NCT05168475TerminatedPhase 2
Biologics in Refractory Vasculitis: A Trial of Biologic Therapy for Refractory Primary Non-ANCA Associated Vasculitis
Biologics in Refractory Vasculitis (BIOVAS): A Pragmatic, Randomised, Double-blind, Placebo-controlled, Modified-crossover Trial of Biologic Therapy for Refractory Primary Non-ANCA Associated Vasculitis in Adults and Children
Source: ClinicalTrials.gov · Last updated 17 Jun 2025
Reason given: NIHR withdrawal of funding
Brief summary (registry, in English)
Vasculitis occur when the body's immune system, rather than protecting the body, attacks blood vessels, causing injury to the vessel and the part of the body it supplies with blood. Vasculitis is rare, and there are a number of different types, which can affect both adults and children. We treat vasculitis with steroids and drugs aiming to damp down the activity of the immune system, but they often cause side effects. Some patients do not improve with this treatment, or cannot tolerate it and their vasculitis worsens; this is known as refractory vasculitis. Patients with refractory vasculitis are at high risk of health complications from the disease and its therapy and are in need of newer more effective treatments with fewer side effects. Biologics are drugs which are designed to precisely target parts of the immune system and may have fewer side effects. Biologics have been used for several years to treat vasculitis, particularly anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis or AAV. However, for many of the rarer types of vasculitis, and especially those vasculitis disease types that are not ANCA-associated, there is little information to support use of biologic therapies as effective treatments. The purpose of this trial is to find out whether biologics are effective and represent value for money for participants with refractory vasculitis. The trial will include patients with Non-ANCA-associated vasculitis (NAAV)
- Status (registry)
- Terminated
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 22 (actual)
- First submitted
- 9 Dec 2021
- Start date
- 14 Jul 2021
- Primary completion date
- 29 Nov 2023
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Diseases
- ANCA-associated vasculitis
- NCT number
- NCT05168475
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment failure/contraindication to ≥ 2 active trial IMPs
- Increase in the dose or frequency of background immunosuppressive (e.g. methotrexate) or anti-cytokine therapy within 30 days of screening visit
- Concomitant use of any biologic and/or anti-TNF agent other than the trial IMPs during the trial period
- Recent or upcoming major surgery within 45 days of screening visit
- Administration of live or live attenuated vaccines within 45 days of screening
- Have received an investigational medicinal product (IMP) within 5 half-lives or 30 days prior to screening
Other illness
- Have an active systemic bacterial, viral or fungal infection, or tuberculosis
- Hepatitis B (HB) core antibody (Ab) or HB surface antigen positive or hepatitis C antibody positive or human immunodeficiency virus (HIV) antibody test positive
- History of malignancy within five years prior to screening visit or any evidence of persistent malignancy, except fully excised basal cell or squamous cell carcinomas of the skin, or cervical carcinoma in situ which has been treated or excised in a curative procedure
- Severe disease, which in the opinion of the physician prevents randomisation to placebo
- Symptomatic congestive heart failure (NYHA class III/IV) requiring prescription medication within 90 days of screening visit
- Demyelinating disorders
- History or presence of any medical condition or disease which, in the opinion of the Investigator, may place the participant at unacceptable risk because of trial participation
- Hypersensitivity to the active IMP substance or to any of the formulation excipients
Lab values
- Use of intravenous immunoglobulins within 30 days, or cyclophosphamide or lymphocyte depleting biologic (e.g. rituximab) within 6 months of screening visit
- Leukocyte count < 3.5 x 109 cells/l, platelet count < 100 x 109 cells/l, neutrophil count of < 2 x 109 cells/l
- ALT or ALP > 3 times the upper limit of normal
Other
- Pregnant or breastfeeding, or inability/unwillingness to use a highly effective method of contraceptive if a woman of childbearing potential (WOCBP;see section 11.9)
- Diagnosis of adenosine deaminase type 2 (DADA2)
Who the study is looking for
- Aged at least 5 years
- Have given, or their parent/ legal guardian aged ≥ 16 years old has given, written informed consent
- Diagnosis of NAAV (Appendix 4)
- Refractory disease defined by:
- Active disease, BVASv3-BIOVAS/ PVAS with ≥ 1 severe (new/worse) or ≥ 3 non-severe (new/worse) items despite 12 weeks of conventional therapy prior to screening visit OR
- Inability to reduce prednisolone below 15mg/day or (0.2mg/kg/day in case of children) without relapse in the 12 weeks prior to screening visit
Age in the registry: 5 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cambridge University Hospitals NHS Foundation Trust | Cambridge | United Kingdom | Unknown status |
| Glasgow Royal Infirmary | Glasgow | United Kingdom | Unknown status |
| Guy's and St Thomas | London | United Kingdom | Unknown status |
| Great Ormond Street Hospital NHS Foundation Trust | London | United Kingdom | Unknown status |
| East Kent Hospitals | Margate | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.