Actively Recruiting
A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of D-2570 as Induction Therapy 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
22 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of D-2570 in adults with moderately to severely active ulcerative colitis in this multicenter, randomized, double-blind, placebo-controlled Phase 2 clinical trial. The study plans to include 120 participants who have had ulcerative colitis for at least three months and have active disease confirmed by specific clinical scores and endoscopy. The trial aims to better understand treatment options for this condition by comparing D-2570 to a placebo. The study is divided into two parts: Part A with 30 subjects and Part B with 90 subjects. Participants are randomized equally into three groups: two different doses of D-2570 or placebo. They will take their assigned medication once daily for 12 consecutive weeks. Part A includes an additional single-dose pharmacokinetic study period to assess how the drug is processed in the body, while both parts share the same population selection, randomization, blinding, dosing, and outcome assessments. Participants will undergo regular evaluations including clinical remission assessment at week 12 as the primary outcome. Secondary outcomes include clinical response, symptomatic remission, stool frequency and rectal bleeding scores, endoscopic improvement, and biomarkers such as fecal calprotectin and C-reactive protein measured at weeks 4, 8, and 12. Safety will be monitored throughout the 12-week treatment. The trial duration and follow-up periods are planned to capture detailed information on treatment effects and safety.
CONDITIONS
Brief 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...
- Subjects voluntarily consent to participate and agree to follow study procedures
- Males and females aged 18 to 70 years at consent
- Diagnosed with ulcerative colitis for at least 3 months, confirmed by endoscopy and clinical features
- Intestinal involvement of 15 cm or more from the anal verge confirmed by endoscopy
- Active moderate to severe ulcerative colitis with a modified Mayo score of 5 to 9, including stool frequency subscore �32, rectal bleeding subscore �31, and endoscopic subscore �32
- History of inadequate response, loss of response, or intolerance to one or more standard treatments
- Stable doses of oral 5-ASAs, oral glucocorticoids (prednisone �3c= 20 mg/day or equivalent), or probiotics for at least 2 weeks before screening and during the study, or discontinued these treatments at least 2 weeks before screening
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 with diverticula
- History of colonic resection, colectomy, or surgery for ulcerative colitis, or planned surgery during the study
- Current or past untreated gastrointestinal dysplasia; must have screening colonoscopy within 1 year if UC duration is more than 8 years
- Serious or active herpes zoster/herpes simplex infections
- History or evidence of active, latent, or suspected tuberculosis without proper treatment
- Positive tests for HIV, syphilis, hepatitis C, or hepatitis B infections with elevated viral loads
- Recent live vaccine within 3 months or inactivated vaccine within 30 days before randomization, or planned vaccination during study
- Major surgery within 8 weeks before randomization or planned surgery during study unless deemed safe by investigator
- Recent serious infections requiring intravenous treatment or hospitalization within 3 months, or antibiotic/antiviral treatment within 2 weeks before randomization
- Recent stool positive for C. difficile or other enteric infections within 3 months unless successfully treated and cleared before screening
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 weeks
Participants take the assigned investigational product (D-2570 or placebo) once daily for 12 consecutive weeks to evaluate the safety and efficacy of the treatment for ulcerative colitis.
Weekly visits for up to 12 weeks
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.
S
shilin sha
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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