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

Crohn's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03677648
• Other study ID #: RSJ10201
• Status: Completed
• Phase: Phase 2
• Start date: May 14, 2019
• Est. completion date: December 9, 2021

Study information

• Verified date: June 2022
• Source: Reistone Biopharma Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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 Early withdrawn subjects during the first treatment phase cannot enter the extension phase.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: December 9, 2021
• Est. primary completion date: September 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

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

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing
China	The First Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui
China	Nanfang Hospital of Southern Medical University	Changchun
China	The first Hospital of Jilin University	Changchun	Jilin
China	Xiangya Hospital Central South University	Changsha
China	The First People's Hospital of Changzhou	Changzhou	Jiangsu
China	st China Hospital Sichuan University	Chengdu
China	Fujian Provincial Hospital	Fuzhou
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong
China	The First Affiliated Hospital of Nanchang University	Guangzhou	Guangzhou
China	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	The Sixth Affiliated Hospital of Sun Yat-Sen University	Guangzhou	Guangzhou
China	Sir Run Run Shaw Hospital, Affiliated with the Zhejiang University School of Medicine	Hangzhou	Zheijiang
China	Huzhou Central Hospital	Huzhou	Zheijiang
China	Qilu Hospital of Shandong University	Jinan
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Jiangsu Province Hospital	Nanjing
China	Nanjing First Hospital	Nanjing
China	The Affiliated Hospital of Nanjing University School	Nanjing
China	Zhongda Hospital Southeast University	Nanjing	Jiangsu
China	Henan Provincial People's Hospital	Pingxiang	Hunan
China	Renji Hospital, Shanghai Jiaotong University School of Medicine	Shanghai
China	Ruijin Hospital, Shanghai Jiaotong University, School of Medicne	Shanghai	Shanghai
China	Shanghai Changhai Hospital	Shanghai	Shanghai
China	Shanghai East Hospital	Shanghai	Shanghai
China	Shanghai Xinhua Hospital	Shanghai	Shanghai
China	The University of Hong Kong-Shenzhen Hospital	Shenzhen
China	Second hospital of Shanxi Medical university	Taiyuan
China	Shanxi Provincial People's Hospital	Taiyuan
China	Tianjin Union Medical Center	Tianjin	Tianjin
China	Renmin Hospital of Wuhan University	Wuhan	Hubei
China	Tongji Hospital Affiliated to Tongji Medicine College, Huazhong University of Science & Technology	Wuhan	Hubei
China	Wuxi People's Hospital	Wuxi	Jiangsu
China	Yangzhou First People's Hospital	Yangzhou	Jiangsu
China	Yijishan Hospital of Wannan Medical College	Yingshan	Anhul
China	Henan Provincial People's Hospital	Zhengzhou	Henan
Poland	Indywidualma Specjalistyczna Praktyka Lekarska Maciej Zymla	Knurów
Poland	Amicare Sp. z o.o. Sp.k	Lódz
Poland	SALVE Zaklad Opieki Zdrowotnej Sp. zo.o.	Lódz
Poland	Nzoz Allmedica Badania	Nowy Targ
Poland	Provita Profamilia	Piotrków Trybunalski
Poland	SOLUMED Centrum Medyczne	Poznan
Poland	KO-MED Central Kliniczne Plulawy	Pulawy
Poland	Gabinet Lekarski Bartosz Korczowski	Rzeszów
Poland	Specjalistyczna Praktyka Lekarska dr med. Marek Horynski	Sopot
Poland	KO-MED Centra Kliniczne Staszow	Staszów
Poland	EZ-MED Centrum Medyczne	Swidnica
Poland	Centralny Szpital Kliniczny MSW	Warszawa
Poland	Centrum Zdrowia MDM	Warszawa
Poland	Nzoz Vivamed	Warszawa
Poland	PlanetMed sp. z o.o.	Wroclaw
Ukraine	RCI Chernivtsi Regional Clinical Hospital Dept of Gastroenterology Bukovinsky SMU	Chernivtsi
Ukraine	I.I.Mechnykov Dnipropetrovsk	Dnipro
Ukraine	I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital	Dnipro
Ukraine	Ivano-Frankivsk Hospital	Ivano-Frankivs'k
Ukraine	Ivano-Frankivsk Med. University	Ivano-Frankivs'k
Ukraine	CHI Kharkiv City Clinical Hospital #13	Kharkiv
Ukraine	Public nonprofit enterprise	Kharkiv
Ukraine	Kherson City Clinical Hospital	Kherson
Ukraine	Khmelnyski Regional Hospital	Khmelnytskyi
Ukraine	Tx-Dx Center Adonis Plus Ltd	Kiev
Ukraine	Healthy and Happy	Kyiv
Ukraine	Kyiv City Clinical Hospital	Kyiv
Ukraine	Kyiv Clin Hospital on Railway St. 2	Kyiv
Ukraine	Kyiv Regional Hospital #2	Kyiv
Ukraine	Med. Cen.of Limited Liability	Kyiv
Ukraine	Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU	Lviv
Ukraine	Lviv Regional Clinical Hosp	Lviv
Ukraine	CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM	Vinnytsia
Ukraine	Center of primary health care	Vinnytsia
Ukraine	Communal Institution Center of the Primary Medical- Sanitary Care#2	Vinnytsia
Ukraine	Medical Center Pulse	Vinnytsia
Ukraine	RCH Vinnytsia, Dept. Therapy	Vinnytsia
Ukraine	Vinnytsia M I Pyrogov	Vinnytsia
Ukraine	City Clinical Hospital	Zaporizhzhya
Ukraine	O.F. Herbachevskiyi Zhytomyr Regional Clinical Hospital	Zhytomyr
United States	West Central Gastroenterology d/b/a Gastro Florida	Clearwater	Florida
United States	NECCR Primacare Research, LLC	Fall River	Massachusetts
United States	Wellness Clinical Research, LLLC-Central Florida	Lake Wales	Florida
United States	Digestive Disease Specialists, Inc.	Oklahoma City	Oklahoma
United States	West Central Gastroenterology d/b/a Gastro Florida	Tampa	Florida
United States	Wilmington Health	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Reistone Biopharma Company Limited

Countries where clinical trial is conducted

United States,  China,  Poland,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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