Phase 1 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:

Note: The Phase 1a portion of this trial (healthy volunteers) is no longer enrolling. The Phase 1b portion (patients with SLE or RA) is actively recruiting.

General requirements for Phase 1b (all patients):

• Men and women between 18 and 75 years of age
• People who are able to understand, agree to, and sign a consent form, and who are able to attend scheduled study visits
• People who are willing and able to use highly effective contraception during the study and for a period after it ends

Additional requirements for people with SLE (lupus):

• People who have had a confirmed diagnosis of SLE for at least 6 months, meeting a recognised set of classification criteria
• People whose lupus is considered active at the time of screening
• People who have certain lupus-related antibodies present in their blood and low levels of certain proteins called complement (C3/C4)
• People who are already on a stable lupus treatment plan, which may include antimalarials, low-dose steroids, and at least one standard disease-modifying medication
• People who are up to date on recommended vaccinations for their age

Additional requirements for people with RA (rheumatoid arthritis):

• People who have had a confirmed diagnosis of RA for at least 3 months, meeting a recognised set of classification criteria
• People whose RA is considered moderately to severely active at the time of screening
• People who test positive for certain RA-related antibodies (rheumatoid factor and/or anti-CCP antibodies)
• People who are already on a stable RA treatment plan, which may include low-dose steroids and at least one standard disease-modifying medication

Who may not be able to join:

• People who are pregnant or breastfeeding
• People who have a known allergy or reaction to the study drug (NTR-1011), its inactive ingredients, or related products
• People who have taken another experimental drug within 30 days (or within 5 half-lives of that drug) before the first dose, or who are currently enrolled in another clinical trial
• People who have had a cancer diagnosis within the past year (some limited exceptions may apply — confirm with trial site)
• People with significant kidney problems, severe liver problems, or severe lung disease
• People with uncontrolled high blood pressure or serious heart or blood vessel disease, such as a recent heart attack, stroke, or certain irregular heart rhythms
• People with an active, recurring, or high-risk infection, including active or untreated latent tuberculosis, opportunistic infections, or ongoing hepatitis B
• People who have recently had COVID-19 symptoms without a documented negative test result
• People who have received a live vaccine within 4 weeks before the screening visit, or who plan to receive one within 4 weeks after the last dose
• People with significant nervous system conditions or pain-amplifying conditions (such as epilepsy or fibromyalgia) that could affect study assessments
• People who have had major surgery within 8 weeks before screening, or who have surgery planned within 6 months after the study baseline visit
• People with a history of bone marrow, stem cell, or organ transplant (cornea transplants may be excepted — confirm with trial site)
• People with uncontrolled diabetes in the past 12 months (some exceptions may apply — confirm with trial site)
• People who have had a blood clot within the past 12 months (some exceptions may apply — confirm with trial site)
• People who have significantly abnormal blood test results (such as liver enzymes or blood cell counts) at the time of screening

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