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Ulcerative ColitisPhase 3NCT05181137

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

A Phase 3 study testing SHR0302 in people with Ulcerative Colitis, run by Reistone Biopharma Company Limited at 113 sites in 5 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Ulcerative Colitis
What is being tested?
SHR0302
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
368 participants
Where
113 sitesin 5 countries
Study dates
5 Nov 2021to 31 Mar 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • Inclusion Criteria for Part 2 1. Subject has completed Part 1 and achieved clinical response at week 8
  • 1. Subject has completed the 8-week Part 1 and was classified as not meeting clinical response criteria. OR Subject has discontinued treatment early in the Maintenance phase due to disease worsening OR Subject has completed the Maintenance phase.
  • Study Exclusion Criteria for Part 1

Who cannot join

  • 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.
Show all 37Show fewer
  • 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.
  • Interferon therapy within 8 weeks prior to baseline.
  • Intravenous corticosteroids or rectally administered formulation of corticosteroids or 5- ASA within 2 weeks prior to baseline.
  • Subject had any prior treatment with lymphocyte-depleting agents/therapies (such as CamPath® [alemtuzumab], alkylating agents [e.g., cyclophosphamide or chlorambucil], total lymphoid irradiation, etc.). Subjects who have received rituximab or other selective B lymphocyte depleting agents are eligible if they have not received such therapy for at least 1 year prior to baseline.
  • Subject has previously received JAK inhibitors, such as tofacitinib, baricitinib, upadacitinib, filgotinib.
  • Subject with evidence of clinically relevant laboratory abnormalities which may affect subject safety or interpretation of study results at screening
  • Subject has a screening 12-lead ECG that demonstrates clinically relevant abnormalities
  • Subject currently has or had:
  • A clinically significant infection within 1 month of baseline (e.g., those requiring hospitalization or parenteral antimicrobial therapy or have opportunistic infections).
  • A history of more than one episode of herpes zoster, or disseminated zoster (single episode).
  • Any infection otherwise judged by the investigator to have the potential for exacerbation by participation in the study.
  • Any infection requiring antimicrobial therapy within 2 weeks of screening.
  • Subject has current immunization with any live virus vaccine or history of immunization with any live virus vaccine within 8 weeks of baseline.
  • Subject with a first-degree relative with a hereditary immunodeficiency.
  • Subject with a history of any lymphoproliferative disorder (such as EBV-related lymphoproliferative disorder, as reported in some subjects on other immunosuppressive drugs), history of lymphoma, leukemia, multiple myeloma, or signs and symptoms that are suggestive of current lymphatic disease.
  • Subject has any condition possibly affecting oral drug absorption e.g., gastrectomy, or clinically significant diabetic gastroenteropathy, or certain types of bariatric surgery such as gastric bypass. (Procedures such as gastric banding, gastric balloon that simply divide stomach into separate chambers, are NOT exclusionary.) Subject has undergone significant trauma or major surgery within 4 weeks of baseline.
  • Women who are pregnant or lactating, or planning pregnancy while enrolled in the study. Male who plan to donate sperm during the study and within 30 days after the last dose of study drug.
  • Subject who has a history of alcohol or drug abuse with less than 6 months of abstinence prior to baseline that in the opinion of the investigator will preclude participation in the study.
  • Subject with malignancies or with a history of malignancies with exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin.
  • Subject infected with human immunodeficiency virus (HIV) or hepatitis B or C viruses.
  • Subject has received any investigational drug or device within 3 months, or 5 half-lives (if known) prior to baseline.
  • Subject is receiving or expected to receive prohibited concomitant medication(s) in the 4 weeks prior to the first dose of study drug and through follow-up visit.
  • Any other condition which in the opinion of the investigator would make the subject unsuitable for inclusion in the study.
  • Subject with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, gastrointestinal, urogenital, nervous system, musculoskeletal, skin, sensory, endocrine (including uncontrolled diabetes or thyroid disease), or hematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
  • Subject with a history of thromboembolic events, including deep vein thromboses (DVT), pulmonary embolism (PE), and those with known inherited conditions that predispose to hypercoagulability.
  • Study Exclusion Criteria for Parts 2 and 3
  • Subject with any clinically significant condition at the end of 8-week Induction treatment from Part 1 Induction phase, and Part 2 Maintenance Phase that in the opinion of investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis.
  • Subject who, in the opinion of the investigator or sponsor, is unlikely to be cooperative or able to comply with study procedures, or any other condition which in the opinion of the investigator would make the subject unsuitable for inclusion.

Trial locations and contacts

113 sites in 5 countries.

Minna Sun contact

+86 18611785877

minna.sun@reistonebio.com

Lingyu Guo contact

+86 13311061570

lingyu.guo@reistonebio.com

113 sites in 5 countries

China59 sites, 51 recruiting

  • Baotou Central Hospital

    Baotou, Inner Mongolia

    Ling Zhang

    Ling Zhang

    Recruiting

  • Beijing Military Area General Hospital/Seventh Medical Center of PLA General Hospital

    Beijing, Beijing Municipality

    Jianqiu Sheng

    Jianqiu Sheng

    Recruiting

  • Peking University First Hospital

    Beijing, Beijing Municipality

    Terminated

  • Peking University Third Hospital

    Beijing, Beijing Municipality

    Shigang Ding

    Shigang Ding

    Recruiting

  • Tsinghua University Changgung Hospital

    Beijing, Beijing Municipality

    Bo Jiang

    Bo Jiang

    Not yet recruiting

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui

    Qizhi Wang

    Qizhi Wang

    Recruiting

  • Binzhou Medical University Hospital

    Binzhou, Shandong

    Chengxia Liu

    Recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan

    Xuehong Wang

    Xuehong Wang

    Recruiting

  • Xiangya Hospital Central South University

    Changsha, Hunan

    Xiaomei Zhang

    Xiaomei Zhang

    Recruiting

  • West China Hospital Sichuan University

    Chengdu, Sichuan

    Yan Zhang

    Yan Zhang

    Recruiting

  • Army Medical Center of PLA

    Chongqing, Chongqing Municipality

    Dongfeng Chen

    Dongfeng Chen

    Recruiting

  • Chongqing People's Hospital

    Chongqing, Chongqing Municipality

    Hong Guo

    Hong Guo

    Recruiting

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

    Bingqiang Zhang

    Bingqiang Zhang

    Recruiting

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian

    Chengdang Wang

    Chengdang Wang

    Recruiting

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong

    Yongjia Zhou

    Yongjian Zhou

    Recruiting

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong

    Baili Chen

    Baili Chen

    Recruiting

  • The Sixth Affiliated Hospital of Sun Yat-Sen University

    Guangzhou, Guangdong

    Xiang Gao

    Xiang Gao

    Recruiting

  • Third Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong

    Mingsong Li

    Mingsong Li

    Recruiting

  • The First Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine

    Hangzhou, Zhejiang

    Yihong Fan

    Yihong Fan

    Recruiting

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang

    Yan Chen

    Yan Chen

    Recruiting

  • Anhui Provincial Hospital

    Hefei, Anhui

    Li Xie

    Li Xie

    Recruiting

  • Huai'an First People's Hospital

    Huai'an, Jiangsu

    Weijie Dai

    Weijie Dai

    Recruiting

  • Jingzhou First People's Hospital

    Jingzhou, Hubei

    Qing Zhang

    Qing Zhang

    Recruiting

  • Jinhua Municipal Central Hospical

    Jinhua, Zhejiang

    Jin Ding

    Jin Ding

    Recruiting

  • Liaocheng People's Hospital

    Liaocheng, Shandong

    Peng Yan

    Peng Yan

    Recruiting

  • The First Affiliated Hospital of Henan University of Science and Technoloy

    Luoyang, Henan

    Yingjian Zhang

    Yingjian Zhang

    Recruiting

  • Jiangsu Province Hospital

    Nanjing, Jiangsu

    Hongjie Zhang

    Hongjie Zhang

    Not yet recruiting

  • Nanjing First Hospital

    Nanjing, Jiangsu

    Zhenyu Zhang

    Zhenyu Zhang

    Recruiting

  • Nanjing General Hospital of Nanjing Military Command

    Nanjing, Jiangsu

    Fangyu Wang

    Fangyu Wang

    Recruiting

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu

    Hong Chen

    Hong Chen

    Recruiting

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi

    Xiaoping Lv

    Xiaoping Lv

    Recruiting

  • Ningbo First Hospital

    Ningbo, Zhejiang

    Xiaoyun Ding

    Xiaoyun Ding

    Recruiting

  • Huashan Hospital, Fudan University

    Shanghai, Shanghai Municipality

    Liang Zhong

    Liang Zhong

    Recruiting

  • Longhua Hospital Shanghai University of Traditional Chinese Medicine

    Shanghai, Shanghai Municipality

    Terminated

  • Renji Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality

    Terminated

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality

    Jie Zhong

    Jie Zhong

    Recruiting

  • Shanghai Changhai Hospital

    Shanghai, Shanghai Municipality

    Yiqi Du

    Yiqi Du

    Recruiting

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality

    Terminated

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality

    Terminated

  • Shanghai Sixth People's Hospital

    Shanghai, Shanghai Municipality

    Terminated

  • Zhongshan Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality

    Xizhong Shen

    Xizhong Shen

    Recruiting

  • Shanxi Provincial People's Hospital

    Shanxi, Shanxi

    Terminated

  • Shengjing Hospital Of China Medical University

    Shenyang, Liaoning

    Changqing Zheng

    Changqing Zheng

    Recruiting

  • The First Hospital of China Medical University

    Shenyang, Liaoning

    Terminated

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong

    Bing Zou

    Bing Zou

    Recruiting

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei

    Xiaolan Zhang

    Xiaolan Zhang

    Recruiting

  • Affiliated Taihe Hospital of Hubei University of Medicine

    Shiyan, Hubei

    Shengbao Li

    Recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu

    Weichang Chen

    Weichang Chen

    Recruiting

  • The First Hospital of Shanxi Medical University

    Taiyuan, Shanxi

    Lijuan Huo

    Lijuan Huo

    Recruiting

  • Tianjin medical University General Hospital

    Tianjin, Tianjin Municipality

    Bangmao Wang

    Bangmao Wang

    Recruiting

  • Tianjin Union Medical Center

    Tianjin, Tianjin Municipality

    Yandi Liu

    Yandi Liu

    Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang

    Xiangrong Chen

    Xiangrong Chen

    Recruiting

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei

    Ping An

    Ping An

    Not yet recruiting

  • The First Affiliated Hospitial of Xiamen University

    Xiamen, Fujian

    Jianwei Zheng

    Jianwei Zheng

    Recruiting

  • Subei People's Hospital of Jiangsu province

    Yangzhou, Jiangsu

    Zhen Zhu

    Zhen Zhu

    Recruiting

  • Henan Provincial People's Hospital

    Zhengzhou, Henan

    Xiuling Li

    Xiuling Li

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

    Bingrong Liu

    Bingrong Liu

    Recruiting

  • The Second Affiliated Hospital of Zhengzhou University

    Zhengzhou, Hena

    Baisui Feng

    Feng Feng

    Recruiting

  • Zhuzhou Central Hospital

    Zhuzhou, Hunan

    Hongbing Zhou

    Hongbing Zhou

    Recruiting

Other trials in China

United States23 sites

  • Michigan Medical

    Ann Arbor, Michigan, 48109

    Terminated

  • NY Scientific

    Brooklyn, New York, 11235

    Terminated

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

    Terminated

  • Charlotte Gastroenterology & Hepatology P.L.L.C

    Charlotte, North Carolina, 28207

    Withdrawn

  • Research Institute of Michigan

    Chesterfield, Michigan, 48047

    Withdrawn

  • John Hopkins University

    Columbia, Maryland, 21045

    Terminated

  • Digestive Health Specialists

    Dothan, Alabama, 36301

    Completed

  • Omni Clinical Research

    Houston, Texas, 77034

    Terminated

  • IHS Health

    Kissimmee, Florida, 34741

    Active, not recruiting

  • Om Research LLC

    Lancaster, California, 93534

    Terminated

  • UTMB Health

    League City, Texas, 77573

    Terminated

  • Dade Research Center

    Miami, Florida, 33126

    Terminated

  • Advocate Aurora Health - Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

    Terminated

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37204

    Terminated

  • Yale University

    New Haven, Connecticut, 06510

    Terminated

  • One Health Research Clinic Atlanta, LLC

    Norcross, Georgia, 30039

    Active, not recruiting

  • DiGiovanna Institute for Medical Education & Research

    North Massapequa, New York, 11758

    Terminated

  • DDSI

    Oklahoma City, Oklahoma, 73112

    Withdrawn

  • Central Sooner Research

    Oklahoma City, Oklahoma, 73118

    Terminated

  • Gastro Florida

    Pinellas Park, Florida, 33781

    Completed

  • McGuire Research Institute

    Richmond, Virginia, 23249

    Terminated

  • University of Utah

    Salt Lake City, Utah, 84132

    Terminated

  • IACT Health

    Suffolk, Virginia, 23435

    Withdrawn

Other trials in United States

Ukraine14 sites

  • Communal Nonprofit Enterprise "Cherkasy Regional Hospital of Cherkasy Oblast Council"

    Cherkasy

    Active, not recruiting

  • Regional Municipal Non-commercial Enterprise "Chernivtsi Emergency Medical Hospital"

    Chernivtsi

    Withdrawn

  • Public Non-Profit Enterprise "Regional Clinical Hospital under Ivano-Frankivsk Regional Council"

    Ivano-Frankivsk

    Withdrawn

  • Public Non-Profit Institution: O.O. Shalimov City Clinical Hospital #2 under Kharkiv City Council

    Kharkiv

    Withdrawn

  • Public Non-Profit Enterprise "Khmelnytskyi Regional Hospital" under Khmelnytskyi Regional Council

    Khmelnytskyi

    Withdrawn

  • Clinical Hospital "Feofaniia"

    Kyiv

    Completed

  • Medical Center "Consylium Medical"

    Kyiv

    Active, not recruiting

  • Medical Center OK!Clinic+ of the Company with Limited Liability International Institute of Clinical Research

    Kyiv

    Withdrawn

  • Municipal Enterprise "Volyn Regional Clinical Hospital" of Volyn Regional Council

    Lutsk

    Active, not recruiting

  • Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical Hospital"

    Lviv

    Withdrawn

  • Public Non-Profit Enterprise under Sumy Regional Council "Sumy Regional Clinical Hospital"

    Sumy

    Withdrawn

  • Communal Non-Commercial Enterprise: Vinnytsia City Clinical Hospital #1

    Vinnytsia

    Withdrawn

  • Public Non-Profit Enterprise "City Hospital #6" under Zaporizhia City Council

    Zaporizhia

    Active, not recruiting

  • "Medibor Plus" Llc

    Zhytomyr

    Completed

Other trials in Ukraine

Poland13 sites

  • CLINSANTE Clinical Research Centre Ewa Galczak-Nowak, Malgorzata Trzaska

    Bydgoszcz

    Withdrawn

  • MZ BADANIA Slowik Zymla General Partnership

    Knurów

    Active, not recruiting

  • "Landa" Specialist Doctor's Offices

    Krakow

    Withdrawn

  • PLEJADY Medical Centre

    Krakow

    Active, not recruiting

  • AMED Medical Centre Branch in Lodz

    Lodz

    Withdrawn

  • Oswiecim Clinical Trial Centre

    Oświęcim

    Active, not recruiting

  • Private Healthcare Institution Specialist Clinics Termedica

    Poznan

    Withdrawn

  • Dariusz Kleczkowski Specialist Medical Practice

    Sopot

    Active, not recruiting

  • Torun Gastrology Centre "Gastromed"

    Torun

    Active, not recruiting

  • MDM Healthcare Centre

    Warsaw

    Withdrawn

  • WIP Warsaw IBD Point

    Warsaw

    Active, not recruiting

  • Medical Centre Oporow

    Wroclaw

    Active, not recruiting

  • ETG Zamosc

    Zamość

    Active, not recruiting

Other trials in Poland

Georgia4 sites

  • Curatio, Jsc

    Tbilisi

    Active, not recruiting

  • JSC Infectious Diseases, AIDS and Clinical Immunology Research Center

    Tbilisi

    Active, not recruiting

  • LTD Central University Clinic After Academic N. Kipshidze

    Tbilisi

    Completed

  • LTD The First Medical Center

    Tbilisi

    Active, not recruiting

Other trials in Georgia

About this study

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

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.

Read the 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.

Being tested
SHR0302, Placebo
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHR0302Drug

    Oral tablets taken once daily (QD)

  • PlaceboDrug

    Oral tablets taken once daily (QD)

Study groups in NCT05181137
Study groupRoleWhat they receive
Part 1 Active Experimental: SHR0302 Dose#1ExperimentalSHR0302 Oral tablets taken once daily (QD) for 8 weeks SHR0302 Oral tablets taken once daily (QD)
Receives: Drug: SHR0302
Part 1 Placebo Comparator: PlaceboPlacebo comparatorPlacebo Oral tablets taken once daily (QD) for 8 weeks
Receives: Drug: Placebo
Part 2 Active Experimental: SHR0302 Dose#2ExperimentalSHR0302 Oral tablets taken once daily (QD) for 44 weeks
Receives: Drug: SHR0302
Part 2 Placebo Comparator: PlaceboPlacebo comparatorPlacebo Comparator: Maintenance Treatment Placebo Comparator: Placebo
Receives: Drug: Placebo
Part 3 Active Experimental: SHR0302 Dose#2ExperimentalSHR0302 Oral tablets taken once daily (QD) for 26 weeks
Receives: Drug: SHR0302

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical remission at week 8 (Part 1)

    The percentage of subjects in clinical remission at week 8.

    Measured: 8 weeks

  2. Clinical remission at week 52 (Part 2)

    The percentage of subjects in clinical remission at week 52.

    Measured: 52 weeks

Secondary outcomes (13)

  1. Endoscopic remission at week 8 (Part 1)

    The percentage of subjects with endoscopic remission at week 8.

    Measured: 8 weeks

  2. Clinical response at week 8 (Part 1)

    The percentage of subjects with clinical response at week 8.

    Measured: 8 weeks

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

    Change from baseline in partial Mayo score at week 2, 4, and 8.

    Measured: 8 weeks

  4. Change in total Mayo score and 9-point modified Mayo score at week 8 (Part 1)

    Change in total Mayo score and 9-point modified Mayo score at week 8.

    Measured: 8 weeks

  5. Subjects with endoscopic remission (Part 2)

    The percentage of subjects with endoscopic remission at week 52.

    Measured: 52 weeks

  6. Subjects with clinical response at week 52 (Part 2)

    The percentage of subjects with clinical response at week 52.

    Measured: 52 weeks

  7. 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 12, 16, 24, 32, 40, and 52.

    Measured: 52 weeks

  8. Change in total Mayo score and 9-point modified Mayo score at week 52 (Part 2)

    Change in total Mayo score and 9-point modified Mayo score at week 52.

    Measured: 52 weeks

  9. Subjects in corticosteroid-free remission at week 52 (Part 2)

    Percentage of subjects in corticosteroid-free remission at week 52.

    Measured: 52 weeks

  10. Subjects who maintain clinical remission at week 52 (Part 2)

    Percentage of subjects who maintain clinical remission at week 52

    Measured: 52 weeks

  11. Subjects in clinical remission per partial Mayo score at week E26 (Part 3)

    The percentage of subjects in clinical remission per partial Mayo score at week E26.

    Measured: 26 weeks (extension)

  12. Subjects in corticosteroid-free remission per Partial Mayo score at week E26 (Part 3)

    The percentage of subjects in corticosteroid-free remission per Partial Mayo score at week E26.

    Measured: 26 weeks (extension)

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

    Change from baseline in Partial Mayo score at week E2, E12, and E26.

    Measured: 26 weeks (extension)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2022
  2. Study start5 Nov 2021
  3. Primary completion31 Oct 2024 (estimated)
  4. Study completion31 Mar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
368 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05181137
Sponsor's protocol ID
RSJ10135
Status last verified
Sep 2023
First submitted
10 Dec 2021
Last updated
5 Sep 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SHR0302 in people with Ulcerative Colitis, run by Reistone Biopharma Company Limited at 113 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 113 sites in China, United States, Ukraine, Poland, Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Minna Sun (+86 18611785877, minna.sun@reistonebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical remission at week 8 (Part 1) (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05181137.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2023.

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