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:

• You fully understand what the trial involves, including its purpose and possible side effects, and are willing to sign a consent form agreeing to take part.
• You are between 18 and 65 years old (inclusive) at the time of signing the consent form, and there are no restrictions based on gender.
• You agree not to try to have a child — and not to donate sperm or eggs — during the trial and for at least 12 months after receiving the treatment, and you are willing to use effective birth control with your partner during this time.
• You have been diagnosed with systemic lupus erythematosus (SLE) according to recognised international medical guidelines from 2019.
• During the screening process, at least one of the following blood tests comes back positive: antinuclear antibody (ANA) at a level of 1:80 or higher, anti-dsDNA antibody, or anti-Sm antibody (confirm with trial site if unsure which tests apply to you).

Who may not be able to join:

• You are thought to be likely to have an allergic reaction to the trial drug or any of its ingredients.
• You have had a central nervous system condition (such as epilepsy, stroke, encephalitis, or similar) within the 8 weeks before starting the trial.
• You have previously had a major organ transplant (such as heart, lung, kidney, or liver) or a bone marrow or stem cell transplant.
• You have another serious or unstable health condition affecting organs such as the liver, kidneys, lungs, or mental health, or you have an active infection, and the medical team believes joining the trial would significantly increase your health risks.
• You currently have a known or suspected cancer.
• You have severe high blood pressure in the lungs (pulmonary arterial hypertension above 70 mmHg), or a milder form of this condition combined with serious heart or lung problems.
• You have antiphospholipid syndrome (APS), have had a history of a severe form called catastrophic antiphospholipid syndrome (CAPS), or the medical team believes you have a higher-than-normal risk of blood clots (confirm with trial site).
• You have had a shingles (herpes zoster) infection within the 90 days before starting the trial, or any infection serious enough to require a hospital stay or injected antibiotics within the 60 days before starting.
• You have had major surgery within 28 days before starting the trial, or major surgery is planned during the trial period.
• You test positive during screening for HIV, hepatitis B, hepatitis C, or syphilis.
• There are any other concerns identified by the medical team that could affect your safety, your ability to follow the trial rules, or the reliability of the trial results.

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