SPH3127-US-01 is a multi-center, randomized, double-blind, placebo-controlled study to
evaluate the safety, pharmacokinetics, and preliminary efficacy of SPH3127 for the treatment
of mild-to-moderate ulcerative colitis.
SPH3127-US-01 is a proof-of-concept multi-center, randomized, double-blind,
placebo-controlled study to evaluate the safety, pharmacokinetics, and preliminary efficacy
of of daily oral administration of SPH3127 or placebo for 8 weeks in patients with
mild-to-moderate ulcerative colitis. After meeting all inclusion and exclusion criteria,
eligible patients will be randomized to receive SPH3127 (50 mg daily, 50 mg twice daily) or
placebo tablets; all patients will take 2 tablets (SPH3127 or placebo) twice a day for 8
weeks. All randomized subjects will have the opportunity to enter an active-treatment
extension (50 mg SPH3127 once or twice daily) for an additional 10 months.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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