ANCA Associated VasculitisPhase 4NCT05962840
Efficacy and Safety for Rituximab Combined With Telitacicept in the Treatment of ANCA-associated Vasculitis (TTCAAVREM)
A Phase 4 study testing Telitacicept in people with ANCA Associated Vasculitis, run by Chinese SLE Treatment And Research Group at 1 site in China.
Trial summary
This study is a prospective, open-labelled, randomized, controlled, single-center clinical trial. The aim of this study is to investigate the remission rate of patients treated with Telitacicept combined with Rituximab in remission-induction and Telitacicept alone in remission-maintain treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- ANCA Associated Vasculitis
- What is being tested?
- Telitacicept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 29 Jun 2023to 31 Dec 2026
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients age 18 to 65 years, both genders can be included.
- Patients who are newly diagnosed or relapsing granulomatosis with polyangiitis or microscopic polyangiitis must fulfill the 2022 ACR/EULAR classification criteria of GPA or MPA.
- Patients have severe active AAV according to the 2021 ACR/vasculitis foundation definition.
- Patients have to be PR3-ANCA-positive at diagnosis or during the course of their disease.
Who cannot join
- Patients who had been treated with Rituximab but had to stop due to adverse events or intolerance.
- Patients who had other autoimmune diseases.
- Patients with severe liver dysfunction (defined as the 2-folds elevation of normal upper limit or Child grade III), heart failure or ESRD (eGFR<30ml/min).
- Patients who are pregnant or have planned for pregnancy in next 2 years.
- Patients with uncontrolled sever hypertension, diabetes, active bacteria or fungal infection.
- Patients with active hepatitis virus infection as well as patients who have active mycobacteria infection.
- Patients with malignancy.
- Patients who are not eligible according to the judge of the principal investigators.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, 100730
Yunjiao Yang, MD, 86-13671313079, yangyunjiao81@163.com
Hanqi Wang, RN, 86-15810927696, lijing6515@pumch.cn
About this study
Official title: A Prospective, Randomized, Single-blinded Placebo-controlled, Single Center Clinical Study of the Efficacy and Safety for Rituximab Combined With Telitacicept in the Treatment of ANCA-associated Vasculitis
This study is a prospective, open-labelled, randomized, controlled, single-center clinical trial. The aim of this study is to investigate the remission rate of patients treated with Telitacicept combined with Rituximab in remission-induction and Telitacicept alone in remission-maintain treatment.
Read the detailed description
Background: The basic theme of AAV is relapse and remission. The maintenance therapy of AAV aimed to reduce or prevent relapse is very challenge. Although many medications have been used for the maintenance of AAV, Telitacicept (a BAFF/APRIL dual-target-inhibitor, which has been proved to be effect in treatment of SLE) has not been studied yet. One study tested the efficacy of Belimumab in the maintenance therapy for AAV. When taken Rituximab as remission-induction treatment, no relapse was observed. However, the sample size of this study is small, and the Belimumab, as a BAFF inhibitor, was not been proved to have effect on APRIL.
Many experiences have been accumulated about the efficacy and safety of Telitacicept in Chinese patients with rheumatic diseases. But there is no study to show its effectiveness in the reduction of the relapse of AAV in China. In this study, we take Telitacicept as maintain treatment in AAV patients who receive Rituximab as remission-induction treatment, to verify the effectiveness of Telitacicept in maintenance therapy of AAV.
Objectives: To investigate the effectiveness of Telitacicept in reducing relapse rate by using from remission-induction treatment combined with Rituximab to maintenance treatment of AAV.
Study Design: This is a prospective, randomized, open-label, control, pilot study.
- Conditions
- ANCA Associated Vasculitis
- Being tested
- Telitacicept, Placebo of Telitacicept
- Keywords
- Telitacicept, relapse rate, remission maintain treatment
- Medical subject headings
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
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
Patient will be treated with Telitacicept (Taiai the commercial name) 80 mg every week subcutaneously for 12 months
Placebo of TelitaciceptOther
Patient will be treated with placebo of Telitacicept (Taiai the commercial name) 80 mg every week subcutaneously for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Placebo arm | Placebo comparator | Patients with active AAV will be treated with Rituximab and glucocorticoid to induce remission. And the placebo of Telitacicept would be given 80 mg every week subcutaneously for 12 months. Glucocorticoid would be tapered as recommended by 2022 EULAR AAV recommendation (as protocol of PEXIVAS study) Receives: Other: Placebo of Telitacicept |
| Telitacicept treatment arm | Experimental | Patients with active AAV will be treated with Rituximab and glucocorticoid to induce remission. And the Telitacicept would be given 80 mg every week subcutaneously for 12 months. Glucocorticoid would be tapered as recommended by 2022 EULAR AAV recommendation (as protocol of PEXIVAS study) Receives: Drug: Telitacicept |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time of first relapse during 24 months follow-up of two groups
The time from baseline to first relapse(re-appearance of disease with a BVAS >0) of patients during 24 months follow-up of two groups
Measured: from inclusion to the end of the study, 24 months in total
Secondary outcomes (8)
The time to remission of two groups
The time from baseline to remission (disappearance of disease with a BVAS = 0) of patients of two groups
Measured: from inclusion to the end of the study, 24 months in total
The time from remission to first relapse of two groups
The time from remission (disappearance of disease with a BVAS = 0) to first relapse (re-appearance of disease with a BVAS >0) of patients of two groups
Measured: from inclusion to the end of the study, 24 months in total
The percentage of patients with sustained remission at months 12 and at months 24 of two groups
The percentage of patients with sustained remission (disappearance of disease with a BVAS = 0) at months 12 and at months 24 of two groups
Measured: from inclusion to the end of the study, 24 months in total
The percentage of patients with relapse at months 12 and at months 24 of two groups
The percentage of patients with relapse (re-appearance of disease with a BVAS >0), major relapse (re-appearance or worsening of disease with a BVAS >0 and involvement of at least one major organ, a life-threatening manifestation, or both) and minor relapse (re-appearance of disease with a BVAS >0 without involvement of major organ or a life-threatening manifestation) at months 12 and at months 24 of two groups
Measured: from inclusion to the end of the study, 24 months in total
The rate of adverse events and their severity in both treatment groups during 24 months of the study period.
The rate of adverse events and their severity (Severe events were defined as the adverse events of grade 3 or 4, deaths caused by any cause, cancers, side effects that necessitate hospitalization) in both treatment groups during the study period.
Measured: from inclusion to the end of the study, 24 months in total
The percentage of patients who progress to ESRD at the end of the study
The percentage of patients who progress to ESRD at the end of the study
Measured: from inclusion to the end of the study, 24 months in total
The time of ANCA from positive to negative of two groups
The time of ANCA from positive to negative of two groups
Measured: from inclusion to the end of the study, 24 months in total
The rate of complication of AAV in both treatment groups during 24 months of the study period.
The rate of complication of AAV in both treatment groups during 24 months of the study period.
Measured: from inclusion to the end of the study, 24 months in total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start29 Jun 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ANCA Associated VasculitisStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, randomized, single-blinded, placebo-controlled, pilot study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese SLE Treatment And Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College Hospital
- Responsible party
- Sponsor
- Investigators
- Jing Li, MD, Principal investigator, Peking Unione Mdecial College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05962840
- Sponsor's protocol ID
- CSTAR-K2956
- Status last verified
- Jul 2023
- First submitted
- 18 Jul 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only patient clincial information coud be released to public
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Single-blinded Placebo-controlled, Single Center Clinical Study of the Efficacy and Safety for Rituximab Combined With Telitacicept in the Treatment of ANCA-associated Vasculitis
- ClinicalTrials.gov ID
- NCT05962840
- Acronym / sponsor ID
- CSTAR-K2956
- Conditions
- ANCA Associated Vasculitis
- Keywords
- Telitacicept, relapse rate, remission maintain treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chinese SLE Treatment And Research GroupUniversity, hospital or other
- Collaborators
- Peking Union Medical College Hospital
- Study start
- 29 Jun 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Jul 2023 (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-labelled, randomized, controlled, single-center clinical trial. The aim of this study is to investigate the remission rate of patients treated with Telitacicept combined with Rituximab in remission-induction and Telitacicept alone in remission-maintain treatment.
Detailed description
Background: The basic theme of AAV is relapse and remission. The maintenance therapy of AAV aimed to reduce or prevent relapse is very challenge. Although many medications have been used for the maintenance of AAV, Telitacicept (a BAFF/APRIL dual-target-inhibitor, which has been proved to be effect in treatment of SLE) has not been studied yet. One study tested the efficacy of Belimumab in the maintenance therapy for AAV. When taken Rituximab as remission-induction treatment, no relapse was observed. However, the sample size of this study is small, and the Belimumab, as a BAFF inhibitor, was not been proved to have effect on APRIL.
Many experiences have been accumulated about the efficacy and safety of Telitacicept in Chinese patients with rheumatic diseases. But there is no study to show its effectiveness in the reduction of the relapse of AAV in China. In this study, we take Telitacicept as maintain treatment in AAV patients who receive Rituximab as remission-induction treatment, to verify the effectiveness of Telitacicept in maintenance therapy of AAV.
Objectives: To investigate the effectiveness of Telitacicept in reducing relapse rate by using from remission-induction treatment combined with Rituximab to maintenance treatment of AAV.
Study Design: This is a prospective, randomized, open-label, control, pilot study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- prospective, randomized, single-blinded, placebo-controlled, pilot study
| Arm | Type | Receives |
|---|---|---|
| Placebo arm | Placebo comparator | Other: Placebo of TelitaciceptPatients with active AAV will be treated with Rituximab and glucocorticoid to induce remission. And the placebo of Telitacicept would be given 80 mg every week subcutaneously for 12 months. Glucocorticoid would be tapered as recommended by 2022 EULAR AAV recommendation (as protocol of PEXIVAS study) |
| Telitacicept treatment arm | Experimental | Drug: TelitaciceptPatients with active AAV will be treated with Rituximab and glucocorticoid to induce remission. And the Telitacicept would be given 80 mg every week subcutaneously for 12 months. Glucocorticoid would be tapered as recommended by 2022 EULAR AAV recommendation (as protocol of PEXIVAS study) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients age 18 to 65 years, both genders can be included.
- Patients who are newly diagnosed or relapsing granulomatosis with polyangiitis or microscopic polyangiitis must fulfill the 2022 ACR/EULAR classification criteria of GPA or MPA.
- Patients have severe active AAV according to the 2021 ACR/vasculitis foundation definition.
- Patients have to be PR3-ANCA-positive at diagnosis or during the course of their disease.
Key exclusion criteria (8 listed)
- Patients who had been treated with Rituximab but had to stop due to adverse events or intolerance.
- Patients who had other autoimmune diseases.
- Patients with severe liver dysfunction (defined as the 2-folds elevation of normal upper limit or Child grade III), heart failure or ESRD (eGFR<30ml/min).
- Patients who are pregnant or have planned for pregnancy in next 2 years.
- Patients with uncontrolled sever hypertension, diabetes, active bacteria or fungal infection.
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 namePatient will be treated with Telitacicept (Taiai the commercial name) 80 mg every week subcutaneously for 12 months | Drug | Telitacicept treatment arm |
| Placebo of TelitaciceptPatient will be treated with placebo of Telitacicept (Taiai the commercial name) 80 mg every week subcutaneously for 12 months | Other | Placebo arm |
Primary outcome
The time of first relapse during 24 months follow-up of two groups
Time frame: from inclusion to the end of the study, 24 months in total
The time from baseline to first relapse(re-appearance of disease with a BVAS >0) of patients during 24 months follow-up of two groups
8 secondary outcomes
The time to remission of two groups
Time frame: from inclusion to the end of the study, 24 months in total
The time from remission to first relapse of two groups
Time frame: from inclusion to the end of the study, 24 months in total
The percentage of patients with sustained remission at months 12 and at months 24 of two groups
Time frame: from inclusion to the end of the study, 24 months in total
The percentage of patients with relapse at months 12 and at months 24 of two groups
Time frame: from inclusion to the end of the study, 24 months in total
The rate of adverse events and their severity in both treatment groups during 24 months of the study period.
Time frame: from inclusion to the end of the study, 24 months in total
The percentage of patients who progress to ESRD at the end of the study
Time frame: from inclusion to the end of the study, 24 months in total
The time of ANCA from positive to negative of two groups
Time frame: from inclusion to the end of the study, 24 months in total
The rate of complication of AAV in both treatment groups during 24 months of the study period.
Time frame: from inclusion to the end of the study, 24 months in total
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 27 Jul 2023.
- Individual participant dataSharing planned: No. Only patient clincial information coud be released to public
Related trials for ANCA Associated Vasculitis
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
Active, not recruitingPhase 2
Safety and Efficacy of Tarperprumig in Adult Participants With Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
RecruitingPhase 1/2
A Phase 1/2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2)
Systemic Sclerosis, Idiopathic Inflammatory Myopathies
Not yet recruitingPhase 2
Trial of VIS954 in the Treatment of Antineutrophil Cytoplasmic Antibody-associated Vasculitis
Antineutrophil Cytoplasmic Antibody-associated Vasculitis
RecruitingObservational study
Studies of the Natural History, Pathogenesis, and Outcome of Idiopathic Systemic Vasculitis
Takayasu's Arteritis, Giant Cell Arteritis
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 Li, MD principal investigator
Peking Unione Mdecial College Hospital
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 ANCA Associated Vasculitis, run by Chinese SLE Treatment And Research Group 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 4 inclusion and 8 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 27 Jul 2023. 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. Some participants in this study may receive a placebo. 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?
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 Yunjiao Yang, MD (86-13671313079, yangyunjiao81@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time of first relapse during 24 months follow-up of two groups (time frame: from inclusion to the end of the study, 24 months in total). 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 27 Jul 2023.