Rituximab and Belimumab Combination Therapy in PR3 Vasculitis

• Status: Recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Mechanistic study to assess whether dual B-cell immunotherapy by co-administration of rituximab and belimumab will result in improvements in biological endpoints, functional outcomes and clinical status compared to rituximab with placebo.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rachel Jones
• Collaborators: GlaxoSmithKline; Imperial College London; Medical Research Council; Newcastle University; University College, London; University of Cambridge; University of Glasgow
• Treatments: Belimumab; Prednisolone; Prednisone; Rituximab

Criteria

Inclusion Criteria:

Participants must be 18 of age

• Have a diagnosis of AAV (granulomatosis with polyangiitis or microscopic polyangiitis)

• Have PR3 ANCA positivity by ELISA at screening

• Have active disease defined by one major or three minor disease activity items on BVAS/WG

• Be capable of giving signed informed consent

Exclusion Criteria:

• MPO ANCA or anti-GBM antibody positivity by ELISA at screening

• Presence of pulmonary haemorrhage with hypoxia at screening

• Estimated glomerular filtration rate (eGFR) <30 ml/min/1.73m2 at screening

• Have an acute serious or chronic infection at screening

• Have received any B cell targeted therapy within 364 days of Day 1

• Have received any steroid injection (e.g., intramuscular [IM], intraarticular, or IV) within 60 days of Day 1 (unless given during or 14 days before screening period)

• Have received >1.5mg methylprednisolone (IV) between 14 days prior to screening and Day 1 (including Day 1).

• Have received oral prednisolone >10mg/day (or equivalent) on average over the 30 days prior to screening

• Have undetectable peripheral blood B cells at screening

• Have IgG <400mg/dl at screening