebo |
| Group M3 | Experimental | dose level 3 of 627 Receives: Drug: 627; Drug: Placebo |
| Group M4 | Experimental | dose level 4 of 627 Receives: Drug: 627; Drug: Placebo |
| Group A | Experimental | 627 Dose A subcutaneous (SC) injection. Receives: Drug: 627 |
| Group B | Experimental | 627 Dose B subcutaneous (SC) injection. Receives: Drug: 627 |
| Placebo | Placebo comparator | Placebo subcutaneous (SC) injection. Receives: Drug: Placebo |
| Group C | Experimental | 627 subcutaneous (SC) injection. Receives: Drug: 627 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse Events
Measured: During the 36-week study period
Secondary outcomes (7)
Clinical remission based on Mayo Score (MMS)
Proportion of subjects achieving clinical remission based on Mayo Score (MMS) (Rectal Bleeding Score [RBS] = 0, Endoscopic Score [ES] ≤ 1 without friability, and Stool Frequency Score [SFS] ≤ 1and not exceeding baseline).
Measured: Week 14
Clinical response based on Mayo Score (MMS)
Proportion of subjects achieving clinical response based on Mayo Score (MMS) (≥2-point and ≥30% reduction in MMS from baseline, and ≥1-point reduction in Rectal Bleeding Score [RBS] or RBS value ≤1 point).
Measured: Week 14
Endoscopic improvement
Proportion of subjects achieving endoscopic improvement (Endoscopic Score [ES] ≤ 1 without friability).
Measured: Week 14
Endoscopic remission
Proportion of subjects achieving endoscopic remission (Endoscopic Score [ES] = 0).
Measured: Week 14
Symptomatic remission
Proportion of subjects achieving symptomatic remission (Rectal Bleeding Score [RBS] = 0 and Stool Frequency Score [SFS] = 0).
Measured: During the 36-week study period
Symptomatic response
Proportion of subjects achieving symptomatic response (≥30% reduction from baseline in combined RBS and SFS total scores).
Measured: During the 36-week study period
Time to achievement of symptomatic remission and symptomatic response
Measured: During the 36-week study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start28 Mar 2026
- Primary completion28 Feb 2029 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis (UC)Studies of the same condition, open and under way.
- More trials run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07507513
- Sponsor's protocol ID
- SSGJ-627-UC-II-01
- Status last verified
- Jul 2026
- First submitted
- 26 Mar 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- SSGJ-627-UC-II-01
- Conditions
- Ulcerative Colitis (UC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Mar 2026 (actual)
- Primary completion
- 28 Feb 2029 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 2 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the efficacy and safety of 627 in patients with UC.
Detailed description
Ulcerative colitis (UC) is a chronic non-specific intestinal disease characterized by continuous and diffuse inflammatory changes in the colorectal mucosa. Despite the availability of advanced therapies, there remains a significant unmet medical need, such as inadequate or loss of response to one or more of the following therapies, corticosteroid dependence, or intolerance to one or more therapies. The purpose of this study is to evaluate the efficacy and safety of 627 in patients with moderate to severe UC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Group M1 | Experimental | Drug: 627, Drug: Placebodose level 1 of 627 |
| Group M2 | Experimental | Drug: 627, Drug: Placebodose level 2 of 627 |
| Group M3 | Experimental | Drug: 627, Drug: Placebodose level 3 of 627 |
| Group M4 | Experimental | Drug: 627, Drug: Placebodose level 4 of 627 |
| Group A | Experimental | Drug: 627627 Dose A subcutaneous (SC) injection. |
| Group B | Experimental | Drug: 627627 Dose B subcutaneous (SC) injection. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo subcutaneous (SC) injection. |
| Group C | Experimental | Drug: 627627 subcutaneous (SC) injection. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 627627 subcutaneous (SC) injection. | Drug | Group A, Group B, Group C, Group M1, Group M2, Group M3, Group M4 |
| PlaceboPlacebo subcutaneous (SC) injection. | Drug | Group M1, Group M2, Group M3, Group M4, Placebo |
Primary outcome
Number of participants with Adverse Events
Time frame: During the 36-week study period
7 secondary outcomes
Clinical remission based on Mayo Score (MMS)
Time frame: Week 14
Clinical response based on Mayo Score (MMS)
Time frame: Week 14
Endoscopic improvement
Time frame: Week 14
Endoscopic remission
Time frame: Week 14
Symptomatic remission
Time frame: During the 36-week study period
Symptomatic response
Time frame: During the 36-week study period
Time to achievement of symptomatic remission and symptomatic response
Time frame: During the 36-week study period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 627 in people with Ulcerative Colitis (UC), run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qinghong Zhou (+86 18911301578, zhouqinghong@3sbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Adverse Events (time frame: During the 36-week study period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.