A Phase 2 Study of D-2570 in Subjects With Moderately to Severely Active Ulcerative Colitis (NCT07035041) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Phase 2 Study of D-2570 in Subjects With Moderately to Severely Active Ulcerative Colitis
China120 participantsStarted 2025-05-22
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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;
. Males and females, 18 to 70 years of age, inclusive at the time of signing of ICF;
. 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;
. Involved intestinal segment extending ≥ 15 cm from the anal verge as confirmed by a screening endoscopy;
. 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);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of subjects achieving clinical remission at Week 12 of treatment.
. 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:
. 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;
. If 5-ASAs and glucocorticoids have already been discontinued, they must have been discontinued for ≥ 2 weeks prior to the screening endoscopy;
Exclusion criteria
. 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 surgical intervention for UC, or anticipated need for, as assessed by the investigator, surgical intervention for UC during the study, or with other gastrointestinal diseases or surgical histories that may affect the absorption of study treatment;
. Current gastrointestinal dysplasia or past confirmed gastrointestinal dysplasia that has not been eradicated; For subjects diagnosed with UC for more than 8 years, a colonoscopy to screen for dysplasia should have been performed within 1 year prior to randomization or may be conducted during the screening colonoscopy.
. Previous history of serious herpes zoster/herpes simplex infection, including but not limited to disseminated herpes simplex/herpes zoster infection, generalized herpes zoster, herpetic encephalitis/meningitis, ocular herpes, recurrent herpes zoster, or other serious herpes zoster/herpes simplex infections assessed by the investigator, or presence of herpes zoster/herpes simplex infection at screening;
. History of tuberculosis, active tuberculosis, latent tuberculosis, or clinical manifestations suggestive of tuberculosis infection; for subjects with latent tuberculosis infection (i.e., tested positive interferon-gamma release assay \[IGRA\] for Mycobacterium tuberculosis at screening) but without any symptoms, signs, laboratory findings, or imaging evidence of tuberculosis infection, re-screening is allowed after completing at least 4 weeks of standard preventive anti-tuberculosis treatment and evaluation by the investigator; subjects with indeterminate IGRA results must undergo a repeat test for confirmation, if the second test result is also indeterminate, the subject will be excluded from the study;
. Test positive for human immunodeficiency virus (HIV) antibody, or syphilis antibody (that is the subject develops an active or latent syphilis infection), or positive for hepatitis C virus (HCV) antibody and hepatitis C virus ribonucleic acid (HCV RNA) test or a viral load greater than the upper limit of normal at the study site, or positive for hepatitis B surface antigen (HBsAg). For subjects who are HBsAg-negative but positive for hepatitis B core antibody (HBcAb), further hepatitis B virus deoxyribonucleic acid (HBV DNA) test is required. If HBV DNA is tested positive or the viral load exceeds the upper limit of normal at the study site, they will also be excluded;
. Previous administration of a live vaccine within 3 months or an inactivated vaccine within 30 days prior to randomization, or planning to administer a live vaccine during the study or within 1 month after the last dose of investigational product;
. Have undergone a major surgery within 8 weeks prior to randomization, or planning to undergo any surgery during the study, unless the investigator determines that the surgery will not increase the subject's risk or affect his/her ability to receive study treatment and comply with the study requirements;