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

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SHR0302
Placebo
Sponsored by
Reistone Biopharma Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • Wellness Clinical Research, LLLC-Central Florida
  • West Central Gastroenterology d/b/a Gastro Florida
  • Digestive Disease Specialists, Inc.
  • Guangdong Provincial People's Hospital
  • The First Affiliated Hospital, Sun Yat-sen University
  • Henan Provincial People's Hospital
  • Baotou Central Hospital
  • Liaocheng People's Hospital
  • Peking University Shougang Hospital
  • Peking University Third Hospital
  • The First Affiliated Hospital of Bengbu Medical College
  • The First Hospital of Jillin University
  • Xiangya Hospital Central South University
  • West China Hospital Sichuan University
  • Fujian Provincial Hospital
  • The Sixth Affiliated Hospital of Sun Yat- Sen University
  • Sir Run Run Shaw Hospital
  • Huaian First People's Hospital
  • Huzhou Central Hospital
  • Qilu Hospital of Shandong University
  • The First People's Hospital of Lianyungang
  • Jiangsu Province Hospital
  • Nanjing First Hospital
  • Nanjing Drum Tower Hospital
  • Zhongda Hospital Southeast University
  • Pingxiang People's Hospital
  • Shanghai East Hospital
  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
  • Renji Hospital, Shanghai Jiaotong University School of Medicine
  • The First Hospital of China Medical University
  • The University of Hong Kong - Shenzhen Hospital
  • Shanxi Provincial People's Hospital
  • Second Hospital of Shanxi Medical University
  • Tianjin Union Medical Center
  • The First Affiliated Hospital of Wenzhou Medical University
  • Tongji Hospital Affiliated to Tongji Medicine College
  • Renmin Hospital of Wuhan University
  • Yijishan Hospital of Wannan Medical College
  • Indywidualma Specjalistyczna Praktyka Lekarska Maciej Zymla
  • NZOZ Almedica
  • SOLUMED Centrum Medyczne
  • KO-MED Centra Kliniczne Plulawy
  • Specjalistyczna Praktyka Lekarska dr med. Marek Horynski
  • KO-MED Centra Kliniczne Staszow
  • Twoja Przychodnia-Szczecinskie Centrum Medyczne
  • Nzoz Formed
  • Nzoz Formed
  • Nzoz Vivamed
  • PlanetMed sp. z o.o.
  • Amicare Sp. z o.o. Sp.k
  • IP Clinic
  • Wellness Clinical Research, LLC
  • RCI Chernivtsi Regional Clinical Hospital Dept of Gastroenterology Bukovinsky SMU
  • I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital
  • Central City Clinical Hospital Dept of Theraphy No. 2 SHEI Ivano-Frankivsk NMU
  • Ivana -Frankivsk Hospital
  • CHI Kharkiv City Clinical Hospital #13
  • CI Karabelesh Kherson CCH
  • Kherson City Clinical Hospital
  • Khmelnytska Regional Hospital
  • Kyiv City Clinical Hospital #1
  • Kyiv Railway Clinical Hospital #2 of Branch "Health Center" of the Public Joint Stock Company "Ukrai
  • CNE of Lviv Regional Council Lviv Regional Clinical Hospital
  • Vinnytsia M.I.Pyrogov Regional Clinical Hospital
  • CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM
  • CI City Clinical Hospital #6 Dept of Gastroenterology
  • O.F. Herbachevskiyi Zhytomyr Regional Clinical Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

SHR0302 8mg QD

SHR0302 4mg BD

SHR0302 4mg QD

placebo

Arm Description

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).

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).

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).

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
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
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).

Full Information

First Posted
September 16, 2018
Last Updated
May 31, 2023
Sponsor
Reistone Biopharma Company Limited
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1. Study Identification

Unique Protocol Identification Number
NCT03675477
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
April 13, 2019 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
February 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Reistone Biopharma Company Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
164 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SHR0302 8mg QD
Arm Type
Experimental
Arm Description
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).
Arm Title
SHR0302 4mg BD
Arm Type
Experimental
Arm Description
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).
Arm Title
SHR0302 4mg QD
Arm Type
Experimental
Arm Description
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).
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
SHR0302
Other Intervention Name(s)
Ivarmacitinib
Intervention Description
The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK (known as a Janus kinase inhibitor).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo Oral Tablet
Primary Outcome Measure Information:
Title
The Percentage of Subject Achieve Clinical Response at Week 8
Description
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
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
The Percentage of Subjects Achieve Clinical Remission
Description
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)
Time Frame
Week 8
Title
The Percentage of Subjects Achieve Clinical Remission at Week 8
Description
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
Time Frame
Week 8
Title
The Percentage of Subjects Achieve Endoscopic Remission (Mucosal Healing) at Week 8
Description
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).
Time Frame
Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiang Chen
Organizational Affiliation
Reistone Pharma
Official's Role
Study Director
Facility Information:
Facility Name
Wellness Clinical Research, LLLC-Central Florida
City
Lake Wales
State/Province
Florida
ZIP/Postal Code
33853
Country
United States
Facility Name
West Central Gastroenterology d/b/a Gastro Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33626
Country
United States
Facility Name
Digestive Disease Specialists, Inc.
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Name
The First Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Henan Provincial People's Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
453000
Country
China
Facility Name
Baotou Central Hospital
City
Baotou
State/Province
Inner Mongalia
ZIP/Postal Code
014040
Country
China
Facility Name
Liaocheng People's Hospital
City
Liaocheng
State/Province
Shandong
ZIP/Postal Code
252000
Country
China
Facility Name
Peking University Shougang Hospital
City
Beijing
ZIP/Postal Code
100041
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
The First Affiliated Hospital of Bengbu Medical College
City
Bengbu
ZIP/Postal Code
233004
Country
China
Facility Name
The First Hospital of Jillin University
City
Changchun
ZIP/Postal Code
130021
Country
China
Facility Name
Xiangya Hospital Central South University
City
Changsha
ZIP/Postal Code
410008
Country
China
Facility Name
West China Hospital Sichuan University
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
Fujian Provincial Hospital
City
Fuzhou
ZIP/Postal Code
350001
Country
China
Facility Name
The Sixth Affiliated Hospital of Sun Yat- Sen University
City
Guangzhou
ZIP/Postal Code
510655
Country
China
Facility Name
Sir Run Run Shaw Hospital
City
Hangzhou
ZIP/Postal Code
310016
Country
China
Facility Name
Huaian First People's Hospital
City
Huai'an
ZIP/Postal Code
223300
Country
China
Facility Name
Huzhou Central Hospital
City
Huzhou
ZIP/Postal Code
313000
Country
China
Facility Name
Qilu Hospital of Shandong University
City
Jinan
ZIP/Postal Code
250012
Country
China
Facility Name
The First People's Hospital of Lianyungang
City
Lianyungang
ZIP/Postal Code
222061
Country
China
Facility Name
Jiangsu Province Hospital
City
Nanjing
ZIP/Postal Code
210006
Country
China
Facility Name
Nanjing First Hospital
City
Nanjing
ZIP/Postal Code
210006
Country
China
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
ZIP/Postal Code
210008
Country
China
Facility Name
Zhongda Hospital Southeast University
City
Nanjing
ZIP/Postal Code
210009
Country
China
Facility Name
Pingxiang People's Hospital
City
Pingxiang
ZIP/Postal Code
337000
Country
China
Facility Name
Shanghai East Hospital
City
Shanghai
ZIP/Postal Code
200000
Country
China
Facility Name
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Renji Hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai
ZIP/Postal Code
200127
Country
China
Facility Name
The First Hospital of China Medical University
City
Shenyang
ZIP/Postal Code
110001
Country
China
Facility Name
The University of Hong Kong - Shenzhen Hospital
City
Shenzhen
ZIP/Postal Code
518000
Country
China
Facility Name
Shanxi Provincial People's Hospital
City
Taiyuan
ZIP/Postal Code
030001
Country
China
Facility Name
Second Hospital of Shanxi Medical University
City
Taiyuan
ZIP/Postal Code
030012
Country
China
Facility Name
Tianjin Union Medical Center
City
Tianjin
ZIP/Postal Code
300000
Country
China
Facility Name
The First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
ZIP/Postal Code
325000
Country
China
Facility Name
Tongji Hospital Affiliated to Tongji Medicine College
City
Wuhan
ZIP/Postal Code
430030
Country
China
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan
ZIP/Postal Code
430060
Country
China
Facility Name
Yijishan Hospital of Wannan Medical College
City
Wuhu
ZIP/Postal Code
241001
Country
China
Facility Name
Indywidualma Specjalistyczna Praktyka Lekarska Maciej Zymla
City
Knurów
ZIP/Postal Code
44-190
Country
Poland
Facility Name
NZOZ Almedica
City
Nowy Targ
ZIP/Postal Code
34400
Country
Poland
Facility Name
SOLUMED Centrum Medyczne
City
Poznań
ZIP/Postal Code
60-529
Country
Poland
Facility Name
KO-MED Centra Kliniczne Plulawy
City
Puławy
ZIP/Postal Code
24-100
Country
Poland
Facility Name
Specjalistyczna Praktyka Lekarska dr med. Marek Horynski
City
Sopot
ZIP/Postal Code
81-756
Country
Poland
Facility Name
KO-MED Centra Kliniczne Staszow
City
Staszów
ZIP/Postal Code
28-200
Country
Poland
Facility Name
Twoja Przychodnia-Szczecinskie Centrum Medyczne
City
Szczecin
ZIP/Postal Code
71434
Country
Poland
Facility Name
Nzoz Formed
City
Wadowice
ZIP/Postal Code
01868
Country
Poland
Facility Name
Nzoz Formed
City
Wadowice
ZIP/Postal Code
34100
Country
Poland
Facility Name
Nzoz Vivamed
City
Warszawa
ZIP/Postal Code
03-580
Country
Poland
Facility Name
PlanetMed sp. z o.o.
City
Wrocław
ZIP/Postal Code
53-333
Country
Poland
Facility Name
Amicare Sp. z o.o. Sp.k
City
Łódź
ZIP/Postal Code
90-644
Country
Poland
Facility Name
IP Clinic
City
Łódź
ZIP/Postal Code
90752
Country
Poland
Facility Name
Wellness Clinical Research, LLC
City
Vega Baja
ZIP/Postal Code
00694
Country
Puerto Rico
Facility Name
RCI Chernivtsi Regional Clinical Hospital Dept of Gastroenterology Bukovinsky SMU
City
Chernivtsi
ZIP/Postal Code
58002
Country
Ukraine
Facility Name
I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital
City
Dnipro
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Central City Clinical Hospital Dept of Theraphy No. 2 SHEI Ivano-Frankivsk NMU
City
Ivano-Frankivs'k
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Ivana -Frankivsk Hospital
City
Ivano-Frankivs'k
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
CHI Kharkiv City Clinical Hospital #13
City
Kharkiv
ZIP/Postal Code
61124
Country
Ukraine
Facility Name
CI Karabelesh Kherson CCH
City
Kherson
ZIP/Postal Code
73000
Country
Ukraine
Facility Name
Kherson City Clinical Hospital
City
Kherson
ZIP/Postal Code
73000
Country
Ukraine
Facility Name
Khmelnytska Regional Hospital
City
Khmelnytskyi
ZIP/Postal Code
29000
Country
Ukraine
Facility Name
Kyiv City Clinical Hospital #1
City
Kyiv
ZIP/Postal Code
02091
Country
Ukraine
Facility Name
Kyiv Railway Clinical Hospital #2 of Branch "Health Center" of the Public Joint Stock Company "Ukrai
City
Kyiv
ZIP/Postal Code
03049
Country
Ukraine
Facility Name
CNE of Lviv Regional Council Lviv Regional Clinical Hospital
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
Vinnytsia M.I.Pyrogov Regional Clinical Hospital
City
Vinnytsia
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM
City
Vinnytsia
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
CI City Clinical Hospital #6 Dept of Gastroenterology
City
Zaporizhzhia
ZIP/Postal Code
69035
Country
Ukraine
Facility Name
O.F. Herbachevskiyi Zhytomyr Regional Clinical Hospital
City
Zhytomyr
ZIP/Postal Code
10002
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35963369
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.
Results Reference
derived

Learn more about this trial

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

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