Diffuse Cutaneous Systemic SclerosisPhase 2NCT06375005
Efficacy and Safety of Telitacicept in the Treatment of Systemic Sclerosis
A Phase 2 study testing Telitacicept and Mycophenolate Mofetil in people with Diffuse Cutaneous Systemic Sclerosis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 9 sites in China.
Trial summary
This study is a prospective, open-label, randomized, controlled, multi-center clinical trial. The aim of this study is to investigate the efficacy and safety of Telitacicept in adults with early diffuse cutaneous systemic sclerosis (dcSSc), with Mycophenolate Mofetil (MMF) administered as a background treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diffuse Cutaneous Systemic Sclerosis
- What is being tested?
- Telitacicept and Mycophenolate Mofetil
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 9 sitesChina
- Study dates
- 6 Jan 2025to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women aged 18-70 years old.
- Systemic sclerosis, as defined by ACR/EULAR (American College of Rheumatology/European League Against Rheumatism) 2013 criteria.
- dcSSc (diffuse cutaneous systemic sclerosis) according to the LeRoy criteria.
- Disease duration of ≤ 18 months (defined as time from the first non-Raynaud's phenomenon manifestation).
- ≥ 10 mRSS units at the screening visit.
- Negative serum pregnancy test in a woman of childbearing potential at the screening visit.
- Ability to render informed consent in accordance with institutional guidelines.
Who cannot join
- Limited scleroderma.
- Disease duration of greater than 3 years.
- Rheumatic autoimmune disease other than SSc.
- Systemic sclerosis-like illness associated with environmental agents such as vinyl chloride, or bleomycin.
- Any prior history of renal crisis.
- Intermediate- or high-risk pulmonary arterial hypertension.
Show all 30Show fewer
- Pulmonary disease with FVC < 50% of predicted or DLCO (hemoglobin-corrected) < 40% of predicted at screening or requires oxygen therapy.
- Underwent major surgery within 8 weeks prior to randomization or planned major surgery during the trial period.
- Use of immunosuppressive therapies, including methotrexate, azathioprine, hydroxychloroquine, leflunomide, tacrolimus, sirolimus, and mycophenolate mofetil within 4 weeks prior to randomization, and cyclophosphamide within 3 months prior to randomization.
- Use of other anti-fibrotic agents, including colchicine, D-penicillamine, thalidomide, nintedanib, pirfenidone, tyrosine kinase inhibitors (imatinib, nilotinib, dasatinib) within 4 weeks prior to randomization.
- Use of corticosteroids at doses exceeding the equivalent of prednisone 10 mg daily, or intravenous and intramuscular corticosteroid injections within 4 weeks prior to randomization.
- Use of Intravenous Immunoglobulin (IVIG) within 12 weeks within 4 weeks prior to randomization.
- Prior use of belimumab, rituximab, or other B-Cell depleting therapies ever.
- Use of other biologics or small molecule targeted therapies, including anakinra within 1 week prior to randomization, ixekizumab within 2 weeks prior to randomization, and infliximab, certolizumab pegol, golimumab, adalimumab, abatacept, tocilizumab within 8 weeks prior to randomization, and janus kinase inhibitors within 2 weeks prior to randomization.
- Prior use of other cell depletion therapies.
- Concurrent serious medical condition which in the opinion of the investigator makes the patient inappropriate for this study such as severe central nervous system disease，severe heart failure, arrhythmia, unstable atherosclerotic cardiovascular disease, severe GI involvement, severe hypertension or severe diabetes.
- Abnormal results in hepatitis B or hepatitis C testing indicating active or chronic infection.
- Active tuberculosis (TB) or latent TB infection.
- Seropositive for human immunodeficiency virus (HIV) or known history of HIV infection.
- Known active bacterial, viral, fungal, mycobacterial, or other infection，including major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening, or oral antibiotics within 2 weeks prior to screening.
- Primary or secondary immunodeficiency.
- IgA deficiency (<10 mg/dL) or IgG deficiency (<400 mg/dL).
- Participation in another clinical research study involving the evaluation of another investigational drug within 3 months of entry into this study.
- Any of the following at the screening visit: Hemoglobin <8.0 g/dL; WBC <3 x 10^9/L; Neutrophil <1.5 x 10^9/L; platelets <75 x 10^9/L; serum ALT or AST > 1.5 x ULN; TBil > ULN; eGFR < 40mL/min/1.73m^2.
- Malignant disease within 5 years prior to screening, with the exception of excised/cured local basal or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix;
- Immunization with a live/attenuated vaccine within 4 weeks prior to randomization.
- Pregnant or breast feeding women or women of childbearing potential not willing to use adequate contraception.
- History of allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies.
- Immunization with a live/attenuated vaccine within 4 weeks prior to randomization.
- Patients anticipated to be non-compliant with the protocol requirements or expected not to complete the trial as planned (e.g., those with psychiatric disorders, history of alcohol abuse, drug abuse, or substance misuse).
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
China9 sites, 9 recruiting
- Recruiting
Hangzhou First People's Hospital
Hangzhou, Zhejiang, 310006
- Recruiting
Sir Run Run Shaw Hospital, Zhejiang University School Of Medicine
Hangzhou, Zhejiang, 310016
- Recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016
Jing Xue, PhD, 86-13858121751, jingxue@zju.edu.cn
- Recruiting
Changxing People's Hospital
Huzhou, Zhejiang, 313100
- Recruiting
The First Hospital of Jiaxing
Jiaxing, Zhejiang, 314000
- Recruiting
Ningbo First Hospital
Ningbo, Zhejiang, 315000
- Recruiting
Huashan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200433
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
- Recruiting
Affiliated Hospital of Yangzhou University
Yangzhou, Jiangsu, 225009
About this study
Official title: The Efficacy and Safety of Telitacicept in the Treatment of Early Diffuse Cutaneous Systemic Sclerosis: a Multicenter, Open-label, Randomized Controlled Study
This study is a prospective, open-label, randomized, controlled, multi-center clinical trial. The aim of this study is to investigate the efficacy and safety of Telitacicept in adults with early diffuse cutaneous systemic sclerosis (dcSSc), with Mycophenolate Mofetil (MMF) administered as a background treatment.
- Conditions
- Diffuse Cutaneous Systemic Sclerosis
- Being tested
- Telitacicept, Mycophenolate Mofetil
- Medical subject headings
- Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelitaciceptDrug
Also called Taiai for commercial name
Telitacicept is fusion protein comprising a recombinant transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI) receptor fused to the fragment crystallizable (Fc) domain of human immunoglobulin G (IgG). Telitacicept binds to and neutralizes the activity of two cell-signalling molecules, B-lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL), thereby suppressing the development and survival of plasma cells and mature B cells. Telitacicept will be subcutaneously injected at a dose of 160mg per week, lasting for 48 weeks.
Also called MMF
All patients will receive background therapy with Mycophenolate Mofetil (MMF), administered orally at a dose of 0.5g twice daily for 48 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Mycophenolate Mofetil + Telitacicept | Experimental | All patients who enroll in this trial will receive mycophenolate mofetil (MMF), which is a drug commonly given to patients with systemic sclerosis in clinical practice. Participants will be treated with MMF 0.5g twice a day for 48 weeks. Telitacicept will be subcutaneously injected at a dose of 160mg per week, lasting for 48 weeks. Receives: Drug: Telitacicept; Drug: Mycophenolate Mofetil |
| Mycophenolate Mofetil | Active comparator | Participants will be treated with MMF 0.5g twice a day for 48 weeks. Receives: Drug: Mycophenolate Mofetil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 48
Skin thickness was assessed by the mRSS. The mRSS was rated with scores ranging from 0 (normal) to 3 (severe skin thickening) across 17 different sites. The total score was the sum of the individual skin scores in the 17 body areas (e.g., face, hands, fingers; proximal area of the arms, distal area of the arms, thorax, abdomen; proximal area of the legs, and distal area of the legs, feet), giving a range of 0-51 units and had been validated for participants with systemic sclerosis (SSc). A negative change from baseline showed improvement.
Measured: Baseline, Week 48
Percentage of Participants With Treatment-related Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: Week 52
Secondary outcomes (13)
Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 24
Skin thickness was assessed by the mRSS. The mRSS was rated with scores ranging from 0 (normal) to 3 (severe skin thickening) across 17 different sites. The total score was the sum of the individual skin scores in the 17 body areas (e.g., face, hands, fingers; proximal area of the arms, distal area of the arms, thorax, abdomen; proximal area of the legs, and distal area of the legs, feet), giving a range of 0-51 units and had been validated for participants with systemic sclerosis (SSc). A negative change from baseline showed improvement.
Measured: Baseline, Week 24
Percentage of Participants Who Improved in Modified Rodnan Skin Score (mRSS) by ≥20%, ≥40%, ≥60% From Baseline to Week 24 and Week 48
Skin thickness was assessed by the mRSS. The mRSS was rated with scores ranging from 0 (normal) to 3 (severe skin thickening) across 17 different sites. The total score was the sum of the individual skin scores in the 17 body areas (e.g., face, hands, fingers; proximal area of the arms, distal area of the arms, thorax, abdomen; proximal area of the legs, and distal area of the legs, feet), giving a range of 0-51 units and had been validated for participants with systemic sclerosis (SSc). A negative change from baseline showed improvement. Percentage of participants who achieved improvement in mRSS by ≥20%, ≥40%, ≥60% from baseline to week 24 and week 48 were reported.
Measured: Baseline, Week 24 and 48
American College of Rheumatology Composite Response Index for Systemic Sclerosis (ACR-CRISS) and Revised ACR-CRISS at Week 24 and 48
CRISS forms a composite response index consisting of SSc-related organ involvement and the following five variables: mRSS, FVC percent predicted, physician's and patient's global assessments, and HAQ-DI score. The resulting index is a 2-step process that captures clinically meaningful worsening of internal organ involvement and the core variables that show change.
Measured: Week 24 and 48
Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted at Week 24 and Week 48
FVC is pulmonary function test and will be conducted as per the study Pulmonary Function Manual, which is based on the American Thoracic Society/European Respiratory Society (ATS/ERS) Consensus Statement. FVC is the maximum amount of air exhaled from the lungs after taking the deepest breath possible. Negative change in FVC percent predicted indicates worsening.
Measured: Week 24 and 48
Change From Baseline in Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) Percent Predicted (Corrected For Hemoglobin) at Week 24 and Week 48
Diffusing capacity of the lungs for carbon monoxide (DLCO) measures how much oxygen travels from the alveoli of the lungs to the blood stream. It is used to determine the severity of lung disease. DLCO for a given individual is compared to reference or predicted values.
Measured: Week 24 and 48
Change From Baseline in Patient's Global Assessment at Week 24 and Week 48
Patient global assessment for overall disease represents the patient's assessment of the patient's global scleroderma on a 0 (excellent) -10 (extremely poor) Likert scale. Higher score means worse outcome.
Measured: Baseline, Week 24 and 48
Change From Baseline in Physician's Global Assessment at Week 24 and Week 48
This assessment represents the physician's assessment of the patient's current disease activity on a 0 (excellent) -10 (extremely poor) Likert scale. Higher score means worse outcome.
Measured: Baseline, Week 24 and 48
Change From Baseline in Short Form-36 (SF-36) Questionnaire at Week 24 and Week 48
The Short Form 36 (SF-36) is a validated 36 item questionnaire which measures quality of life across eight domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, general health.
Measured: Baseline, Week 24 and 48
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 24 and Week 48
The HAQ-DI is a composite measure from which a 'Standard Disability Index' score can be computed to assess a patient's disability level. Generally, a score of 0-1 represents mild to moderate difficulty, 1-2 moderate to severe disability and 2-3 severe to very severe disability. The HAQ-DI comprises 20 items that assess patient abilities across 8 functional activities: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. Each item is rated on a 4-point scale: 0=Without ANY difficulty, 1=With SOME difficulty, 2=With MUCH difficulty, 3=UNABLE to do. The 8 scores of the 8 sections are summed and divided by 8. In the event that one section is not completed by a subject then the summed score would be divided by 7. The final overall HAQ-DI score ranges from 0 to 3 and positive change indicates worse health-related quality of life (HRQoL).
Measured: Baseline, Week 24 and 48
Change From Baseline in Physical Function Assessed by Scleroderma Health Assessment Questionnaire Disability Index (SHAQ-DI) at Week 24 and Week 48
SHAQ-DI assessed five scleroderma-specific visual analogue scale (VAS) items to explore the impact of participant's disease. These items were developed to measure the effect of scleroderma on five elements of disease that could have a great impact on a participant's daily activities. Each VAS item was rated separately (0-100 millimeters [mm]), with higher scores indicating more severe disease. The five items were: 1) intestinal disease, 2) breathing problem, 3) Raynaud syndrome, 4) finger ulcers, and 5) overall disease.
Measured: Baseline, Week 24 and 48
Change From Baseline in Tender Joint Counts at Week 24 and Week 48
28 joints are assessed for tenderness (positive or negative). The number of tender joint counts ranges from 0 to 28. A higher number indicates worse outcome.
Measured: Baseline, Week 24 and 48
Change From Baseline in Swollen Joint Counts at Week 24 and Week 48
28 joints are assessed for swelling (positive or negative). The number of swollen joint count ranges from 0 to 28. A higher number indicates worse outcome.
Measured: Baseline, Week 24 and 48
Change From Baseline in Digital Ulcer Counts at Week 24 and Week 48
Digital ulcers refer to lesions (on the finger or distal to the metacarpophalangeal joint) with loss of surface epithelisation and a visually discernible depth.
Measured: Baseline, Week 24 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start6 Jan 2025
- Primary completion6 Jan 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Cutaneous Systemic SclerosisStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- JING XUE, PhD, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06375005
- Sponsor's protocol ID
- 2024-0381
- Status last verified
- Mar 2024
- First submitted
- 16 Apr 2024
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Telitacicept in the Treatment of Early Diffuse Cutaneous Systemic Sclerosis: a Multicenter, Open-label, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06375005
- Acronym / sponsor ID
- 2024-0381
- Conditions
- Diffuse Cutaneous Systemic Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 6 Jan 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective, open-label, randomized, controlled, multi-center clinical trial. The aim of this study is to investigate the efficacy and safety of Telitacicept in adults with early diffuse cutaneous systemic sclerosis (dcSSc), with Mycophenolate Mofetil (MMF) administered as a background treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mycophenolate Mofetil + Telitacicept | Experimental | Drug: Telitacicept, Drug: Mycophenolate MofetilAll patients who enroll in this trial will receive mycophenolate mofetil (MMF), which is a drug commonly given to patients with systemic sclerosis in clinical practice. Participants will be treated with MMF 0.5g twice a day for 48 weeks. Telitacicept will be subcutaneously injected at a dose of 160mg per week, lasting for 48 weeks. |
| Mycophenolate Mofetil | Active comparator | Drug: Mycophenolate MofetilParticipants will be treated with MMF 0.5g twice a day for 48 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men or women aged 18-70 years old.
- Systemic sclerosis, as defined by ACR/EULAR (American College of Rheumatology/European League Against Rheumatism) 2013 criteria.
- dcSSc (diffuse cutaneous systemic sclerosis) according to the LeRoy criteria.
- Disease duration of ≤ 18 months (defined as time from the first non-Raynaud's phenomenon manifestation).
- ≥ 10 mRSS units at the screening visit.
Key exclusion criteria (30 listed)
- Limited scleroderma.
- Disease duration of greater than 3 years.
- Rheumatic autoimmune disease other than SSc.
- Systemic sclerosis-like illness associated with environmental agents such as vinyl chloride, or bleomycin.
- Any prior history of renal crisis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelitaciceptAlso: Taiai for commercial nameTelitacicept is fusion protein comprising a recombinant transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI) receptor fused to the fragment crystallizable (Fc) domain of human immunoglobulin G (IgG). Telitacicept binds to and neutralizes the activity of two cell-signalling molecules, B-lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL), thereby suppressing the development and survival of plasma cells and mature B cells. Telitacicept will be subcutaneously injected at a dose of 160mg per week, lasting for 48 weeks. | Drug | Mycophenolate Mofetil + Telitacicept |
| Mycophenolate MofetilAlso: MMFAll patients will receive background therapy with Mycophenolate Mofetil (MMF), administered orally at a dose of 0.5g twice daily for 48 weeks. | Drug | Mycophenolate Mofetil, Mycophenolate Mofetil + Telitacicept |
Primary outcome
Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 48
Time frame: Baseline, Week 48
Skin thickness was assessed by the mRSS. The mRSS was rated with scores ranging from 0 (normal) to 3 (severe skin thickening) across 17 different sites. The total score was the sum of the individual skin scores in the 17 body areas (e.g., face, hands, fingers; proximal area of the arms, distal area of the arms, thorax, abdomen; proximal area of the legs, and distal area of the legs, feet), giving a range of 0-51 units and had been validated for participants with systemic sclerosis (SSc). A negative change from baseline showed improvement.
Percentage of Participants With Treatment-related Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Week 52
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
13 secondary outcomes
Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 24
Time frame: Baseline, Week 24
Percentage of Participants Who Improved in Modified Rodnan Skin Score (mRSS) by ≥20%, ≥40%, ≥60% From Baseline to Week 24 and Week 48
Time frame: Baseline, Week 24 and 48
American College of Rheumatology Composite Response Index for Systemic Sclerosis (ACR-CRISS) and Revised ACR-CRISS at Week 24 and 48
Time frame: Week 24 and 48
Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted at Week 24 and Week 48
Time frame: Week 24 and 48
Change From Baseline in Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) Percent Predicted (Corrected For Hemoglobin) at Week 24 and Week 48
Time frame: Week 24 and 48
Change From Baseline in Patient's Global Assessment at Week 24 and Week 48
Time frame: Baseline, Week 24 and 48
Change From Baseline in Physician's Global Assessment at Week 24 and Week 48
Time frame: Baseline, Week 24 and 48
Change From Baseline in Short Form-36 (SF-36) Questionnaire at Week 24 and Week 48
Time frame: Baseline, Week 24 and 48
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 24 and Week 48
Time frame: Baseline, Week 24 and 48
Change From Baseline in Physical Function Assessed by Scleroderma Health Assessment Questionnaire Disability Index (SHAQ-DI) at Week 24 and Week 48
Time frame: Baseline, Week 24 and 48
Change From Baseline in Tender Joint Counts at Week 24 and Week 48
Time frame: Baseline, Week 24 and 48
Change From Baseline in Swollen Joint Counts at Week 24 and Week 48
Time frame: Baseline, Week 24 and 48
Change From Baseline in Digital Ulcer Counts at Week 24 and Week 48
Time frame: Baseline, Week 24 and 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
Related trials for Diffuse Cutaneous Systemic Sclerosis
RecruitingPhase 1
A Safety and Efficacy Study Evaluating CTX112 in Adult Subjects With Refractory Autoimmune Disease
SLE (Systemic Lupus), Lupus Erythematosus, Systemic
RecruitingPhase 1/2
Controlling Hyperactive Immunity With Long-lived Lymphocytes
Diffuse Cutaneous Systemic Sclerosis, Rheumatoid Arthritis (RA)
Active, not recruitingPhase 2
Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic Sclerosis
Systemic Sclerosis
Active, not recruitingPhase 2
A Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis
Diffuse Cutaneous Systemic Sclerosis
RecruitingPhase 2
EncompaSSc: Evaluation of MTX-474 in Participants With Diffuse Cutaneous Systemic Sclerosis (dcSSc)
Diffuse Cutaneous Systemic Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
JING XUE, PhD principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Telitacicept and Mycophenolate Mofetil in people with Diffuse Cutaneous Systemic Sclerosis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 9 sites in China.
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 7 inclusion and 30 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: looking for participants now, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact JING XUE, PhD (86-13858121751, jingxue@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 48 (time frame: Baseline, Week 48). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Feb 2025.