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Ulcerative ColitisPhase 2NCT03675477

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

A Phase 2 study testing SHR0302 in people with Ulcerative Colitis, run by Reistone Biopharma Company Limited at 67 sites in 5 countries.

Completed

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

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Ulcerative Colitis
What is being tested?
SHR0302
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
164 participants
Where
67 sitesin 5 countries
Study dates
13 Apr 2019to 3 Feb 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 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.

Who cannot join

  • 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).

Trial locations and contacts

67 sites in 5 countries.

67 sites in 5 countries

China35 sites

  • Baotou Central Hospital

    Baotou, Inner Mongalia, 014040

  • Peking University Shougang Hospital

    Beijing, 100041

  • Peking University Third Hospital

    Beijing, 100191

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, 233004

  • The First Hospital of Jillin University

    Changchun, 130021

  • Xiangya Hospital Central South University

    Changsha, 410008

  • West China Hospital Sichuan University

    Chengdu, 610041

  • Fujian Provincial Hospital

    Fuzhou, 350001

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510000

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510080

  • The Sixth Affiliated Hospital of Sun Yat- Sen University

    Guangzhou, 510655

  • Sir Run Run Shaw Hospital

    Hangzhou, 310016

  • Huaian First People's Hospital

    Huai'an, 223300

  • Huzhou Central Hospital

    Huzhou, 313000

  • Qilu Hospital of Shandong University

    Jinan, 250012

  • The First People's Hospital of Lianyungang

    Lianyungang, 222061

  • Liaocheng People's Hospital

    Liaocheng, Shandong, 252000

  • Jiangsu Province Hospital

    Nanjing, 210006

  • Nanjing First Hospital

    Nanjing, 210006

  • Nanjing Drum Tower Hospital

    Nanjing, 210008

  • Zhongda Hospital Southeast University

    Nanjing, 210009

  • Pingxiang People's Hospital

    Pingxiang, 337000

  • Shanghai East Hospital

    Shanghai, 200000

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, 200025

  • Renji Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, 200127

  • The First Hospital of China Medical University

    Shenyang, 110001

  • The University of Hong Kong - Shenzhen Hospital

    Shenzhen, 518000

  • Shanxi Provincial People's Hospital

    Taiyuan, 030001

  • Second Hospital of Shanxi Medical University

    Taiyuan, 030012

  • Tianjin Union Medical Center

    Tianjin, 300000

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325000

  • Tongji Hospital Affiliated to Tongji Medicine College

    Wuhan, 430030

  • Renmin Hospital of Wuhan University

    Wuhan, 430060

  • Yijishan Hospital of Wannan Medical College

    Wuhu, 241001

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, 453000

Other trials in China

Ukraine15 sites

  • RCI Chernivtsi Regional Clinical Hospital Dept of Gastroenterology Bukovinsky SMU

    Chernivtsi, 58002

  • I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital

    Dnipro, 49005

  • Central City Clinical Hospital Dept of Theraphy No. 2 SHEI Ivano-Frankivsk NMU

    Ivano-Frankivsk, 76018

  • Ivana -Frankivsk Hospital

    Ivano-Frankivsk, 76018

  • CHI Kharkiv City Clinical Hospital #13

    Kharkiv, 61124

  • CI Karabelesh Kherson CCH

    Kherson, 73000

  • Kherson City Clinical Hospital

    Kherson, 73000

  • Khmelnytska Regional Hospital

    Khmelnytskyi, 29000

  • Kyiv City Clinical Hospital #1

    Kyiv, 02091

  • Kyiv Railway Clinical Hospital #2 of Branch "Health Center" of the Public Joint Stock Company "Ukrai

    Kyiv, 03049

  • CNE of Lviv Regional Council Lviv Regional Clinical Hospital

    Lviv, 79010

  • Vinnytsia M.I.Pyrogov Regional Clinical Hospital

    Vinnytsia, 21018

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

    Vinnytsia, 21029

  • CI City Clinical Hospital #6 Dept of Gastroenterology

    Zaporizhzhya, 69035

  • O.F. Herbachevskiyi Zhytomyr Regional Clinical Hospital

    Zhytomyr, 10002

Other trials in Ukraine

Poland13 sites

  • Indywidualma Specjalistyczna Praktyka Lekarska Maciej Zymla

    Knurów, 44-190

  • Amicare Sp. z o.o. Sp.k

    Lodz, 90-644

  • IP Clinic

    Lodz, 90752

  • NZOZ Almedica

    Nowy Targ, 34400

  • SOLUMED Centrum Medyczne

    Poznan, 60-529

  • KO-MED Centra Kliniczne Plulawy

    Puławy, 24-100

  • Specjalistyczna Praktyka Lekarska dr med. Marek Horynski

    Sopot, 81-756

  • KO-MED Centra Kliniczne Staszow

    Staszów, 28-200

  • Twoja Przychodnia-Szczecinskie Centrum Medyczne

    Szczecin, 71434

  • Nzoz Formed

    Wadowice, 01868

  • Nzoz Formed

    Wadowice, 34100

  • Nzoz Vivamed

    Warsaw, 03-580

  • PlanetMed sp. z o.o.

    Wroclaw, 53-333

Other trials in Poland

United States3 sites

  • 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

Other trials in United States

Puerto Rico1 site

  • Wellness Clinical Research, LLC

    Vega Baja, 00694

Other trials in Puerto Rico

About this study

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.

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.

Being tested
SHR0302, Placebo
Medical subject headings
Colitis, Ulcerative

What participants receive

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

  • SHR0302Drug

    Also called Ivarmacitinib

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

  • PlaceboDrug

    Placebo Oral Tablet

Study groups in NCT03675477
Study groupRoleWhat they receive
SHR0302 8mg QDExperimentalParticipants 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).
Receives: Drug: SHR0302
SHR0302 4mg BDExperimentalParticipants 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).
Receives: Drug: SHR0302
SHR0302 4mg QDExperimentalParticipants 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).
Receives: Drug: SHR0302
placeboPlacebo comparatorParticipants randomized in this arm will receive the placebo until week 8, and then will be re-randomized into one of the 3 active arms ( 4mg QD, 4mg BD, 8mg QD of SHR0302) in a 1:1:1 allocation ratio until the end of the study at week 16. Those who had completed the first 8-week of the treatment phase, but decided not to enter into the extension phase were also required to attend the 2-week follow-up visit. Participants who immaturely withdrew during the first treatment phase could not enter the extension phase. SHR0302: The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK (known as a JAK inhibitor). Placebos: Placebo Oral Tablet
Receives: Drug: SHR0302; Drug: Placebo

What is being measured

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

  1. The Percentage of Subject Achieve Clinical Response at Week 8

    Clinical response is defined as a decrease from baseline in a 9-point modified Mayo score of at least 2 points and at least 30%, with an accompanying reduction in the subscore for rectal bleeding of at least 1 point or absolute subscore for rectal bleeding of 0 or 1.

    The 9-point modified Mayo score is the Mayo score excluding the Physician Global Assessment sub-score, hence the maximum is 9 points and the minimum is 0 point, includes:

    Stool Frequency 0 = Normal

    1. = 1-2 stools/day more than normal
    2. = 3-4 stools/day more than normal
    3. = 5 or more stools/day than normal

    Rectal bleeding 0 = None

    1. = Visible blood with stool less than half the time
    2. = Visible blood with stool half of the time or more
    3. = Passing blood alone

    Mucosal appearance at endoscopy 0 = Normal or inactive disease

    1. = Mild disease (erythema, decreased vascular pattern, mild friability
    2. = Moderate disease (marked erythema, absent vascular pattern, friability, erosio

    Measured: Week 8

Secondary outcomes (3)

  1. 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. = 1-2 stools/day more than normal
    2. = 3-4 stools/day more than normal
    3. = 5 or more stools/day than normal

    Rectal bleeding 0 = None

    1. = Visible blood with stool less than half the time
    2. = Visible blood with stool half of the time or more
    3. = Passing blood alone

    Mucosal appearance at endoscopy 0 = Normal or inactive disease

    1. = Mild disease (erythema, decreased vascular pattern, mild friability
    2. = Moderate disease (marked erythema, absent vascular pattern, friability, erosions)
    3. = Severe disease (spontaneous bleeding, ulceration)

    Measured: Week 8

  2. 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. = 1-2 stools/day more than normal
    2. = 3-4 stools/day more than normal
    3. = 5 or more stools/day than normal

    Rectal bleeding 0 = None

    1. = Visible blood with stool less than half the time
    2. = Visible blood with stool half of the time or more
    3. = Passing blood alone

    Mucosal appearance at endoscopy 0 = Normal or inactive disease

    1. = Mild disease (erythema, decreased vascular pattern, mild friability
    2. = Moderate disease (marked erythema, absent vascular patt

    Measured: Week 8

  3. 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).

    Measured: Week 8

Timeline

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

  1. First posted18 Sep 2018
  2. Study start13 Apr 2019
  3. Primary completion30 Nov 2020
  4. Study completion3 Feb 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
164 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03675477
Sponsor's protocol ID
RSJ10101
Other IDs
2018-003364-31, 2018
Status last verified
Dec 2022
First submitted
16 Sep 2018
Last updated
2 Jun 2023
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35963369

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SHR0302 in people with Ulcerative Colitis, run by Reistone Biopharma Company Limited at 67 sites in 5 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 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 67 sites in China, Ukraine, Poland, United States, Puerto Rico. 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?

Yes. Results are posted in the registry (first posted 22 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Subject Achieve Clinical Response at Week 8 (time frame: Week 8). 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 NCT03675477, which also lists 1 linked publication.

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 2 Jun 2023.

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