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Crohn's DiseasePhase 2NCT03677648

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

A Phase 2 study testing SHR0302 in people with Crohn's Disease, run by Reistone Biopharma Company Limited at 82 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Crohn's Disease
What is being tested?
SHR0302
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
112 participants
Where
82 sitesin 4 countries
Study dates
14 May 2019to 9 Dec 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

82 sites in 4 countries.

82 sites in 4 countries

China36 sites

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 10083

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui, 233004

  • The first Hospital of Jilin University

    Changchun, Jilin, 130061

  • Nanfang Hospital of Southern Medical University

    Changchun, 130021

  • Xiangya Hospital Central South University

    Changsha, 410008

  • The First People's Hospital of Changzhou

    Changzhou, Jiangsu, 213002

  • st China Hospital Sichuan University

    Chengdu, 610041

  • Fujian Provincial Hospital

    Fuzhou, 350001

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510080

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510080

  • The First Affiliated Hospital of Nanchang University

    Guangzhou, Guangzhou, 510515

  • The Sixth Affiliated Hospital of Sun Yat-Sen University

    Guangzhou, Guangzhou, 510655

  • Sir Run Run Shaw Hospital, Affiliated with the Zhejiang University School of Medicine

    Hangzhou, Zheijiang, 310020

  • Huzhou Central Hospital

    Huzhou, Zheijiang, 313003

  • Qilu Hospital of Shandong University

    Jinan, 250012

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu, 210009

  • Jiangsu Province Hospital

    Nanjing, 210006

  • Nanjing First Hospital

    Nanjing, 210006

  • The Affiliated Hospital of Nanjing University School

    Nanjing, 210008

  • Henan Provincial People's Hospital

    Pingxiang, Hunan, 337005

  • Ruijin Hospital, Shanghai Jiaotong University, School of Medicne

    Shanghai, Shanghai Municipality, 200025

  • Shanghai Xinhua Hospital

    Shanghai, Shanghai Municipality, 200092

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 200120

  • Shanghai Changhai Hospital

    Shanghai, Shanghai Municipality, 200433

  • Renji Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, 200127

  • The University of Hong Kong-Shenzhen Hospital

    Shenzhen, 518053

  • Shanxi Provincial People's Hospital

    Taiyuan, 030001

  • Second hospital of Shanxi Medical university

    Taiyuan, 030012

  • Tianjin Union Medical Center

    Tianjin, Tianjin Municipality, 300121

  • Tongji Hospital Affiliated to Tongji Medicine College, Huazhong University of Science & Technology

    Wuhan, Hubei, 430030

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430060

  • Wuxi People's Hospital

    Wuxi, Jiangsu, 214023

  • Yangzhou First People's Hospital

    Yangzhou, Jiangsu, 225001

  • Yijishan Hospital of Wannan Medical College

    Yingshan, Anhul, 241001

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, 450003

Other trials in China

Ukraine25 sites

  • RCI Chernivtsi Regional Clinical Hospital Dept of Gastroenterology Bukovinsky SMU

    Chernivtsi, 58002

  • I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital

    Dnipro, 49005

  • I.I.Mechnykov Dnipropetrovsk

    Dnipro, 49005

  • Ivano-Frankivsk Hospital

    Ivano-Frankivsk, 76018

  • Ivano-Frankivsk Med. University

    Ivano-Frankivsk, 76018

  • CHI Kharkiv City Clinical Hospital #13

    Kharkiv, 61124

  • Public nonprofit enterprise

    Kharkiv, 61172

  • Kherson City Clinical Hospital

    Kherson, 7300

  • Khmelnyski Regional Hospital

    Khmelnytskyi, 29000

  • Tx-Dx Center Adonis Plus Ltd

    Kiev, 2002

  • Healthy and Happy

    Kyiv, 01033

  • Kyiv City Clinical Hospital

    Kyiv, 02091

  • Kyiv Clin Hospital on Railway St. 2

    Kyiv, 03049

  • Med. Cen.of Limited Liability

    Kyiv, 08711

  • Kyiv Regional Hospital #2

    Kyiv

  • Lviv Regional Clinical Hosp

    Lviv, 79010

  • Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU

    Lviv, 79059

  • Medical Center Pulse

    Vinnytsia, 21001

  • RCH Vinnytsia, Dept. Therapy

    Vinnytsia, 21005

  • Vinnytsia M I Pyrogov

    Vinnytsia, 21018

  • CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM

    Vinnytsia, 21029

  • Communal Institution Center of the Primary Medical- Sanitary Care#2

    Vinnytsia, 21050

  • Center of primary health care

    Vinnytsia

  • City Clinical Hospital

    Zaporizhzhya, 69035

  • O.F. Herbachevskiyi Zhytomyr Regional Clinical Hospital

    Zhytomyr, 10002

Other trials in Ukraine

Poland15 sites

  • Indywidualma Specjalistyczna Praktyka Lekarska Maciej Zymla

    Knurów, 44-190

  • Amicare Sp. z o.o. Sp.k

    Lodz, 90-644

  • SALVE Zakład Opieki Zdrowotnej Sp. zo.o.

    Lodz, 91-211

  • Nzoz Allmedica Badania

    Nowy Targ, 34400

  • Provita Profamilia

    Piotrkow Trybunalski, 97300

  • SOLUMED Centrum Medyczne

    Poznan, 60-529

  • KO-MED Central Kliniczne Plulawy

    Puławy, 24-100

  • Gabinet Lekarski Bartosz Korczowski

    Rzeszów, 35-302

  • Specjalistyczna Praktyka Lekarska dr med. Marek Horynski

    Sopot, 81-756

  • KO-MED Centra Kliniczne Staszow

    Staszów, 28-200

  • EZ-MED Centrum Medyczne

    Swidnica, 58-100

  • Centrum Zdrowia MDM

    Warsaw, 00-635

  • Centralny Szpital Kliniczny MSW

    Warsaw, 02507

  • Nzoz Vivamed

    Warsaw, 03-580

  • PlanetMed sp. z o.o.

    Wroclaw, 53-333

Other trials in Poland

United States6 sites

  • West Central Gastroenterology d/b/a Gastro Florida

    Clearwater, Florida, 33756

  • NECCR Primacare Research, LLC

    Fall River, Massachusetts, 02721

  • Wellness Clinical Research, LLLC-Central Florida

    Lake Wales, Florida, 33853

  • Digestive Disease Specialists, Inc.

    Oklahoma City, Oklahoma, 73112

  • West Central Gastroenterology d/b/a Gastro Florida

    Tampa, Florida, 33626

  • Wilmington Health

    Wilmington, North Carolina, 28401

Other trials in United States

About this study

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

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.

Conditions
Crohn's Disease
Being tested
SHR0302, Placebos
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHR0302Drug

    The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK (known as a JAK inhibitor).

  • PlacebosDrug

    Placebos

Study groups in NCT03677648
Study groupRoleWhat they receive
SHR0302 dose AActive comparatorParticipants randomized in this arm will receive dose A of SHR0302 until end of study at week 24.
Receives: Drug: SHR0302
SHR0302 dose BExperimentalParticipants randomized in this arm will receive dose B of SHR0302 until end of study at week 24.
Receives: Drug: SHR0302
SHR0302 dose CExperimentalParticipants randomized in this arm will receive dose C of SHR0302 until end of study at week 24.
Receives: Drug: SHR0302
PlaceboPlacebo comparatorParticipants 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.
Receives: Drug: SHR0302; Drug: Placebos

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: week12

Secondary outcomes (3)

  1. 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.

    Measured: week 1, 4, 8, 12, 13, 16, and 24

  2. 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.

    Measured: week 1, 4, 8, 12, 13, 16, and 24

  3. 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.

    Measured: week 1, 4, 8, 12, 13, 16, and 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2018
  2. Study start14 May 2019
  3. Primary completion16 Sep 2021
  4. Study completion9 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03677648
Sponsor's protocol ID
RSJ10201
Status last verified
Jun 2022
First submitted
17 Sep 2018
Last updated
15 Mar 2023
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SHR0302 in people with Crohn's Disease, run by Reistone Biopharma Company Limited at 82 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 82 sites in China, Ukraine, Poland, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The percentage of subjects achieving clinical remission at week 12. (time frame: week12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03677648.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.

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