Comparing Telitacicept with Azathioprine for ANCA-associated Vasculitis Maintenance

A Prospective, Open-label, Controlled, Single Center Clinical Study of the Efficacy and Safety for Telitacicept in the Remission Maintenance Treatment of ANCA-associated Vasculitis

This study is testing if adding a new drug called Telitacicept to the standard treatment can help people with ANCA-associated vasculitis stay in remission longer.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Chinese SLE Treatment And Research Group (Academic / other)
• Drugs / interventions: Rituximab, prednisone, Belimumab
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT05965284 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the efficacy and safety of Telitacicept in combination with azathioprine compared to azathioprine alone for maintaining remission in patients with ANCA-associated vasculitis (AAV). It is a prospective, open-label, randomized, controlled, single-center trial involving patients aged 18 to 65 who are in complete remission after treatment with glucocorticoids and Rituximab. The study will assess relapse rates to determine if the addition of Telitacicept can improve maintenance therapy outcomes for AAV patients. The trial is significant as Telitacicept has not been previously studied in this context, despite its potential benefits in rheumatic diseases.

Who should consider this trial

Good fit: Ideal candidates are patients aged 18 to 65 with newly diagnosed or relapsing granulomatosis with polyangiitis or microscopic polyangiitis who are in complete remission after treatment.

Not a fit: Patients with TPMT gene mutations or those who have previously experienced adverse effects from azathioprine may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective maintenance therapy option for patients with ANCA-associated vasculitis, potentially reducing relapse rates.

How similar studies have performed: While other studies have explored maintenance therapies for AAV, the specific use of Telitacicept in this context is novel and has not been previously tested.

Eligibility criteria

Inclusion Criteria:

1. Patients age 18 to 65 years, both genders can be included.
2. 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.
3. Patients who are in complete remission after combined treatment with glucocorticoids and Rituximab. Remission is defined as a Birmingham Vasculitis Activity Score (BVAS version 3) of 0. And the daily dosage of prednisone are no more than 10mg (or equivalent).
4. Patients have to be ANCA-positive at diagnosis or during the course of their disease.

Exclusion Criteria:

1. Patients with TPMT gene mutation.
2. Patients who had been treated with either AZA but relapsed in the past.
3. Patients who had been treated with either AZA but had to stop due to adverse events or intolerance.
4. Patients who have planned for pregnancy in next 1.5 years.
5. 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).
6. Patients with uncontrolled sever hypertension, diabetes, active bacteria or fungal infection;
7. Patients with active hepatitis virus infection as well as patients who have active mycobacteria infection;
8. Patients who had other autoimmune diseases.
9. Patients with malignancy.
10. Patients who are not eligible according to the judge of the principal investigators or site investigators.

Where this trial is running

Beijing, Beijing Municipality

• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: JIng Li, M.D. — Peking Unione Mdecial College Hospital
• Study coordinator: Yunjiao Yang, M.D.

Conditions ANCA-associated Vasculitis; Maintenance Therapy; Telitacicept; Azathioprine; Relapse rate