Clinical trial NCT03675477: A Phase II Study in Patients With Moderate to Severe Active Ulcerative Colitis.
Official title: A Phase II Randomized, Placebo Controlled, Double-blind, 4 Arms Dose-ranging Study to Evaluate the Efficacy and Safety of SHR0302 Compared to Placebo in Patients With Moderate to Severe Active Ulcerative Colitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ulcerative Colitis
Lead sponsor: Reistone Biopharma Company Limited
Sponsor class: INDUSTRY
First posted: 2018-09-18
Enrollment: 164
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, multicenter phase II study to investigate the safety and efficacy of SHR0302 in patients with moderate to severe active ulcerative colitis. The study aims to evaluate the optimal dose of SHR0302 and time needed to induce clinical response in active ulcerative colitis patients.

This is an 8+8 weeks study, in which participants who complete the first 8 weeks treatment phase, will have the option to enter a blinded active arms 8-week extension phase. Early withdrawn subjects during the first treatment phase can not enter the extension phase. The total duration of the study participation, including extension and follow-up, will be approximately 18 weeks.

SHR0302 is a Janus kinase 1(JAK1) inhibitor, capable of blocking Janus kinase-signal transducer and activator of transcription (JAK-STATs) pathway and controlling inflammation. Therefore it has the potential to be a treatment for ulcerative colitis.


Eligibility 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).

Primary outcomes:
measure: The Percentage of Subject Achieve Clinical Response at Week 8
timeFrame: Week 8
Secondary outcomes:
measure: The Percentage of Subjects Achieve Clinical Remission
timeFrame: Week 8
measure: The Percentage of Subjects Achieve Clinical Remission at Week 8
timeFrame: Week 8
measure: The Percentage of Subjects Achieve Endoscopic Remission (Mucosal Healing) at Week 8
timeFrame: Week 8
Other outcomes:
Locations:
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: Oklahoma City
country: United States
facility: Digestive Disease Specialists, Inc.
state: Oklahoma
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: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Baotou
country: China
facility: Baotou Central Hospital
state: Inner Mongalia
city: Liaocheng
country: China
facility: Liaocheng People's Hospital
state: Shandong
city: Beijing
country: China
facility: Peking University Shougang Hospital
city: Beijing
country: China
facility: Peking University Third Hospital
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical College
city: Changchun
country: China
facility: The First Hospital of Jillin University
city: Changsha
country: China
facility: Xiangya Hospital Central South University
city: Chengdu
country: China
facility: West China Hospital Sichuan University
city: Fuzhou
country: China
facility: Fujian Provincial Hospital
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital of Sun Yat- Sen University
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital
city: Huai'an
country: China
facility: Huaian First People's Hospital
city: Huzhou
country: China
facility: Huzhou Central Hospital
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
city: Lianyungang
country: China
facility: The First People's Hospital of Lianyungang
city: Nanjing
country: China
facility: Jiangsu Province Hospital
city: Nanjing
country: China
facility: Nanjing First Hospital
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
city: Pingxiang
country: China
facility: Pingxiang People's Hospital
city: Shanghai
country: China
facility: Shanghai East Hospital
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine
city: Shanghai
country: China
facility: Renji Hospital, Shanghai Jiaotong University School of Medicine
city: Shenyang
country: China
facility: The First Hospital of China Medical University
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: Tianjin
country: China
facility: Tianjin Union Medical Center
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
city: Wuhan
country: China
facility: Tongji Hospital Affiliated to Tongji Medicine College
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
city: Wuhu
country: China
facility: Yijishan Hospital of Wannan Medical College
city: Knurów
country: Poland
facility: Indywidualma Specjalistyczna Praktyka Lekarska Maciej Zymla
city: Nowy Targ
country: Poland
facility: NZOZ Almedica
city: Poznań
country: Poland
facility: SOLUMED Centrum Medyczne
city: Puławy
country: Poland
facility: KO-MED Centra Kliniczne Plulawy
city: Sopot
country: Poland
facility: Specjalistyczna Praktyka Lekarska dr med. Marek Horynski
city: Staszów
country: Poland
facility: KO-MED Centra Kliniczne Staszow
city: Szczecin
country: Poland
facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne
city: Wadowice
country: Poland
facility: Nzoz Formed
city: Wadowice
country: Poland
facility: Nzoz Formed
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: IP Clinic
city: Vega Baja
country: Puerto Rico
facility: Wellness Clinical Research, LLC
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: Ivano-Frankivs'k
country: Ukraine
facility: Central City Clinical Hospital Dept of Theraphy No. 2 SHEI Ivano-Frankivsk NMU
city: Ivano-Frankivs'k
country: Ukraine
facility: Ivana -Frankivsk Hospital
city: Kharkiv
country: Ukraine
facility: CHI Kharkiv City Clinical Hospital #13
city: Kherson
country: Ukraine
facility: CI Karabelesh Kherson CCH
city: Kherson
country: Ukraine
facility: Kherson City Clinical Hospital
city: Khmelnytskyi
country: Ukraine
facility: Khmelnytska Regional Hospital
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Hospital #1
city: Kyiv
country: Ukraine
facility: Kyiv Railway Clinical Hospital #2 of Branch "Health Center" of the Public Joint Stock Company "Ukrai
city: Lviv
country: Ukraine
facility: CNE of Lviv Regional Council Lviv Regional Clinical Hospital
city: Vinnytsia
country: Ukraine
facility: Vinnytsia M.I.Pyrogov Regional Clinical Hospital
city: Vinnytsia
country: Ukraine
facility: CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM
city: Zaporizhzhia
country: Ukraine
facility: CI City Clinical Hospital #6 Dept of Gastroenterology
city: Zhytomyr
country: Ukraine
facility: O.F. Herbachevskiyi Zhytomyr Regional Clinical Hospital
Study officials:
affiliation: Reistone Pharma
name: Xiang Chen
role: STUDY_DIRECTOR
References:
citation: Chen B, Zhong J, Li X, Pan F, Ding Y, Zhang Y, Chen H, Liu F, Zhang Z, Zhang L, Drozda R, Oliinyk O, Goh AH, Chen X, Sun X, Rubin DT, Sandborn WJ, Chen M. Efficacy and Safety of Ivarmacitinib in Patients With Moderate-to-Severe, Active, Ulcerative Colitis: A Phase II Study. Gastroenterology. 2022 Dec;163(6):1555-1568. doi: 10.1053/j.gastro.2022.08.007. Epub 2022 Aug 10.