Moderate to severe atopic dermatitis
Conditions
Interventions
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.18-70 years old(including 18 and 70),male or female. 2.Chronic AD(according to the guidelines of AD from the American Academy of Dermatology in 2014) at the time of screening visit. 3.Meet the criteria below at the same time at both screening visit and baseline visit: IGA=3, EASI=16, BSA affected by AD=10%. 4.With history of inadequately controlled with topical medications, or topical treatment is medically inadvisable before the screening visit. 5.No birth plan or willing to use adequate birth control during study and within 6 months after the study. 6.With ability to understand contents of informed consent form (ICF), willing to sign and comply with terms in ICF. 7.Willing and able to comply with the planned clinic visits.
Exclusion criteria
Exclusion criteria: 1.Pregnant or breast-feeding women. 2.Allergic to ingredients or excipients of the study drugs. 3.Treatment with Dupilumab or other same-target drugs before the screening visit. 4.Treatment with an investigational drug or a medical device within 3 weeks before the screening visit. 5.History of or presence of diseases at screening visit as below: 1) Systematic chronic or acute infection requiring with treatment with antibodies, anti-virals, anti-parasitics, anti-protozoals, or anti-fungals within 4 weeks before the screening visit, or herpes simplex infection within 2 weeks before the screening visit, or superficial skin infection within 1 weeks before the screening visit. (If have an infection, the patient can be re-screened after infection has subsided for only once).2)History of or suspected immunosuppressive disorders, including invasive occasional infectious diseases (eg. histoplasmosis, listeriosis, coccidiodomycosis, pneumocystosis, and aspergillosis), even if the infection has subsided, or there are unusually frequent, recurrent or long-term infections,the patient should be ruled out.3)History of VKC or AKC within 6 months before the screening visit.4)History of malignancy within 5 years before the screening visit (except patients with a history of completely treated carcinoma in situ of cervix, and non-metastatic squamous or basal cell carcinoma of the skin).5)Any other medical or psychological history which may present an unreasonable risk to the study patient as a result of his/her participation in this clinical trial, may make patients participation unreliable, or may interfere with study assessments , in the opinion of the investigator, such as circulatory system abnormalities, endocrine system abnormalities, nervous system diseases, hematological system diseases, immune system diseases, mental diseases, etc. 6.Presence of any infectious diseases at screening visit as below:1)History of tuberculosis, or active or latent TB infection at the time of screening(according to T-spot.TB or QuantiFERON-TB Gold test results).2)Positive hepatitis B surface antigen (or negative HBsAg plus positive HBcAb plus positive HBV-DNA).3)Positive hepatitis C antibody plus positive HCV-RNA.4)Positive treponema pallidum antibody plus positive RPR test.5)History of HIV infection, or positive HIV antibody. 7.using or history of use of treatments below: 1)Treatment with TCS, or TCI ,or PDE-4 inhibitor, or JAK inhibitor, within 1 weeks before the baseline visit.2)Treatment with systematic traditional Chinese medicine therapies within 2 weeks before the baseline visit, or with topical traditional Chinese medicine therapies within 1 weeks before the baseline visit.3)Treatment with systematic corticosteroids, or systematic immunosuppressive/immunomodulating drugs (eg. cyclosporine, mycophenolate-mofetil, IFN-?, azathioprine, methotrexate), or phototherapy (NBUVB, UVB, UVA1, PUVA) within 4 weeks before the baseline visit.4)Treatment with allergen-specific immunotherapy (SIT) within 6 months before the baseline visit.5)Treatment with a live vaccine or an attenuated vaccine within 12 weeks before the baseline visit. 8.Laboratory testing results meet one of the criteria below at the time of screening and baseline visit:1)Aspartate aminotransferase (AST)/alanine aminotransferase (ALT)>2×the upper limit of normal (ULN) .2)Serum creatinine>1.2ULN. 9.Surgical procedure plans which may interfere with study assessments during the study. 10.Any conditi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in Eczema Area and Severity Index Score (EASI) from Baseline to week 16.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with IGA of 0 (clear) or 1 (almost clear) and a reduction of at least 2-point at week 16.;Proportion of subjects with IGA of a reduction of at least 2-point at week 16.;Proportion of subjects with EASI-50?EASI-75?EASI-90 at week 16.;Change in weekly Peak Daily Pruritus Numerical Rating Scale (NRS) score from baseline to week 16.;Change in Body Surface Area (BSA) affected by AD at every visit from baseline to week 16.;Change in skin lesion condition at every visit from baseline to week 16.;Proportion of subjects with IGA of 0 (clear) or 1 (almost clear) and a reduction of at least 2-point at every visit from baseline to week 24.;Proportion of subjects with a reduction of at least 2-point at every visit from baseline to week 24.;Proportion of subjects with EASI-50?EASI-75?EASI-90 at every visit from baseline to week 24.;Change in weekly Peak Daily Pruritus Numerical Rating Scale (NRS) score at every visit from baseline to week 24.;Change in Body Surface Area (BSA) affected by AD at every visit from baseline to week 24.;Change in skin lesions at every visit from baseline to week 16.;TEAEs;Serum concentrations of QX005N;ADA;Thymus and Activation Regulated Chemokine(TARC), total IgE level; | — |
Countries
China
Contacts
Public ContactJin Hongzhong
Outcome results
None listed