Phase 1 Eczema 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 aged 12 years or older
• People who are able to understand the study and give their agreement to take part (or have a parent/guardian do so on their behalf)
• People who have a confirmed genetic change in the STAT3 gene that causes a condition called Hyper-IgE syndrome (also known as Job's syndrome)
• People who are already enrolled in a specific NIH natural history study (protocol 00-I-0159) for Hyper-IgE syndrome
• People who also have either lupus (SLE) meeting recognised classification standards, or moderate-to-severe atopic dermatitis (eczema) meeting specific severity score thresholds at the screening visit
• People who are able to swallow tablets and are willing to follow the study medication schedule
• People taking steroid medications (such as prednisone) at a dose of less than 10 mg per day, with that dose having been stable for at least 30 days before the study starts
• People taking antimalarial medications (such as hydroxychloroquine, chloroquine, or quinacrine) at a stable dose for at least 90 days before the study starts, and within specified maximum daily dose limits
• People taking cholesterol-lowering medications, provided those were started at least 90 days before the study begins and the dose has been stable for at least 30 days
• People who are capable of becoming pregnant and agree to use at least one reliable method of contraception during the study, starting 30 days before the study drug begins — acceptable methods include an intrauterine device (IUD), surgical sterilisation (tubes tied), a vasectomised partner, abstinence, or hormonal contraception combined with a barrier method

Who may not be able to join:

• People with a known allergic reaction or sensitivity to the study drug baricitinib or similar medications (JAK inhibitors)
• People who have taken part in another clinical trial involving an experimental drug within the past 6 months (or longer, depending on the drug), unless it was a COVID-19 vaccine or emergency-authorised COVID-19 therapy
• People who plan to join another clinical trial involving an experimental drug while this study is ongoing
• People who have used immune-suppressing or immune-modifying medications within the 90 days before the study starts, except for low-dose steroids (10 mg or less of prednisone per day)
• People who have been treated with rituximab within the 6 months before the study starts
• People currently taking methotrexate, mycophenolate mofetil, belimumab, or other immune-modifying or biologic medications — or who stopped taking these medications less than 90 days before the study starts
• People who have received cyclophosphamide or high-dose methylprednisolone (given by infusion) within the 6 months before the study starts
• People with high cholesterol or high triglyceride levels on fasting blood tests taken within the 90 days before the study starts (total cholesterol above 250 mg/dL, LDL above 180 mg/dL, or triglycerides above 300 mg/dL)
• People with a history of alcohol or drug misuse within the 6 months before the study starts
• People with certain significant abnormal blood test results at screening, including liver enzyme levels that are too high, low red blood cell counts, low white blood cell counts, low platelet counts, or signs of kidney problems (confirm specific thresholds with the trial site)
• People who have a major surgical procedure planned during the study period
• People who plan to receive a live vaccine within one month of starting the study drug
• People with known or suspected immune system disorders other than Job's syndrome, lupus-like disease, or atopic dermatitis
• People with active serious infections (such as certain fungal or bacterial infections) that suggest a severely weakened immune system, or who have unusually frequent or long-lasting infections
• People with known active tuberculosis (TB) — people with previously treated TB may be eligible; people with untreated latent TB (TB that is not active) will be assessed by an infection specialist before a decision is made
• People with HIV infection
• People with untreated hepatitis B or hepatitis C infection
• People who are unwilling to take a preventive antiviral medication (such as entecavir) if they show evidence of past hepatitis B infection with specific test results (confirm details with trial site)
• People found to have certain viral markers (BK or JC virus detected in the blood) at the screening visit
• People with an active infection requiring antibiotic or antiviral treatment that has not resolved at least 14 days before the first dose of the study drug
• People with active kidney disease, active central nervous system (brain or spinal cord) disease, or severe disease activity in any organ (other than joints) that requires immediate immune-suppressing treatment, as judged by the study doctor
• People with a history of most cancers — exceptions may apply for certain skin cancers or cervical changes that were fully treated and in remission for at least 12 months (or 5 years for other cancers), to be confirmed with the trial site
• People who are pregnant or currently breastfeeding
• People currently receiving kidney dialysis (either haemodialysis or peritoneal dialysis)
• People with certain heart or vascular conditions, including a history of heart attack, heart failure, cardiomyopathy, severe heart valve disease, significant heart rhythm problems, stroke or mini-stroke (TIA), aneurysm of the coronary arteries, or a known history of blood clots in arteries or veins
• People with uncontrolled diabetes or uncontrolled high blood pressure
• Current smokers, or people who stopped smoking less than 3 years ago, or people with a significant long-term smoking history (more than 20 pack-years)
• People with a history of bowel perforation or diverticulitis with a high risk of perforation
• People currently taking a medication called probenecid or similar drugs that can interfere with how the study drug is processed by the body
• People with uncontrolled thyroid disease, as assessed by the study doctor
• People with other medical conditions, physical examination findings, heart trace (ECG) results, or blood test findings that the study doctor believes could make participation unsafe or affect the study results

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