Phase 2 Vasculitis Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are 18 years old or older
• You have been diagnosed with a relapsing (returning) condition called granulomatosis with polyangiitis (GPA), confirmed by recognised medical classification systems, and a specific blood marker called PR3-ANCA is present at the time of joining
• Your disease is currently active, meaning your symptoms score at least 3 points on a standard disease activity measurement used by doctors (BVAS)
• You started or increased a steroid treatment (at a dose of no more than 1 mg/kg/day) within the last 21 days before joining the trial
• You are able to sign a consent form to confirm you understand and agree to take part
• You are covered by social security (or are entitled to it)

Who may not be able to join:

• You have a different type of vasculitis (blood vessel inflammation), including a type linked to a different blood marker called MPO-ANCA
• Your disease is currently in remission (not active, scoring below 3 on the BVAS scale)
• You have been newly diagnosed with GPA for the first time (this trial is for people whose GPA has returned)
• You have received a medicine called rituximab in the last 6 months
• You have received a medicine called cyclophosphamide in the last 6 months
• You have severe heart failure classified at the most serious level (Class IV) by standard medical guidelines
• You are known to carry HIV, hepatitis B (including a past infection), or hepatitis C
• You have an active cancer or have had cancer in the last 5 years, with the exception of certain low-risk skin cancers or a specific type of prostate cancer controlled by hormone treatment
• You have had an allergic reaction to a biological medicine or a monoclonal antibody treatment in the past
• You have had an allergic reaction to obinutuzumab (the study drug) or any of its ingredients
• You have a medical reason that prevents you from safely taking the supporting medicines used in this trial (such as steroids, paracetamol, or an antihistamine)
• You have other serious uncontrolled health problems — such as drug or alcohol misuse, active or recurring infections, or severe mental health conditions — that could affect your safe participation in the trial
• The trial team has reason to believe you may not be able to follow the treatment plan as required
• You are pregnant or breastfeeding; women who could become pregnant must have a negative pregnancy test before starting and must use a reliable form of contraception throughout the trial and for at least 18 months after the last dose of the study drug
• You are a man who is unwilling to use contraception (condom) throughout the trial and for at least 18 months after the last dose of the study drug (unless you have had a permanent sterilisation procedure)
• You are already taking part in another clinical trial involving an experimental treatment
• You are legally protected (for example, under guardianship or court order) or you are currently detained
• You are not able to give written consent to participate
• You have severe liver problems or breathing difficulties that require you to use oxygen through your nose
• You have an active infection or a history of long-term or frequently returning infections
• You have received a live virus vaccine within the 4 weeks before joining the trial

Important: Always verify eligibility with the trial site directly before applying.