Atopic dermatitis
Conditions
Interventions
50mg QD group:Take the medication on an empty stomach, once a day, for a duration of 12 weeks.
100mg QD group:Take the medication on an empty stomach, once a day, for a duration of 12 weeks.
200mg QD group:Take the medication on an empty stomach, once a day, for a duration of 12 weeks.
Placebo:Take the medication on an empty stomach, once a day, for a duration of 12 weeks.
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: Participants must meet all of the following criteria to participate in the trial: (1) Voluntarily sign an informed consent form (ICF), be able to communicate well with the researcher, and understand and comply with the requirements and limitations of this study; (2) When signing the ICF, the age should be between 18 and 75 years old, with no gender restrictions; (3) During screening/baseline visits, the patient was diagnosed with AD by the researcher according to Hanifin&Rajka criteria (1980) (Appendix 1), and the disease duration from the first appearance of AD related rash/symptoms to screening was >= 1 year; (4) During screening and baseline, according to the researcher's evaluation, it meets the criteria for moderate to severe Alzheimer's disease: Eczema area and severity index (EASI) score >= 16; Researcher's overall assessment (IGA) score >= 3; Affected body surface area (BSA) >= 10%; Itch NRS score >= 4; (5) According to the researchers' judgment, the participants have a history of poor response or intolerance to external corticosteroids (TCS) or external calcineurin inhibitors (TCI) treatment, or other medical considerations do not recommend external treatment; (6) Able and willing to use only moisturizers provided by the sponsor that do not contain ingredients that affect efficacy evaluation, starting at least 7 days before baseline, and continue to use them during the study period; (7) All female participants with reproductive potential and all male participants must sign the ICF and have no pregnancy or sperm donation plan for at least 3 months after the last dose of the study. They must comply with contraception regulations and use at least one highly effective contraceptive method . (Note: Male participants who cohabit with female partners with reproductive potential must be willing to use condoms on the basis of their partner's use of efficient contraceptive methods).
Exclusion criteria
Exclusion criteria: Exclusion criteria: Participants who meet any of the following exclusion criteria must be excluded: (1) Suffering from other skin diseases (such as systemic erythroderma, psoriasis, lupus erythematosus, Netherton syndrome, etc.) that may confuse the diagnosis of AD or affect the evaluation of treatment efficacy, skin infections, or pigmentation, scars, fetal spots, tattoos, etc. at the affected area, which may affect the evaluation of skin lesions according to the researcher's judgment; (2) Have a history of severe herpes zoster or severe herpes simplex (including but not limited to disseminated herpes zoster, generalized herpes zoster, central nervous system herpes zoster, ocular herpes zoster, recurrent herpes zoster (occurring twice or more within 2 years), or a current history of herpes simplex or herpes zoster infection; (3) History of bacterial, fungal, or viral infections requiring hospitalization or intravenous anti infective treatment within 3 months prior to the first administration; (4) History of bacterial, fungal, or viral infections requiring oral anti infective treatment within 4 weeks prior to the first administration; (5) Within 7 days before the first administration, there is an active infection or acute disease state (such as fever, nausea, vomiting, or diarrhea); (6) In screening or baseline, the presence of chronic or recurrent infectious diseases, including but not limited to chronic kidney infection, recurrent urinary tract infection, chronic chest infection, fungal infection (except for superficial nail fungal infection) or infectious skin wounds or ulcers, may increase the safety risk of participants as assessed by the investigator; (7) Meet any of the following tuberculosis screening criteria: Present or past medical history of active tuberculosis infection; During the screening period, the researcher judged that there were signs or symptoms of active tuberculosis; Chest CT indicates current or previous active tuberculosis infection; The results of the interferon gamma release test show evidence of latent tuberculosis infection, defined as: positive interferon gamma release test during screening or uncertain results from two consecutive interferon gamma release tests, and no clinical symptoms. Unless there is a record indicating that the participant has completed sufficient treatment for latent tuberculosis infection, or started preventive treatment at least 4 weeks before the first dose, and agrees to complete subsequent preventive treatment courses, the entire course of preventive measures does not need to be completed before the first dose. Note: 1)The use of rifampicin or rifampicin for tuberculosis prevention is not allowed. 2)If the tuberculosis test result is uncertain, a retest can be conducted once. (8) Those who have received attenuated live vaccine within 4 weeks before the first administration, or plan to receive attenuated live vaccine at any time during the treatment period or within 8 weeks after the completion of the study; (9) Patients with significant or unstable digestive/hepatobiliary, renal/urinary, cardiovascular, respiratory, endocrine, hematological, immune, or central nervous system diseases within 6 months prior to the first administration, who, according to the researcher's judgment, do not meet the clinical research conditions, such as but not limited to pancreatitis, unstable angina, myocardial infarction, symptomatic congestive heart failure (New York
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with at least 75% improvement from baseline in the Eczema Area and Severity Index (EASI 75); | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of participants whose eczema area and severity index improved by at least 75% compared to baseline (EASI 75);Proportion of participants reaching EASI 50/90 ;The proportion of participants who achieved IGA score of 0 or 1 and improved by >= 2 points from baseline ;The proportion of participants who achieved 0 or 1 IGA score;The proportion of participants whose Itch NRS scores improved by >= 4 points from baseline ;Percentage change in EASI score compared to baseline ;Percentage change in SCORAD score compared to baseline ;Changes in Itch NRS score compared to baseline ;Percentage changes in affected body surface area (BSA) compared to baseline ;Changes in Dermatology Quality of Life Index (DLQI) scores from baseline ; | — |
Countries
China
Contacts
Public ContactCui yong
China-Japan Friendship Hospital
Outcome results
None listed