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

Sponsor

Reistone Biopharma Company Limited (Industry)

Overall Status

Completed

CT.gov ID

NCT03675477

Collaborator

(none)

164

Enrollment

Locations

Arms

21.7

Actual Duration (Months)

2.4

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The proposed study is a randomized, double-blind,placebo-controlled, multi-center phase II study to investigatethe safety and efficacy of SHR0302 in patients with moderate to severe activeulcerative colitis. The study aims to evaluate the optimal dose of SHR0302 andtime needed in inducing clinical response in active ulcerative colitispatients.

This is an 8+8 weeksstudy, in which participants who complete the first 8 weeks treatment phase, will have the option to enter a blinded activearms 8-week extension phase. Early withdrawn subjects during the first treatment phasecannot enter the extension phase. The total duration of the study participation, including extension and follow-up, will be approximately 18weeks.

SHR0302 is a JAK1 inhibitor, capable of blocking JAK-STATs pathway and control inflammation. Therefore it has the potential to be a treatment for UC.

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis	Drug: SHR0302 Drug: Placebos	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

164 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Apr 13, 2019

Actual Primary Completion Date :

Nov 30, 2020

Actual Study Completion Date :

Feb 3, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: SHR0302 dose A Participants randomized in this arm will receive dose A of SHR0302 until end of study at week 16.	Drug: SHR0302 The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK (known as a JAK inhibitor).
Active Comparator: SHR0302 dose B Participants randomized in this arm will receive dose B of SHR0302 until end of study at week 16.	Drug: SHR0302 The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK (known as a JAK inhibitor).
Active Comparator: SHR0302 dose C Participants randomized in this arm will receive dose D of SHR0302 until end of study at week 16.	Drug: SHR0302 The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK (known as a JAK inhibitor).
Placebo Comparator: palcebo Participants randomized in this arm will receive placebo until week 8, 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 16.	Drug: SHR0302 The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK (known as a JAK inhibitor). Drug: Placebos Placebo Oral Tablet

Outcome Measures

Primary Outcome Measures

The percentage of subject achieve clinical response at week 8 [Week 8]
Clinical response is defined as decrease from baseline in 9-point modified Mayo score of at least 2 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or absolute subscore for rectal bleeding of 0 or 1

Secondary Outcome Measures

The percentage of subjects achieve clinical remission [Week 8]
The percentage of subjects 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
The percentage of subjects achieve clinical remission at week 8 [Week 8]
The percentage of subjects achieve clinical remission at week 8 as per total Mayo score of 2 points or lower ≤2, with no individual subscore exceeding 1point and a rectal bleeding subscore of 0.
The percentage of subjects achieve endoscopic remission (mucosal healing) at week 8, defined by Mayo endoscopic subscore ≤ 1 point. [Week 8]
The percentage of subjects achieve endoscopic remission (mucosal healing) at week 8, defined by Mayo endoscopic subscore ≤ 1 point.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wellness Clinical Research, LLLC-Central Florida	Lake Wales	Florida	United States	33853
2	West Central Gastroenterology d/b/a Gastro Florida	Tampa	Florida	United States	33626
3	Digestive Disease Specialists, Inc.	Oklahoma City	Oklahoma	United States	73112
4	Guangdong Provincial People's Hospital	Guangzhou	Guangdong	China	510000
5	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong	China	510080
6	Henan Provincial People's Hospital	Zhengzhou	Henan	China	453000
7	Baotou Central Hospital	Baotou	Inner Mongalia	China	014040
8	Liaocheng People's Hospital	Liaocheng	Shandong	China	252000
9	Peking University Shougang Hospital	Beijing		China	100041
10	Peking University Third Hospital	Beijing		China	100191
11	The First Affiliated Hospital of Bengbu Medical College	Bengbu		China	233004
12	The First Hospital of Jillin University	Changchun		China	130021
13	Xiangya Hospital Central South University	Changsha		China	410008
14	West China Hospital Sichuan University	Chengdu		China	610041
15	Fujian Provincial Hospital	Fuzhou		China	350001
16	The Sixth Affiliated Hospital of Sun Yat- Sen University	Guangzhou		China	510655
17	Sir Run Run Shaw Hospital	Hangzhou		China	310016
18	Huaian First People's Hospital	Huai'an		China	223300
19	Huzhou Central Hospital	Huzhou		China	313000
20	Qilu Hospital of Shandong University	Jinan		China	250012
21	The First People's Hospital of Lianyungang	Lianyungang		China	222061
22	Jiangsu Province Hospital	Nanjing		China	210006
23	Nanjing First Hospital	Nanjing		China	210006
24	Nanjing Drum Tower Hospital	Nanjing		China	210008
25	Zhongda Hospital Southeast University	Nanjing		China	210009
26	Pingxiang People's Hospital	Pingxiang		China	337000
27	Shanghai East Hospital	Shanghai		China	200000
28	Ruijin Hospital, Shanghai Jiaotong University School of Medicine	Shanghai		China	200025
29	Renji Hospital, Shanghai Jiaotong University School of Medicine	Shanghai		China	200127
30	The First Hospital of China Medical University	Shenyang		China	110001
31	The University of Hong Kong - Shenzhen Hospital	Shenzhen		China	518000
32	Shanxi Provincial People's Hospital	Taiyuan		China	030001
33	Second Hospital of Shanxi Medical University	Taiyuan		China	030012
34	Tianjin Union Medical Center	Tianjin		China	300000
35	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou		China	325000
36	Tongji Hospital Affiliated to Tongji Medicine College	Wuhan		China	430030
37	Renmin Hospital of Wuhan University	Wuhan		China	430060
38	Yijishan Hospital of Wannan Medical College	Wuhu		China	241001
39	Indywidualma Specjalistyczna Praktyka Lekarska Maciej Zymla	Knurów		Poland	44-190
40	NZOZ Almedica	Nowy Targ		Poland	34400
41	SOLUMED Centrum Medyczne	Poznań		Poland	60-529
42	KO-MED Centra Kliniczne Plulawy	Puławy		Poland	24-100
43	Specjalistyczna Praktyka Lekarska dr med. Marek Horynski	Sopot		Poland	81-756
44	KO-MED Centra Kliniczne Staszow	Staszów		Poland	28-200
45	Twoja Przychodnia-Szczecinskie Centrum Medyczne	Szczecin		Poland	71434
46	Nzoz Formed	Wadowice		Poland	01868
47	Nzoz Formed	Wadowice		Poland	34100
48	Nzoz Vivamed	Warszawa		Poland	03-580
49	PlanetMed sp. z o.o.	Wrocław		Poland	53-333
50	Amicare Sp. z o.o. Sp.k	Łódź		Poland	90-644
51	IP Clinic	Łódź		Poland	90752
52	Wellness Clinical Research, LLC	Vega Baja		Puerto Rico	00694
53	RCI Chernivtsi Regional Clinical Hospital Dept of Gastroenterology Bukovinsky SMU	Chernivtsi		Ukraine	58002
54	I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital	Dnipro		Ukraine	49005
55	Central City Clinical Hospital Dept of Theraphy No. 2 SHEI Ivano-Frankivsk NMU	Ivano-Frankivs'k		Ukraine	76018
56	Ivana -Frankivsk Hospital	Ivano-Frankivs'k		Ukraine	76018
57	CHI Kharkiv City Clinical Hospital #13	Kharkiv		Ukraine	61124
58	CI Karabelesh Kherson CCH	Kherson		Ukraine	73000
59	Kherson City Clinical Hospital	Kherson		Ukraine	73000
60	Khmelnytska Regional Hospital	Khmelnytskyi		Ukraine	29000
61	Kyiv City Clinical Hospital #1	Kyiv		Ukraine	02091
62	Kyiv Railway Clinical Hospital #2 of Branch "Health Center" of the Public Joint Stock Company "Ukrai	Kyiv		Ukraine	03049
63	CNE of Lviv Regional Council Lviv Regional Clinical Hospital	Lviv		Ukraine	79010
64	Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU	Lviv		Ukraine	79059
65	Vinnytsia M.I.Pyrogov Regional Clinical Hospital	Vinnytsia		Ukraine	21018
66	CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM	Vinnytsia		Ukraine	21029
67	CI City Clinical Hospital #6 Dept of Gastroenterology	Zaporizhzhia		Ukraine	69035
68	O.F. Herbachevskiyi Zhytomyr Regional Clinical Hospital	Zhytomyr		Ukraine	10002

Sponsors and Collaborators

Reistone Biopharma Company Limited

Investigators

Study Director: Tia Boonyapredee, Reistone Biopharma

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Reistone Biopharma Company Limited

ClinicalTrials.gov Identifier:

NCT03675477

Other Study ID Numbers:

RSJ10101
2018-003364-31

First Posted:

Sep 18, 2018

Last Update Posted:

Apr 9, 2021

Last Verified:

Nov 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Colitis

Colitis, Ulcerative

Ulcer

Study Results

No Results Posted as of Apr 9, 2021