A Phase II Study in Patients With Moderate to Severe Active Crohn's Disease

Study Purpose

The proposed study is a randomized, double-blind, placebo-controlled, multi-center Phase II study to investigate the safety and efficacy of SHR0302 in patients with moderate to severe active Crohn's Disease. The study aims to evaluate the optimal dose of SHR0302 and time needed in inducing clinical remission in active CD. This is an 12+12 weeks study, in which participants who complete the first 12 weeks treatment phase, will have the option to enter a blinded active arms 12-week extension phase. Early withdrawn subjects during the first treatment phase cannot enter the extension phase. The total duration of the study participation, including extension and follow-up, will be approximately 26 weeks. With the wealth of scientific evidence on JAK/STAT involvement in IBD, the data from similar class of new drugs and the current data on SHR0302 (JAK1 inhibitor), support the rationale to proceed with phase II studies to evaluate the efficacy and safety of SHR0302 in patients with moderate to severe active CD.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Male and Female subject at ≥18 and ≤ 75 years of age at randomization.
  • - Subjects with a documented three-month history of diagnosed ileal, colonic, or ileocolonic Crohn's Disease at the time of randomization.
  • - Currently having Crohn's Disease with Crohn's Disease Activity Index (CDAI) score ≥ 220 to ≤450.

Exclusion Criteria:

  • - Diagnosis of indeterminate colitis, or clinical findings suggestive of Ulcerative Colitis.
  • - Subject with CD with stoma, gastric or ileoanal pouch, proto-colectomy or total colectomy, symptomatic stenosis or stricture, history of bowel perforation, suspected abscess; actively draining fistula.
  • - Treatment naïve subjects diagnosed with Crohn's disease, (without previous exposure to treatment).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03677648
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Reistone Biopharma Company Limited
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Tia Boonyapredee
Principal Investigator Affiliation Reistone Biopharma
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries China, Poland, Ukraine, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn's Disease
Arms & Interventions

Arms

Active Comparator: SHR0302 dose A

Participants randomized in this arm will receive dose A of SHR0302 until end of study at week 24.

Experimental: SHR0302 dose B

Participants randomized in this arm will receive dose B of SHR0302 until end of study at week 24.

Experimental: SHR0302 dose C

Participants randomized in this arm will receive dose C of SHR0302 until end of study at week 24.

Placebo Comparator: Placebo

Participants randomized in this arm will receive placebo until week 12, and then will be re-randomized into one of the 3 active arms (dose A, dose B, and dose C of SHR0302) in a 1:1:1 allocation ratio until the end of study at week 24.

Interventions

Drug: - SHR0302

The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK (known as a JAK inhibitor).

Drug: - Placebos

Placebos

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Clearwater, Florida

Status

Terminated

Address

West Central Gastroenterology d/b/a Gastro Florida

Clearwater, Florida, 33756

Lake Wales, Florida

Status

Terminated

Address

Wellness Clinical Research, LLLC-Central Florida

Lake Wales, Florida, 33853

Tampa, Florida

Status

Terminated

Address

West Central Gastroenterology d/b/a Gastro Florida

Tampa, Florida, 33626

NECCR Primacare Research, LLC, Fall River, Massachusetts

Status

Terminated

Address

NECCR Primacare Research, LLC

Fall River, Massachusetts, 02721

Wilmington Health, Wilmington, North Carolina

Status

Terminated

Address

Wilmington Health

Wilmington, North Carolina, 28401

Digestive Disease Specialists, Inc., Oklahoma City, Oklahoma

Status

Terminated

Address

Digestive Disease Specialists, Inc.

Oklahoma City, Oklahoma, 73112

International Sites

Bengbu, Anhui, China

Status

Terminated

Address

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, 233004

Yingshan, Anhul, China

Status

Recruiting

Address

Yijishan Hospital of Wannan Medical College

Yingshan, Anhul, 241001

Peking University Third Hospital, Beijing, Beijing, China

Status

Recruiting

Address

Peking University Third Hospital

Beijing, Beijing, 10083

Site Contact

Shichang M Ding

max.zhang@reistonebio.com

+8618662156927

Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China

Status

Recruiting

Address

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080

Site Contact

Weihong Sha

max.zhang@reistonebio.com

+8618662156927

Guangzhou, Guangdong, China

Status

Recruiting

Address

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080

Site Contact

Baili Chen

max.zhang@reistonebio.com

+8618662156927

Guangzhou, Guangzhou, China

Status

Recruiting

Address

The First Affiliated Hospital of Nanchang University

Guangzhou, Guangzhou, 510515

Site Contact

Side M Liu

max.zhang@reistonebio.com

+8618662156927

Guangzhou, Guangzhou, China

Status

Recruiting

Address

The Sixth Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangzhou, 510655

Site Contact

Bin M Yang

yangbin101@hotmail.com

+8618662156927

Henan Provincial People's Hospital, Zhengzhou, Henan, China

Status

Recruiting

Address

Henan Provincial People's Hospital

Zhengzhou, Henan, 450003

Site Contact

Xiuling Li

max.zhang@reistonebio.com

+8618662156927

Wuhan, Hubei, China

Status

Recruiting

Address

Tongji Hospital Affiliated to Tongji Medicine College, Huazhong University of Science & Technology

Wuhan, Hubei, 430030

Site Contact

Dean Tian

max.zhang@reistonebio.com

+8618662156927

Renmin Hospital of Wuhan University, Wuhan, Hubei, China

Status

Recruiting

Address

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060

Site Contact

Yijuan W Ding

max.zhang@reistonebio.com

+8618662156927

Henan Provincial People's Hospital, Pingxiang, Hunan, China

Status

Recruiting

Address

Henan Provincial People's Hospital

Pingxiang, Hunan, 337005

The First People's Hospital of Changzhou, Changzhou, Jiangsu, China

Status

Recruiting

Address

The First People's Hospital of Changzhou

Changzhou, Jiangsu, 213002

Zhongda Hospital Southeast University, Nanjing, Jiangsu, China

Status

Recruiting

Address

Zhongda Hospital Southeast University

Nanjing, Jiangsu, 210009

Site Contact

Hong S Chen

max.zhang@reistonebio.com

+8618662156927

Wuxi People's Hospital, Wuxi, Jiangsu, China

Status

Recruiting

Address

Wuxi People's Hospital

Wuxi, Jiangsu, 214023

Site Contact

Qiang Zhan

max.zhang@reistonebio.com

+8618662156927

Yangzhou First People's Hospital, Yangzhou, Jiangsu, China

Status

Recruiting

Address

Yangzhou First People's Hospital

Yangzhou, Jiangsu, 225001

Site Contact

Yanbing Ding

max.zhang@reistonebio.com

+8618662156927

Nanchang, Jiangxi, China

Status

Recruiting

Address

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006

Site Contact

Youxiang Chen

max.zhang@reistonebio.com

+8618662156927

Shanghai, Shanghai, China

Status

Recruiting

Address

Ruijin Hospital, Shanghai Jiaotong University, School of Medicne

Shanghai, Shanghai, 200025

Shanghai Xinhua Hospital, Shanghai, Shanghai, China

Status

Recruiting

Address

Shanghai Xinhua Hospital

Shanghai, Shanghai, 200092

Site Contact

Wensong Ge

max.zhang@reistonebio.com

+8618662156927

Shanghai East Hospital, Shanghai, Shanghai, China

Status

Recruiting

Address

Shanghai East Hospital

Shanghai, Shanghai, 200120

Shanghai Changhai Hospital, Shanghai, Shanghai, China

Status

Recruiting

Address

Shanghai Changhai Hospital

Shanghai, Shanghai, 200433

Tianjin Union Medical Center, Tianjin, Tianjin, China

Status

Recruiting

Address

Tianjin Union Medical Center

Tianjin, Tianjin, 300121

Site Contact

Yandi A Liu

max.zhang@reistonebio.com

+8618662156927

Hangzhou, Zheijiang, China

Status

Recruiting

Address

Sir Run Run Shaw Hospital, Affiliated with the Zhejiang University School of Medicine

Hangzhou, Zheijiang, 310020

Huzhou Central Hospital, Huzhou, Zheijiang, China

Status

Recruiting

Address

Huzhou Central Hospital

Huzhou, Zheijiang, 313003

Site Contact

Jiang C Liu

max.zhang@reistonebio.com

+8618662156927

Changchun, China

Status

Recruiting

Address

Nanfang Hospital of Southern Medical University

Changchun, , 130021

Site Contact

Yang J Shi

max.zhang@reistonebio.com

+8618662156927

Changsha, China

Status

Recruiting

Address

Xiangya Hospital Central South University

Changsha, , 410008

Site Contact

Xiaowei S Liu

max.zhang@reistonebio.com

+8618662156927

st China Hospital Sichuan University, Chengdu, China

Status

Recruiting

Address

st China Hospital Sichuan University

Chengdu, , 610041

Site Contact

Yan S Zhang

max.zhang@reistonebio.com

+8618662156927

Fujian Provincial Hospital, Fuzhou, China

Status

Terminated

Address

Fujian Provincial Hospital

Fuzhou, , 350001

Qilu Hospital of Shandong University, Jinan, China

Status

Terminated

Address

Qilu Hospital of Shandong University

Jinan, , 250012

Jiangsu Province Hospital, Nanjing, China

Status

Recruiting

Address

Jiangsu Province Hospital

Nanjing, , 210006

Site Contact

Guoxin P Zhang

max.zhang@reistonebio.com

+8618662156927

Nanjing First Hospital, Nanjing, China

Status

Recruiting

Address

Nanjing First Hospital

Nanjing, , 210006

Site Contact

Zhenyu F Zhang

max.zhang@reistonebio.com

+8618662156927

Nanjing, China

Status

Terminated

Address

The Affiliated Hospital of Nanjing University School

Nanjing, , 210008

Shanghai, China

Status

Recruiting

Address

Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, , 200127

Site Contact

Zhihua o Ran

max.zhang@reistonebio.com

+8618662156927

Shenzhen, China

Status

Recruiting

Address

The University of Hong Kong-Shenzhen Hospital

Shenzhen, , 518053

Site Contact

Weiji Seto

max.zhang@reistonebio.com

+8618662156927

Shanxi Provincial People's Hospital, Taiyuan, China

Status

Recruiting

Address

Shanxi Provincial People's Hospital

Taiyuan, , 030001

Site Contact

Junping P Wang

max.zhang@reistonebio.com

+8618662156927

Taiyuan, China

Status

Recruiting

Address

Second hospital of Shanxi Medical university

Taiyuan, , 030012

Site Contact

Qi M Wang

max.zhang@reistonebio.com

+8618662156927

Knurów, Poland

Status

Terminated

Address

Indywidualma Specjalistyczna Praktyka Lekarska Maciej Zymla

Knurów, , 44-190

Nzoz Allmedica Badania, Nowy Targ, Poland

Status

Terminated

Address

Nzoz Allmedica Badania

Nowy Targ, , 34400

Provita Profamilia, Piotrków Trybunalski, Poland

Status

Terminated

Address

Provita Profamilia

Piotrków Trybunalski, , 97300

SOLUMED Centrum Medyczne, Poznań, Poland

Status

Terminated

Address

SOLUMED Centrum Medyczne

Poznań, , 60-529

KO-MED Central Kliniczne Plulawy, Puławy, Poland

Status

Active, not recruiting

Address

KO-MED Central Kliniczne Plulawy

Puławy, , 24-100

Gabinet Lekarski Bartosz Korczowski, Rzeszów, Poland

Status

Terminated

Address

Gabinet Lekarski Bartosz Korczowski

Rzeszów, , 35-302

Sopot, Poland

Status

Terminated

Address

Specjalistyczna Praktyka Lekarska dr med. Marek Horynski

Sopot, , 81-756

KO-MED Centra Kliniczne Staszow, Staszów, Poland

Status

Terminated

Address

KO-MED Centra Kliniczne Staszow

Staszów, , 28-200

Centrum Zdrowia MDM, Warszawa, Poland

Status

Terminated

Address

Centrum Zdrowia MDM

Warszawa, , 00-635

Centralny Szpital Kliniczny MSW, Warszawa, Poland

Status

Terminated

Address

Centralny Szpital Kliniczny MSW

Warszawa, , 02507

Nzoz Vivamed, Warszawa, Poland

Status

Terminated

Address

Nzoz Vivamed

Warszawa, , 03-580

PlanetMed sp. z o.o., Wrocław, Poland

Status

Terminated

Address

PlanetMed sp. z o.o.

Wrocław, , 53-333

Amicare Sp. z o.o. Sp.k, Łódź, Poland

Status

Terminated

Address

Amicare Sp. z o.o. Sp.k

Łódź, , 90-644

SALVE Zakład Opieki Zdrowotnej Sp. zo.o., Łódź, Poland

Status

Terminated

Address

SALVE Zakład Opieki Zdrowotnej Sp. zo.o.

Łódź, , 91-211

EZ-MED Centrum Medyczne, Świdnica, Poland

Status

Terminated

Address

EZ-MED Centrum Medyczne

Świdnica, , 58-100

Chernivtsi, Ukraine

Status

Terminated

Address

RCI Chernivtsi Regional Clinical Hospital Dept of Gastroenterology Bukovinsky SMU

Chernivtsi, , 58002

Dnipro, Ukraine

Status

Terminated

Address

I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital

Dnipro, , 49005

I.I.Mechnykov Dnipropetrovsk, Dnipro, Ukraine

Status

Terminated

Address

I.I.Mechnykov Dnipropetrovsk

Dnipro, , 49005

Ivano-Frankivsk Hospital, Ivano-Frankivs'k, Ukraine

Status

Terminated

Address

Ivano-Frankivsk Hospital

Ivano-Frankivs'k, , 76018

Ivano-Frankivsk Med. University, Ivano-Frankivs'k, Ukraine

Status

Terminated

Address

Ivano-Frankivsk Med. University

Ivano-Frankivs'k, , 76018

CHI Kharkiv City Clinical Hospital #13, Kharkiv, Ukraine

Status

Terminated

Address

CHI Kharkiv City Clinical Hospital #13

Kharkiv, , 61124

Public nonprofit enterprise, Kharkiv, Ukraine

Status

Terminated

Address

Public nonprofit enterprise

Kharkiv, , 61172

Kherson City Clinical Hospital, Kherson, Ukraine

Status

Terminated

Address

Kherson City Clinical Hospital

Kherson, , 7300

Khmelnyski Regional Hospital, Khmelnytskyi, Ukraine

Status

Terminated

Address

Khmelnyski Regional Hospital

Khmelnytskyi, , 29000

Tx-Dx Center Adonis Plus Ltd, Kiev, Ukraine

Status

Terminated

Address

Tx-Dx Center Adonis Plus Ltd

Kiev, , 2002

Healthy and Happy, Kyiv, Ukraine

Status

Terminated

Address

Healthy and Happy

Kyiv, , 01033

Kyiv City Clinical Hospital, Kyiv, Ukraine

Status

Terminated

Address

Kyiv City Clinical Hospital

Kyiv, , 02091

Kyiv Clin Hospital on Railway St. 2, Kyiv, Ukraine

Status

Terminated

Address

Kyiv Clin Hospital on Railway St. 2

Kyiv, , 03049

Med. Cen.of Limited Liability, Kyiv, Ukraine

Status

Terminated

Address

Med. Cen.of Limited Liability

Kyiv, , 08711

Kyiv Regional Hospital #2, Kyiv, Ukraine

Status

Terminated

Address

Kyiv Regional Hospital #2

Kyiv, ,

Lviv Regional Clinical Hosp, Lviv, Ukraine

Status

Terminated

Address

Lviv Regional Clinical Hosp

Lviv, , 79010

Lviv, Ukraine

Status

Terminated

Address

Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU

Lviv, , 79059

Medical Center Pulse, Vinnytsia, Ukraine

Status

Terminated

Address

Medical Center Pulse

Vinnytsia, , 21001

RCH Vinnytsia, Dept. Therapy, Vinnytsia, Ukraine

Status

Terminated

Address

RCH Vinnytsia, Dept. Therapy

Vinnytsia, , 21005

Vinnytsia M I Pyrogov, Vinnytsia, Ukraine

Status

Terminated

Address

Vinnytsia M I Pyrogov

Vinnytsia, , 21018

Vinnytsia, Ukraine

Status

Terminated

Address

CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM

Vinnytsia, , 21029

Vinnytsia, Ukraine

Status

Terminated

Address

Communal Institution Center of the Primary Medical- Sanitary Care#2

Vinnytsia, , 21050

Center of primary health care, Vinnytsia, Ukraine

Status

Terminated

Address

Center of primary health care

Vinnytsia, ,

City Clinical Hospital, Zaporizhzhya, Ukraine

Status

Terminated

Address

City Clinical Hospital

Zaporizhzhya, , 69035

Zhytomyr, Ukraine

Status

Terminated

Address

O.F. Herbachevskiyi Zhytomyr Regional Clinical Hospital

Zhytomyr, , 10002

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