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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003364-31 | EudraCT Number |
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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 Early withdrawn subjects during the first treatment phase can not enter the extension phase.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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR0302 8mg QD | Experimental | Participants 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 | Experimental | Participants 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 | Experimental | Participants 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR0302 | Drug | The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK (known as a Janus kinase inhibitor). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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
Rectal bleeding 0 = None
Mucosal appearance at endoscopy 0 = Normal or inactive disease
| Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| 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
Rectal bleeding 0 = None
Mucosal appearance at endoscopy 0 = Normal or inactive disease
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiang Chen | Reistone Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wellness Clinical Research, LLLC-Central Florida | Lake Wales | Florida | 33853 | United States | ||
| West Central Gastroenterology d/b/a Gastro Florida |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35963369 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | SHR0302 8mg QD | Participants 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). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Phase |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 20, 2020 | Sep 20, 2022 |
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| placebo | Placebo Comparator | Participants 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 |
|
|
| Placebo | Drug | Placebo Oral Tablet |
|
| Week 8 |
| 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
Rectal bleeding 0 = None
Mucosal appearance at endoscopy 0 = Normal or inactive disease
| Week 8 |
| 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 |
| 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 |
| FG001 | SHR0302 4mg BD | Participants 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). |
| FG002 | SHR0302 4mg QD | Participants 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). |
| FG003 | Placebo | Participants 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
| Extension Phase |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SHR0302 8mg QD | Participants 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). |
| BG001 | SHR0302 4mg BD | Participants 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). |
| BG002 | SHR0302 4mg QD | Participants 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). |
| BG003 | Placebo | Participants 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 |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Time since initial primary diagnosis | Mean | Standard Deviation | years |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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
Rectal bleeding 0 = None
Mucosal appearance at endoscopy 0 = Normal or inactive disease
| Posted | Number | percentage of participants | 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
Rectal bleeding 0 = None
Mucosal appearance at endoscopy 0 = Normal or inactive disease
| Posted | Number | percentage of participants | 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
Rectal bleeding 0 = None
Mucosal appearance at endoscopy 0 = Normal or inactive disease
| Posted | Number | percentage of participants | 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). | Posted | Number | percentage of participants | Week 8 |
|
18 weeks
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 receive the active drug. In the extension phase, participants randomized into placebo in the treatment phase were randomized into one of the three active groups above (4mg QD, 4mg BD, and 8mg QD) in a 1:1:1 ratio. Participants randomized to the active arms in the treatment phase remained in the same dose group in the extension phase.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Phase-SHR0302 8mg QD | Participants randomized in this arm will receive dose A of SHR0302 until the end of the study at week 16. SHR0302: The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK (known as a JAK inhibitor). | 0 | 41 | 2 | 41 | 13 | 41 |
| EG001 | Treatment Phase-SHR0302 4mg BD | Participants randomized in this arm will receive dose B of SHR0302 until the end of the study at week 16. SHR0302: The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK (known as a JAK inhibitor). | 0 | 41 | 0 | 41 | 11 | 41 |
| EG002 | Treatment Phase-SHR0302 4mg QD | Participants randomized in this arm will receive dose C of SHR0302 until the end of the study at week 16. SHR0302: The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK (known as a JAK inhibitor). | 0 | 41 | 2 | 41 | 12 | 41 |
| EG003 | Treatment Phase-Placebo | Participants randomized in this arm will receive placebo of SHR0302 until the end of the study at week 16. SHR0302: The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK (known as a JAK inhibitor). | 0 | 41 | 2 | 41 | 7 | 41 |
| EG004 | Extension Phase-SHR0302 8mg QD → SHR0302 8mg QD | 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 receive active drug. In the extension phase, participants randomized into placebo in the treatment phase were randomized into one of the three active groups above (dose A, dose B, and dose C) in a 1:1:1 ratio. Participants randomized to the active arms in the treatment phase remained in the same dose group in the extension phase. | 0 | 36 | 1 | 36 | 13 | 36 |
| EG005 | Extension Phase-SHR0302 4mg BD → SHR0302 4mg BD | 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 receive active drug. In the extension phase, participants randomized into placebo in the treatment phase were randomized into one of the three active groups above (dose A, dose B, and dose C) in a 1:1:1 ratio. Participants randomized to the active arms in the treatment phase remained in the same dose group in the extension phase. | 0 | 39 | 0 | 39 | 8 | 39 |
| EG006 | Extension Phase-SHR0302 4mg QD → SHR0302 4mg QD | 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 receive active drug. In the extension phase, participants randomized into placebo in the treatment phase were randomized into one of the three active groups above (dose A, dose B, and dose C) in a 1:1:1 ratio. Participants randomized to the active arms in the treatment phase remained in the same dose group in the extension phase. | 0 | 35 | 0 | 35 | 11 | 35 |
| EG007 | Extension Phase-placebo → SHR0302 8mg QD | 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 receive active drug. In the extension phase, participants randomized into placebo in the treatment phase were randomized into one of the three active groups above (dose A, dose B, and dose C) in a 1:1:1 ratio. Participants randomized to the active arms in the treatment phase remained in the same dose group in the extension phase. | 0 | 11 | 1 | 11 | 5 | 11 |
| EG008 | Extension Phase-placebo → SHR0302 4mg BD | 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 receive active drug. In the extension phase, participants randomized into placebo in the treatment phase were randomized into one of the three active groups above (dose A, dose B, and dose C) in a 1:1:1 ratio. Participants randomized to the active arms in the treatment phase remained in the same dose group in the extension phase. | 0 | 10 | 1 | 10 | 5 | 10 |
| EG009 | Extension Phase-placebo → SHR0302 4mg QD | 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 receive active drug. In the extension phase, participants randomized into placebo in the treatment phase were randomized into one of the three active groups above (dose A, dose B, and dose C) in a 1:1:1 ratio. Participants randomized to the active arms in the treatment phase remained in the same dose group in the extension phase. | 0 | 13 | 0 | 13 | 5 | 13 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis ulcerative | Gastrointestinal disorders | Systematic Assessment |
| ||
| Anal abscess | Infections and infestations | Systematic Assessment |
| ||
| Cytomegalovirus infection | Infections and infestations | Systematic Assessment |
| ||
| Liver abscess | Infections and infestations | Systematic Assessment |
| ||
| Synovitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Eosinophilia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Erythropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Leukopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Sinus bradycardia | Cardiac disorders | Systematic Assessment |
| ||
| Colitis ulcerative | Gastrointestinal disorders | Systematic Assessment |
| ||
| Folliculitis | Infections and infestations | Systematic Assessment |
| ||
| Gastrointestinal infection | Infections and infestations | Systematic Assessment |
| ||
| Influenza | Infections and infestations | Systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Bilirubin conjugated increased | Investigations | Systematic Assessment |
| ||
| Blood bilirubin increased | Investigations | Systematic Assessment |
| ||
| Blood bilirubin unconjugated increased | Investigations | Systematic Assessment |
| ||
| Blood creatine phosphokinase increased | Investigations | Systematic Assessment |
| ||
| Blood phosphorus decreased | Investigations | Systematic Assessment |
| ||
| Blood thyroid stimulating hormone decreased | Investigations | Systematic Assessment |
| ||
| C-reactive protein increased | Investigations | Systematic Assessment |
| ||
| Haematocrit decreased | Investigations | Systematic Assessment |
| ||
| Haemoglobin decreased | Investigations | Systematic Assessment |
| ||
| High density lipoprotein decreased | Investigations | Systematic Assessment |
| ||
| Lymphocyte count decreased | Investigations | Systematic Assessment |
| ||
| Neutrophil count decreased | Investigations | Systematic Assessment |
| ||
| Neutrophil count increased | Investigations | Systematic Assessment |
| ||
| Platelet count decreased | Investigations | Systematic Assessment |
| ||
| Protein urine present | Investigations | Systematic Assessment |
| ||
| Transaminases increased | Investigations | Systematic Assessment |
| ||
| White blood cell count decreased | Investigations | Systematic Assessment |
| ||
| Hypercholesterolaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Sexual dysfunction | Reproductive system and breast disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roger Liu, Medical Director | ReistoneBiopharma | +8613917512446 | roger.liu@reistonebio.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 23, 2021 | Sep 20, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000615713 | ivarmacitinib |
Not provided
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG001 | SHR0302 4mg BD | Participants 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). |
| OG002 | SHR0302 4mg QD | Participants 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). |
| OG003 | Placebo | Participants 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 |
|
|
| OG001 | SHR0302 4mg BD | Participants 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). |
| OG002 | SHR0302 4mg QD | Participants 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). |
| OG003 | Placebo | Participants 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 |
|
|
| OG002 | SHR0302 4mg QD | Participants 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). |
| OG003 | Placebo | Participants 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 |
|
|