Trial intelligence / Profile preview

SSGJ-627 in Moderate to Severe Active Ulcerative Colitis

NCT07507513Phase 2

Key facts

Status: Recruiting
Start: Mar 2026
Primary completion: Feb 2029
Countries: 1
Sponsor: 3S Guojian Pharmaceutical
Modality: Monoclonal Antibodies

Drugs: SSGJ-627
Conditions: ulcerative colitis (UC)

Overview

Phase 2, randomised, double-blind trial of SSGJ-627 in ulcerative colitis (UC) (8 arms), sponsored by 3S Guojian Pharmaceutical. Primary endpoint: Number of participants with Adverse Events at 36 weeks. Started Mar 2026; status: recruiting.

Design

8 arms

Study design: RandomizedDouble-blind

Group M1
dose level 1 of 627
Group M2
dose level 2 of 627
Group M3
dose level 3 of 627
Group M4
dose level 4 of 627
Group A
627 Dose A subcutaneous (SC) injection.
Group B
627 Dose B subcutaneous (SC) injection.

2 more in the full profile.

Who it enrols

Adults aged 18-75 with moderate to severe active ulcerative colitis for at least 3 months, who have inadequate response, intolerance, or corticosteroid dependence to prior therapies. Excludes patients with severe infections, positive HBV/HCV/HIV/TP, recent cardiovascular/cerebrovascular diseases, or recent malignancies.

Endpoints

Primary

Number of participants with Adverse Events36 weeks

Secondary

Clinical remission based on Mayo Score (MMS)14 weeks
Clinical response based on Mayo Score (MMS)14 weeks
Endoscopic improvement14 weeks
Endoscopic remission14 weeks
Symptomatic remission36 weeks
Symptomatic response36 weeks
Time to achievement of symptomatic remission and symptomatic response36 weeks

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