A Phase II Study in Patients With Moderate to Severe Active Ulcerative Colitis.

Ulcerative Colitis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03675477
• Other study ID #: RSJ10101
• Secondary ID: 2018-003364-31
• Status: Completed
• Phase: Phase 2
• Start date: April 13, 2019
• Est. completion date: February 3, 2021

Study information

• Verified date: December 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, 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 Early withdrawn subjects during the first treatment phase can not enter the extension phase.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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: February 3, 2021
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

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

Locations

Country	Name	City	State
China	Baotou Central Hospital	Baotou	Inner Mongalia
China	Peking University Shougang Hospital	Beijing
China	Peking University Third Hospital	Beijing
China	The First Affiliated Hospital of Bengbu Medical College	Bengbu
China	The First Hospital of Jillin University	Changchun
China	Xiangya Hospital Central South University	Changsha
China	West China Hospital Sichuan University	Chengdu
China	Fujian Provincial Hospital	Fuzhou
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong
China	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	The Sixth Affiliated Hospital of Sun Yat- Sen University	Guangzhou
China	Sir Run Run Shaw Hospital	Hangzhou
China	Huaian First People's Hospital	Huai'an
China	Huzhou Central Hospital	Huzhou
China	Qilu Hospital of Shandong University	Jinan
China	The First People's Hospital of Lianyungang	Lianyungang
China	Liaocheng People's Hospital	Liaocheng	Shandong
China	Jiangsu Province Hospital	Nanjing
China	Nanjing Drum Tower Hospital	Nanjing
China	Nanjing First Hospital	Nanjing
China	Zhongda Hospital Southeast University	Nanjing
China	Pingxiang People's Hospital	Pingxiang
China	Renji Hospital, Shanghai Jiaotong University School of Medicine	Shanghai
China	Ruijin Hospital, Shanghai Jiaotong University School of Medicine	Shanghai
China	Shanghai East Hospital	Shanghai
China	The First Hospital of China Medical University	Shenyang
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
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou
China	Renmin Hospital of Wuhan University	Wuhan
China	Tongji Hospital Affiliated to Tongji Medicine College	Wuhan
China	Yijishan Hospital of Wannan Medical College	Wuhu
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	IP Clinic	Lódz
Poland	NZOZ Almedica	Nowy Targ
Poland	SOLUMED Centrum Medyczne	Poznan
Poland	KO-MED Centra Kliniczne Plulawy	Pulawy
Poland	Specjalistyczna Praktyka Lekarska dr med. Marek Horynski	Sopot
Poland	KO-MED Centra Kliniczne Staszow	Staszów
Poland	Twoja Przychodnia-Szczecinskie Centrum Medyczne	Szczecin
Poland	Nzoz Formed	Wadowice
Poland	Nzoz Formed	Wadowice
Poland	Nzoz Vivamed	Warszawa
Poland	PlanetMed sp. z o.o.	Wroclaw
Puerto Rico	Wellness Clinical Research, LLC	Vega Baja
Ukraine	RCI Chernivtsi Regional Clinical Hospital Dept of Gastroenterology Bukovinsky SMU	Chernivtsi
Ukraine	I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital	Dnipro
Ukraine	Central City Clinical Hospital Dept of Theraphy No. 2 SHEI Ivano-Frankivsk NMU	Ivano-Frankivs'k
Ukraine	Ivana -Frankivsk Hospital	Ivano-Frankivs'k
Ukraine	CHI Kharkiv City Clinical Hospital #13	Kharkiv
Ukraine	CI Karabelesh Kherson CCH	Kherson
Ukraine	Kherson City Clinical Hospital	Kherson
Ukraine	Khmelnytska Regional Hospital	Khmelnytskyi
Ukraine	Kyiv City Clinical Hospital #1	Kyiv
Ukraine	Kyiv Railway Clinical Hospital #2 of Branch "Health Center" of the Public Joint Stock Company "Ukrai	Kyiv
Ukraine	CNE of Lviv Regional Council Lviv Regional Clinical Hospital	Lviv
Ukraine	CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM	Vinnytsia
Ukraine	Vinnytsia M.I.Pyrogov Regional Clinical Hospital	Vinnytsia
Ukraine	CI City Clinical Hospital #6 Dept of Gastroenterology	Zaporizhzhia
Ukraine	O.F. Herbachevskiyi Zhytomyr Regional Clinical Hospital	Zhytomyr
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

Sponsors (1)

Lead Sponsor	Collaborator
Reistone Biopharma Company Limited

Countries where clinical trial is conducted

United States,  China,  Poland,  Puerto Rico,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Percentage of Subject Achieve Clinical Response at Week 8	Clinical response is defined as a decrease from baseline in a 9-point modified Mayo score of at least 2 points and at least 30%, with an accompanying reduction in the subscore for rectal bleeding of at least 1 point or absolute subscore for rectal bleeding of 0 or 1.; The 9-point modified Mayo score is the Mayo score excluding the Physician Global Assessment sub-score, hence the maximum is 9 points and the minimum is 0 point, includes: Stool Frequency 0 = Normal; = 1-2 stools/day more than normal; = 3-4 stools/day more than normal; = 5 or more stools/day than normal; Rectal bleeding 0 = None; = Visible blood with stool less than half the time; = Visible blood with stool half of the time or more; = Passing blood alone; Mucosal appearance at endoscopy 0 = Normal or inactive disease; = Mild disease (erythema, decreased vascular pattern, mild friability; = Moderate disease (marked erythema, absent vascular pattern, friability, erosio	Week 8
Secondary	The Percentage of Subjects Achieve Clinical Remission	Clinical remission was defined as a total Mayo score of 2 points or lower, with no individual sub-score exceeding 1 point. The percentage of subjects who achieve clinical remission per 9-point modified Mayo score at week 8, where stool frequency subscore = 1, rectal bleeding subscore of 0, and endoscopic subscore = 1.; 9-point modified Mayo score includes: Stool Frequency 0 = Normal; = 1-2 stools/day more than normal; = 3-4 stools/day more than normal; = 5 or more stools/day than normal; Rectal bleeding 0 = None; = Visible blood with stool less than half the time; = Visible blood with stool half of the time or more; = Passing blood alone; Mucosal appearance at endoscopy 0 = Normal or inactive disease; = Mild disease (erythema, decreased vascular pattern, mild friability; = Moderate disease (marked erythema, absent vascular pattern, friability, erosions); = Severe disease (spontaneous bleeding, ulceration)	Week 8
Secondary	The Percentage of Subjects Achieve Clinical Remission at Week 8	Clinical remission was defined as a total Mayo score of 2 points or lower, with no individual sub-score exceeding 1 point. The percentage of subjects achieve clinical remission at week 8 as per a total Mayo score of 2 points or lower =2, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0.; The 9-point modified Mayo score includes: Stool Frequency 0 = Normal; = 1-2 stools/day more than normal; = 3-4 stools/day more than normal; = 5 or more stools/day than normal; Rectal bleeding 0 = None; = Visible blood with stool less than half the time; = Visible blood with stool half of the time or more; = Passing blood alone; Mucosal appearance at endoscopy 0 = Normal or inactive disease; = Mild disease (erythema, decreased vascular pattern, mild friability; = Moderate disease (marked erythema, absent vascular patt	Week 8
Secondary	The Percentage of Subjects Achieve Endoscopic Remission (Mucosal Healing) at Week 8	Endoscopic remission was defined by Mayo endoscopic subscore = 1 point. Mayo endoscopic subscore defines score 0 as normal or inactive disease, score 1 as mild disease (erythema, decreased vascular pattern, mild friability); score 2 as moderate disease (marked erythema, absent vascular pattern, friability, erosions); score 3 as severe disease (spontaneous bleeding, ulceration).	Week 8