To Evaluate the Phase III Clinical Trial of TQH2722 Injection in the Treatment of Moderate to Severe Atopic Dermatitis

Korábbi kezelés

• Used immunosuppressants/immunomodulatory drugs, ultraviolet phototherapy, systemic Chinese medicine treatment within 4 weeks before randomization.
• Received topical calcineurin inhibitors (TCS), topical calcineurin inhibitors (TCI), and other topical preparations within 2 weeks before randomization.
• Received anti-interleukin-4 receptor alpha (IL-4R) monoclonal antibodies, anti-ige monoclonal antibodies, or other biologic agents within 12 weeks or 5 half-lives (whichever is longer) prior to randomization.
• Had received live attenuated vaccine within 12 weeks prior to randomization or planned to receive it during the study period.
• Use of antihistamines within 1 week prior to randomization (unless you have received steady doses of antihistamines for at least 7 days).
• Received allergen specific immunotherapy within 6 months before randomization.
• Screening period of treponema pallidum antibody positive.
• Participated in clinical trials of other drugs or medical devices within 12 weeks prior to randomization.
• Treatment-requiring infections were present in the 4 weeks prior to randomization.
• During the study period, subjects plan to undergo major surgical operations.
• Alcohol, drug abuse and known drug dependence.

Más betegség

• There is a history of clinically significant illness that the investigator believes poses a risk to the safety of the subject and is poorly controlled.
• A known or suspected history of immunosuppression (immune deficiency).
• Subjects with any type of active malignancy or a history of malignancy (except cervical cancer or non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma, and papillary thyroid carcinoma that have been cured for more than 5 years prior to the screening period).
• Subject may have active Mycobacterium tuberculosis infection.
• Subjects with severe liver and kidney function impairment.
• Screening period HIV antibody positive, or have a history of HIV infection.
• History of atopic keratoconjunctivitis with corneal involvement.
• The subject has any medical or psychiatric symptoms that interfere with participation in the study or with the interpretation of the study results.

Egyéb

• There are skin comorbidities that may interfere with study evaluation.
• Pregnant or lactating women.

• The age of signing the informed consent is 18-75 years old, regardless of gender.
• Meet the 2014 American Academy of Dermatology (AAD) standards, diagnosed as AD.
• During screening and baseline visit, eczema area and severity score (EASI) ≥16 points; Investigator global score (IGA) ≥3 points; Affected body surface area (BSA) ≥10%; Baseline pruritus Peak Value Scale (NRS) weekly mean ≥4 points.
• Have received at least 4 weeks of moderate-to-strong action or at least 2 weeks of super effective external glucocorticoid (TCS) treatment or sufficient duration of systemic glucocorticoid treatment, the efficacy is not sufficient; Or subjects cannot receive the above treatment due to adverse reactions or potential risks.