InventisBio closes enrollment in Phase 2 oral D-2570 ulcerative colitis trial
The 120-patient China trial has stopped recruiting on schedule, setting up a clinical remission readout at Week 12 in a field crowded with approved biologics and JAK inhibitors.
Executive Summary
- InventisBio's Phase 2 trial of its oral drug D-2570 in ulcerative colitis has closed enrollment exactly at its planned target and moved to Active, not recruiting, keeping the study on its original timeline.
- The status change advances rather than threatens the pending readout: it confirms the trial reached full enrollment without delay or shortfall ahead of its primary completion date.
- The ulcerative colitis field has multiple approved biologics and small molecules already addressing the same second-line-plus population, and no trial in the competitive set shares D-2570's target or mechanism, so the readout will be judged against that established standard of care rather than against a direct comparator.
- The trial's primary endpoint, clinical remission at Week 12, is the disclosure that will determine whether the oral candidate can compete in a market already served by injectable and oral options.
The status change
InventisBio Co., Ltd's trial of D-2570, an oral therapy for moderately to severely active ulcerative colitis, has stopped recruiting patients. The registry shows the status moved from Recruiting to Active, not recruiting, with enrollment landing at 120 patients, matching the trial's original target with no shortfall or overshoot. The trial is a multicenter, randomized, quadruple-masked, placebo-controlled study across three arms conducted at sites in China. It started dosing on May 22, 2025, and the primary completion date remains July 30, 2026, unchanged since the trial began. NCT07035041+1A Phase 2 Study of D-2570 in Subjects With Moderately to Severely Active Ulcerative ColitisNCT07035041InventisBio Enrollment Closed in Phase 2 D-2570 Trial for Ulcerative ColitisJul 17, 2026
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
What the trial tests
The primary endpoint is the proportion of subjects achieving clinical remission at Week 12, defined by a modified Mayo score requiring a stool frequency subscore of 1 or less with at least a 1-point drop from baseline, no rectal bleeding, and an endoscopic subscore of 1 or less. Secondary measures track endoscopic improvement, C-reactive protein and fecal calprotectin normalization, and adverse events through Week 12. Enrolled patients had documented inadequate response, loss of response, or intolerance to at least one standard-of-care treatment for ulcerative colitis, placing the trial in a second-line-or-later population. NCT07035041A Phase 2 Study of D-2570 in Subjects With Moderately to Severely Active Ulcerative ColitisNCT07035041
Operational read
The enrollment change registers as routine: the operational model's threshold for a enrollment shift is a move of 20% or more, and this trial closed at 0% change from its target. No protocol amendment has touched the primary completion date, endpoints, or eligibility criteria since the trial's initial registration, and the registry-churn proxy for this study reads as stable. InventisBio has completed 17 of 18 prior trials with one terminated, a track record that supports the sponsor's operational reliability on this program. NCT07035041A Phase 2 Study of D-2570 in Subjects With Moderately to Severely Active Ulcerative ColitisNCT07035041
The competitive field
Ulcerative colitis already has multiple approved treatment options, including mesalamine and corticosteroids for induction and maintenance in the indication. Biologics and small molecules in active development for the same disease include AbbVie's risankizumab, Eli Lilly's mirikizumab, Takeda's vedolizumab, and Bristol-Myers Squibb's ozanimod, none of which share D-2570's target or mechanism class on record. No trial in the competitive set functions as a direct same-target comparator to D-2570, so the Week 12 data will be read against the established remission rates these approved and late-stage mechanisms have set in the same second-line-plus population, rather than against a head-to-head rival.
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.