Phase 1 Psoriatic Arthritis 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:

• People who have signed a consent form before any study procedures begin.
• People aged 18 or older, of any race or ethnicity.
• People whose body weight falls within a healthy range for their height (BMI between 18.0 and 35.0).
• People who are willing and able to attend scheduled clinic visits, stay in hospital when required, and complete blood tests and heart tests as part of the study.
• People diagnosed with rheumatoid arthritis (RA) for at least 3 months before the screening visit, with enough joint tenderness and swelling (at least 6 tender and 6 swollen joints) confirmed at two separate time points, and who have been on a stable dose of standard arthritis medication for at least 4 weeks — or who cannot tolerate standard arthritis medications.
• People diagnosed with psoriatic arthritis (PsA) for at least 3 months before screening, with at least one psoriasis skin patch of 2 cm or larger (not in the armpit or groin area), enough joint tenderness and swelling (at least 3 tender and 3 swollen joints) confirmed at two separate time points, and who have been on a stable dose of standard treatment for at least 4 weeks — or who cannot tolerate those treatments.
• People who are considered to be in good general health by the study doctor, based on tests, medical history, and physical check-up done at the screening visit.
• Women who are post-menopausal (at least 1 year, confirmed by a hormone test if less than 2 years since last period), or who have had a permanent sterilisation procedure, or who agree to use two highly effective forms of contraception from screening until 6 weeks after the last dose of the study drug (confirm specific methods accepted with trial site).
• Male participants who agree to use two highly effective forms of contraception with partners who could become pregnant, from screening until 90 days after the last dose of the study drug (confirm specific methods accepted with trial site).
• Women who test negative for pregnancy at screening and again on the first day of treatment.

Who may not be able to join:

• People with a significant medical condition or any other health reason that the study doctor believes would interfere with safe participation.
• People with a history of significant drug or alcohol problems in the past 6 months, as judged by the study doctor.
• Women who are pregnant, breastfeeding, currently undergoing fertility treatment, or planning to become pregnant during the study.
• People with a history of cancer in the past 5 years, except for certain treated skin cancers (non-spreading basal cell or squamous cell skin cancer) or a localised form of cervical cancer that has been fully treated.
• People with a history of other immune system, rheumatic, or skin diseases beyond RA or PsA (a secondary condition called Sjögren's syndrome is an exception and is allowed).
• People whose RA or PsA has caused serious involvement of other body systems, such as blood vessel inflammation, lung scarring, or a condition called Felty's syndrome.
• People who currently have certain types of psoriasis other than the most common plaque type (for example, pustular or erythrodermic forms) — nail psoriasis is allowed.
• People who have taken part in another clinical trial or received an experimental treatment within the past 3 months (or longer, depending on the drug) before the first dose of the study drug.
• People who have previously received certain specific treatments, including cell-depleting therapies (such as rituximab), targeted synthetic DMARDs (such as JAK inhibitors including baricitinib, tofacitinib, or upadacitinib), or biologic medications (such as adalimumab, secukinumab, or tocilizumab), among others (confirm full list with trial site).
• People who have not responded to more than one treatment targeting a protein called tumour necrosis factor (TNF).
• People taking steroid tablets at a dose higher than the equivalent of 10 mg of prednisone per day, or whose steroid dose has not been stable for at least 4 weeks before the first study dose — or who have received steroid injections (into joints, muscle, or vein) within 8 weeks before the first dose.
• People who have used certain psoriasis skin treatments (such as retinoids, topical steroids, or topical JAK inhibitors) within 2 weeks before the first dose, or certain light therapies within 4 weeks before the first dose.
• People taking strong opioid pain medicines within 2 weeks before the first study visit, or whose pain medicine dose has not remained stable throughout the screening period.
• People who have tested positive for COVID-19 during the screening period, or who have received a COVID-19 vaccine (including a booster) in the past 30 days, or who have received certain COVID-19 antiviral treatments within the past 30 days.
• People who show signs of active or latent tuberculosis (TB) based on blood tests, skin tests, or chest X-ray at screening.
• People who have had an active or returning infection in the past 4 weeks before screening that required antibiotic treatment (by tablet or by drip).
• People whose blood test results at screening fall outside acceptable ranges — for example, low red blood cell levels, low white blood cell counts, abnormal liver test results, or reduced kidney function (confirm specific values with trial site).
• People whose kidney function has worsened significantly in the past 3 months, or whose kidney filtration rate is below a certain level (confirm with trial site).
• People with a history of active or latent TB, unless there is documented proof of a completed course of TB treatment following local guidelines.
• People whose heart electrical activity reading (ECG) shows certain abnormalities at screening — specifically, a measurement called QTc(F) interval above 450 milliseconds in men or above 470 milliseconds in women.
• People who test positive for hepatitis B, hepatitis C, or HIV.
• People who have lost more than 250 mL of blood or donated blood in the past 56 days, or donated plasma in the past 7 days before screening.
• People who have received a live or inactivated vaccine in the past 30 days before screening (confirm specific vaccines with trial site).
• People who have been hospitalised for an infection or received antibiotic treatment by drip in the past 3 months, or who have taken oral antibiotics in the past 2 weeks before the first study visit.
• People who work at the study site or for the company sponsoring the trial, or who are immediate family members of such people.

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