This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial. The target population is patients with moderately to severely active ulcerative colitis. A total of 120 subjects are planned to be included.
The study is divided into two parts, Part A and Part B. Part A will include 30 subjects, while Part B will include 90 subjects. The primary difference between Part A and Part B is that Part A includes a single-dose pharmacokinetic (PK) study period. Other aspects, such as population selection, randomization and blinding, dosing regimens, and outcome assessments (safety and efficacy), are consistent between Part A and Part B.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
Subjects will then be randomized in a 1:1:1 ratio to D-2570 or placebo . They will enter the study treatment period and take the assigned investigational product once daily for 12 consecutive weeks.
Subjects will then be randomized in a 1:1:1 ratio to D-2570 or placebo . They will enter the study treatment period and take the assigned investigational product once daily for 12 consecutive weeks.
Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
RECRUITINGProportion of subjects achieving clinical remission at Week 12 of treatment.
Definition of clinical remission: Based on the modified Mayo score including stool frequency subscore, rectal bleeding subscore, and endoscopic subscore. All the following criteria must be met: Stool frequency (SF) subscore ≤ 1, with a ≥1-point decrease from baseline; Rectal bleeding (RB) subscore = 0; Endoscopic subscore (ES) ≤ 1.
Time frame: Week 12
Proportion of subjects achieving clinical response at Week 12 of treatment;
Time frame: Week 12
● Proportion of subjects achieving symptomatic remission at 4, 8, 12 weeks of treatment;
Time frame: 4, 8, 12 weeks
RB subscore change from baseline at 4, 8, 12 weeks of treatment;
Time frame: 4, 8, 12 weeks
SF subscore change from baseline at 4, 8, 12 weeks of treatment;
Time frame: 4, 8, 12 weeks
Proportion of subjects achieving endoscopic improvement at 12 weeks of treatment.
Time frame: Week 12
Proportion of subjects achieving ES of 0 at 12 weeks of treatment;
Time frame: Week 12
ES change from baseline at 12 weeks of treatment;
Time frame: Week 12
Proportion of subjects with normal fecal calprotectin at 4, 8, 12 weeks of treatment;
Time frame: 4, 8, 12 weeks
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Proportion of subjects with normal C-reactive protein at 4, 8, 12 weeks of treatment;
Time frame: 4, 8, 12 weeks
Plasma concentrations of D-2570
Time frame: 0-week 12
safety(AEs)
An Adverse Event (AE) is definedas any new untoward medicaloccurrence or worsening of a preexistingmedical condition in a clinicalinvestigation participant administeredstudy treatment and that does notnecessarily have a causal relationshipwith this treatment.
Time frame: 0-week12