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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

A Phase 2 Study of D-2570 in Subjects 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

A Phase 2 Study of D-2570 in Subjects With Moderately to Severely Active Ulcerative Colitis (NCT07035041) is a Phase 2 interventional studying UC - Ulcerative Colitis and Moderately to Severely Active Ulcerative Colitis, sponsored by InventisBio Co., Ltd. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against UC - Ulcerative Colitis and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 120 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused UC - Ulcerative Colitis subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form 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: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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;

Treatments Being Tested

DRUG

D-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.

DRUG

Placebo

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.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
Hangzhou, Zhejiang, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07035041), the sponsor (InventisBio Co., Ltd), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07035041 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07035041?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07035041?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07035041. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07035041. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.