The Purpose of This Study is to Evaluate the Efficacy and Safety of 627 in the Treatment of UC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 627, Placebo.
- Who it may be relevant to
- Registry conditions: Ulcerative Colitis (UC). Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
Overview
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.
Interventions
- Drug 627
627 subcutaneous (SC) injection. - Drug Placebo
Placebo subcutaneous (SC) injection.
Primary outcome measures
- Number of participants with Adverse Events [Time frame: During the 36-week study period]
Secondary outcome measures (7)
- 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]
Eligibility criteria
Inclusion criteria
- 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).
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Affiliated Hospital, Sun Yat-sen University — Guangzhou
Identifiers
NCT: NCT07507513 · SSGJ-627-UC-II-01