Systemic SclerosisPhase 4NCT06546540
The Safety and Efficacy of Telitacicept in the Treatment of Systemic Sclerosis
A Phase 4 study testing Telitacicept in people with Systemic Sclerosis, run by Peking University Third Hospital at 1 site in China.
Trial summary
Systemic sclerosis (SSc) is a chronic, multisystem autoimmune disease characterized by potentially widespread and progressive skin fibrosis and vascular abnormalities, and may involve the musculoskeletal, gastrointestinal, pulmonary, cardiac, renal, neuromuscular, and urogenital systems. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- Telitacicept
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 8 Jun 2024to 30 Mar 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects with systemic sclerosis who met the ACR2013 classification criteria for systemic sclerosis and approved this trial
- Age: 18 years or older
- Lung function FVC% > 50%
- Positive for ANA or scleroderma related autoantibodies
- Patients with disease activity after conventional treatment: new skin involvement or deterioration of two new body areas or skin thickening and deterioration after 6 months of conventional treatment (δMRSS ≥0 points)
- The dose of the following drugs was stable for at least 6 months before the first use of the study drug: mycophenolate mofetil, cyclophosphamide；First use of study drug precorticosteroids (≤10 mg prednisone/day or equivalent) for at least 30 days
Who cannot join
- Subjects who did not consent to participate in the clinical trial
- Subjects with mixed connective tissue disease or overlap syndrome
- Focal scleroderma
- Pregnant women, lactating women and men or women who have planned to have children in the last 12 month
- Allergic reaction: History of allergy to human derived biological products
- Participants who had participated in any clinical trial within 28 days prior to initial screening/or within a 5-fold half-life of the study compound (whichever is longer)
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- Those who have received live vaccine in the last month
- B cell-targeted therapies such as rituximab, iparizumab, and beliumab were used within one year
- Tumor necrosis factor inhibitors and interleukin-receptor blockers were used within one year.
- Patients who used intravenous gamma globulin (IVIG), prednisone ≧100 mg/d for more than 14 days within one month or underwent plasma exchange surgery
- Use Chinese medicine for treatment within one month
- There is active infection (such as herpes zoster, HIV infection, active tuberculosis, etc.) during the screening period
- There are serious complications such as uncontrolled congestive heart failure, arrhythmias, severe pulmonary hypertension or hypertension, severe gastrointestinal involvement, liver function impairment, active infection, severe diabetes mellitus, atherosclerotic heart disease, malignancy, AIDS, or severe peripheral vascular disease.
- Patients with severe depression, psychosis or suicidal ideation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Third Hospital
Beijing
Jing Chai, 86-010-18610089752
About this study
Official title: Evaluator Blind, Controlled, Preliminary Clinical Study of Telitacicept in the Treatment of Diffuse Systemic Sclerosis With Progressive Skin Progression
Systemic sclerosis (SSc) is a chronic, multisystem autoimmune disease characterized by potentially widespread and progressive skin fibrosis and vascular abnormalities, and may involve the musculoskeletal, gastrointestinal, pulmonary, cardiac, renal, neuromuscular, and urogenital systems. At present, there is no clear and effective drug treatment for the progression of scleroderma skin lesions, and there is a lack of authoritative treatment recommendations. In recent years, research on the treatment of B cells in SSc suggests that targeted B cell therapy has certain safety and effectiveness for SSc patients. Telitacicept is a fully human fusion protein that is a fusion of TACI protein and IgG1 protein. Telitacicept can inhibit the further development and maturation of immature B cells by blocking BLyS. At the same time, Telitacicept can also inhibit the differentiation of mature B cells into plasma cells by blocking APRIL, and affect the secretion of abnormal self reactive plasma cell autoantibodies, better controlling disease activity. The effectiveness and safety of SSc treatment require further research. This study is an evaluator blind, parallel controlled clinical trial that included 20 SSc patients who still had skin progression despite conventional treatment. The patients were divided into two groups, one group included patients who did not improve with conventional treatment for skin lesions, and the other group included patients who received traditional conventional treatment. The main outcome of the study was to evaluate the efficacy and safety of Telitacicept in the treatment of progressive skin lesions in SSc, and the secondary outcome was to evaluate the impact of Telitacicept on lung function, gastrointestinal symptoms, pulmonary arterial hypertension, disease activity, and quality of life in SSc.
- Conditions
- Systemic Sclerosis
- Being tested
- Telitacicept
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelitaciceptDrug
160mg，once weekly
| Study group | Role | What they receive |
|---|---|---|
| Telitacicept | Experimental | Not described Receives: Drug: Telitacicept |
| Conventional | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of mRSS in patients after 52 weeks of treatment
The range and degree of skin thickening can be evaluated using the modified Rodnan skin score (mRSS) . The evaluator palpated 17 areas of the patient's body, and calculated the skin thickness of each area on a scale of 0-3 points, with a total score of 51 points. The skin progression was evaluated through changes in mRSS scores.
Measured: base line and week 52
The safety of Telitacicept
Evaluate adverse drug reactions
Measured: up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start8 Jun 2024
- Primary completion10 Dec 2025 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mu Rong, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06546540
- Sponsor's protocol ID
- BYSYDL2021005
- Status last verified
- Aug 2024
- First submitted
- 4 Aug 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluator Blind, Controlled, Preliminary Clinical Study of Telitacicept in the Treatment of Diffuse Systemic Sclerosis With Progressive Skin Progression
- ClinicalTrials.gov ID
- NCT06546540
- Acronym / sponsor ID
- BYSYDL2021005
- Conditions
- Systemic Sclerosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 8 Jun 2024 (actual)
- Primary completion
- 10 Dec 2025 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 9 Aug 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.
Systemic sclerosis (SSc) is a chronic, multisystem autoimmune disease characterized by potentially widespread and progressive skin fibrosis and vascular abnormalities, and may involve the musculoskeletal, gastrointestinal, pulmonary, cardiac, renal, neuromuscular, and urogenital systems. At present, there is no clear and effective drug treatment for the progression of scleroderma skin lesions, and there is a lack of authoritative treatment recommendations. In recent years, research on the treatment of B cells in SSc suggests that targeted B cell therapy has certain safety and effectiveness for SSc patients. Telitacicept is a fully human fusion protein that is a fusion of TACI protein and IgG1 protein. Telitacicept can inhibit the further development and maturation of immature B cells by blocking BLyS. At the same time, Telitacicept can also inhibit the differentiation of mature B cells into plasma cells by blocking APRIL, and affect the secretion of abnormal self reactive plasma cell autoantibodies, better controlling disease activity. The effectiveness and safety of SSc treatment require further research. This study is an evaluator blind, parallel controlled clinical trial that included 20 SSc patients who still had skin progression despite conventional treatment. The patients were divided into two groups, one group included patients who did not improve with conventional treatment for skin lesions, and the other group included patients who received traditional conventional treatment. The main outcome of the study was to evaluate the efficacy and safety of Telitacicept in the treatment of progressive skin lesions in SSc, and the secondary outcome was to evaluate the impact of Telitacicept on lung function, gastrointestinal symptoms, pulmonary arterial hypertension, disease activity, and quality of life in SSc.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telitacicept | Experimental | Drug: Telitacicept |
| Conventional | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects with systemic sclerosis who met the ACR2013 classification criteria for systemic sclerosis and approved this trial
- Age: 18 years or older
- Lung function FVC% > 50%
- Positive for ANA or scleroderma related autoantibodies
- Patients with disease activity after conventional treatment: new skin involvement or deterioration of two new body areas or skin thickening and deterioration after 6 months of conventional treatment (δMRSS ≥0 points)
Key exclusion criteria (14 listed)
- Subjects who did not consent to participate in the clinical trial
- Subjects with mixed connective tissue disease or overlap syndrome
- Focal scleroderma
- Pregnant women, lactating women and men or women who have planned to have children in the last 12 month
- Allergic reaction: History of allergy to human derived biological products
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 |
|---|---|---|
| Telitacicept160mg，once weekly | Drug | Telitacicept |
Primary outcome
Changes of mRSS in patients after 52 weeks of treatment
Time frame: base line and week 52
The range and degree of skin thickening can be evaluated using the modified Rodnan skin score (mRSS) . The evaluator palpated 17 areas of the patient's body, and calculated the skin thickness of each area on a scale of 0-3 points, with a total score of 51 points. The skin progression was evaluated through changes in mRSS scores.
The safety of Telitacicept
Time frame: up to 52 weeks
Evaluate adverse drug reactions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Telitacicept in people with Systemic Sclerosis, run by Peking University Third Hospital at 1 site 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 6 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Chai (86-010-18610089752, chaijing1008@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of mRSS in patients after 52 weeks of treatment (time frame: base line and week 52). 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 9 Aug 2024.