Phase 2 Psoriasis 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 sign a consent form agreeing to participate
• Men and women who have been diagnosed with stable plaque psoriasis for 6 months or more, where "stable" means no major changes in the appearance or severity of the condition
• People whose doctor considers them a suitable candidate for systemic (whole-body) treatment for their psoriasis
• People where psoriasis covers at least 10% of their body surface area at the time of screening and on the first day of the study
• People with a psoriasis severity score (called PASI) of 12 or higher, and a doctor's overall assessment score (called sPGA) of 3 or higher, at both the screening visit and the first day of the study
• Men and women aged 18 to 70 years at the time of screening
• Women who could become pregnant must have a negative pregnancy test at screening and within 24 hours before starting the study treatment
• Women who could become pregnant must agree to use a highly effective form of contraception throughout the treatment period and for 33 days after the last dose
• Men who are sexually active with women who could become pregnant must agree to use contraception during treatment and for 3 days after the last dose, and must also agree not to donate sperm during this time

Who may not be able to join:

• People who have had phototherapy (light treatment) within 4 weeks before being enrolled in the trial
• People who have had an active infection or fever-related illness within 7 days before the first day of the study
• People who were hospitalised for a serious bacterial, fungal, or viral infection requiring intravenous antibiotics or antiviral treatment within 60 days before the first day of the study
• People who have any untreated bacterial infection within 60 days before the first day of the study
• People with ongoing signs of a long-term (chronic) bacterial infection, such as chronic kidney, bone, or lung infections
• People with a history of a confirmed infection in a joint implant (prosthesis) that was not removed or replaced, or who received antibiotics for a suspected joint implant infection that was not removed or replaced
• People who received a live vaccine within 60 days before the first day of the study, or who plan to receive one during the study or within 60 days of finishing treatment
• People who have active herpes zoster (shingles) sores at the time of screening or on the first day of the study
• People with a history of serious herpes zoster or herpes simplex infection, including infections that spread widely across the body, affected the brain or eyes, or returned more than once within 2 years
• People who test positive for hepatitis B virus at screening (confirm with trial site for specific test definitions)
• People who test positive for both hepatitis C antibody and a confirmatory hepatitis C test at screening
• People who test positive for HIV at screening
• People with a known or suspected condition that weakens the immune system, including a history of certain rare or serious infections, removal of the spleen, or a primary immune deficiency
• People with a history of active tuberculosis (TB), regardless of whether it was treated
• People showing signs or symptoms of active TB during the screening period, as assessed by the study doctor
• People whose chest imaging (such as a chest X-ray or CT scan) taken during screening or within 6 months before screening shows signs of current or past active TB
• People with a positive test result for latent (inactive) TB infection, unless they have completed documented adequate treatment within the past 5 years, or have started a course of preventive treatment and have been reassessed after at least one month of that treatment (confirm with trial site)
• People who have had major surgery within 8 weeks before the first day of the study, or who have planned surgery within the first 52 weeks of the study
• People who have donated more than 500 mL of blood within 4 weeks before the first day of the study, or who plan to donate blood during the study
• People the study doctor considers to have a drug or alcohol use problem within the past 6 months
• People who use medical marijuana or prescription marijuana for medicinal purposes
• People with a serious or unstable medical condition (such as affecting the kidneys, liver, blood, gut, hormones, lungs, mental health, nerves, or immune system) that, in the study doctor's judgement, would significantly increase the risk of participating
• People who have had an unstable heart or cardiovascular event (such as a heart attack, stroke, unstable chest pain, or rapid irregular heartbeat) within the past 3 months, or who were hospitalised for a heart-related procedure (such as fitting a pacemaker or a procedure to open blocked arteries) within 3 months before screening
• People with uncontrolled high blood pressure (a reading above 160/100 mmHg on two separate occasions)
• People with severe heart failure classified as Class III or IV by standard medical criteria
• People who have had cancer (including blood cancers or lymphoma) within the past 5 years, with the exception of certain treated skin cancers or treated cervical carcinoma in situ with no signs of return
• People with uncontrolled mental health conditions considered clinically significant by the study doctor, or any history of suicidal thoughts, suicidal behaviour, or suicide attempts
• People who have received the investigational drugs being studied in this trial (deucravacitinib or apremilast) within the past 6 months
• People who have previously used certain biologic medicines for psoriasis and have not waited long enough since the last dose — the required waiting period varies depending on the type of biologic used (confirm with trial site for specific medicines and timeframes)
• People who have taken certain non-biologic psoriasis medicines or immune-suppressing medicines (such as methotrexate, cyclosporine, oral steroids, or others) within 4 weeks before the first day of the study
• People who have used leflunomide within 6 months before the first day of the study
• People who have used opioid painkillers within 4 weeks before the first day of the study
• People who have taken lithium, antimalarial medicines, or injected gold treatments within 4 weeks before the first day of the study
• People who have taken strong medicines known to affect how the body processes other drugs (called strong CYP450 inducers, such as rifampin, phenobarbital, carbamazepine, or phenytoin) within 4 weeks before the first day of the study
• People who have used strong topical (applied to the skin) psoriasis treatments — such as high-strength steroid creams, certain skin acids, or other prescription skin treatments — within 2 weeks before the first day of the study (some lower-strength products on certain body areas may be permitted — confirm with trial site)
• People who have used medicated shampoos containing steroids, coal tar, high-strength salicylic acid, or vitamin D3 within 2 weeks before the first day of the study
• People who have received an experimental antibody or biologic treatment within the past 6 months, or any other experimental treatment within 30 days or 5 half-lives (whichever is longer) before the first day of the study, or who are currently enrolled in another clinical trial
• People whose blood test results at screening fall outside acceptable ranges for white blood cells, lymphocytes, neutrophils, platelets, or haemoglobin levels (confirm with trial site for specific values)
• People whose blood test results show liver enzyme levels more than 3 times the upper limit of normal, or bilirubin levels more than twice the upper limit of normal
• People whose thyroid hormone levels are outside the normal range
• People with significant heart rhythm abnormalities on an electrocardiogram (ECG) that the study doctor considers would make participation unsafe
• People with significantly reduced kidney function, based on a standard kidney function test result below a certain threshold (confirm with trial site)

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