Moderately to Severely Active Ulcerative Colitis, UC - Ulcerative Colitis
Conditions
Keywords
Moderately to Severely Active Ulcerative Colitis, UC
Brief summary
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.
Detailed description
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.
Interventions
DRUGD-2570
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.
DRUGPlacebo
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.
Sponsors
InventisBio Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Subjects who meet all of the following criteria can be included in this study: 1. Subjects voluntarily take part in the study after being fully informed, sign a written informed consent form (ICF), and agree to follow procedures specified in the study protocol; 2. Males and females, 18 to 70 years of age, inclusive at the time of signing of ICF; 3. Have had an established diagnosis of ulcerative colitis (UC) of ≥ 3 months in duration prior to signing of ICF, which is supported by endoscopy reports, histopathology reports and clinical manifestations consistent with UC, as determined by investigators; 4. Involved intestinal segment extending ≥ 15 cm from the anal verge as confirmed by a screening endoscopy; 5. Active moderate to severe UC, defined by a modified Mayo score of 5 to 9 points at screening, which includes a stool frequency (SF) subscore of ≥ 2, a rectal bleeding (RB) subscore ≥ 1 and an endoscopic (ES) subscore of ≥ 2 (based on a screening endoscopy, confirmed by central reading); 6. Documentation of an inadequate response, loss of response, or intolerance (defined as interruption of drug due to an adverse reaction as evaluated by the investigator) to a treatment course of 1 or more of the following standard of care medications: 7. If a subject is using oral 5-ASAs, and/or oral glucocorticoids (≤ 20 mg/day of prednisone or equivalent dose, or ≤ 9 mg/day of budesonide or equivalent dose), and/or probiotics to treat UC, the dosage must remain stable for ≥ 2 weeks prior to the screening endoscopy and during the study period; 8. If 5-ASAs and glucocorticoids have already been discontinued, they must have been discontinued for ≥ 2 weeks prior to the screening endoscopy; *
Exclusion criteria
Subjects cannot be included in the study if any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects achieving clinical remission at Week 12 of treatment. | Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects achieving clinical response at Week 12 of treatment; | Week 12 | — |
| ● Proportion of subjects achieving symptomatic remission at 4, 8, 12 weeks of treatment; | 4, 8, 12 weeks | — |
| RB subscore change from baseline at 4, 8, 12 weeks of treatment; | 4, 8, 12 weeks | — |
| SF subscore change from baseline at 4, 8, 12 weeks of treatment; | 4, 8, 12 weeks | — |
| Proportion of subjects achieving endoscopic improvement at 12 weeks of treatment. | Week 12 | — |
| Proportion of subjects achieving ES of 0 at 12 weeks of treatment; | Week 12 | — |
| ES change from baseline at 12 weeks of treatment; | Week 12 | — |
| Proportion of subjects with normal fecal calprotectin at 4, 8, 12 weeks of treatment; | 4, 8, 12 weeks | — |
| Proportion of subjects with normal C-reactive protein at 4, 8, 12 weeks of treatment; | 4, 8, 12 weeks | — |
| Plasma concentrations of D-2570 | 0-week 12 | — |
| safety（AEs） | 0-week12 | 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. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORqian Cao, phD
Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
Outcome results
None listed