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A Phase II Study in Patients With Moderate to Severe Active Crohn's Disease

Primary Purpose

Crohn's Disease

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

About this trial

This is an interventional treatment trial for Crohn's Disease

Eligibility Criteria

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

Inclusion Criteria:

  • Male and Female subject at ≥18 and ≤ 75 years of age at randomization.
  • Subjects with a documented three-month history of diagnosed ileal, colonic, or ileocolonic Crohn's Disease at the time of randomization.
  • Currently having Crohn's Disease with Crohn's Disease Activity Index (CDAI) score ≥ 220 to ≤450.

Exclusion Criteria:

  • Diagnosis of indeterminate colitis, or clinical findings suggestive of Ulcerative Colitis.
  • Subject with CD with stoma, gastric or ileoanal pouch, proto-colectomy or total colectomy, symptomatic stenosis or stricture, history of bowel perforation, suspected abscess; actively draining fistula.
  • Treatment naïve subjects diagnosed with Crohn's disease, (without previous exposure to treatment).

Sites / Locations

  • West Central Gastroenterology d/b/a Gastro Florida
  • Wellness Clinical Research, LLLC-Central Florida
  • West Central Gastroenterology d/b/a Gastro Florida
  • NECCR Primacare Research, LLC
  • Wilmington Health
  • Digestive Disease Specialists, Inc.
  • The First Affiliated Hospital of Bengbu Medical College
  • Yijishan Hospital of Wannan Medical College
  • Peking University Third Hospital
  • Guangdong Provincial People's Hospital
  • The First Affiliated Hospital, Sun Yat-sen University
  • The First Affiliated Hospital of Nanchang University
  • The Sixth Affiliated Hospital of Sun Yat-Sen University
  • Henan Provincial People's Hospital
  • Tongji Hospital Affiliated to Tongji Medicine College, Huazhong University of Science & Technology
  • Renmin Hospital of Wuhan University
  • Henan Provincial People's Hospital
  • The First People's Hospital of Changzhou
  • Zhongda Hospital Southeast University
  • Wuxi People's Hospital
  • Yangzhou First People's Hospital
  • The First Affiliated Hospital of Nanchang University
  • The first Hospital of Jilin University
  • Ruijin Hospital, Shanghai Jiaotong University, School of Medicne
  • Shanghai Xinhua Hospital
  • Shanghai East Hospital
  • Shanghai Changhai Hospital
  • Tianjin Union Medical Center
  • Sir Run Run Shaw Hospital, Affiliated with the Zhejiang University School of Medicine
  • Huzhou Central Hospital
  • Nanfang Hospital of Southern Medical University
  • Xiangya Hospital Central South University
  • st China Hospital Sichuan University
  • Fujian Provincial Hospital
  • Qilu Hospital of Shandong University
  • Jiangsu Province Hospital
  • Nanjing First Hospital
  • The Affiliated Hospital of Nanjing University School
  • Renji Hospital, Shanghai Jiaotong University School of Medicine
  • The University of Hong Kong-Shenzhen Hospital
  • Shanxi Provincial People's Hospital
  • Second hospital of Shanxi Medical university
  • Indywidualma Specjalistyczna Praktyka Lekarska Maciej Zymla
  • Nzoz Allmedica Badania
  • Provita Profamilia
  • SOLUMED Centrum Medyczne
  • KO-MED Central Kliniczne Plulawy
  • Gabinet Lekarski Bartosz Korczowski
  • Specjalistyczna Praktyka Lekarska dr med. Marek Horynski
  • KO-MED Centra Kliniczne Staszow
  • Centrum Zdrowia MDM
  • Centralny Szpital Kliniczny MSW
  • Nzoz Vivamed
  • PlanetMed sp. z o.o.
  • Amicare Sp. z o.o. Sp.k
  • SALVE Zakład Opieki Zdrowotnej Sp. zo.o.
  • EZ-MED Centrum Medyczne
  • RCI Chernivtsi Regional Clinical Hospital Dept of Gastroenterology Bukovinsky SMU
  • I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital
  • I.I.Mechnykov Dnipropetrovsk
  • Ivano-Frankivsk Hospital
  • Ivano-Frankivsk Med. University
  • CHI Kharkiv City Clinical Hospital #13
  • Public nonprofit enterprise
  • Kherson City Clinical Hospital
  • Khmelnyski Regional Hospital
  • Tx-Dx Center Adonis Plus Ltd
  • Healthy and Happy
  • Kyiv City Clinical Hospital
  • Kyiv Clin Hospital on Railway St. 2
  • Med. Cen.of Limited Liability
  • Kyiv Regional Hospital #2
  • Lviv Regional Clinical Hosp
  • Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU
  • Medical Center Pulse
  • RCH Vinnytsia, Dept. Therapy
  • Vinnytsia M I Pyrogov
  • CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM
  • Communal Institution Center of the Primary Medical- Sanitary Care#2
  • Center of primary health care
  • City Clinical Hospital
  • O.F. Herbachevskiyi Zhytomyr Regional Clinical Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Placebo Comparator

Arm Label

SHR0302 dose A

SHR0302 dose B

SHR0302 dose C

Placebo

Arm Description

Participants randomized in this arm will receive dose A of SHR0302 until end of study at week 24.

Participants randomized in this arm will receive dose B of SHR0302 until end of study at week 24.

Participants randomized in this arm will receive dose C of SHR0302 until end of study at week 24.

Participants randomized in this arm will receive placebo until week 12, 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 24.

Outcomes

Primary Outcome Measures

The percentage of subjects achieving clinical remission at week 12.
The percentage of subjects achieving clinical remission at week 12, defined as Crohn's Disease Activity Index (CDAI) score < 150.

Secondary Outcome Measures

The percentage of subjects achieving clinical remission defined as mean daily stool frequency (SF) ≤2.5, and abdominal pain (AP) ≤ 1 using the Patient Reported Outcome from CDAI at week 1, 4, 8, 12, 13, 16, and 24.
The percentage of subjects achieving clinical remission defined as mean daily stool frequency (SF) ≤2.5, and abdominal pain (AP) ≤ 1 using the Patient Reported Outcome from CDAI at week 1, 4, 8, 12, 13, 16, and 24.
The percentage of subjects achieving clinical remission defined as PRO2 < 8 at week 1, 4, 8, 12, 13, 16, and 24.
The percentage of subjects achieving clinical remission defined as PRO2 < 8 at week 1, 4, 8, 12, 13, 16, and 24.
The percentage of subjects achieving clinical response defined as a CDAI decrease from baseline of ≥ 100 points at week 1, 4, 8, 12, 13, 16, and 24.
The percentage of subjects achieving clinical response defined as a CDAI decrease from baseline of ≥ 100 points at week 1, 4, 8, 12, 13, 16, and 24.

Full Information

First Posted
September 17, 2018
Last Updated
March 14, 2023
Sponsor
Reistone Biopharma Company Limited
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1. Study Identification

Unique Protocol Identification Number
NCT03677648
Brief Title
A Phase II Study in Patients With Moderate to Severe Active Crohn's Disease
Official Title
A Phase II Randomized, Placebo Controlled, Double-blind, Four Arms Dose-ranging Study to Evaluate the Efficacy and Safety of SHR0302 Compared to Placebo in Patients With Moderate to Severe Active Crohn's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
May 14, 2019 (Actual)
Primary Completion Date
September 16, 2021 (Actual)
Study Completion Date
December 9, 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, multi-center Phase II study to investigate the safety and efficacy of SHR0302 in patients with moderate to severe active Crohn's Disease. The study aims to evaluate the optimal dose of SHR0302 and time needed in inducing clinical remission in active CD. This is an 12+12 weeks study, in which participants who complete the first 12 weeks treatment phase, will have the option to enter a blinded active arms 12-week extension phase. Early withdrawn subjects during the first treatment phase cannot enter the extension phase. The total duration of the study participation, including extension and follow-up, will be approximately 26 weeks. With the wealth of scientific evidence on JAK/STAT involvement in IBD, the data from similar class of new drugs and the current data on SHR0302 (JAK1 inhibitor), support the rationale to proceed with phase II studies to evaluate the efficacy and safety of SHR0302 in patients with moderate to severe active CD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
SHR0302 dose A
Arm Type
Active Comparator
Arm Description
Participants randomized in this arm will receive dose A of SHR0302 until end of study at week 24.
Arm Title
SHR0302 dose B
Arm Type
Experimental
Arm Description
Participants randomized in this arm will receive dose B of SHR0302 until end of study at week 24.
Arm Title
SHR0302 dose C
Arm Type
Experimental
Arm Description
Participants randomized in this arm will receive dose C of SHR0302 until end of study at week 24.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants randomized in this arm will receive placebo until week 12, 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 24.
Intervention Type
Drug
Intervention Name(s)
SHR0302
Intervention Description
The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK (known as a JAK inhibitor).
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
Placebos
Primary Outcome Measure Information:
Title
The percentage of subjects achieving clinical remission at week 12.
Description
The percentage of subjects achieving clinical remission at week 12, defined as Crohn's Disease Activity Index (CDAI) score < 150.
Time Frame
week12
Secondary Outcome Measure Information:
Title
The percentage of subjects achieving clinical remission defined as mean daily stool frequency (SF) ≤2.5, and abdominal pain (AP) ≤ 1 using the Patient Reported Outcome from CDAI at week 1, 4, 8, 12, 13, 16, and 24.
Description
The percentage of subjects achieving clinical remission defined as mean daily stool frequency (SF) ≤2.5, and abdominal pain (AP) ≤ 1 using the Patient Reported Outcome from CDAI at week 1, 4, 8, 12, 13, 16, and 24.
Time Frame
week 1, 4, 8, 12, 13, 16, and 24
Title
The percentage of subjects achieving clinical remission defined as PRO2 < 8 at week 1, 4, 8, 12, 13, 16, and 24.
Description
The percentage of subjects achieving clinical remission defined as PRO2 < 8 at week 1, 4, 8, 12, 13, 16, and 24.
Time Frame
week 1, 4, 8, 12, 13, 16, and 24
Title
The percentage of subjects achieving clinical response defined as a CDAI decrease from baseline of ≥ 100 points at week 1, 4, 8, 12, 13, 16, and 24.
Description
The percentage of subjects achieving clinical response defined as a CDAI decrease from baseline of ≥ 100 points at week 1, 4, 8, 12, 13, 16, and 24.
Time Frame
week 1, 4, 8, 12, 13, 16, and 24

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 at ≥18 and ≤ 75 years of age at randomization. Subjects with a documented three-month history of diagnosed ileal, colonic, or ileocolonic Crohn's Disease at the time of randomization. Currently having Crohn's Disease with Crohn's Disease Activity Index (CDAI) score ≥ 220 to ≤450. Exclusion Criteria: Diagnosis of indeterminate colitis, or clinical findings suggestive of Ulcerative Colitis. Subject with CD with stoma, gastric or ileoanal pouch, proto-colectomy or total colectomy, symptomatic stenosis or stricture, history of bowel perforation, suspected abscess; actively draining fistula. Treatment naïve subjects diagnosed with Crohn's disease, (without previous exposure to treatment).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiang Chen
Organizational Affiliation
Reistone Biopharma
Official's Role
Study Director
Facility Information:
Facility Name
West Central Gastroenterology d/b/a Gastro Florida
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
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
NECCR Primacare Research, LLC
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02721
Country
United States
Facility Name
Wilmington Health
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Digestive Disease Specialists, Inc.
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
The First Affiliated Hospital of Bengbu Medical College
City
Bengbu
State/Province
Anhui
ZIP/Postal Code
233004
Country
China
Facility Name
Yijishan Hospital of Wannan Medical College
City
Yingshan
State/Province
Anhul
ZIP/Postal Code
241001
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
10083
Country
China
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
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
The First Affiliated Hospital of Nanchang University
City
Guangzhou
State/Province
Guangzhou
ZIP/Postal Code
510515
Country
China
Facility Name
The Sixth Affiliated Hospital of Sun Yat-Sen University
City
Guangzhou
State/Province
Guangzhou
ZIP/Postal Code
510655
Country
China
Facility Name
Henan Provincial People's Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Facility Name
Tongji Hospital Affiliated to Tongji Medicine College, Huazhong University of Science & Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Facility Name
Henan Provincial People's Hospital
City
Pingxiang
State/Province
Hunan
ZIP/Postal Code
337005
Country
China
Facility Name
The First People's Hospital of Changzhou
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213002
Country
China
Facility Name
Zhongda Hospital Southeast University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Facility Name
Wuxi People's Hospital
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214023
Country
China
Facility Name
Yangzhou First People's Hospital
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225001
Country
China
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
The first Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130061
Country
China
Facility Name
Ruijin Hospital, Shanghai Jiaotong University, School of Medicne
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Shanghai Xinhua Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200092
Country
China
Facility Name
Shanghai East Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200120
Country
China
Facility Name
Shanghai Changhai Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Tianjin Union Medical Center
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300121
Country
China
Facility Name
Sir Run Run Shaw Hospital, Affiliated with the Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zheijiang
ZIP/Postal Code
310020
Country
China
Facility Name
Huzhou Central Hospital
City
Huzhou
State/Province
Zheijiang
ZIP/Postal Code
313003
Country
China
Facility Name
Nanfang Hospital of Southern Medical 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
st 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
Qilu Hospital of Shandong University
City
Jinan
ZIP/Postal Code
250012
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
The Affiliated Hospital of Nanjing University School
City
Nanjing
ZIP/Postal Code
210008
Country
China
Facility Name
Renji Hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai
ZIP/Postal Code
200127
Country
China
Facility Name
The University of Hong Kong-Shenzhen Hospital
City
Shenzhen
ZIP/Postal Code
518053
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
Indywidualma Specjalistyczna Praktyka Lekarska Maciej Zymla
City
Knurów
ZIP/Postal Code
44-190
Country
Poland
Facility Name
Nzoz Allmedica Badania
City
Nowy Targ
ZIP/Postal Code
34400
Country
Poland
Facility Name
Provita Profamilia
City
Piotrków Trybunalski
ZIP/Postal Code
97300
Country
Poland
Facility Name
SOLUMED Centrum Medyczne
City
Poznań
ZIP/Postal Code
60-529
Country
Poland
Facility Name
KO-MED Central Kliniczne Plulawy
City
Puławy
ZIP/Postal Code
24-100
Country
Poland
Facility Name
Gabinet Lekarski Bartosz Korczowski
City
Rzeszów
ZIP/Postal Code
35-302
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
Centrum Zdrowia MDM
City
Warszawa
ZIP/Postal Code
00-635
Country
Poland
Facility Name
Centralny Szpital Kliniczny MSW
City
Warszawa
ZIP/Postal Code
02507
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
SALVE Zakład Opieki Zdrowotnej Sp. zo.o.
City
Łódź
ZIP/Postal Code
91-211
Country
Poland
Facility Name
EZ-MED Centrum Medyczne
City
Świdnica
ZIP/Postal Code
58-100
Country
Poland
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
I.I.Mechnykov Dnipropetrovsk
City
Dnipro
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Ivano-Frankivsk Hospital
City
Ivano-Frankivs'k
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Ivano-Frankivsk Med. University
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
Public nonprofit enterprise
City
Kharkiv
ZIP/Postal Code
61172
Country
Ukraine
Facility Name
Kherson City Clinical Hospital
City
Kherson
ZIP/Postal Code
7300
Country
Ukraine
Facility Name
Khmelnyski Regional Hospital
City
Khmelnytskyi
ZIP/Postal Code
29000
Country
Ukraine
Facility Name
Tx-Dx Center Adonis Plus Ltd
City
Kiev
ZIP/Postal Code
2002
Country
Ukraine
Facility Name
Healthy and Happy
City
Kyiv
ZIP/Postal Code
01033
Country
Ukraine
Facility Name
Kyiv City Clinical Hospital
City
Kyiv
ZIP/Postal Code
02091
Country
Ukraine
Facility Name
Kyiv Clin Hospital on Railway St. 2
City
Kyiv
ZIP/Postal Code
03049
Country
Ukraine
Facility Name
Med. Cen.of Limited Liability
City
Kyiv
ZIP/Postal Code
08711
Country
Ukraine
Facility Name
Kyiv Regional Hospital #2
City
Kyiv
Country
Ukraine
Facility Name
Lviv Regional Clinical Hosp
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU
City
Lviv
ZIP/Postal Code
79059
Country
Ukraine
Facility Name
Medical Center Pulse
City
Vinnytsia
ZIP/Postal Code
21001
Country
Ukraine
Facility Name
RCH Vinnytsia, Dept. Therapy
City
Vinnytsia
ZIP/Postal Code
21005
Country
Ukraine
Facility Name
Vinnytsia M I Pyrogov
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
Communal Institution Center of the Primary Medical- Sanitary Care#2
City
Vinnytsia
ZIP/Postal Code
21050
Country
Ukraine
Facility Name
Center of primary health care
City
Vinnytsia
Country
Ukraine
Facility Name
City Clinical Hospital
City
Zaporizhzhya
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

Learn more about this trial

A Phase II Study in Patients With Moderate to Severe Active Crohn's Disease

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