Phase 2 Lupus 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:

• People who are willing to take part in the study and are able to sign a consent form, attend all required visits, and complete all study-related procedures.
• People who have been diagnosed with Systemic Lupus Erythematosus (SLE) — a long-term immune system condition — for at least 24 weeks before the screening visit, confirmed using recognised international medical classification standards.
• People whose blood tests show certain markers linked to SLE, specifically high levels of antinuclear antibodies (ANA), or positive results for anti-double-stranded DNA (anti-dsDNA) antibodies, or positive results for anti-Smith (anti-Sm) antibodies.
• People whose SLE is currently active enough to score at or above a certain level on a standard disease activity measurement, with symptoms affecting the joints and/or skin (confirm with trial site for exact scoring details).
• People aged between 18 and 75 years old at the time of signing the consent form.
• People who have been on a stable SLE treatment regimen for at least 12 weeks before the screening visit, with no dose changes for at least 4 weeks before screening, and who are able to continue that same treatment throughout the study.
• People taking hydroxychloroquine (an antimalarial medicine used for SLE), either alone or combined with one type of immunosuppressant medicine, up to a maximum dose of 400 mg per day.
• People taking corticosteroids (such as prednisone) as part of their SLE treatment, provided the dose has been stable for at least 2 weeks before screening and does not exceed 40 mg per day — noting that corticosteroids alone, without other SLE medication, are not permitted as the sole background treatment.
• People taking one type of anti-inflammatory painkiller (NSAID) at a stable dose for at least 14 days before screening, maintained at that dose throughout the study — noting that NSAIDs alone, without other SLE medication, are not permitted as the sole background treatment.
• People taking low-dose aspirin for heart or clot-prevention purposes may continue this alongside other permitted medications, provided the dose remains stable.
• Women who are able to become pregnant must have a negative blood pregnancy test within 7 days before enrolling, and must agree to use effective contraception during the study and for 6 months afterwards. Men must also agree to use effective contraception during the study and for 6 months afterwards.

Who may not be able to join:

• People whose SLE was caused by a medication (known as drug-induced lupus).
• People who have another autoimmune condition such as multiple sclerosis, psoriasis, or inflammatory bowel disease (note: secondary Sjögren's syndrome — a condition causing dry eyes and mouth — does not automatically exclude someone; confirm with trial site).
• People who have an overlapping condition alongside SLE, such as systemic sclerosis or mixed connective tissue disease.
• People who have antiphospholipid syndrome alongside SLE and have previously experienced a serious blood clot or certain pregnancy complications (confirm with trial site for specific details).
• People who have previously had lupus affecting the brain (lupus encephalopathy).
• People with active, severe lupus affecting the kidneys that requires strong medicines such as high-dose corticosteroids or certain chemotherapy-type drugs (people with lupus kidney involvement that is currently under control may still be considered).
• People who are currently pregnant or breastfeeding.
• People with a serious or unstable medical condition affecting organs such as the kidneys, liver, lungs, heart, or digestive system, or who have an active infection, where a doctor judges that taking part would significantly increase health risks.
• People who have had a major operation within 30 days before the first study treatment, or who plan to have surgery during the study.
• People who have had cancer or a cancer-related blood condition within the past 5 years (certain fully treated skin cancers with no signs of return may be considered; confirm with trial site).
• People with significant heart failure (classified as Class III or IV by standard medical criteria), recent severe heart failure symptoms, or a history of serious heart rhythm problems requiring ongoing medication.
• People who have had a heart attack, unstable chest pain, or a major stroke or brain blood vessel event within 24 weeks before screening.
• People who currently have or recently had (within 3 months before enrolment) a digestive system condition or surgery that might affect how the study medicine is absorbed.
• People who, in a doctor's judgement, have a non-SLE condition that is likely to require additional steroid treatment during the study (such as asthma).
• People who have had significant blood loss (more than 500 mL) or a blood transfusion within 4 weeks before enrolment.
• People who are unable to swallow medicines by mouth.
• People who are unable to have blood drawn through a vein.
• People with a history of substance misuse that cannot be managed, or who have a psychiatric disorder.
• People who are unable to follow the rules of the study treatment plan, including stopping any prohibited medicines within the required timeframes.
• People who are currently using more than one type of immunosuppressant medicine.
• People who have previously taken a TYK2 inhibitor medicine (a specific type of targeted therapy; confirm with trial site).
• People who have previously taken certain medicines that target interferon, such as anifrolumab, rontalizumab, or similar drugs in a clinical trial.
• People who have taken any other investigational (trial) medicine within 12 weeks or 5 half-lives of that medicine before screening, whichever period is longer.
• People whose chest X-ray taken within the past 6 months shows signs of active tuberculosis (TB).
• People who have active hepatitis B, hepatitis C, or HIV infection, based on blood test results.
• People currently receiving treatment for a long-term (chronic) infection.
• People who need treatment for syphilis.
• People who have a condition — present from birth or developed later — that causes the immune system to not work properly.
• People with a history of repeated serious infections that required hospitalisation or intravenous (injected) antibiotics, or who have needed intravenous anti-infection treatment within 30 days before enrolment, or oral anti-infection treatment within 14 weeks before enrolment.
• People who have had a widespread (systemic) case of shingles in the past, or who have had two or more episodes of shingles in the past two years, or whose most recent shingles infection had not fully cleared up within 12 weeks before screening.
• People who have received a live vaccine within 90 days before enrolment, or an inactivated (non-live) vaccine within 30 days before enrolment.
• People with clinically significant abnormalities on a chest X-ray or heart tracing (ECG).
• People with significant abnormal results on laboratory (blood or urine) tests that remain abnormal after a repeat test during the screening period.
• People with a history of a serious allergic reaction to any medicine, or who are known to be allergic to any ingredient in the study medicine.
• People who are unable or unwilling to follow the study plan and requirements.
• People who have had, or are planning to have, a bone marrow transplant or a solid organ transplant.
• People for whom the study doctor judges that participation would seriously affect their safety or their ability to complete the study.

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