Phase 2 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 who are willing to follow the study procedures, attend required follow-up appointments, and sign a consent form agreeing to take part
• People who are able to complete study questionnaires on their own or with help from a caregiver or support person
• People who are between 18 and 70 years old (inclusive) at the time of signing the consent form
• People who have been formally diagnosed with atopic dermatitis (eczema) using recognised diagnostic criteria, and who have had a history of atopic dermatitis or eczema for at least 1 year before the screening visit
• People whose atopic dermatitis is rated as moderately to severely active based on a standard skin assessment score (EASI ≥16) at both the screening and baseline visits
• People whose skin condition is rated at a certain level of severity by the investigating doctor (IGA score of 3 or higher on a standard scale) at both screening and baseline visits
• People whose atopic dermatitis affects at least 10% of their total body surface area at both screening and baseline visits
• People who report a moderate-to-severe average itch score (4 or higher out of 10) based on daily itch ratings recorded over the 7 days before the start of the study
• People who, within the 6 months before screening, did not respond adequately to topical (applied to skin) medications, or for whom topical medications were not medically appropriate due to significant side effects or safety concerns
• People who have been regularly applying a basic, plain moisturiser to their skin at least twice a day for at least 7 days in a row before the start of the study
• People of childbearing potential, and their partners, who agree to use an accepted form of contraception throughout the study and for 6 months after it ends, and who do not plan to donate eggs or sperm during that time

Who may not be able to join:

• People who are pregnant, breastfeeding, or have a positive pregnancy test result at screening
• People who have consumed more than 14 units of alcohol per week on average, or who have misused drugs, within the 6 months before screening
• People whose blood test results at screening or baseline fall outside acceptable ranges — including low haemoglobin, low white blood cell count, low neutrophil count, or low platelet count (confirm with trial site for specific values)
• People whose liver function blood tests (ALT or AST) are significantly above the normal upper limit, or whose bilirubin or creatinine levels are above acceptable thresholds (confirm with trial site for specific values)
• People who test positive for hepatitis B (with viral activity detected), hepatitis C (with viral activity detected), HIV, or syphilis
• People whose heart tracing (ECG) at screening shows clinically significant abnormalities, such as signs of heart attack, serious irregular heartbeat, or a prolonged QT interval (a measure of heart electrical activity)
• People who have a history of certain serious eye conditions related to allergies (vernal or atopic keratoconjunctivitis), or who have active skin conditions that could be confused with atopic dermatitis or make it difficult to assess treatment effects (such as psoriasis, ringworm, lupus affecting the skin, or contact dermatitis)
• People with a known or suspected history of immune system disorders, or a history of serious, unusual, or frequently recurring infections
• People who have an active infection requiring systemic (whole-body) treatment with antibiotics or similar medicines within 2 weeks before screening, or between screening and the baseline visit
• People with evidence of active tuberculosis or a suspected hidden tuberculosis infection
• People who have been diagnosed with lymphoma, leukaemia, or any cancer within the 5 years before screening (with some exceptions for certain fully removed skin cancers — confirm with trial site)
• People with significant ongoing medical conditions affecting the heart, brain, lungs, liver, kidneys, digestive system, hormones, blood, nervous system, or mental health that could interfere with the study, as determined by the investigating doctor
• People with a known allergy to the study drug (SM17) or its ingredients, a history of severe allergic reactions to other medicines or to monoclonal antibody treatments, or a history of serious skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis
• People who have recently used systemic (whole-body) corticosteroids, immune-suppressing medicines, or JAK inhibitors for atopic dermatitis within 4 weeks before the baseline visit, and who cannot stop these during the study
• People who have used antihistamines or inhaled corticosteroids within 1 week before baseline at a dose that is not stable, and who cannot continue at a stable dose throughout the study
• People who have used systemic herbal treatments for atopic dermatitis within 4 weeks before baseline and cannot stop these during the study
• People who have received ultraviolet light therapy for atopic dermatitis, or who regularly used artificial tanning for their skin condition, within 4 weeks before baseline
• People who have had 2 or more bleach baths within the 2 weeks before baseline
• People who have used topical corticosteroids, topical calcineurin inhibitors, topical traditional Chinese medicines, or other topical treatments (such as PDE-4 inhibitors) for atopic dermatitis within 1 week before baseline
• People who have previously received certain biologic medicines (such as rituximab or other cell-depleting agents) or other biologics within a specific timeframe before baseline (confirm with trial site for exact timeframes)
• People who have received allergen immunotherapy (desensitisation treatment) within 6 months before baseline
• People who have used prescription moisturisers or moisturisers containing active ingredients such as ceramides, hyaluronic acid, urea, or related substances within 1 week before baseline
• People who have had major surgery within 3 months before baseline, have not yet recovered from surgery, or plan to have major surgery during the study
• People who have donated blood, experienced significant blood loss, received a blood transfusion, or donated bone marrow stem cells within certain timeframes before screening (confirm with trial site for specific timeframes)
• People who have received a live attenuated vaccine (such as certain vaccines that use a weakened form of a virus) within 3 months before baseline, or who plan to receive one during the study
• People who have taken part in another interventional clinical trial within 6 months before baseline
• People who have previously taken part in a clinical study involving an anti-IL-25 antibody or anti-IL-17RB antibody (including SM17)
• People who have had other conditions within 12 months before screening that, in the investigating doctor's opinion, could pose a risk to their safety or interfere with the study

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