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SHR0302 for Ulcerative Colitis

Phase 3

Recruiting

Research Sponsored by Reistone Biopharma Company Limited

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject has completed Part 1 and achieved clinical response at week 8

Subject has active Ulcerative Colitis with a 9-point modified Mayo score of at least 5 at baseline, with an endoscopic subscore of at least 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 weeks

Awards & highlights

Study Summary

This trial will test if a new drug is effective and safe for people with Ulcerative Colitis.

Who is the study for?

Adults aged 18-75 with moderately to severely active Ulcerative Colitis can join this trial. They must have a history of the disease for at least three months and not responded well to conventional treatments or certain biological therapies. People who've had recent infections, surgery for Ulcerative Colitis, or are pregnant cannot participate.Check my eligibility

What is being tested?

The study is testing SHR0302 against a placebo in people with Ulcerative Colitis. It's a Phase 3 trial where participants are randomly assigned to either the test drug or placebo without knowing which one they're getting, ensuring that results are unbiased.See study design

What are the potential side effects?

While specific side effects of SHR0302 aren't listed here, similar drugs often cause symptoms like headaches, nausea, increased risk of infection, and possibly liver issues. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I completed the first part of the study and saw improvement by week 8.

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I have active Ulcerative Colitis with moderate to severe symptoms.

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I am between 18 and 75 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Clinical remission at week 52 (Part 2)

Clinical remission at week 8 (Part 1)

Secondary outcome measures

Change from baseline in Partial Mayo score at week E2, E12, and E26 (Part 3)

Change from baseline in partial Mayo score at week 12, 16, 24, 32, 40, and 52 (Part 2)

Change from baseline in partial Mayo score at week 2, 4, and 8 (Part 1)

+10 more

Side effects data

From 2021 Phase 2 trial • 164 Patients • NCT03675477

Protein urine present

Upper respiratory tract infection

Blood thyroid stimulating hormone decreased

Aspartate aminotransferase increased

Blood creatine phosphokinase increased

Transaminases increased

Neutrophil count decreased

Anaemia

Colitis ulcerative

Lymphocyte count decreased

White blood cell count decreased

Hypokalaemia

Alanine aminotransferase increased

100%

80%

60%

40%

20%

Study treatment Arm

Extension Phase-SHR0302 4mg QD → SHR0302 4mg QD

Extension Phase-placebo → SHR0302 4mg QD

Treatment Phase-Placebo

Extension Phase-placebo → SHR0302 4mg BD

Extension Phase-SHR0302 4mg BD → SHR0302 4mg BD

Extension Phase-placebo → SHR0302 8mg QD

Extension Phase-SHR0302 8mg QD → SHR0302 8mg QD

Treatment Phase-SHR0302 8mg QD

Treatment Phase-SHR0302 4mg BD

Treatment Phase-SHR0302 4mg QD

Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: Part 3 Active Experimental: SHR0302 Dose#2Experimental Treatment1 Intervention

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

Group II: Part 2 Active Experimental: SHR0302 Dose#2Experimental Treatment1 Intervention

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

Group III: Part 1 Active Experimental: SHR0302 Dose#1Experimental Treatment1 Intervention

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

Group IV: Part 2 Placebo Comparator: PlaceboPlacebo Group1 Intervention

Placebo Comparator: Maintenance Treatment Placebo Comparator: Placebo

Group V: Part 1 Placebo Comparator: PlaceboPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SHR0302

2020

Completed Phase 3

~1700

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Reistone Biopharma Company LimitedLead Sponsor

10 Previous Clinical Trials

1,932 Total Patients Enrolled

1 Trials studying Ulcerative Colitis

164 Patients Enrolled for Ulcerative Colitis

Xiang ChenStudy DirectorReistone Pharma

3 Previous Clinical Trials

706 Total Patients Enrolled

1 Trials studying Ulcerative Colitis

164 Patients Enrolled for Ulcerative Colitis

Media Library

Placebo (Placebo) Clinical Trial Eligibility Overview. Trial Name: NCT05181137 — Phase 3

Ulcerative Colitis Research Study Groups: Part 2 Placebo Comparator: Placebo, Part 3 Active Experimental: SHR0302 Dose#2, Part 1 Placebo Comparator: Placebo, Part 1 Active Experimental: SHR0302 Dose#1, Part 2 Active Experimental: SHR0302 Dose#2

Ulcerative Colitis Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05181137 — Phase 3

Placebo (Placebo) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05181137 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are subjects still being accepted for this research?

"The trial is actively recruiting, as seen on clinicaltrials.gov. This specific study was initially posted on November 5th, 2021, and was last updated September 7th, 2022."

Answered by AI

What are the researchers' aims for this experiment?

"The purpose of this 8-week long trial is to induce clinical remission in patients by week 52. Secondary goals include measuring the change in partial Mayo score from baseline at weeks 12, 16, 24, 32, 40, and 52, as well as the change in total Mayo score and 9-point modified Mayo score at week 52. The percentage of patients who maintain clinical remission at week 52 will also be monitored."

Answered by AI

What is the status of SHR0302's FDA approval process?

"There is some evidence from earlier phases of testing to support the efficacy of SHR0302 as well as multiple rounds of data affirming its safety. Therefore, our team rates it as a 3 on our safety scale."

Answered by AI

Are octogenarians still candidates for this experiment?

"Eligibility requirements for this clinical trial state that applicants must be between 18-75 years old. There are currently 70 studies underway for patients who are under 18 and 364 studies for patients above the age of 65."

Answered by AI

What types of people are best suited for this research?

"This trial is recruiting 368 patients with ulcerative colitis aged 18-75. Patients must meet the following criteria:Inclusion Criteria for Part 1:-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 cortic"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase 3 Study to Investigate the Efficacy and Safety of SHR0302 With Moderately to Severely Active Ulcerative Colitis

2021. "A Phase 3 Study to Investigate the Efficacy and Safety of SHR0302 With Moderately to Severely Active Ulcerative Colitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05181137.

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