Clinical Trials/NCT05181137

NCT05181137

Recruiting

Phase 3

A Phase 3 Study to Evaluate the Efficacy and Long-term Safety of SHR0302 Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis

Reistone Biopharma Company Limited113 sites in 2 countries368 target enrollmentNovember 5, 2021

ConditionsUlcerative Colitis

InterventionsSHR0302 Placebo

DrugsSHR0302 Placebo

Overview

Phase: Phase 3
Intervention: SHR0302
Conditions: Ulcerative Colitis
Sponsor: Reistone Biopharma Company Limited
Enrollment: 368
Locations: 113
Primary Endpoint: Clinical remission at week 8 (Part 1)
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a randomized, double-blind, placebo-controlled, multicenter Phase 3 study that will enroll approximately 368 subjects aged 18 to 75 years old with Moderately to Severely Active Ulcerative Colitis.

Detailed Description

This study consists of a screening period followed by a placebo-controlled Part 1 phase and then a placebo-controlled Part 2 phase. An open label Part 3 phase is open to subjects who: complete the Part 2, are considered non-responders following the Part 1, or have disease worsening during Part 2.

Registry

clinicaltrials.gov

Start Date

November 5, 2021

End Date

March 31, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Reistone Biopharma Company Limited

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Inclusion Criteria for Part 1
•Male or female subjects must be at least at ≥18 and ≤75 years of age
•Subject has at least a three-month history of Ulcerative Colitis diagnosis at baseline.
•Subject has active Ulcerative Colitis with a 9-point modified Mayo score of ≥ 5 at baseline, with an endoscopic subscore of ≥ 2
•Subject is deemed by the physician as having inadequate response, loss of response or intolerance to at least one conventional treatment (oral 5-ASA, immunosuppressants or corticosteroids), or was previously exposed to anti-TNF therapy (e.g., infliximab, adalimumab) or other biological treatment (e.g., vedolizumab) having
•Discontinued the treatment for:
•Infliximab: a minimum of 8 weeks prior to baseline.
•Adalimumab: a minimum of 10 weeks prior to baseline.
•Ustekinumab: a minimum of 14 weeks prior to baseline.
•Vedolizumab: a minimum of 17 weeks prior to baseline.

Exclusion Criteria

•Subject has a diagnosis of indeterminate colitis, or clinical findings suggestive of Crohn'sDisease.
•Subject with Ulcerative Colitis, which is confined to a proctitis (distal 15 cm or less).
•Treatment naïve subject diagnosed with Ulcerative Colitis (without previous exposure to any of the following therapies for UC treatment: oral 5-ASA, corticosteroids, immunosuppressants, or biological treatments).
•Subject is displaying clinical signs of ischemic colitis, fulminant colitis or toxic megacolon.
•Subject had previous surgery as a treatment for Ulcerative Colitis or likely to require surgery during the study period.
•Subject has evidence of pathogenic bowel infection. Subjects had Clostridium difficile or other intestinal infection within 30 days of screening endoscopy or test positive at screening for C.difficile toxin or other intestinal pathogens.
•Subject currently has or has a history of active tuberculosis (TB) or latent TB infection.
•Subject is receiving any of the following therapies:
•Azathioprine/6-mercaptopurine, methotrexate, thalidomide within 7 days prior to baseline.
•Cyclosporine, mycophenolate, tacrolimus within 4 weeks prior to baseline.

Arms & Interventions

Part 1 Active Experimental: SHR0302 Dose#1

SHR0302 Oral tablets taken once daily (QD) for 8 weeks SHR0302 Oral tablets taken once daily (QD)

Intervention: SHR0302

Part 1 Placebo Comparator: Placebo

Placebo Oral tablets taken once daily (QD) for 8 weeks

Intervention: Placebo

Part 2 Active Experimental: SHR0302 Dose#2

SHR0302 Oral tablets taken once daily (QD) for 44 weeks

Intervention: SHR0302

Part 2 Placebo Comparator: Placebo

Placebo Comparator: Maintenance Treatment Placebo Comparator: Placebo

Intervention: Placebo

Part 3 Active Experimental: SHR0302 Dose#2

SHR0302 Oral tablets taken once daily (QD) for 26 weeks

Intervention: SHR0302

Outcomes

Primary Outcomes

Clinical remission at week 8 (Part 1)

Time Frame: 8 weeks

The percentage of subjects in clinical remission at week 8.

Clinical remission at week 52 (Part 2)

Time Frame: 52 weeks

The percentage of subjects in clinical remission at week 52.

Secondary Outcomes

Change in total Mayo score and 9-point modified Mayo score at week 52 (Part 2)(52 weeks)
Endoscopic remission at week 8 (Part 1)(8 weeks)
Clinical response at week 8 (Part 1)(8 weeks)
Change in total Mayo score and 9-point modified Mayo score at week 8 (Part 1)(8 weeks)
Change from baseline in partial Mayo score at week 2, 4, and 8 (Part 1)(8 weeks)
Subjects with endoscopic remission (Part 2)(52 weeks)
Subjects with clinical response at week 52 (Part 2)(52 weeks)
Change from baseline in partial Mayo score at week 12, 16, 24, 32, 40, and 52 (Part 2)(52 weeks)
Subjects in corticosteroid-free remission at week 52 (Part 2)(52 weeks)
Subjects who maintain clinical remission at week 52 (Part 2)(52 weeks)
Subjects in clinical remission per partial Mayo score at week E26 (Part 3)(26 weeks (extension))
Subjects in corticosteroid-free remission per Partial Mayo score at week E26 (Part 3)(26 weeks (extension))
Change from baseline in Partial Mayo score at week E2, E12, and E26 (Part 3)(26 weeks (extension))