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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
Must not have
Subject with Ulcerative Colitis, which is confined to proctitis (distal 15 cm or less)
Subject had previous surgery as a treatment for Ulcerative Colitis or likely to require surgery during the study period
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights
Pivotal Trial

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.
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.
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
Select...
I completed the first part of the study and saw improvement by week 8.
Select...
I have active Ulcerative Colitis with moderate to severe symptoms.
Select...
I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My ulcerative colitis affects only the rectum or the last part of my colon.
Select...
I had surgery for Ulcerative Colitis or might need one soon.
Select...
I have Ulcerative Colitis and haven't been treated with common UC medications.
Select...
I have been diagnosed with indeterminate colitis or symptoms that may suggest Crohn's Disease.
Select...
I currently have or have had tuberculosis.
Select...
I am showing signs of severe colon inflammation.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Clinical remission at week 52 (Part 2)
Clinical remission at week 8 (Part 1)
Secondary study objectives
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
12%
Anaemia
5%
Nasopharyngitis
5%
Hypercholesterolaemia
2%
Colitis ulcerative
2%
Upper respiratory tract infection
2%
Neutrophil count increased
2%
Leukocytosis
2%
Lymphocyte count decreased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Extension Phase-placebo → SHR0302 4mg QD
Treatment Phase-SHR0302 4mg BD
Treatment Phase-SHR0302 4mg QD
Extension Phase-SHR0302 4mg BD → SHR0302 4mg BD
Treatment Phase-Placebo
Extension Phase-SHR0302 8mg QD → SHR0302 8mg QD
Extension Phase-SHR0302 4mg QD → SHR0302 4mg QD
Extension Phase-placebo → SHR0302 8mg QD
Extension Phase-placebo → SHR0302 4mg BD
Treatment Phase-SHR0302 8mg QD

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
~1730

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 Colitis
164 Patients Enrolled for Colitis
Xiang ChenStudy DirectorReistone Pharma
3 Previous Clinical Trials
706 Total Patients Enrolled
1 Trials studying Colitis
164 Patients Enrolled for Colitis

Media Library

Placebo (Placebo) Clinical Trial Eligibility Overview. Trial Name: NCT05181137 — Phase 3
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
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
~90 spots leftby Dec 2025
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