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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

About this trial

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

Eligibility criteria

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • 627
  • Placebo

Treatment groups

288 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.