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 Early withdrawn subjects during the first treatment phase cannot enter the extension phase.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.

Michael WeissAwad AmirCapozza ThomasMahesh AllamDavid Stokesberry
Principal Investigator Affiliation West Central Gastro FloridaWest Central Gastro FloridaNECCR Primacare Research, LLCWellness Clinical Research, LLLC-Central FloridaDigestive Disease Specialists, Inc
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

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

Recruiting

Address

West Central Gastroenterology d/b/a Gastro Florida

Clearwater, Florida, 33756

Site Contact

Michael L Weiss

max.zhang@reistonebio.com

+8618662156927

Lake Wales, Florida

Status

Recruiting

Address

Wellness Clinical Research, LLLC-Central Florida

Lake Wales, Florida, 33853

Site Contact

Allam Mahesh

max.zhang@reistonebio.com

+8618662156927

Tampa, Florida

Status

Recruiting

Address

West Central Gastroenterology d/b/a Gastro Florida

Tampa, Florida, 33626

Site Contact

Awad Amir

max.zhang@reistonebio.com

+8618662156927

NECCR Primacare Research, LLC, Fall River, Massachusetts

Status

Recruiting

Address

NECCR Primacare Research, LLC

Fall River, Massachusetts, 02721

Site Contact

Capozza Thomas

max.zhang@reistonebio.com

+8618662156927

Wilmington Health, Wilmington, North Carolina

Status

Recruiting

Address

Wilmington Health

Wilmington, North Carolina, 28401

Site Contact

Mathew Mlot, MD

mmlot@wilmingtonhealth.com

910-341-1321 #1,2,3

Digestive Disease Specialists, Inc., Oklahoma City, Oklahoma

Status

Recruiting

Address

Digestive Disease Specialists, Inc.

Oklahoma City, Oklahoma, 73112

Site Contact

Stokesberry David

max.zhang@reistonebio.com

+8618662156927

International Sites

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

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

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

Knurów, Poland

Status

Recruiting

Address

Indywidualma Specjalistyczna Praktyka Lekarska Maciej Zymla

Knurów, , 44-190

Site Contact

Zymla Maciej

max.zhang@reistonebio.com

+8618662156927

SOLUMED Centrum Medyczne, Poznań, Poland

Status

Not yet recruiting

Address

SOLUMED Centrum Medyczne

Poznań, , 60-529

Site Contact

Marek Karczewski

max.zhang@reistonebio.com

+8618662156927

KO-MED Central Kliniczne Plulawy, Puławy, Poland

Status

Recruiting

Address

KO-MED Central Kliniczne Plulawy

Puławy, , 24-100

Site Contact

Wolanski Lukasz

max.zhang@reistonebio.com

+8618662156927

Gabinet Lekarski Bartosz Korczowski, Rzeszów, Poland

Status

Recruiting

Address

Gabinet Lekarski Bartosz Korczowski

Rzeszów, , 35-302

Site Contact

Bartosz Korczowski

max.zhang@reistonebio.com

+8618662156927

Sopot, Poland

Status

Recruiting

Address

Specjalistyczna Praktyka Lekarska dr med. Marek Horynski

Sopot, , 81-756

Site Contact

Dariusz Kleczkowski

max.zhang@reistonebio.com

+8618662156927

KO-MED Centra Kliniczne Staszow, Staszów, Poland

Status

Not yet recruiting

Address

KO-MED Centra Kliniczne Staszow

Staszów, , 28-200

Site Contact

Jacek Kieltucki

max.zhang@reistonebio.com

+8618662156927

Centrum Zdrowia MDM, Warszawa, Poland

Status

Not yet recruiting

Address

Centrum Zdrowia MDM

Warszawa, , 00-635

Site Contact

Jaroslaw Kierkus

max.zhang@reistonebio.com

+8618662156927

Nzoz Vivamed, Warszawa, Poland

Status

Active, not recruiting

Address

Nzoz Vivamed

Warszawa, , 03-580

PlanetMed sp. z o.o., Wrocław, Poland

Status

Recruiting

Address

PlanetMed sp. z o.o.

Wrocław, , 53-333

Site Contact

Barbara Wozniak-Stolarska

max.zhang@reistonebio.com

+8618662156927

Amicare Sp. z o.o. Sp.k, Łódź, Poland

Status

Not yet recruiting

Address

Amicare Sp. z o.o. Sp.k

Łódź, , 90-644

Site Contact

Rafal Drozda

max.zhang@reistonebio.com

+8618662156927

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

Status

Recruiting

Address

SALVE Zakład Opieki Zdrowotnej Sp. zo.o.

Łódź, , 91-211

Site Contact

Bartosz Lesniowski

max.zhang@reistonebio.com

+8618662156927

EZ-MED Centrum Medyczne, Świdnica, Poland

Status

Recruiting

Address

EZ-MED Centrum Medyczne

Świdnica, , 58-100

Site Contact

Witold Marczynski

max.zhang@reistonebio.com

+8618662156927

Chernivtsi, Ukraine

Status

Not yet recruiting

Address

RCI Chernivtsi Regional Clinical Hospital Dept of Gastroenterology Bukovinsky SMU

Chernivtsi, , 58002

Site Contact

Oleksandr Fediv

max.zhang@reistonebio.com

+8618662156927

Dnipro, Ukraine

Status

Not yet recruiting

Address

I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital

Dnipro, , 49005

Site Contact

Olha Khodasenko

max.zhang@reistonebio.com

+8618662156927

CHI Kharkiv City Clinical Hospital #13, Kharkiv, Ukraine

Status

Not yet recruiting

Address

CHI Kharkiv City Clinical Hospital #13

Kharkiv, , 61124

Site Contact

Viktoriia Reznikova

max.zhang@reistonebio.com

+8618662156927

Lviv, Ukraine

Status

Not yet recruiting

Address

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

Lviv, , 79059

Site Contact

Valeriy Vdovychenko

max.zhang@reistonebio.com

+8618662156927

Vinnytsia, Ukraine

Status

Not yet recruiting

Address

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

Vinnytsia, , 21029

Site Contact

Halyna Tomashkevych

max.zhang@reistonebio.com

+8618662156927

Vinnytsia, Ukraine

Status

Not yet recruiting

Address

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

Vinnytsia, , 21050

Site Contact

Viacheslav Chernobrovyi

max.zhang@reistonebio.com

+8618662156927

Zhytomyr, Ukraine

Status

Not yet recruiting

Address

O.F. Herbachevskiyi Zhytomyr Regional Clinical Hospital

Zhytomyr, , 10002

Site Contact

Yuriy Bilotskyi

max.zhang@reistonebio.com

+8618662156927

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. For a full description of terms please refer to our Terms, Conditions & Privacy.