D-2570 for adults with moderately to severely active ulcerative colitis

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

This study will test whether D-2570 is safe and can reduce symptoms in adults aged 18–70 with moderately to severely active ulcerative colitis compared with placebo.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: InventisBio Co., Ltd (Industry-sponsored)
• Drugs / interventions: radiation, prednisone
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT07035041 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, placebo-controlled Phase 2 trial will enroll about 120 adults with moderately to severely active ulcerative colitis and is split into Part A (30 subjects with a single-dose PK period) and Part B (90 subjects). Subjects are randomized to receive D-2570 or placebo with identical blinding and outcome assessments across both parts. The trial will monitor safety and efficacy outcomes, including clinical disease activity based on modified Mayo scores and endoscopic findings. Pharmacokinetics are specifically characterized in Part A while both parts contribute to pooled safety and efficacy analyses.

Who should consider this trial

Good fit: Adults 18–70 with an established diagnosis of UC for at least 3 months, disease extending ≥15 cm from the anal verge, and a modified Mayo score of 5–9 with required stool frequency, rectal bleeding, and endoscopic subscores are ideal candidates.

Not a fit: People with mild UC, disease confined to less than 15 cm, failure to meet the modified Mayo score criteria, or major comorbidities that exclude trial participation are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, D-2570 could reduce symptoms and mucosal inflammation and provide a new treatment option for people with moderate-to-severe UC.

How similar studies have performed: Other pharmacologic treatments for UC have shown benefit in phase 2/3 trials, but D-2570 itself is a novel agent and its effectiveness in this population has not yet been established.

Eligibility criteria

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 exclusion criteria is met:

1. Diagnosed or suspected Crohn's disease, indeterminate colitis, fulminant colitis, toxic megacolon, microscopic colitis, ischemic colitis, radiation colitis, or colitis associated with diverticula;
2. 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;
3. 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.

   Subjects with a history of adenomatous polyps are eligible if the polyps have been completely removed (as documented in the medical records), and no residual polyps or evidence of dysplasia is found in the colonoscopy and histological examination at screening.
4. 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;
5. 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;
6. 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;
7. 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;
8. 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;
9. History of a serious viral, bacterial, or fungal infection which requires intravenous (IV) anti-infectives, or hospitalization for treatment within 3 months prior to randomization, or develops a viral, bacterial, or fungal infection which requires antibiotics/anti-viral treatment within 2 weeks prior to randomization;
10. History of stool positive for C. difficile test or evidence for other enteric pathogen infections within 3 months prior to randomization or at screening. Subjects may be re-screened 30 days after completion of a standard of care course with anti-infectives, and subsequent negative testing for corresponding tests and no persistent symptoms of infection with the pathogen, upon evaluation by the investigator;

Where this trial is running

Hangzhou, Zhejiang

• Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: qian Cao, phD — Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
• Study coordinator: qian cao, Dr.

Conditions UC - Ulcerative Colitis; Moderately to Severely Active Ulcerative Colitis; UC