Rituximab and Belimumab Combination Therapy in PR3 Vasculitis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03967925
• Date of registration: 18/01/2019
• Prospective Registration: Yes
• Primary sponsor: Rachel Jones
• Public title: Rituximab and Belimumab Combination Therapy in PR3 Vasculitis COMBIVAS
• Scientific title: A Randomised, Double Blind, Controlled Mechanistic Study of Rituximab and Belimumab Combination Therapy in PR3 ANCA-associated Vasculitis
• Date of first enrolment: February 1, 2019
• Target sample size: 30
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03967925
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2

Countries of recruitment

United Kingdom

Contacts

• Name: Kim Mynard

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Granulomatosis With Polyangiitis

ANCA Associated Vasculitis

Intervention(s)

Drug: Prednisolone

Drug: Belimumab

Drug: Rituximab

Primary Outcome(s)

Time to PR3 ANCA negativity [Time Frame: Analysed at 24 months]

Secondary Outcome(s)

Change from baseline of certain cell subsets [Time Frame: 2 years]

Time to clinical remission [Time Frame: 2 years]

Incidence of serious adverse events (SAEs) [Time Frame: 2 years]

Proportion of participants with PR3 ANCA negativity [Time Frame: 2 years]

Secondary ID(s)

206852

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Imperial College London

University of Glasgow

Medical Research Council

University College, London

University of Cambridge

GlaxoSmithKline

Newcastle University