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

NCT03677648 | Completed Phase 2 FDA Drug

• 1 other identifier: RSJ10201
• Study Type: interventional
• Target: 112
• Locations: 4 countries
• Sites: 82

Brief Summary

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 Early withdrawn subjects during the first treatment phase cannot enter the extension phase.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

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

  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

Study Arms (4)

SHR0302 dose A

ACTIVE COMPARATOR

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

Drug: SHR0302

SHR0302 dose B

EXPERIMENTAL

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

Drug: SHR0302

SHR0302 dose C

EXPERIMENTAL

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

Drug: SHR0302

Placebo

PLACEBO COMPARATOR

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: SHR0302; Drug: Placebos

Interventions

SHR0302 DRUG

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

Placebo; SHR0302 dose A; SHR0302 dose B; SHR0302 dose C

Placebos DRUG

Placebos

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Reistone Biopharma Company Limited: lead

Study Sites (82)

West Central Gastroenterology d/b/a Gastro Florida

Clearwater, Florida, 33756, United States

Location

Wellness Clinical Research, LLLC-Central Florida

Lake Wales, Florida, 33853, United States

Location

West Central Gastroenterology d/b/a Gastro Florida

Tampa, Florida, 33626, United States

Location

NECCR Primacare Research, LLC

Fall River, Massachusetts, 02721, United States

Location

Wilmington Health

Wilmington, North Carolina, 28401, United States

Location

Digestive Disease Specialists, Inc.

Oklahoma City, Oklahoma, 73112, United States

Location

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, 233004, China

Location

Yijishan Hospital of Wannan Medical College

Yingshan, Anhul, 241001, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, 10083, China

Location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Location

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

The First Affiliated Hospital of Nanchang University

Guangzhou, Guangzhou, 510515, China

Location

The Sixth Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangzhou, 510655, China

Location

Henan Provincial People's Hospital

Zhengzhou, Henan, 450003, China

Location

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

Wuhan, Hubei, 430030, China

Location

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

Location

Henan Provincial People's Hospital

Pingxiang, Hunan, 337005, China

Location

The First People's Hospital of Changzhou

Changzhou, Jiangsu, 213002, China

Location

Zhongda Hospital Southeast University

Nanjing, Jiangsu, 210009, China

Location

Wuxi People's Hospital

Wuxi, Jiangsu, 214023, China

Location

Yangzhou First People's Hospital

Yangzhou, Jiangsu, 225001, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

Location

The first Hospital of Jilin University

Changchun, Jilin, 130061, China

Location

Ruijin Hospital, Shanghai Jiaotong University, School of Medicne

Shanghai, Shanghai Municipality, 200025, China

Location

Shanghai Xinhua Hospital

Shanghai, Shanghai Municipality, 200092, China

Location

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200120, China

Location

Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Tianjin Union Medical Center

Tianjin, Tianjin Municipality, 300121, China

Location

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

Hangzhou, Zheijiang, 310020, China

Location

Huzhou Central Hospital

Huzhou, Zheijiang, 313003, China

Location

Nanfang Hospital of Southern Medical University

Changchun, 130021, China

Location

Xiangya Hospital Central South University

Changsha, 410008, China

Location

st China Hospital Sichuan University

Chengdu, 610041, China

Location

Fujian Provincial Hospital

Fuzhou, 350001, China

Location

Qilu Hospital of Shandong University

Jinan, 250012, China

Location

Jiangsu Province Hospital

Nanjing, 210006, China

Location

Nanjing First Hospital

Nanjing, 210006, China

Location

The Affiliated Hospital of Nanjing University School

Nanjing, 210008, China

Location

Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, 200127, China

Location

The University of Hong Kong-Shenzhen Hospital

Shenzhen, 518053, China

Location

Shanxi Provincial People's Hospital

Taiyuan, 030001, China

Location

Second hospital of Shanxi Medical university

Taiyuan, 030012, China

Location

Indywidualma Specjalistyczna Praktyka Lekarska Maciej Zymla

Knurów, 44-190, Poland

Location

Amicare Sp. z o.o. Sp.k

Lodz, 90-644, Poland

Location

SALVE Zakład Opieki Zdrowotnej Sp. zo.o.

Lodz, 91-211, Poland

Location

Nzoz Allmedica Badania

Nowy Targ, 34400, Poland

Location

Provita Profamilia

Piotrkow Trybunalski, 97300, Poland

Location

SOLUMED Centrum Medyczne

Poznan, 60-529, Poland

Location

KO-MED Central Kliniczne Plulawy

Puławy, 24-100, Poland

Location

Gabinet Lekarski Bartosz Korczowski

Rzeszów, 35-302, Poland

Location

Specjalistyczna Praktyka Lekarska dr med. Marek Horynski

Sopot, 81-756, Poland

Location

KO-MED Centra Kliniczne Staszow

Staszów, 28-200, Poland

Location

EZ-MED Centrum Medyczne

Swidnica, 58-100, Poland

Location

Centrum Zdrowia MDM

Warsaw, 00-635, Poland

Location

Centralny Szpital Kliniczny MSW

Warsaw, 02507, Poland

Location

Nzoz Vivamed

Warsaw, 03-580, Poland

Location

PlanetMed sp. z o.o.

Wroclaw, 53-333, Poland

Location

RCI Chernivtsi Regional Clinical Hospital Dept of Gastroenterology Bukovinsky SMU

Chernivtsi, 58002, Ukraine

Location

I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital

Dnipro, 49005, Ukraine

Location

I.I.Mechnykov Dnipropetrovsk

Dnipro, 49005, Ukraine

Location

Ivano-Frankivsk Hospital

Ivano-Frankivsk, 76018, Ukraine

Location

Ivano-Frankivsk Med. University

Ivano-Frankivsk, 76018, Ukraine

Location

CHI Kharkiv City Clinical Hospital #13

Kharkiv, 61124, Ukraine

Location

Public nonprofit enterprise

Kharkiv, 61172, Ukraine

Location

Kherson City Clinical Hospital

Kherson, 7300, Ukraine

Location

Khmelnyski Regional Hospital

Khmelnytskyi, 29000, Ukraine

Location

Tx-Dx Center Adonis Plus Ltd

Kiev, 2002, Ukraine

Location

Healthy and Happy

Kyiv, 01033, Ukraine

Location

Kyiv City Clinical Hospital

Kyiv, 02091, Ukraine

Location

Kyiv Clin Hospital on Railway St. 2

Kyiv, 03049, Ukraine

Location

Med. Cen.of Limited Liability

Kyiv, 08711, Ukraine

Location

Kyiv Regional Hospital #2

Kyiv, Ukraine

Location

Lviv Regional Clinical Hosp

Lviv, 79010, Ukraine

Location

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

Lviv, 79059, Ukraine

Location

Medical Center Pulse

Vinnytsia, 21001, Ukraine

Location

RCH Vinnytsia, Dept. Therapy

Vinnytsia, 21005, Ukraine

Location

Vinnytsia M I Pyrogov

Vinnytsia, 21018, Ukraine

Location

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

Vinnytsia, 21029, Ukraine

Location

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

Vinnytsia, 21050, Ukraine

Location

Center of primary health care

Vinnytsia, Ukraine

Location

City Clinical Hospital

Zaporizhzhya, 69035, Ukraine

Location

O.F. Herbachevskiyi Zhytomyr Regional Clinical Hospital

Zhytomyr, 10002, Ukraine

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

ivarmacitinib

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Xiang Chen

  Reistone Biopharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2018
• First Posted: September 19, 2018
• Study Start: May 14, 2019
• Primary Completion: September 16, 2021
• Study Completion: December 9, 2021
• Last Updated: March 15, 2023

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

UA (25); PL (15); US (6); CN (36)