Clinical trial NCT03677648: A Phase II Study in Patients With Moderate to Severe Active Crohn's Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn's Disease
Lead sponsor: Reistone Biopharma Company Limited
Sponsor class: INDUSTRY
First posted: 2018-09-19
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Early withdrawn subjects during the first treatment phase cannot enter the extension phase.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


Eligibility 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).

Primary outcomes:
measure: The percentage of subjects achieving clinical remission at week 12.
timeFrame: week12
Secondary outcomes:
measure: 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.
timeFrame: week 1, 4, 8, 12, 13, 16, and 24
measure: The percentage of subjects achieving clinical remission defined as PRO2 < 8 at week 1, 4, 8, 12, 13, 16, and 24.
timeFrame: week 1, 4, 8, 12, 13, 16, and 24
measure: 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.
timeFrame: week 1, 4, 8, 12, 13, 16, and 24
Other outcomes:
Locations:
city: Clearwater
country: United States
facility: West Central Gastroenterology d/b/a Gastro Florida
state: Florida
city: Lake Wales
country: United States
facility: Wellness Clinical Research, LLLC-Central Florida
state: Florida
city: Tampa
country: United States
facility: West Central Gastroenterology d/b/a Gastro Florida
state: Florida
city: Fall River
country: United States
facility: NECCR Primacare Research, LLC
state: Massachusetts
city: Wilmington
country: United States
facility: Wilmington Health
state: North Carolina
city: Oklahoma City
country: United States
facility: Digestive Disease Specialists, Inc.
state: Oklahoma
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical College
state: Anhui
city: Yingshan
country: China
facility: Yijishan Hospital of Wannan Medical College
state: Anhul
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Guangzhou
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital of Sun Yat-Sen University
state: Guangzhou
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital Affiliated to Tongji Medicine College, Huazhong University of Science & Technology
state: Hubei
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
city: Pingxiang
country: China
facility: Henan Provincial People's Hospital
state: Hunan
city: Changzhou
country: China
facility: The First People's Hospital of Changzhou
state: Jiangsu
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi People's Hospital
state: Jiangsu
city: Yangzhou
country: China
facility: Yangzhou First People's Hospital
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: The first Hospital of Jilin University
state: Jilin
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University, School of Medicne
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Xinhua Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai East Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Changhai Hospital
state: Shanghai
city: Tianjin
country: China
facility: Tianjin Union Medical Center
state: Tianjin
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, Affiliated with the Zhejiang University School of Medicine
state: Zheijiang
city: Huzhou
country: China
facility: Huzhou Central Hospital
state: Zheijiang
city: Changchun
country: China
facility: Nanfang Hospital of Southern Medical University
city: Changsha
country: China
facility: Xiangya Hospital Central South University
city: Chengdu
country: China
facility: st China Hospital Sichuan University
city: Fuzhou
country: China
facility: Fujian Provincial Hospital
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
city: Nanjing
country: China
facility: Jiangsu Province Hospital
city: Nanjing
country: China
facility: Nanjing First Hospital
city: Nanjing
country: China
facility: The Affiliated Hospital of Nanjing University School
city: Shanghai
country: China
facility: Renji Hospital, Shanghai Jiaotong University School of Medicine
city: Shenzhen
country: China
facility: The University of Hong Kong-Shenzhen Hospital
city: Taiyuan
country: China
facility: Shanxi Provincial People's Hospital
city: Taiyuan
country: China
facility: Second hospital of Shanxi Medical university
city: Knurów
country: Poland
facility: Indywidualma Specjalistyczna Praktyka Lekarska Maciej Zymla
city: Nowy Targ
country: Poland
facility: Nzoz Allmedica Badania
city: Piotrków Trybunalski
country: Poland
facility: Provita Profamilia
city: Poznań
country: Poland
facility: SOLUMED Centrum Medyczne
city: Puławy
country: Poland
facility: KO-MED Central Kliniczne Plulawy
city: Rzeszów
country: Poland
facility: Gabinet Lekarski Bartosz Korczowski
city: Sopot
country: Poland
facility: Specjalistyczna Praktyka Lekarska dr med. Marek Horynski
city: Staszów
country: Poland
facility: KO-MED Centra Kliniczne Staszow
city: Warszawa
country: Poland
facility: Centrum Zdrowia MDM
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny MSW
city: Warszawa
country: Poland
facility: Nzoz Vivamed
city: Wrocław
country: Poland
facility: PlanetMed sp. z o.o.
city: Łódź
country: Poland
facility: Amicare Sp. z o.o. Sp.k
city: Łódź
country: Poland
facility: SALVE Zakład Opieki Zdrowotnej Sp. zo.o.
city: Świdnica
country: Poland
facility: EZ-MED Centrum Medyczne
city: Chernivtsi
country: Ukraine
facility: RCI Chernivtsi Regional Clinical Hospital Dept of Gastroenterology Bukovinsky SMU
city: Dnipro
country: Ukraine
facility: I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital
city: Dnipro
country: Ukraine
facility: I.I.Mechnykov Dnipropetrovsk
city: Ivano-Frankivs'k
country: Ukraine
facility: Ivano-Frankivsk Hospital
city: Ivano-Frankivs'k
country: Ukraine
facility: Ivano-Frankivsk Med. University
city: Kharkiv
country: Ukraine
facility: CHI Kharkiv City Clinical Hospital #13
city: Kharkiv
country: Ukraine
facility: Public nonprofit enterprise
city: Kherson
country: Ukraine
facility: Kherson City Clinical Hospital
city: Khmelnytskyi
country: Ukraine
facility: Khmelnyski Regional Hospital
city: Kiev
country: Ukraine
facility: Tx-Dx Center Adonis Plus Ltd
city: Kyiv
country: Ukraine
facility: Healthy and Happy
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Hospital
city: Kyiv
country: Ukraine
facility: Kyiv Clin Hospital on Railway St. 2
city: Kyiv
country: Ukraine
facility: Med. Cen.of Limited Liability
city: Kyiv
country: Ukraine
facility: Kyiv Regional Hospital #2
city: Lviv
country: Ukraine
facility: Lviv Regional Clinical Hosp
city: Lviv
country: Ukraine
facility: Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU
city: Vinnytsia
country: Ukraine
facility: Medical Center Pulse
city: Vinnytsia
country: Ukraine
facility: RCH Vinnytsia, Dept. Therapy
city: Vinnytsia
country: Ukraine
facility: Vinnytsia M I Pyrogov
city: Vinnytsia
country: Ukraine
facility: CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM
city: Vinnytsia
country: Ukraine
facility: Communal Institution Center of the Primary Medical- Sanitary Care#2
city: Vinnytsia
country: Ukraine
facility: Center of primary health care
city: Zaporizhzhya
country: Ukraine
facility: City Clinical Hospital
city: Zhytomyr
country: Ukraine
facility: O.F. Herbachevskiyi Zhytomyr Regional Clinical Hospital
Study officials:
affiliation: Reistone Biopharma
name: Xiang Chen
role: STUDY_DIRECTOR
References: