Actively Recruiting
A Phase 2 Study of D-2570 in Subjects With Moderately to Severely Active Ulcerative Colitis
Led by InventisBio Co., Ltd · Updated on 2025-06-24
120
Participants Needed
1
Research Sites
84 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase 2 Study of D-2570 in Subjects With Moderately to Severely Active Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 70 years at the time of consent
- Diagnosis of ulcerative colitis for at least 3 months confirmed by endoscopy, histopathology, and clinical symptoms
- Involved intestinal segment extending at least 15 cm from the anal verge confirmed by screening endoscopy
- Active moderate to severe ulcerative colitis with modified Mayo score between 5 and 9, including stool frequency subscore ≥ 2, rectal bleeding subscore ≥ 1, and endoscopic subscore ≥ 2 confirmed by central reading
- Documented inadequate response, loss of response, or intolerance to at least one standard treatment for ulcerative colitis
- Stable doses of oral 5-ASAs, glucocorticoids (≤ 20 mg/day prednisone or equivalent, or ≤ 9 mg/day budesonide or equivalent), or probiotics for at least 2 weeks before screening endoscopy and during the study period
- If 5-ASAs and glucocorticoids have been discontinued, must have been discontinued for at least 2 weeks before screening endoscopy
- Provided written informed consent and agreed to follow study procedures
You will not qualify if you...
- Diagnosed or suspected Crohn's disease, indeterminate colitis, fulminant colitis, toxic megacolon, microscopic colitis, ischemic colitis, radiation colitis, or colitis associated with diverticula
- History of colonic resection, subtotal or total colectomy, or planned surgical intervention for ulcerative colitis during the study
- Current or unresolved gastrointestinal dysplasia or history of dysplasia without eradication
- Previous serious herpes zoster or herpes simplex infections, or active infection at screening
- History or evidence of active, latent, or suspected tuberculosis; positive IGRA test without standard preventive treatment
- Positive tests for HIV antibody, active or latent syphilis, hepatitis C antibody with viral load above normal, or hepatitis B surface antigen positive; positive HBV DNA test if HBsAg-negative but HBcAb-positive
- Live vaccine within 3 months or inactivated vaccine within 30 days before randomization, or planned vaccination during study or within 1 month after last dose
- Major surgery within 8 weeks before randomization or planned surgery during study unless deemed safe by investigator
- History of serious infections requiring IV treatment or hospitalization within 3 months before randomization, or infections requiring antibiotics or antivirals within 2 weeks before randomization
- Positive stool test for C. difficile or other enteric pathogens within 3 months before randomization or at screening unless successfully treated and re-screened negative
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310016
Actively Recruiting
Research Team
Q
qian cao, Dr.
CONTACT
S
shilin sha
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here