Evaluation of Rovadicitinib Compared to the Protocol Selected by Researchers in Third Line and Subsequent Studies of Moderate to Severe Chronic Graft-versus-host Disease

Last updated: December 5, 2025
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Transplant Rejection

Treatment

Mycophenolate mofetil

Imatinib

Methotrexate

Clinical Study ID

NCT06682169
TQ05105-III-01
  • Ages 18-70
  • All Genders

Study Summary

The aim of this study is to demonstrate that in subjects with moderate to severe chronic graft-versus-host disease in the third line and beyond, the use of rosuvastatin compared to the protocol chosen by the researchers can significantly improve the objective response rate of subjects at week 24.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age: 18 to 70 years old; Karnofsky (KPS) ≥ 60 points; Expected survival periodexceeding 6 months;

  • Previously received allogeneic hematopoietic stem cell transplantation;

  • According to NIH standards, the clinical diagnosis is moderate to severe cGVHD;

  • Previously received systematic treatment for cGVHD with 2-5 lines;

  • Stable dosage of corticosteroids and other immunosuppressants received within 2weeks prior to screening;

  • The main organ functions well;

  • Starting from Day 1 after enrollment in the control group of this study,participants must receive one of the drugs specified in the study protocol;

  • Female participants of childbearing age should agree to use contraceptive measures (such as intrauterine devices, birth control pills, or condoms) during the studyperiod and for 6 months after the end of the study; Serum pregnancy test negativewithin 7 days prior to enrollment in the study, and must be a non lactating subject;Male participants should agree to use contraceptive measures during the study periodand within 6 months after the end of the study period;

  • Subjects voluntarily joined this study, signed informed consent, and had goodcompliance.

Exclusion

Exclusion Criteria:

  • Has experienced or currently suffers from other malignant tumors within the past 3years;

  • Known or suspected active aGVHD;

  • Individuals with interstitial pneumonia, non infectious pneumonia, uncontrolledactive infections, or infections requiring systematic treatment within the first 7days of randomization, except for those deemed suitable for inclusion by theresearchers;

  • The occurrence and progression of other underlying diseases include post transplantlymphoid tissue proliferative diseases and recurrence of primary malignanthematological diseases;

  • Random failure of allogeneic hematopoietic stem cell transplantation within thefirst 6 months or having received 2 allogeneic hematopoietic stem cell transplantsin the past;

  • Used JAK inhibitors, Bruton's tyrosine kinase (BTK) inhibitors, etc. within thefirst 2 weeks of randomization;

  • There are multiple factors that can affect oral medication, such as inability toswallow, intestinal obstruction, etc;

  • Individuals with a history of abuse of psychotropic drugs who are unable to quit orhave mental disorders;

  • Subjects with any severe and/or uncontrolled illnesses;

  • Individuals who are allergic to research drugs or their components;

  • Participated in other clinical trials within the first 4 weeks of randomization;

  • According to the researcher's judgment, there are accompanying diseases thatseriously endanger the safety of the subjects or affect the completion of the study,or subjects who are deemed unsuitable for inclusion due to other reasons.

Study Design

Total Participants: 182
Treatment Group(s): 5
Primary Treatment: Mycophenolate mofetil
Phase: 3
Study Start date:
November 20, 2024
Estimated Completion Date:
December 31, 2030

Connect with a study center

  • The First Affiliated Hospital of USTC Anhui Provincial Hospital

    Hefei, Anhui 230001
    China

    Site Not Available

  • The First Affiliated Hospital of USTC Anhui Provincial Hospital

    Hefei 1808722, Anhui 1818058 230001
    China

    Site Not Available

  • Peking University First Hospital

    Beijing, Beijing 100034
    China

    Site Not Available

  • Peking University People's Hospital

    Beijing, Beijing 100044
    China

    Site Not Available

  • Peking University First Hospital

    Beijing 1816670, Beijing Municipality 2038349 100034
    China

    Site Not Available

  • Peking University People's Hospital

    Beijing 1816670, Beijing Municipality 2038349 100044
    China

    Site Not Available

  • The Southwest Hospital of AMU

    Chongqing, Chongqing 400038
    China

    Site Not Available

  • The Southwest Hospital of AMU

    Chongqing 1814906, Chongqing Municipality 1814905 400038
    China

    Site Not Available

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian 350001
    China

    Site Not Available

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian 361003
    China

    Site Not Available

  • Fujian Medical University Union Hospital

    Fuzhou 1810821, Fujian 1811017 350001
    China

    Site Not Available

  • The First Affiliated Hospital of Xiamen University

    Xiamen 1790645, Fujian 1811017 361003
    China

    Site Not Available

  • The 904 Hospital of the Joint Service Support Force of the People's Liberation Army of China

    Lanzhou, Gansu 730050
    China

    Site Not Available

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu 730000
    China

    Site Not Available

  • The 904 Hospital of the Joint Service Support Force of the People's Liberation Army of China

    Lanzhou 1804430, Gansu 1810676 730050
    China

    Site Not Available

  • The First Hospital of Lanzhou University

    Lanzhou 1804430, Gansu 1810676 730000
    China

    Site Not Available

  • Guangzhou First People's Hospital The First People's Hospital Affiliated to Guangzhou Medical University

    Guangzhou, Guangdong 510180
    China

    Site Not Available

  • Nanfang Hospital

    Guangzhou, Guangdong 510515
    China

    Site Not Available

  • Guangzhou First People's Hospital The First People's Hospital Affiliated to Guangzhou Medical University

    Guangzhou 1809858, Guangdong 1809935 510180
    China

    Site Not Available

  • Nanfang Hospital

    Guangzhou 1809858, Guangdong 1809935 510515
    China

    Site Not Available

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi 530021
    China

    Site Not Available

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning 1799869, Guangxi 1809867 530021
    China

    Site Not Available

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou 550001
    China

    Site Not Available

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang 1809461, Guizhou 1809445 550001
    China

    Site Not Available

  • The Second Hospital of Hebei Medical Hospital

    Shijiazhuang, Hebei 050000
    China

    Site Not Available

  • The Second Hospital of Hebei Medical Hospital

    Shijiazhuang 1795270, Hebei 1808773 050000
    China

    Site Not Available

  • Henan Provincial People's Hospital

    Zhengzhou, Henan 450003
    China

    Site Not Available

  • The Third People's Hospital of Zhengzhou

    Zhengzhou, Henan 450099
    China

    Site Not Available

  • Henan Provincial People's Hospital

    Zhengzhou 1784658, Henan 1808520 450003
    China

    Site Not Available

  • The Third People's Hospital of Zhengzhou

    Zhengzhou 1784658, Henan 1808520 450099
    China

    Site Not Available

  • Henan Cancer Hospital

    Zhenzhou, Henan 1808520 450000
    China

    Active - Recruiting

  • Tongji Hospital Tongji Medical College of HUST

    Wuhan, Hubei 430030
    China

    Site Not Available

  • Wuhan Union Hospital of China

    Wuhan, Hubei 430022
    China

    Site Not Available

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei 430071
    China

    Site Not Available

  • Tongji Hospital Tongji Medical College of HUST

    Wuhan 1791247, Hubei 1806949 430030
    China

    Site Not Available

  • Wuhan Union Hospital of China

    Wuhan 1791247, Hubei 1806949 430022
    China

    Site Not Available

  • Zhongnan Hospital of Wuhan University

    Wuhan 1791247, Hubei 1806949 430071
    China

    Site Not Available

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan Hunan
    China

    Site Not Available

  • The Second Xiangya Hospital of Central South University

    Changsha 1815577, Hunan 1806691 Hunan
    China

    Site Not Available

  • Huai'an Second People's Hospital

    Huai'an, Jiangsu 223200
    China

    Site Not Available

  • Jiangsu Province Hospital

    Nanjing, Jiangsu 210029
    China

    Site Not Available

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu 210009
    China

    Site Not Available

  • Huai'an Second People's Hospital

    Huai'an 1797873, Jiangsu 1806260 223200
    China

    Site Not Available

  • Jiangsu Province Hospital

    Nanjing 1799962, Jiangsu 1806260 210029
    China

    Site Not Available

  • Zhongda Hospital Southeast University

    Nanjing 1799962, Jiangsu 1806260 210009
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi 330006
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University

    Nanchang 1800163, Jiangxi 1806222 330006
    China

    Site Not Available

  • First Hospital of Jilin University

    Changchun, Jilin 130031
    China

    Site Not Available

  • First Hospital of Jilin University

    Changchun 2038180, Jilin 2036500 130031
    China

    Site Not Available

  • The First Hospital of China Medical University

    Shenyang, Liaoning 110001
    China

    Site Not Available

  • The First Hospital of China Medical University

    Shenyang 2034937, Liaoning 2036115 110001
    China

    Site Not Available

  • Qilu Hospital of Shandong University

    Jinan, Shandong 250012
    China

    Site Not Available

  • Tai'an City Central Hospital

    Tai'an, Shandong 271000
    China

    Site Not Available

  • Qilu Hospital of Shandong University

    Jinan 1805753, Shandong 1796328 250012
    China

    Site Not Available

  • Tai'an City Central Hospital

    Tai’an 1793724, Shandong 1796328 271000
    China

    Site Not Available

  • Ruijin Hospital, Shanghai Jiaotong University School Of Medicine

    Shanghai, Shanghai 200025
    China

    Site Not Available

  • Shanghai Jiao Tong University School of Medicine,Renji Hospital

    Shanghai, Shanghai 200001
    China

    Site Not Available

  • Ruijin Hospital, Shanghai Jiaotong University School Of Medicine

    Shanghai 1796236, Shanghai Municipality 1796231 200025
    China

    Site Not Available

  • Shanghai Jiao Tong University School of Medicine,Renji Hospital

    Shanghai 1796236, Shanghai Municipality 1796231 200001
    China

    Site Not Available

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi 030032
    China

    Site Not Available

  • Shanxi Provincial People's Hospital

    Xi'an, Shanxi 710068
    China

    Site Not Available

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shanxi 710061
    China

    Site Not Available

  • Shanxi Bethune Hospital

    Taiyuan 1793511, Shanxi 1795912 030032
    China

    Site Not Available

  • Shanxi Provincial People's Hospital

    Xi’an 11474004, Shanxi 1795912 710068
    China

    Site Not Available

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi’an 11474004, Shanxi 1795912 710061
    China

    Site Not Available

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan 610072
    China

    Site Not Available

  • Sichuan Provincial People's Hospital

    Chengdu 1815286, Sichuan 1794299 610072
    China

    Site Not Available

  • Chinese Academy of Medical Sciences Hematology Hospital

    Tianjin, Tianjin 300052
    China

    Site Not Available

  • Chinese Academy of Medical Sciences Hematology Hospital

    Tianjin 1792947, Tianjin Municipality 1792943 300052
    China

    Site Not Available

  • The First Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang 830054
    China

    Site Not Available

  • The First Hospital of Xinjiang Medical University

    Ürümqi 1529102, Xinjiang 1529047 830054
    China

    Site Not Available

  • The First People's Hospital of Yunnan Province

    Kunming, Yunnan 650032
    China

    Site Not Available

  • The First People's Hospital of Yunnan Province

    Kunming 1804651, Yunnan 1785694 650032
    China

    Site Not Available

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310003
    China

    Site Not Available

  • The Affiliated People's Hospital of Ningbo University

    Ningbo, Zhejiang 315040
    China

    Site Not Available

  • The First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang 315211
    China

    Site Not Available

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang 325005
    China

    Site Not Available

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou 1808926, Zhejiang 1784764 310003
    China

    Active - Recruiting

  • The Affiliated People's Hospital of Ningbo University

    Ningbo 1799397, Zhejiang 1784764 315040
    China

    Site Not Available

  • The First Affiliated Hospital of Ningbo University

    Ningbo 1799397, Zhejiang 1784764 315211
    China

    Site Not Available

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou 1791388, Zhejiang 1784764 325005
    China

    Site Not Available

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