Phase 1 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 have signed a consent form before any study procedures begin.
• People aged 18 or older, regardless of race or ethnicity.
• People whose body mass index (a measure of body weight relative to height) falls between 18.0 and 40.0 at the screening visit.
• People who are willing and able to follow all study requirements, including clinic visits, an inpatient stay, blood tests, and heart trace (ECG) tests.
• People whom the study doctor judges to be in good general health, based on physical checks, blood tests, medical history, and heart traces done at the screening visit.
• Women who are past menopause, have had a permanent sterilisation procedure, or — if they could become pregnant and are sexually active in a way that could lead to pregnancy — agree to use two highly effective methods of contraception from screening until 6 weeks after the last dose. Male participants whose partner could become pregnant must also agree to two highly effective contraception methods between them and their partner, from screening until 90 days after the last dose. Accepted methods include hormonal implants, intrauterine devices (IUDs), hormonal IUD systems, tubal occlusion, combined hormonal contraception (pill, vaginal ring, patch, or injection), progestogen-only pill or injection, vasectomy (for male participants), full sexual abstinence throughout the risk period (confirm with trial site), or double-barrier methods such as a condom used together with a cervical cap, diaphragm, or sponge with spermicide.
• Women who have a negative blood pregnancy test at screening, and — if they could become pregnant — a negative urine pregnancy test on the first dosing day.

For the Atopic Dermatitis (eczema) group, additionally:

• People with a confirmed eczema diagnosis for at least 12 months before screening, meeting specific severity scores on standardised skin assessment tools at both screening and the start of the study (confirm exact score thresholds with trial site).
• People with a documented history, recorded by a doctor, of their eczema not responding well enough to topical (applied to skin) treatments within the past 6 months, or who have had significant side effects from topical treatments — for example, not achieving good disease control after at least 4 weeks of a medium-strength topical steroid, having had serious skin or other reactions to topical steroids, or having previously tried and not responded to systemic (whole-body) treatments for eczema.

For the Plaque Psoriasis group, additionally:

• People with a confirmed plaque psoriasis diagnosis for at least 6 months before the start of the study.
• People with plaque psoriasis covering at least 10% of their body surface area (not counting the face or scalp) at both screening and the start of the study.
• People who meet specific severity score thresholds on standardised psoriasis assessment tools at both screening and the start of the study (confirm exact thresholds with trial site).
• People whom the study doctor considers suitable for light therapy or systemic (whole-body) treatment.
• People who have had no significant worsening of their psoriasis in the 3 months before screening.

Who may not be able to join:

• People with a history of significant medical conditions that, in the study doctor's opinion, would interfere with taking part.
• People with a significant history of drug or alcohol misuse in the past 6 months, in the study doctor's opinion.
• Women who are pregnant, breastfeeding, currently undergoing fertility treatments, or who plan to become pregnant during the study or within 6 weeks of the last dose.
• People with other skin conditions that would interfere with the study's skin assessments or treatment response.
• People with a history of any cancer in the past 5 years, except for certain fully treated, non-spreading skin cancers or a localised form of cervical pre-cancer (confirm with trial site).
• People who currently have a skin infection that requires or is being treated with antibiotic creams or tablets.
• People who have had an active shingles (herpes zoster) outbreak within 3 months of screening.
• For the psoriasis group only: People with unstable or drug-triggered forms of psoriasis, or people who have used oral or injected corticosteroids for more than 2 weeks for a non-psoriasis condition within the past 24 weeks.
• People who have taken part in another clinical trial within 3 months, or within 5 times the drug's clearance time (whichever is longer), before the first study dose.
• People who have used certain topical (skin-applied) treatments within 2 weeks before the start of the study, including topical steroids, immune-modulating creams, certain anti-inflammatory creams, antihistamine creams or tablets, or moisturisers/emollients (confirm with trial site).
• People who have recently used certain oral or systemic treatments, including oral retinoids within 2 weeks, or immune-suppressing/modulating drugs or light therapy within 4 weeks before screening. (An inhaled steroid at a stable, low dose may be allowed — confirm with trial site.)
• People who have recently used certain cell-depleting therapies (confirm with trial site), unless at least one year has passed since their last dose.
• People who have used certain biologic medicines — including dupilumab, tralokinumab, ustekinumab, secukinumab, ixekizumab, or anti-TNF treatments — within 8 weeks or 5 times the drug's clearance time (whichever is longer) before the study.
• People whose eczema or psoriasis did not respond well enough to certain biologic medicines (including those listed above).
• People who have had PUVA or UVB light therapy within 4 weeks before the start of the study.
• People with signs of active or latent (hidden) tuberculosis (TB) detected through blood tests, skin tests, or chest X-ray at screening.
• People who have had a serious infection requiring hospitalisation or intravenous antibiotics in the 8 weeks before screening, or an infection requiring oral antibiotics in the 2 weeks before screening.
• People whose blood test results at screening fall outside acceptable ranges for measures including haemoglobin (red blood cells), white blood cells, neutrophils (infection-fighting cells), liver function markers, bilirubin, or platelets (confirm specific values with trial site).
• People with significantly worsened kidney function in the past 3 months, or whose kidney filtration rate is below a certain level at screening (confirm with trial site).
• People with clinically significant abnormal heart trace (ECG) results at screening, including a heart electrical interval measurement that exceeds defined limits (confirm with trial site).
• People who test positive for hepatitis B, hepatitis C (confirmed by further testing), or HIV.
• People who have lost more than 250 mL of blood, 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 within 30 days before screening (confirm specific vaccine types with trial site).
• People with a known allergy or sensitivity to any ingredient in the study drug.
• People who are employees of the study site or the study sponsor, or their immediate family members.

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