The Purpose of This Study is to Evaluate the Efficacy and Safety of 627 in the Treatment of UC

NCT07507513 | Not Yet Recruiting Phase 2

• 1 other identifier: SSGJ-627-UC-II-01
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ulcerative Colitis (UC)

Outcome Measures

Primary Outcomes (1)

• Number of participants with Adverse Events

  During the 36-week study period

Secondary Outcomes (7)

• Clinical remission based on Mayo Score (MMS)

  Week 14

• Clinical response based on Mayo Score (MMS)

  Week 14

• Endoscopic improvement

  Week 14

• Endoscopic remission

  Week 14

• Symptomatic remission

  During the 36-week study period

Other Outcomes (3)

• 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.

Study Arms (8)

Group M1

EXPERIMENTAL

dose level 1 of 627

Drug: 627; Drug: Placebo

Group M2

EXPERIMENTAL

dose level 2 of 627

Drug: 627; Drug: Placebo

Group M3

EXPERIMENTAL

dose level 3 of 627

Drug: 627; Drug: Placebo

Group M4

EXPERIMENTAL

dose level 4 of 627

Drug: 627; Drug: Placebo

Group A

EXPERIMENTAL

627 Dose A subcutaneous (SC) injection.

Drug: 627

Group B

EXPERIMENTAL

627 Dose B subcutaneous (SC) injection.

Drug: 627

Placebo

PLACEBO COMPARATOR

Placebo subcutaneous (SC) injection.

Drug: Placebo

Group C

EXPERIMENTAL

627 subcutaneous (SC) injection.

Drug: 627

Interventions

627 DRUG

627 subcutaneous (SC) injection.

Group A; Group B; Group C; Group M1; Group M2; Group M3; Group M4

Placebo DRUG

Placebo subcutaneous (SC) injection.

Group M1; Group M2; Group M3; Group M4; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

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

Study Sites (1)

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Qinghong Zhou

CONTACT

+86 18911301578; zhouqinghong@3sbio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 2, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): February 28, 2029
• Study Completion (Estimated): December 30, 2029
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)