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

NCT ID: NCT03675477

Last Updated: 2023-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-13
• Study Completion Date: 2021-02-03

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 Early withdrawn subjects during the first treatment phase can not enter the extension phase.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.

Conditions

Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: EXPERIMENTAL

SHR0302

Intervention Type: DRUG

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

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).

Group Type: EXPERIMENTAL

SHR0302

Intervention Type: DRUG

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

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).

Group Type: EXPERIMENTAL

SHR0302

Intervention Type: DRUG

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

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

Group Type: PLACEBO_COMPARATOR

SHR0302

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

Placebo Oral Tablet

Interventions

SHR0302

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

Placebo

Placebo Oral Tablet

Intervention Type: DRUG

Other Intervention Names

Ivarmacitinib

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Reistone Biopharma Company Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiang Chen

Role: STUDY_DIRECTOR

Reistone Pharma

Locations

Wellness Clinical Research, LLLC-Central Florida

Lake Wales, Florida, United States

West Central Gastroenterology d/b/a Gastro Florida

Tampa, Florida, United States

Digestive Disease Specialists, Inc.

Oklahoma City, Oklahoma, United States

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Baotou Central Hospital

Baotou, Inner Mongalia, China

Liaocheng People's Hospital

Liaocheng, Shandong, China

Peking University Shougang Hospital

Beijing, , China

Peking University Third Hospital

Beijing, , China

The First Affiliated Hospital of Bengbu Medical College

Bengbu, , China

The First Hospital of Jillin University

Changchun, , China

Xiangya Hospital Central South University

Changsha, , China

West China Hospital Sichuan University

Chengdu, , China

Fujian Provincial Hospital

Fuzhou, , China

The Sixth Affiliated Hospital of Sun Yat- Sen University

Guangzhou, , China

Sir Run Run Shaw Hospital

Hangzhou, , China

Huaian First People's Hospital

Huai'an, , China

Huzhou Central Hospital

Huzhou, , China

Qilu Hospital of Shandong University

Jinan, , China

The First People's Hospital of Lianyungang

Lianyungang, , China

Jiangsu Province Hospital

Nanjing, , China

Nanjing First Hospital

Nanjing, , China

Nanjing Drum Tower Hospital

Nanjing, , China

Zhongda Hospital Southeast University

Nanjing, , China

Pingxiang People's Hospital

Pingxiang, , China

Shanghai East Hospital

Shanghai, , China

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, , China

Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, , China

The First Hospital of China Medical University

Shenyang, , China

The University of Hong Kong - Shenzhen Hospital

Shenzhen, , China

Shanxi Provincial People's Hospital

Taiyuan, , China

Second Hospital of Shanxi Medical University

Taiyuan, , China

Tianjin Union Medical Center

Tianjin, , China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, , China

Tongji Hospital Affiliated to Tongji Medicine College

Wuhan, , China

Renmin Hospital of Wuhan University

Wuhan, , China

Yijishan Hospital of Wannan Medical College

Wuhu, , China

Indywidualma Specjalistyczna Praktyka Lekarska Maciej Zymla

Knurów, , Poland

Amicare Sp. z o.o. Sp.k

Lodz, , Poland

IP Clinic

Lodz, , Poland

NZOZ Almedica

Nowy Targ, , Poland

SOLUMED Centrum Medyczne

Poznan, , Poland

KO-MED Centra Kliniczne Plulawy

Puławy, , Poland

Specjalistyczna Praktyka Lekarska dr med. Marek Horynski

Sopot, , Poland

KO-MED Centra Kliniczne Staszow

Staszów, , Poland

Twoja Przychodnia-Szczecinskie Centrum Medyczne

Szczecin, , Poland

Nzoz Formed

Wadowice, , Poland

Nzoz Formed

Wadowice, , Poland

Nzoz Vivamed

Warsaw, , Poland

PlanetMed sp. z o.o.

Wroclaw, , Poland

Wellness Clinical Research, LLC

Vega Baja, , Puerto Rico

RCI Chernivtsi Regional Clinical Hospital Dept of Gastroenterology Bukovinsky SMU

Chernivtsi, , Ukraine

I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital

Dnipro, , Ukraine

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

Ivano-Frankivsk, , Ukraine

Ivana -Frankivsk Hospital

Ivano-Frankivsk, , Ukraine

CHI Kharkiv City Clinical Hospital #13

Kharkiv, , Ukraine

CI Karabelesh Kherson CCH

Kherson, , Ukraine

Kherson City Clinical Hospital

Kherson, , Ukraine

Khmelnytska Regional Hospital

Khmelnytskyi, , Ukraine

Kyiv City Clinical Hospital #1

Kyiv, , Ukraine

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

Kyiv, , Ukraine

CNE of Lviv Regional Council Lviv Regional Clinical Hospital

Lviv, , Ukraine

Vinnytsia M.I.Pyrogov Regional Clinical Hospital

Vinnytsia, , Ukraine

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

Vinnytsia, , Ukraine

CI City Clinical Hospital #6 Dept of Gastroenterology

Zaporizhzhia, , Ukraine

O.F. Herbachevskiyi Zhytomyr Regional Clinical Hospital

Zhytomyr, , Ukraine

Countries

United States; China; Poland; Puerto Rico; Ukraine

References

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.

Reference Type: DERIVED

PMID: 35963369 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2018-003364-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

RSJ10101

Identifier Type: -

Identifier Source: org_study_id