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A Phase 2 Study of D-2570 in Subjects With Moderately to Severely Active Ulcerative Colitis

ConditionsUC - Ulcerative ColitisModerately to Severely Active Ulcerative Colitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorInventisBio Co., Ltd

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • D-2570

    Drug

    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.

  • Placebo

    Drug

    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.

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: D-2570 (experimental arm 1)Experimental treatment 1 intervention
Group B: D-2570 (experimental arm 2)Experimental treatment 1 intervention
Group C: placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of subjects achieving clinical remission at Week 12 of treatment.

Definition of clinical remission: Based on the modified Mayo score including stool frequency subscore, rectal bleeding subscore, and endoscopic subscore. All the following criteria must be met: Stool frequency (SF) subscore ≤ 1, with a ≥1-point decrease from baseline; Rectal bleeding (RB) subscore = 0; Endoscopic subscore (ES) ≤ 1.

Time frame
Week 12

Secondary outcomes

1

Proportion of subjects achieving clinical response at Week 12 of treatment;

Time frame
Week 12
2

● Proportion of subjects achieving symptomatic remission at 4, 8, 12 weeks of treatment;

Time frame
4, 8, 12 weeks
3

RB subscore change from baseline at 4, 8, 12 weeks of treatment;

Time frame
4, 8, 12 weeks
4

SF subscore change from baseline at 4, 8, 12 weeks of treatment;

Time frame
4, 8, 12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

InventisBio Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
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