Combining Rituximab and Telitacicept for treating ANCA-associated Vasculitis

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 testing if adding Telitacicept to Rituximab 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, Belimumab
• Locations: 1 site (Beijing)
• Trial ID: NCT05962840 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of Telitacicept in reducing relapse rates in patients with ANCA-associated vasculitis (AAV) who are undergoing remission-induction treatment with Rituximab. It is a prospective, open-label, randomized, controlled, single-center trial that aims to evaluate the efficacy of Telitacicept as a maintenance therapy following Rituximab treatment. The study will enroll patients aged 18 to 65 who meet specific diagnostic criteria for AAV and are PR3-ANCA-positive. The trial will compare the outcomes of patients receiving Telitacicept against those receiving a placebo.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with newly diagnosed or relapsing granulomatosis with polyangiitis or microscopic polyangiitis who are PR3-ANCA-positive.

Not a fit: Patients with severe liver dysfunction, heart failure, end-stage renal disease, or other autoimmune diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment combination could significantly reduce relapse rates in patients with ANCA-associated vasculitis.

How similar studies have performed: While there have been studies on similar treatments for AAV, the specific combination of Telitacicept and Rituximab 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 have severe active AAV according to the 2021 ACR/vasculitis foundation definition.
4. Patients have to be PR3-ANCA-positive at diagnosis or during the course of their disease.

Exclusion Criteria:

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

Where this trial is running

Beijing

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

Study contacts

• Principal investigator: Jing Li, MD — Peking Unione Mdecial College Hospital
• Study coordinator: Yunjiao Yang, MD

Conditions ANCA Associated Vasculitis; Telitacicept; relapse rate; remission maintain treatment