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Rituximab and Belimumab Combination Therapy in PR3 Vasculitis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03967925
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Rachel Jones
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Recruiting
Countries United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

ANCA Associated Vasculitis, Granulomatosis With Polyangiitis
Arms & Interventions

Arms

Active Comparator: Belimumab

Weekly 200mg SC injections of belimumab for 12 months

Placebo Comparator: Belimumab placebo

Weekly SC injections of belimumab placebo for 12 months

Interventions

Drug: - Belimumab

Sub-cutaneous injection

Drug: - Rituximab

IV infusion 1g x 2

Drug: - Prednisolone

20mg prednisolone tapering dose

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Addenbrooke's Hospital, Cambridge, United Kingdom

Status

Recruiting

Address

Addenbrooke's Hospital

Cambridge, ,

Glasgow Royal Infirmary, Glasgow, United Kingdom

Status

Active, not recruiting

Address

Glasgow Royal Infirmary

Glasgow, ,

Imperial College London, London, United Kingdom

Status

Active, not recruiting

Address

Imperial College London

London, ,

Royal Free Hospital, London, United Kingdom

Status

Active, not recruiting

Address

Royal Free Hospital

London, ,

Royal Freemann Hospital, Newcastle, United Kingdom

Status

Active, not recruiting

Address

Royal Freemann Hospital

Newcastle, ,

Nottingham University Hospitals, Nottingham, United Kingdom

Status

Active, not recruiting

Address

Nottingham University Hospitals

Nottingham, ,