A Phase II Study in Patients With Moderate to Severe Active Ulcerative Colitis.
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.
2 other identifiers
interventional
164
5 countries
67
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 Early withdrawn subjects during the first treatment phase can not enter the extension phase.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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2019
67 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 16, 2018
CompletedFirst Posted
Study publicly available on registry
September 18, 2018
CompletedStudy Start
First participant enrolled
April 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 3, 2021
CompletedResults Posted
Study results publicly available
November 22, 2022
CompletedJune 2, 2023
December 1, 2022
1.6 years
September 16, 2018
September 20, 2022
May 31, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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. = 1-2 stools/day more than normal 2. = 3-4 stools/day more than normal 3. = 5 or more stools/day than normal Rectal bleeding 0 = None 1. = Visible blood with stool less than half the time 2. = Visible blood with stool half of the time or more 3. = Passing blood alone Mucosal appearance at endoscopy 0 = Normal or inactive disease 1. = Mild disease (erythema, decreased vascular pattern, mild friability 2. = Moderate disease (marked erythema, absent vascular pattern, friability, erosio
Week 8
Secondary Outcomes (3)
The Percentage of Subjects Achieve Clinical Remission
Week 8
The Percentage of Subjects Achieve Clinical Remission at Week 8
Week 8
The Percentage of Subjects Achieve Endoscopic Remission (Mucosal Healing) at Week 8
Week 8
Study Arms (4)
SHR0302 8mg QD
EXPERIMENTALParticipants randomized in this arm will receive SHR0302 8mg QD for the treatment phase. All participants that had completed the 8-week treatment phase (non-responders or responders) had the option to enter a blinded 8-week extension phase to continue to receive SHR0302 8mg QD. Those who had completed the first 8-week of the treatment phase, but decided not to enter into the extension phase were also required to attend the 2-week follow-up visit. Participants who immaturely withdrew during the first treatment phase could not enter the extension phase. SHR0302: The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK (known as a JAK inhibitor).
SHR0302 4mg BD
EXPERIMENTALParticipants randomized in this arm will receive SHR0302 4mg BD for the treatment phase. All participants that had completed the 8-week treatment phase (non-responders or responders) had the option to enter a blinded 8-week extension phase to continue to receive SHR0302 4mg BD. Those who had completed the first 8-week of the treatment phase, but decided not to enter into the extension phase were also required to attend the 2-week follow-up visit. Participants who immaturely withdrew during the first treatment phase could not enter the extension phase. SHR0302: The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK (known as a JAK inhibitor).
SHR0302 4mg QD
EXPERIMENTALParticipants randomized in this arm will receive SHR0302 4mg QD for the treatment phase. All participants that had completed the 8-week treatment phase (non-responders or responders) had the option to enter a blinded 8-week extension phase to continue to receive SHR0302 4mg QD. Those who had completed the first 8-week of the treatment phase, but decided not to enter into the extension phase were also required to attend the 2-week follow-up visit. Participants who immaturely withdrew during the first treatment phase could not enter the extension phase. SHR0302: The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK (known as a JAK inhibitor).
placebo
PLACEBO COMPARATORParticipants randomized in this arm will receive the placebo until week 8, and then will be re-randomized into one of the 3 active arms ( 4mg QD, 4mg BD, 8mg QD of SHR0302) in a 1:1:1 allocation ratio until the end of the study at week 16. Those who had completed the first 8-week of the treatment phase, but decided not to enter into the extension phase were also required to attend the 2-week follow-up visit. Participants who immaturely withdrew during the first treatment phase could not enter the extension phase. SHR0302: The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK (known as a JAK inhibitor). Placebos: Placebo Oral Tablet
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (67)
Wellness Clinical Research, LLLC-Central Florida
Lake Wales, Florida, 33853, United States
West Central Gastroenterology d/b/a Gastro Florida
Tampa, Florida, 33626, United States
Digestive Disease Specialists, Inc.
Oklahoma City, Oklahoma, 73112, United States
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510000, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080, China
Henan Provincial People's Hospital
Zhengzhou, Henan, 453000, China
Baotou Central Hospital
Baotou, Inner Mongalia, 014040, China
Liaocheng People's Hospital
Liaocheng, Shandong, 252000, China
Peking University Shougang Hospital
Beijing, 100041, China
Peking University Third Hospital
Beijing, 100191, China
The First Affiliated Hospital of Bengbu Medical College
Bengbu, 233004, China
The First Hospital of Jillin University
Changchun, 130021, China
Xiangya Hospital Central South University
Changsha, 410008, China
West China Hospital Sichuan University
Chengdu, 610041, China
Fujian Provincial Hospital
Fuzhou, 350001, China
The Sixth Affiliated Hospital of Sun Yat- Sen University
Guangzhou, 510655, China
Sir Run Run Shaw Hospital
Hangzhou, 310016, China
Huaian First People's Hospital
Huai'an, 223300, China
Huzhou Central Hospital
Huzhou, 313000, China
Qilu Hospital of Shandong University
Jinan, 250012, China
The First People's Hospital of Lianyungang
Lianyungang, 222061, China
Jiangsu Province Hospital
Nanjing, 210006, China
Nanjing First Hospital
Nanjing, 210006, China
Nanjing Drum Tower Hospital
Nanjing, 210008, China
Zhongda Hospital Southeast University
Nanjing, 210009, China
Pingxiang People's Hospital
Pingxiang, 337000, China
Shanghai East Hospital
Shanghai, 200000, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, 200025, China
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, 200127, China
The First Hospital of China Medical University
Shenyang, 110001, China
The University of Hong Kong - Shenzhen Hospital
Shenzhen, 518000, China
Shanxi Provincial People's Hospital
Taiyuan, 030001, China
Second Hospital of Shanxi Medical University
Taiyuan, 030012, China
Tianjin Union Medical Center
Tianjin, 300000, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325000, China
Tongji Hospital Affiliated to Tongji Medicine College
Wuhan, 430030, China
Renmin Hospital of Wuhan University
Wuhan, 430060, China
Yijishan Hospital of Wannan Medical College
Wuhu, 241001, China
Indywidualma Specjalistyczna Praktyka Lekarska Maciej Zymla
Knurów, 44-190, Poland
Amicare Sp. z o.o. Sp.k
Lodz, 90-644, Poland
IP Clinic
Lodz, 90752, Poland
NZOZ Almedica
Nowy Targ, 34400, Poland
SOLUMED Centrum Medyczne
Poznan, 60-529, Poland
KO-MED Centra Kliniczne Plulawy
Puławy, 24-100, Poland
Specjalistyczna Praktyka Lekarska dr med. Marek Horynski
Sopot, 81-756, Poland
KO-MED Centra Kliniczne Staszow
Staszów, 28-200, Poland
Twoja Przychodnia-Szczecinskie Centrum Medyczne
Szczecin, 71434, Poland
Nzoz Formed
Wadowice, 01868, Poland
Nzoz Formed
Wadowice, 34100, Poland
Nzoz Vivamed
Warsaw, 03-580, Poland
PlanetMed sp. z o.o.
Wroclaw, 53-333, Poland
Wellness Clinical Research, LLC
Vega Baja, 00694, Puerto Rico
RCI Chernivtsi Regional Clinical Hospital Dept of Gastroenterology Bukovinsky SMU
Chernivtsi, 58002, Ukraine
I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital
Dnipro, 49005, Ukraine
Central City Clinical Hospital Dept of Theraphy No. 2 SHEI Ivano-Frankivsk NMU
Ivano-Frankivsk, 76018, Ukraine
Ivana -Frankivsk Hospital
Ivano-Frankivsk, 76018, Ukraine
CHI Kharkiv City Clinical Hospital #13
Kharkiv, 61124, Ukraine
CI Karabelesh Kherson CCH
Kherson, 73000, Ukraine
Kherson City Clinical Hospital
Kherson, 73000, Ukraine
Khmelnytska Regional Hospital
Khmelnytskyi, 29000, Ukraine
Kyiv City Clinical Hospital #1
Kyiv, 02091, Ukraine
Kyiv Railway Clinical Hospital #2 of Branch "Health Center" of the Public Joint Stock Company "Ukrai
Kyiv, 03049, Ukraine
CNE of Lviv Regional Council Lviv Regional Clinical Hospital
Lviv, 79010, Ukraine
Vinnytsia M.I.Pyrogov Regional Clinical Hospital
Vinnytsia, 21018, Ukraine
CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM
Vinnytsia, 21029, Ukraine
CI City Clinical Hospital #6 Dept of Gastroenterology
Zaporizhzhia, 69035, Ukraine
O.F. Herbachevskiyi Zhytomyr Regional Clinical Hospital
Zhytomyr, 10002, Ukraine
Related Publications (1)
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.
PMID: 35963369DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Roger Liu, Medical Director
- Organization
- ReistoneBiopharma
Study Officials
- STUDY DIRECTOR
Xiang Chen
Reistone Pharma
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2018
First Posted
September 18, 2018
Study Start
April 13, 2019
Primary Completion
November 30, 2020
Study Completion
February 3, 2021
Last Updated
June 2, 2023
Results First Posted
November 22, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share