Phase 1 Vasculitis Trial, Recruiting

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

Who might be able to join this trial:

General requirements:

• Adults between 18 and 65 years old
• Reasonably good general health and ability to carry out daily activities, as measured by a standard medical scale (ECOG score of 0–2)
• Kidneys, liver, and other organs are functioning at an adequate level
• Women who could become pregnant must have a negative pregnancy test before joining and must agree to use highly effective birth control from the start of a preparatory treatment phase until 2 years after receiving the study drug

For people with Systemic Lupus Erythematosus (SLE — a chronic immune system disease):

• A confirmed SLE diagnosis based on one of three recognised sets of classification guidelines
• Certain specific antibodies detected in blood tests (ANA, anti-dsDNA, or anti-Sm)
• The disease is currently active at a significant level, as measured by standard lupus scoring tools, or a kidney biopsy has confirmed a specific type of lupus-related kidney disease
• The disease has returned or has not responded to at least one immune-suppressing or biological medicine

For people with Inflammatory Muscle Disease (IIM — conditions where the immune system attacks the muscles):

• A confirmed diagnosis of one of the recognised forms of IIM according to 2017 classification guidelines
• The disease is currently active, shown by elevated muscle enzymes, recent abnormal muscle tests, or an active skin rash associated with the condition
• Muscle strength and function fall below specific measured thresholds, along with additional signs of active disease
• If skin is affected, a standard skin disease score must meet a certain threshold
• At least one specific antibody linked to muscle disease is present in blood tests
• The disease has returned or has not responded to at least one immune-suppressing or biological medicine

For people with Systemic Sclerosis (SSc — also known as scleroderma, a condition that hardens skin and can affect organs):

• A confirmed SSc diagnosis according to 2013 classification guidelines
• The disease is currently active, with new or worsening skin or organ changes in the past 6 months, or certain blood markers indicating active inflammation
• A standard skin thickness score above a specific level
• The disease has returned or has not responded to at least one immune-suppressing or biological medicine

For people with ANCA-Associated Vasculitis (AAV — a condition where the immune system inflames blood vessels):

• A confirmed diagnosis of MPA or GPA (two forms of AAV) based on 2022 classification guidelines
• Specific antibodies (ANCA) detected in blood tests
• Active disease shown by specific signs on a standard disease activity tool (BVAS)
• The disease has returned or has not responded to at least one immune-suppressing or biological medicine

Who may not be able to join:

• People with an active infection that is not under control
• People with evidence of chronic Hepatitis B infection who are unable or unwilling to take standard antiviral prevention medicine, or who have a detectable level of the virus in their blood
• People with evidence of Hepatitis C infection who have not completed a curative course of treatment, or who still have a detectable level of the virus in their blood
• People who test positive for HIV
• People who test positive for syphilis
• People with active tuberculosis, or untreated or inadequately treated latent (inactive but present) tuberculosis
• People who have had a serious infection in the 3 months before screening (one that required a hospital stay or intravenous antibiotics), or who have taken antibiotic or antiviral tablets in the month before screening
• People with a heart condition causing an abnormally long electrical signal in the heart (congenital long QT syndrome), or a specific abnormal heart rhythm reading on an ECG at the time of screening (unless explained by a pacemaker or a specific type of heart conduction issue)
• People with uncontrolled high blood pressure, unstable chest pain, significant heart failure, signs of acute reduced blood flow to the heart on an ECG, a heart procedure or heart attack within the past 6 months, uncontrolled irregular heart rhythm, poorly controlled diabetes or other hormone-related conditions, severe long-term lung disease, or any other serious medical condition likely to make tolerating the study treatment very difficult
• People who have had an organ transplant at any time
• Women who are pregnant or currently breastfeeding
• People who have taken another experimental medicine within 4 weeks (or within 5 half-lives of that medicine, whichever is longer) before starting the study drug
• People who have used a biological medicine within the past 3 months, or who have had a stem cell transplant or CAR-T cell therapy within the past 6 months
• People who have received a live or weakened (attenuated) vaccine within 4 weeks before the first study treatment
• People who have another autoimmune or inflammatory condition (such as rheumatoid arthritis, gout, or active fibromyalgia) that could affect how results are measured in the trial
• For SLE patients only: People whose SLE is currently affecting the brain or nervous system
• For IIM patients only: People with severe weakness of the breathing muscles affecting the ability to breathe; permanent muscle weakness from IIM; or a different type of muscle disease such as inclusion body myositis, infection-related, metabolic, inherited muscular dystrophy (or a family history of it), drug- or hormone-related muscle inflammation, or juvenile (childhood) muscle disease
• For SSc patients only: People at risk of a serious sudden kidney complication related to scleroderma; people with a specific stomach blood vessel condition linked to SSc; or people with severe digestive system involvement causing problems absorbing nutrients or intestinal failure
• For AAV patients only: People with vasculitis (blood vessel inflammation) affecting the brain or spinal cord; or people with severe lung bleeding requiring a breathing machine

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