A Phase II Study in Patients With Moderate to Severe Active Ulcerative Colitis.

Study Purpose

The proposed study is a randomized, double-blind,placebo-controlled, multi-center phase II study to investigatethe safety and efficacy of SHR0302 in patients with moderate to severe activeulcerative colitis. The study aims to evaluate the optimal dose of SHR0302 andtime needed in inducing clinical response in active ulcerative colitispatients. This is an 8+8 weeksstudy, in which participants who complete the first 8 weeks treatment phase, will have the option to enter a blinded activearms 8-week extension phase. Early withdrawn subjects during the first treatment phasecannot enter the extension phase. The total duration of the study participation, including extension and follow-up, will be approximately 18weeks. SHR0302 is a JAK1 inhibitor, capable of blocking JAK-STATs pathway and control inflammation. Therefore it has the potential to be a treatment for UC.

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 age ≥ 18 and ≤75 years of age at randomization.
  • - Active ulcerative colitis with a 9-point modified Mayo score of 5 to 9 points and endoscopic subscore of 2 to 3 (The duration of the time between endoscopy and baseline should not exceed 10 days and allow central over read turn over before randomization).
  • - Subject should have at least three-month history of Ulcerative Colitis diagnosis at randomization.

Exclusion Criteria:

  • - Diagnosis of indeterminate colitis, or clinical findings suggestive of Crohn's disease.
  • - Subjects with ulcerative colitis, which is confined to a proctitis (distal 15 cm or less).
  • - Treatment naïve subjects diagnosed with ulcerative colitis (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.

NCT03675477
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.

N/A
Principal Investigator Affiliation N/A
Agency Class

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

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

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

Ulcerative Colitis
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 16.

Active Comparator: SHR0302 dose B

Participants randomized in this arm will receive dose B of SHR0302 until end of study at week 16.

Active Comparator: SHR0302 dose C

Participants randomized in this arm will receive dose D of SHR0302 until end of study at week 16.

Placebo Comparator: palcebo

Participants randomized in this arm will receive placebo until week 8, 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 16.

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

Placebo Oral Tablet

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.

Yuma Gastroenterology LLC, Yuma, Arizona

Status

Recruiting

Address

Yuma Gastroenterology LLC

Yuma, Arizona, 85364

Site Contact

Seth Miller, MD

max.zhang@reistonebio.com

+8618662156927

Clearwater, Florida

Status

Withdrawn

Address

West Central Gastroenterology d/b/a Gastro Florida

Clearwater, Florida, 33756

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

Active, not recruiting

Address

West Central Gastroenterology d/b/a Gastro Florida

Tampa, Florida, 33626

Atlanta Centre for Gastroenterology, Decatur, Georgia

Status

Recruiting

Address

Atlanta Centre for Gastroenterology

Decatur, Georgia, 30033

Site Contact

David Rausher, MD

max.zhang@reistonebio.com

+8618662156927

Kansas City, Kansas

Status

Withdrawn

Address

University of Kansas Medical Centre Research Institute, Inc

Kansas City, Kansas, 66160

NECCR Primacare Research, LLC, Fall River, Massachusetts

Status

Recruiting

Address

NECCR Primacare Research, LLC

Fall River, Massachusetts, 02721

Site Contact

Frederick Schnure

max.zhang@reistonebio.com

+8618662156927

Univ. of Kansas Medical Center, Kansas City, Missouri

Status

Withdrawn

Address

Univ. of Kansas Medical Center

Kansas City, Missouri, 66160

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

The Jackson Clinic ,PA, Jackson, Tennessee

Status

Recruiting

Address

The Jackson Clinic ,PA

Jackson, Tennessee, 38305

Site Contact

Kelly Croom

kcroom@jacksonclinic.com

731-660-8320

PrimeCare Medical Group, Houston, Texas

Status

Recruiting

Address

PrimeCare Medical Group

Houston, Texas, 77024

Site Contact

Isabela Velasco

ivelasco@victoriumresearch.com

832-707-4035

PrimeCare Medical Group, Houston, Texas

Status

Recruiting

Address

PrimeCare Medical Group

Houston, Texas, 77024

Site Contact

Ankur Doshi, MD

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, Doctor

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

Baotou Central Hospital, Baotou, Inner Mongalia, China

Status

Recruiting

Address

Baotou Central Hospital

Baotou, Inner Mongalia, 014040

Site Contact

Lin Zhang

max.zhang@reistonebio.com

+8618662156927

Liaocheng People's Hospital, Liaocheng, Shandong, China

Status

Recruiting

Address

Liaocheng People's Hospital

Liaocheng, Shandong, 252000

Site Contact

Senlin Li

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

Topolowa Medicenter, Kraków, Poland

Status

Recruiting

Address

Topolowa Medicenter

Kraków, , 31506

Site Contact

Zbigniew Wylegala, MD

z.wylegala@gmail.com

+8618662156927

Medicenter Nowy Targ, Nowy Targ, Poland

Status

Recruiting

Address

Medicenter Nowy Targ

Nowy Targ, , 34400

Site Contact

Przemyslaw Zycinski, MD

przy@mp.pl

+8618662156927

Osrodek Badan Klinicznych Allmedica, Nowy Targ, Poland

Status

Recruiting

Address

Osrodek Badan Klinicznych Allmedica

Nowy Targ, , 34400

Site Contact

Mikolaj Krzyzanowski, MD

mikolaj.krzyzanowski@gmail.com

+8618662156927

Provita Profamilia, Piotrków Trybunalski, Poland

Status

Recruiting

Address

Provita Profamilia

Piotrków Trybunalski, , 97300

Site Contact

Krzysztof Kujawski, MD

kkujawski@poczta.fm

+8618662156927

SOLUMED Centrum Medyczne, Poznań, Poland

Status

Recruiting

Address

SOLUMED Centrum Medyczne

Poznań, , 60-529

Site Contact

Marek Karczewski

max.zhang@reistonebio.com

+8618662156927

KO-MED Centra Kliniczne Plulawy, Puławy, Poland

Status

Recruiting

Address

KO-MED Centra Kliniczne Plulawy

Puławy, , 24-100

Site Contact

Wolanski Lukasz

max.zhang@reistonebio.com

+8618662156927

Gabinet Lekarski Bartosz Korczowski, Rzeszow, Poland

Status

Recruiting

Address

Gabinet Lekarski Bartosz Korczowski

Rzeszow, , 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

Darius Kleczkowski

max.zhang@reistonebio.com

+8618662156927

KO-MED Centra Kliniczne Staszow, Staszów, Poland

Status

Recruiting

Address

KO-MED Centra Kliniczne Staszow

Staszów, , 28-200

Site Contact

Jacek Kieltucki

max.zhang@reistonebio.com

+8618662156927

Szczecin, Poland

Status

Recruiting

Address

Twoja Przychodnia-Szczecinskie Centrum Medyczne

Szczecin, , 71434

Site Contact

Beata Gawdis-Wojnarska, MD

gawdis@twojaprzychodnia.com

+8618662156927

Nzoz Formed, Wadowice, Poland

Status

Recruiting

Address

Nzoz Formed

Wadowice, , 34100

Site Contact

Beata Mroziak, MD

bmroziak@medicome.pl

+8618662156927

Centrum Zdrowia MDM, Warszawa, Poland

Status

Recruiting

Address

Centrum Zdrowia MDM

Warszawa, , 00-635

Site Contact

Jaroslaw Kierkus

max.zhang@reistonebio.com

+8618662156927

Warszawa, Poland

Status

Recruiting

Address

Centralny Szpital Kliniczny MSW w Warszawie

Warszawa, , 02507

Site Contact

Grazyna Rydzewska, MD

grazyna.rydzewska@cskmswia.pl

+8618662156927

Nzoz Vivamed, Warszawa, Poland

Status

Recruiting

Address

Nzoz Vivamed

Warszawa, , 03-580

Site Contact

Robert Petryka

max.zhang@reistonebio.com

+8618662156927

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

Recruiting

Address

Amicare Sp. z o.o. Sp.k

Łódź, , 90-644

Site Contact

Rafal Drozda

max.zhang@reistonebio.com

+8618662156927

Łódź, Poland

Status

Recruiting

Address

Santa Familia Centrum Badan, Profilaktyki i Leczenia

Łódź, , 90302

Site Contact

Maria Wisniewska-Jarosinska, MD

majkawj@bmp.net.pl

+8618662156927

IP Clinic, Łódź, Poland

Status

Recruiting

Address

IP Clinic

Łódź, , 90752

Site Contact

Cezary Rudnicki, MD

cezary.rudnicki@ipclinic.pl

+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

Wellness Clinical Research, LLC, Vega Baja, Puerto Rico

Status

Recruiting

Address

Wellness Clinical Research, LLC

Vega Baja, , 00694

Site Contact

Gustavo Albizu, MD

max.zhang@reistonebio.com

+8618662156927

Chernivtsi, Ukraine

Status

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

Recruiting

Address

I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital

Dnipro, , 49005

Site Contact

Olha Khodasenko

max.zhang@reistonebio.com

+8618662156927

Ivano-Frankivs'k, Ukraine

Status

Recruiting

Address

Central City Clinical Hospital Dept of Theraphy No. 2 SHEI Ivano-Frankivsk NMU

Ivano-Frankivs'k, , 76018

Site Contact

Valentyna Dzvonkovska, MD

valentyna.dzvonkovska@yahoo.com

+8618662156927

CHI Kharkiv City Clinical Hospital #13, Kharkiv, Ukraine

Status

Recruiting

Address

CHI Kharkiv City Clinical Hospital #13

Kharkiv, , 61124

Site Contact

Viktoriia Reznikova

max.zhang@reistonebio.com

+8618662156927

CI Karabelesh Kherson CCH, Kherson, Ukraine

Status

Recruiting

Address

CI Karabelesh Kherson CCH

Kherson, , 73000

Site Contact

Halyna Afanasieva, MD

galinakuzmenko.doctor@gmail.com

+8618662156927

Khmelnytska Regional Hospital, Khmelnytskyi, Ukraine

Status

Recruiting

Address

Khmelnytska Regional Hospital

Khmelnytskyi, , 29000

Site Contact

Vitaliy Balytskyy, MD

v.balytskyy@ukr.net

+8618662156927

Kyiv City Clinical Hospital #1, Kyiv, Ukraine

Status

Recruiting

Address

Kyiv City Clinical Hospital #1

Kyiv, , 02091

Site Contact

Inna Markevych, MD

inna.markevich@okclinic.com.ua

+8618662156927

Kyiv, Ukraine

Status

Recruiting

Address

Kyiv Railway Clinical Hospital #2 of Branch "Health Center" of the Public Joint Stock Company "Ukrai

Kyiv, , 03049

Site Contact

Olga Kyrychenko, MD

dr.okirichenko@gmail.com

+8618662156927

Lviv, Ukraine

Status

Recruiting

Address

CNE of Lviv Regional Council Lviv Regional Clinical Hospital

Lviv, , 79010

Site Contact

Oleksiy Leoshyk

oleksiy.leoshyk@gmail.com

+8618662156927

Lviv, Ukraine

Status

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

Recruiting

Address

Vinnytsia M.I.Pyrogov Regional Clinical Hospital

Vinnytsia, , 21018

Site Contact

Natalia Kizlova, MD

gastrovokl@gmail.com

+8618662156927

Vinnytsia, Ukraine

Status

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

Recruiting

Address

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

Vinnytsia, , 21050

Site Contact

Viacheslav Chernobrovyi

max.zhang@reistonebio.com

+8618662156927

Zaporizhzhia, Ukraine

Status

Recruiting

Address

CI City Clinical Hospital #6 Dept of Gastroenterology

Zaporizhzhia, , 69035

Site Contact

Oleksandr Oliinyk, MD

oleinik.alex@gmail.com

+8618662156927

Zhytomyr, Ukraine

Status

Recruiting

Address

O.F. Herbachevskiyi Zhytomyr Regional Clinical Hospital

Zhytomyr, , 10002

Site Contact

Yuriy Bilotskyi

max.zhang@reistonebio.com

+8618662156927

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