Atopic Dermatitis
Conditions
Interventions
Two groups:inject QX005N Injection subcutaneously
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 years old and 70 years old), regardless of gender; 2. Suffering from AD at the screening visit (according to the American Academy of Dermatology 2014 guidelines), and at screening and baseline, according to the investigator's assessment, the degree of AD involvement meets the following three criteria: (1) Investigator's Global Assessment (IGA) score >= 3; (2) Eczema Area and Severity Index (EASI) score >= 16; (3) Involved body surface area (BSA) >= 10%; 3. After a comprehensive examination, including basic vital signs, general physical examination, laboratory tests (blood routine, urine routine, coagulation routine, blood biochemistry, thyroid function, anti-double-stranded DNA antibody, anti-nuclear antibody, RF, hsCRP, ESR) , 12-lead ECG, abdominal color Doppler ultrasound, chest frontal and lateral X-ray or chest CT examination, the results are normal or slightly abnormal but have no clinical significance; 4. Agree to have no reproductive plan during the trial and within 6 months after the trial, and voluntarily take effective contraceptive measures; 5. The subject fully understands the purpose, nature, method and possible adverse reactions of the test, volunteers as a subject, can sign the informed consent form, and abide by the requirements on the informed consent form; 6. The subjects can communicate well with the investigators, and can comply with the protocol requirements for follow-up.
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding women; 2. Allergic to the drug ingredients or excipients of this study; 3. Previous use of dupilumab injection or other IL-4R target drugs; 4. Received study drug treatment within 8 weeks or 5 half-lives (whichever is longer) before screening; 5. Are using the following drugs or have used the following drugs within a specific time before screening: received local glucocorticoid or local calcineurin inhibitor treatment within 1 week before screening; received systemic glucocorticoid treatment within 4 weeks before screening ;Use of systemic immunosuppressive/immunomodulatory therapy (eg, cyclosporine, mycophenolate mofetil, IFN-?, phototherapy (NBUVB, UVB, UVA1, PUVA), azathioprine, methotrexate within 4 weeks prior to screening urea); used systemic or topical Chinese medicine therapy within 4 weeks before screening; received allergen-specific immunotherapy within 6 months before screening; received live vaccines, live attenuated vaccines, or research studies within 2 months before screening During the period, there are plans to receive live vaccines and live attenuated vaccines; any biological agents have been used within 16 weeks or 5 half-lives (whichever is longer) before screening; 6. Patients with systemic acute or chronic infection requiring antibiotics, antiviral drugs, antiparasitic drugs, antiprotozoal drugs or antifungal drugs within 4 weeks before screening, or with herpes simplex infection within 2 weeks before screening, or before screening Suffering from superficial skin infection within 1 week. (Note: After the infection subsides, the patient can be re-screened, only once); 7. History of vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC) within 6 months before screening; 8. History of active tuberculosis, or active or latent tuberculosis infection at screening, or suspected tuberculosis infection at screening; 9. A known or suspected history of immunosuppression, including a history of invasive opportunistic infections (eg, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystis, and aspergillosis), even if the infection has resolved, should also be excluded; or unusual frequent, recurrent, or chronic infections; 10. Malignant tumors within 5 years before screening (completely cured in situ cervical cancer, non-metastatic squamous or basal cell carcinoma of the skin can be selected); 11. Have a history of major clinical diseases, such as circulatory system abnormalities, endocrine system abnormalities, nervous system diseases or blood system diseases, immune system diseases, mental diseases, etc. 12. Plan to undergo major surgery during the study period; 13. Donate blood or lose more than 400mL (inclusive) of blood within 8 weeks before starting to use the drug; 14. During screening or baseline examination, laboratory test indicators meet any of the following criteria: five hepatitis B + HBV-DNA (HBsAg positive and/or HBV-DNA positive), hepatitis C antibody positive, syphilis antibody (screening positive, by the investigator Combined with RPR results), HIV antibody positive; liver function: AST or ALT or total bilirubin>2 times the upper limit of normal (2xULN); renal function: serum creatinine>ULN; blood routine: hemoglobin (male)< 10.0 g/dL (100.0 g/L), or (women) <9.0 g/dL (90.0 g/L); total white blood cells <3.0x10^9/L; neutrophil counts<1.5x10^9/ L; Platelet count <90x10^9/L; 15. The investigator believes that there is a risk to the safety of the s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinety;efficacy; | — |
Countries
China
Contacts
Public ContactJin Hongzhong/Chen Rui
Peking Union Medical College Hospital
Outcome results
None listed