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

December 5, 2025 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

A Randomized, Open Label, Positive Controlled, Multicenter Phase III Clinical Trial Evaluating the Efficacy and Safety of the Selected Regimen of Rovadicitinib in Moderate to Severe Chronic Graft-versus-host Disease in Third Line and Beyond

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

182

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230001
        • Not yet recruiting
        • The First Affiliated Hospital of USTC Anhui Provincial Hospital
        • Contact:
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100034
        • Not yet recruiting
        • Peking University First Hospital
        • Contact:
      • Beijing, Beijing Municipality, China, 100044
        • Not yet recruiting
        • Peking University People's Hospital
        • Contact:
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400038
        • Not yet recruiting
        • The Southwest Hospital of Amu
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Not yet recruiting
        • Fujian Medical University Union Hospital
        • Contact:
      • Xiamen, Fujian, China, 361003
        • Not yet recruiting
        • The First Affiliated Hospital of Xiamen University
        • Contact:
    • Gansu
      • Lanzhou, Gansu, China, 730000
        • Not yet recruiting
        • The First Hospital of Lanzhou University
        • Contact:
      • Lanzhou, Gansu, China, 730050
        • Not yet recruiting
        • The 904 Hospital of the Joint Service Support Force of the People's Liberation Army of China
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Not yet recruiting
        • Nanfang Hospital
        • Contact:
      • Guangzhou, Guangdong, China, 510180
        • Not yet recruiting
        • Guangzhou First People's Hospital The First People's Hospital Affiliated to Guangzhou Medical University
        • Contact:
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Not yet recruiting
        • The First Affiliated Hospital of Guangxi Medical University
        • Contact:
    • Guizhou
      • Guiyang, Guizhou, China, 550001
        • Not yet recruiting
        • The Affiliated Hospital of Guizhou Medical University
        • Contact:
        • Contact:
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • Not yet recruiting
        • The Second Hospital of Hebei Medical Hospital
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Not yet recruiting
        • Henan Provincial People's Hospital
        • Contact:
      • Zhengzhou, Henan, China, 450099
        • Not yet recruiting
        • The Third People's Hospital of Zhengzhou
        • Contact:
      • Zhenzhou, Henan, China, 450000
        • Recruiting
        • Henan Cancer Hospital
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430071
        • Not yet recruiting
        • Zhongnan Hospital of Wuhan University
        • Contact:
      • Wuhan, Hubei, China, 430030
        • Not yet recruiting
        • Tongji Hospital Tongji Medical College of HUST
        • Contact:
      • Wuhan, Hubei, China, 430022
        • Not yet recruiting
        • Wuhan Union Hospital Of China
        • Contact:
    • Hunan
      • Changsha, Hunan, China, Hunan
        • Not yet recruiting
        • The Second Xiangya Hospital of Central South University
        • Contact:
    • Jiangsu
      • Huai'an, Jiangsu, China, 223200
        • Not yet recruiting
        • Huai'an Second People's Hospital
        • Contact:
      • Nanjing, Jiangsu, China, 210009
        • Not yet recruiting
        • Zhongda Hospital Southeast University
        • Contact:
      • Nanjing, Jiangsu, China, 210029
        • Not yet recruiting
        • Jiangsu Province Hospital
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Not yet recruiting
        • The First Affiliated Hospital of Nanchang University
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 130031
        • Not yet recruiting
        • First Hospital of Jilin University
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • Not yet recruiting
        • The First Hospital of China Medical University
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250012
        • Not yet recruiting
        • Qilu Hospital of Shandong University
        • Contact:
      • Tai’an, Shandong, China, 271000
        • Not yet recruiting
        • Tai'an City Central Hospital
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200001
        • Not yet recruiting
        • Shanghai Jiao Tong University School of Medicine，Renji Hospital
        • Contact:
      • Shanghai, Shanghai Municipality, China, 200025
        • Not yet recruiting
        • Ruijin Hospital, Shanghai JiaoTong University School of Medicine
        • Contact:
    • Shanxi
      • Taiyuan, Shanxi, China, 030032
        • Not yet recruiting
        • Shanxi Bethune Hospital
        • Contact:
      • Xi’an, Shanxi, China, 710061
        • Not yet recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
          • Pengcheng He, Doctor
          • Phone Number: 18991232609
          • Email: hpc@163.com
      • Xi’an, Shanxi, China, 710068
        • Not yet recruiting
        • Shanxi Provincial People's Hospital
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610072
        • Not yet recruiting
        • Sichuan Provincial People's Hospital
        • Contact:
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300052
        • Not yet recruiting
        • Chinese Academy of Medical Sciences Hematology Hospital
        • Contact:
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830054
        • Not yet recruiting
        • The First Hospital of Xinjiang Medical University
        • Contact:
    • Yunnan
      • Kunming, Yunnan, China, 650032
        • Not yet recruiting
        • The First People's Hospital of Yunnan Province
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Recruiting
        • The First Affiliated Hospital, Zhejiang University School of Medicine
        • Contact:
      • Ningbo, Zhejiang, China, 315040
        • Not yet recruiting
        • The Affiliated People's Hospital of Ningbo University
        • Contact:
      • Ningbo, Zhejiang, China, 315211
        • Not yet recruiting
        • The First Affiliated Hospital of Ningbo University
        • Contact:
      • Wenzhou, Zhejiang, China, 325005
        • Not yet recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age: 18 to 70 years old; Karnofsky (KPS) ≥ 60 points; Expected survival period exceeding 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 2 weeks 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 study period and for 6 months after the end of the study; Serum pregnancy test negative within 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 period and within 6 months after the end of the study period;
  • Subjects voluntarily joined this study, signed informed consent, and had good compliance.

Exclusion Criteria:

  • Has experienced or currently suffers from other malignant tumors within the past 3 years;
  • Known or suspected active aGVHD；
  • Individuals with interstitial pneumonia, non infectious pneumonia, uncontrolled active infections, or infections requiring systematic treatment within the first 7 days of randomization, except for those deemed suitable for inclusion by the researchers;
  • The occurrence and progression of other underlying diseases include post transplant lymphoid tissue proliferative diseases and recurrence of primary malignant hematological diseases;
  • Random failure of allogeneic hematopoietic stem cell transplantation within the first 6 months or having received 2 allogeneic hematopoietic stem cell transplants in the past;
  • Used JAK inhibitors, Bruton's tyrosine kinase (BTK) inhibitors, etc. within the first 2 weeks of randomization;
  • There are multiple factors that can affect oral medication, such as inability to swallow, intestinal obstruction, etc;
  • Individuals with a history of abuse of psychotropic drugs who are unable to quit or have 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 that seriously 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rovadicitinib
Rovadicitinib: 10mg, taken orally on an empty stomach twice a day, with a minimum interval of 8 hours between each dose, and an optimal interval of 12 hours. Every 28 days is a treatment cycle.
Drug: Rovadicitinib
Rovadicitinib is an inhibitor of Janus associated kinases (JAK) family and Rho associated kinases (ROCK). It can inhibit the sustained abnormal activation of the Janus kinase (JAK) signal transducer and activator of transcription (JAK-STAT) pathway and also inhibit Rho associated kinase 2 (ROCK2). The JAK 1-JAK 2 signaling pathway is a key step in causing inflammation and tissue damage in acute and chronic graft-versus-host disease.
Active Comparator: Imatinib or Methotrexate or Mycophenolate or Rituximab

Methotrexate tablets: 10mg, orally, once a week or 5mg, orally, twice a week.

Metoprolol ester: 250mg-500mg, bid, orally.

Imatinib: 100-400mg, qd, oral.

Rituximab: 375mg/m2, administered intravenously once a week for 4 consecutive weeks.
Drug: Imatinib
Imatinib tyrosine kinase inhibitor is a small molecule protein kinase inhibitor that has the ability to block one or more protein kinases. Clinically used for the treatment of chronic myeloid leukemia and malignant gastrointestinal stromal tumors.
Drug: Methotrexate
Methotrexate is an organic compound, mainly used as an anti folate anti-tumor drug. It inhibits the synthesis of tumor cells by inhibiting dihydrofolate reductase, thereby inhibiting the growth and reproduction of tumor cells.
Drug: Mycophenolate mofetil
Metoprolol ester is an organic compound mainly used as an immunosuppressant
Drug: Rituximab
Rituximab activates antibody dependent cell-mediated phagocytosis and complement dependent cytotoxicity by binding to cluster of differentiation 20 (CD20) antigen, clearing malignant B cells expressing CD20 and achieving therapeutic goals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective remission rate in the 24th week (ORR)
Time Frame: Week 24
Researchers evaluated each organ according to the consensus criteria of the NIH 2014 conference, and at week 24, the percentage of subjects with complete response (CR) or partial response (PR) in all assessable organs was determined.
Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best Objective Response Rate (BOR)
Time Frame: Week 24
The best therapeutic effect among all therapeutic outcomes
Week 24
Duration of Relief (DOR)
Time Frame: Through study completion, an average of 2 year
The duration of symptom relief for patients after receiving treatment
Through study completion, an average of 2 year
Improvement in Lee cGVHD symptom score of subjects in week 24
Time Frame: Week 24
The Lee cGVHD Symptom Score is a tool used to assess the severity of symptoms in chronic graft-versus-host disease (cGVHD), ranging from 0 to 4 points, with a maximum total score of 16 points. The higher the score, the more severe the cGVHD symptoms.
Week 24
Failure free survival (FFS)
Time Frame: Weeks 2, 4, 8, 16, 36, 48, 60, 72, 84, 96
The time from the start of treatment to the occurrence of disease progression or death for any reason in the patient
Weeks 2, 4, 8, 16, 36, 48, 60, 72, 84, 96
Primary disease recurrence rate (MR)
Time Frame: Weeks 8, 16,24， 36, 48
The probability of recurrence of the patient's disease within a certain period of time.
Weeks 8, 16,24， 36, 48
Non-Relapse Mortality (NRM)
Time Frame: Weeks 8, 16,24， 36, 48
NRM was defined as death without recurrent or progressive disease
Weeks 8, 16,24， 36, 48
Overall survival (OS)
Time Frame: Through study completion, an average of 2 year
From randomization to the time of death caused by any reason
Through study completion, an average of 2 year
Percentage of subjects whose daily glucocorticoid dose decreased
Time Frame: Week 24
Percentage of subjects whose daily glucocorticoid dose decreased by ≥ 50% in week 24, and percentage of subjects who discontinued all glucocorticoids
Week 24
Changes in the Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT)
Time Frame: Through study completion, an average of 2 year
The FACT-BMT scale is a tool used to evaluate the quality of life (QOL) of patients after hematopoietic stem cell transplantation, the scale is filled out by the person closest to the patient, and each question has five possible answers on a scale of 0-4. Answer each question item based on the patient's actual situation in the past week, and mark the corresponding number with a "√"
Through study completion, an average of 2 year
Changes in 5-level EQ-5D (EQ-5D-5L)
Time Frame: Through study completion, an average of 2 year
The scoring criteria of EQ-5D-5L scale include five dimensions: action ability, self-care ability, daily activity ability, pain or discomfort, anxiety or depression. After selecting a level for each dimension, a specific rating can be obtained. For example, if an individual chooses "slightly difficult" in terms of action ability, they will score 2 points on that dimension (from 0 to 5, where 0 indicates no difficulty and 5 indicates inability/very serious difficulty)
Through study completion, an average of 2 year
Adverse events (AE)
Time Frame: Through study completion, an average of 2 year
The incidence and severity of adverse events (AE) and serious adverse events (SAE), as well as abnormal laboratory test indicators.
Through study completion, an average of 2 year
Cmax
Time Frame: Day 1, day 8 on cycle 1: 0.5 hour pre-dose, 0.5 hour after dose, day 1 cycle 2: 0.5 hour pre-dose, 2 hours after dose, day 1 cycle 4: 0.5 hour pre-dose, 3 hours after dose, day 1 cycle 6: 0.5 hour pre-dose, 4 hours after dose (28 days as a cycle)
The maximum concentration of medication that enters the bloodstream after administration
Day 1, day 8 on cycle 1: 0.5 hour pre-dose, 0.5 hour after dose, day 1 cycle 2: 0.5 hour pre-dose, 2 hours after dose, day 1 cycle 4: 0.5 hour pre-dose, 3 hours after dose, day 1 cycle 6: 0.5 hour pre-dose, 4 hours after dose (28 days as a cycle)
Ctrough
Time Frame: Day 1, day 8 on cycle 1: 0.5 hour pre-dose, 0.5 hour after dose, day 1 cycle 2: 0.5 hour pre-dose, 2 hours after dose, day 1 cycle 4: 0.5 hour pre-dose, 3 hours after dose, day 1 cycle 6: 0.5 hour pre-dose, 4 hours after dose (28 days as a cycle)
After multiple administrations, the blood drug concentration reaches a relatively stable state, which is called the steady-state concentration
Day 1, day 8 on cycle 1: 0.5 hour pre-dose, 0.5 hour after dose, day 1 cycle 2: 0.5 hour pre-dose, 2 hours after dose, day 1 cycle 4: 0.5 hour pre-dose, 3 hours after dose, day 1 cycle 6: 0.5 hour pre-dose, 4 hours after dose (28 days as a cycle)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2024

Primary Completion (Estimated)

October 1, 2029

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

November 6, 2024

First Submitted That Met QC Criteria

November 8, 2024

First Posted (Actual)

November 12, 2024

Study Record Updates

Last Update Posted (Actual)

December 8, 2025

Last Update Submitted That Met QC Criteria

December 5, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TQ05105-III-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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