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)

This study will evaluate the efficacy and safety of 627 in patients with UC.

Study Overview

• Status: Not yet recruiting
• Conditions: Ulcerative Colitis (UC)
• Intervention / Treatment: Drug: Placebo; Drug: 627

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 Type: Interventional
• Enrollment (Estimated): 288
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Qinghong Zhou; Phone Number: +86 18911301578; Email: zhouqinghong@3sbio.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • The First Affiliated Hospital, Sun Yat-sen University
      • Contact: Minhu Chen; Phone Number: +86 020-87332916; Email: chenminhu@vip.163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo subcutaneous (SC) injection.	Drug: Placebo; Placebo subcutaneous (SC) injection.
Experimental: Group M1; dose level 1 of 627	Drug: Placebo; Placebo subcutaneous (SC) injection.; Drug: 627; 627 subcutaneous (SC) injection.
Experimental: Group M2; dose level 2 of 627	Drug: Placebo; Placebo subcutaneous (SC) injection.; Drug: 627; 627 subcutaneous (SC) injection.
Experimental: Group M3; dose level 3 of 627	Drug: Placebo; Placebo subcutaneous (SC) injection.; Drug: 627; 627 subcutaneous (SC) injection.
Experimental: Group M4; dose level 4 of 627	Drug: Placebo; Placebo subcutaneous (SC) injection.; Drug: 627; 627 subcutaneous (SC) injection.
Experimental: Group A; 627 Dose A subcutaneous (SC) injection.	Drug: 627; 627 subcutaneous (SC) injection.
Experimental: Group B; 627 Dose B subcutaneous (SC) injection.	Drug: 627; 627 subcutaneous (SC) injection.
Experimental: Group C; 627 subcutaneous (SC) injection.	Drug: 627; 627 subcutaneous (SC) injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with Adverse Events	During the 36-week study period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	Week 14
Endoscopic improvement	Proportion of subjects achieving endoscopic improvement (Endoscopic Score [ES] ≤ 1 without friability).	Week 14
Endoscopic remission	Proportion of subjects achieving endoscopic remission (Endoscopic Score [ES] = 0).	Week 14
Symptomatic remission	Proportion of subjects achieving symptomatic remission (Rectal Bleeding Score [RBS] = 0 and Stool Frequency Score [SFS] = 0).	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).	During the 36-week study period
Time to achievement of symptomatic remission and symptomatic response		During the 36-week study period

Other Outcome Measures

Outcome Measure	Time Frame
Peak Plasma Concentration (Cmax).	During the 36-week study period
Area under the Concentration-Time Curve up to the Last Measurable Concentration (AUC 0-last).	During the 36-week study period.
Time to Peak Concentration (Tmax).	During the 36-week study period.

Collaborators and Investigators

• Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): March 31, 2026
• Primary Completion (Estimated): February 28, 2029
• Study Completion (Estimated): December 30, 2029

Study Registration Dates

• First Submitted: March 26, 2026
• First Submitted That Met QC Criteria: March 26, 2026
• First Posted (Actual): April 2, 2026

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: SSGJ-627-UC-II-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No