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

A Phase II Randomized, Placebo Controlled, Double-blind, Four Arms Dose-ranging Study to Evaluate the Efficacy and Safety of SHR0302 Compared to Placebo in Patients With Moderate to Severe Active Crohn's Disease

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 Early withdrawn subjects during the first treatment phase cannot enter the extension phase.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

Study Overview

• Status: Completed
• Conditions: Crohn's Disease
• Intervention / Treatment: Drug: Placebos; Drug: SHR0302

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Changchun, China, 130021
    • Nanfang Hospital of Southern Medical University
  • Changsha, China, 410008
    • Xiangya Hospital Central South University
  • Chengdu, China, 610041
    • st China Hospital Sichuan University
  • Fuzhou, China, 350001
    • Fujian Provincial Hospital
  • Jinan, China, 250012
    • Qilu Hospital of Shandong University
  • Nanjing, China, 210006
    • Jiangsu Province Hospital
  • Nanjing, China, 210006
    • Nanjing First Hospital
  • Nanjing, China, 210008
    • The Affiliated Hospital of Nanjing University School
  • Shanghai, China, 200127
    • Renji Hospital, Shanghai Jiaotong University School of Medicine
  • Shenzhen, China, 518053
    • The University of Hong Kong-Shenzhen Hospital
  • Taiyuan, China, 030001
    • Shanxi Provincial People's Hospital
  • Taiyuan, China, 030012
    • Second Hospital of Shanxi Medical University
  • Anhui
    • Bengbu, Anhui, China, 233004
      • The First Affiliated Hospital of Bengbu Medical college
  • Anhul
    • Yingshan, Anhul, China, 241001
      • Yijishan Hospital of Wannan Medical College
  • Beijing
    • Beijing, Beijing, China, 10083
      • Peking University Third Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • The First Affiliated Hospital, Sun Yat-sen University
    • Guangzhou, Guangdong, China, 510080
      • Guangdong Provincial People's Hospital
  • Guangzhou
    • Guangzhou, Guangzhou, China, 510655
      • The Sixth Affiliated Hospital of Sun Yat-sen University
    • Guangzhou, Guangzhou, China, 510515
      • The first affiliated Hospital of Nanchang University
  • Henan
    • Zhengzhou, Henan, China, 450003
      • Henan Provincial People's Hospital
  • Hubei
    • Wuhan, Hubei, China, 430060
      • Renmin Hospital of Wuhan University
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital Affiliated to Tongji Medicine College, Huazhong University of Science & Technology
  • Hunan
    • Pingxiang, Hunan, China, 337005
      • Henan Provincial People's Hospital
  • Jiangsu
    • Changzhou, Jiangsu, China, 213002
      • The First People's Hospital of Changzhou
    • Nanjing, Jiangsu, China, 210009
      • Zhongda Hospital Southeast University
    • Wuxi, Jiangsu, China, 214023
      • Wuxi People's Hospital
    • Yangzhou, Jiangsu, China, 225001
      • Yangzhou First People's Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • The first affiliated Hospital of Nanchang University
  • Jilin
    • Changchun, Jilin, China, 130061
      • The First Hospital of Jilin University
  • Shanghai
    • Shanghai, Shanghai, China, 200120
      • Shanghai East Hospital
    • Shanghai, Shanghai, China, 200433
      • Shanghai Changhai Hospital
    • Shanghai, Shanghai, China, 200092
      • Shanghai Xinhua hospital
    • Shanghai, Shanghai, China, 200025
      • Ruijin Hospital, Shanghai Jiaotong University, School of Medicne
  • Tianjin
    • Tianjin, Tianjin, China, 300121
      • Tianjin Union Medical Center
  • Zheijiang
    • Hangzhou, Zheijiang, China, 310020
      • Sir Run Run Shaw Hospital, affiliated with the Zhejiang University School of Medicine
    • Huzhou, Zheijiang, China, 313003
      • Huzhou Central Hospital
• Poland
  • Knurów, Poland, 44-190
    • Indywidualma Specjalistyczna Praktyka Lekarska Maciej Zymla
  • Nowy Targ, Poland, 34400
    • Nzoz Allmedica Badania
  • Piotrków Trybunalski, Poland, 97300
    • Provita Profamilia
  • Poznań, Poland, 60-529
    • Solumed Centrum Medyczne
  • Puławy, Poland, 24-100
    • KO-MED Central Kliniczne Plulawy
  • Rzeszów, Poland, 35-302
    • Gabinet Lekarski Bartosz Korczowski
  • Sopot, Poland, 81-756
    • Specjalistyczna Praktyka Lekarska dr med. Marek Horynski
  • Staszów, Poland, 28-200
    • KO-MED Centra Kliniczne Staszow
  • Warszawa, Poland, 03-580
    • NZOZ Vivamed
  • Warszawa, Poland, 00-635
    • Centrum Zdrowia MDM
  • Warszawa, Poland, 02507
    • Centralny Szpital Kliniczny MSW
  • Wrocław, Poland, 53-333
    • Planetmed Sp. z o.o.
  • Łódź, Poland, 90-644
    • AMICARE Sp. z o.o. sp.k
  • Łódź, Poland, 91-211
    • SALVE Zakład Opieki Zdrowotnej Sp. zo.o.
  • Świdnica, Poland, 58-100
    • EZ-MED Centrum Medyczne
• Ukraine
  • Chernivtsi, Ukraine, 58002
    • RCI Chernivtsi Regional Clinical Hospital Dept of Gastroenterology Bukovinsky SMU
  • Dnipro, Ukraine, 49005
    • I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital
  • Dnipro, Ukraine, 49005
    • I.I.Mechnykov Dnipropetrovsk
  • Ivano-Frankivs'k, Ukraine, 76018
    • Ivano-Frankivsk Hospital
  • Ivano-Frankivs'k, Ukraine, 76018
    • Ivano-Frankivsk Med. University
  • Kharkiv, Ukraine, 61124
    • CHI Kharkiv City Clinical Hospital #13
  • Kharkiv, Ukraine, 61172
    • Public nonprofit enterprise
  • Kherson, Ukraine, 7300
    • Kherson City Clinical Hospital
  • Khmelnytskyi, Ukraine, 29000
    • Khmelnyski Regional Hospital
  • Kiev, Ukraine, 2002
    • Tx-Dx Center Adonis Plus Ltd
  • Kyiv, Ukraine, 01033
    • Healthy and Happy
  • Kyiv, Ukraine, 02091
    • Kyiv City Clinical Hospital
  • Kyiv, Ukraine, 03049
    • Kyiv Clin Hospital on Railway St. 2
  • Kyiv, Ukraine, 08711
    • Med. Cen.of Limited Liability
  • Kyiv, Ukraine
    • Kyiv Regional Hospital #2
  • Lviv, Ukraine, 79059
    • Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU
  • Lviv, Ukraine, 79010
    • Lviv Regional Clinical Hosp
  • Vinnytsia, Ukraine, 21029
    • CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM
  • Vinnytsia, Ukraine, 21001
    • Medical Center Pulse
  • Vinnytsia, Ukraine, 21005
    • RCH Vinnytsia, Dept. Therapy
  • Vinnytsia, Ukraine, 21018
    • Vinnytsia M I Pyrogov
  • Vinnytsia, Ukraine, 21050
    • Communal Institution Center of the Primary Medical- Sanitary Care#2
  • Vinnytsia, Ukraine
    • Center of primary health care
  • Zaporizhzhya, Ukraine, 69035
    • City Clinical Hospital
  • Zhytomyr, Ukraine, 10002
    • O.F. Herbachevskiyi Zhytomyr Regional Clinical Hospital
• United States
  • Florida
    • Clearwater, Florida, United States, 33756
      • West Central Gastroenterology d/b/a Gastro Florida
    • Lake Wales, Florida, United States, 33853
      • Wellness Clinical Research, LLLC-Central Florida
    • Tampa, Florida, United States, 33626
      • West Central Gastroenterology d/b/a Gastro Florida
  • Massachusetts
    • Fall River, Massachusetts, United States, 02721
      • NECCR PrimaCare Research, LLC
  • North Carolina
    • Wilmington, North Carolina, United States, 28401
      • wilmington health
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Digestive Disease Specialists, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SHR0302 dose A; Participants randomized in this arm will receive dose A of SHR0302 until end of study at week 24.	Drug: SHR0302; The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK (known as a JAK inhibitor).
Experimental: SHR0302 dose B; Participants randomized in this arm will receive dose B of SHR0302 until end of study at week 24.	Drug: SHR0302; The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK (known as a JAK inhibitor).
Experimental: SHR0302 dose C; Participants randomized in this arm will receive dose C of SHR0302 until end of study at week 24.	Drug: SHR0302; The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK (known as a JAK inhibitor).
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.	Drug: Placebos; Placebos; Drug: SHR0302; The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK (known as a JAK inhibitor).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of subjects achieving clinical remission at week 12.	The percentage of subjects achieving clinical remission at week 12, defined as Crohn's Disease Activity Index (CDAI) score < 150.	week12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of subjects achieving clinical remission defined as mean daily stool frequency (SF) ≤2.5, and abdominal pain (AP) ≤ 1 using the Patient Reported Outcome from CDAI at week 1, 4, 8, 12, 13, 16, and 24.	The percentage of subjects achieving clinical remission defined as mean daily stool frequency (SF) ≤2.5, and abdominal pain (AP) ≤ 1 using the Patient Reported Outcome from CDAI at week 1, 4, 8, 12, 13, 16, and 24.	week 1, 4, 8, 12, 13, 16, and 24
The percentage of subjects achieving clinical remission defined as PRO2 < 8 at week 1, 4, 8, 12, 13, 16, and 24.	The percentage of subjects achieving clinical remission defined as PRO2 < 8 at week 1, 4, 8, 12, 13, 16, and 24.	week 1, 4, 8, 12, 13, 16, and 24
The percentage of subjects achieving clinical response defined as a CDAI decrease from baseline of ≥ 100 points at week 1, 4, 8, 12, 13, 16, and 24.	The percentage of subjects achieving clinical response defined as a CDAI decrease from baseline of ≥ 100 points at week 1, 4, 8, 12, 13, 16, and 24.	week 1, 4, 8, 12, 13, 16, and 24

Collaborators and Investigators

• Sponsor: Reistone Biopharma Company Limited
• Investigators: Study Director: Xiang Chen, Reistone Biopharma

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2019
• Primary Completion (Actual): September 16, 2021
• Study Completion (Actual): December 9, 2021

Study Registration Dates

• First Submitted: September 17, 2018
• First Submitted That Met QC Criteria: September 17, 2018
• First Posted (Actual): September 19, 2018

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: March 14, 2023
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: RSJ10201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No