A Clinical Study of TQH2722 Injection in the Treatment of Moderate to Severe Atopic Dermatitis

Inclusion Criteria:

• Age 18-65 (when signing informed consent), regardless of gender;
• Meets 2014 American Academy of Dermatology (AAD) criteria with diagnosis of atopicdermatitis (AD); In addition, history of AD prior to screening ≥ 6 months; Eczema waspreviously diagnosed but met the 2014 AAD criteria and can still be enrolled.
• Patients with moderate to severe AD at screening and baseline visit (shall meet all 3criteria as follows):

1. total area of AD lesions≥ 10% BSA;
2. IGA ≥3 points;
3. EASI ≥ 16 points;

• Baseline peak pruritus NRS ≥4 (The average peak pruritus intensity score in baselinepeak pruritus NRS will be calculated based on the average of the peak pruritusintensity NRS score (daily score range 0-10) for each day during the 7 days prior torandomization. A minimum of 4 days out of 7 days of scoring is required to calculatethe baseline average score. If the patient's reporting days are less than 4 days inthe 7 days prior to the planned randomization date, randomization should be postponeduntil the requirements are met, but not beyond the maximum period of 14 days forscreening);
• 6 months prior to the screening period, insufficient response to stable (≥1 month)topical corticosteroids (TCS) or calcineurin inhibitors (TCI) (insufficient responsedefined as at least 28 days even if the daily regimen of moderate-high potency TCS (±topical TCI, if applicable) is at least 28 days, or to the maximum recommended courseof treatment (eg, ultra-potent TCS - 14 days) in the product prescribing information (whichever is shorter), Failure to achieve or maintain disease remission or lowdisease activity (equivalent to IGA 0 [=none]-2 [=mild]). or patients who havereceived a record of systemic treatment (adequate dose, adequate course) of AD in thepast 6 months are also considered to have insufficient response to topical drugtherapy, and may be selected for trial after appropriate drug elution and approval bythe sponsor);
• Before the first dose, subjects must have continuously used the emollient twice a dayfor at least 1 week and maintained throughout the trial (Note: the emollient isprovided by the sponsor);
• Be able to read and understand, and be willing to sign informed consent forms;
• Willingness and compliance with research visits and related procedures;
• Female participants of childbearing age should agree that contraception (e.g.,intrauterine devices, pills, or condoms) must be used during the study period and for 6 months after the end of the study; Negative serum pregnancy test within 7 days priorto first dose and must be a non-lactating subject; Male subjects should agree thatcontraception must be used during the study period and for 6 months after the end ofthe study period.

Exclusion Criteria:

• Participants who received the following treatments within the following limited timeprior to randomization:

1. Have used any of the following treatments within 4 weeks or the investigatorbelieves that the following treatments may be required:immunosuppressants/immunomodulatory drugs (eg, systemic glucocorticosteroids,cyclosporine, mycophenolate mofetil, interferon γ (IFN-γ), azathioprine, andmethotrexate); AD phototherapy;
2. Oral Janus Kinase (JAK) inhibitors (including but not limited to upadacitinib)used within 2 weeks;
3. Received systemic traditional Chinese medicine (TCM) treatment within 4 weeks; orwithin 1 week, topical TCM;
4. Treated with leukotriene inhibitors within 4 weeks;
5. Treated with topical preparations of TCS or TCI or phosphodiesterase 4 (PDE⁃4)inhibitors within 2 weeks;
6. Treatment with the following biologics: any cell depleting agent, including butnot limited to rituximab: within 6 months or until the lymphocyte count returnsto normal, whichever is longer; Other biologics: 5 half-lives (if half-lifeknown) or 12 weeks (whichever is longer); Within 4 weeks, receive regularphototherapy (including but not limited to narrow-spectrum UVB, psoralen longwaveultraviolet therapy, etc.) or use artificial sunbathing sheds/rooms;
7. Within 12 weeks, receive live (attenuated) vaccine;
8. Chronic active or acute infection requiring systemic treatment with antibiotics,antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks, orsuperficial skin infection within 1 week prior to baseline visit. After theinfection resolves, screening can be renewed;
9. Antihistamines (including oral, nasal, and topical preparations) within 1 week;

• Abnormal physical examination results during screening or any of the followinglaboratory tests:

1. Hemoglobin< 110 g/L
2. White blood cell (WBC) < 3.5 x 10^9/L
3. Platelet count < 125 x 10^9/L
4. Neutrophils< 1.75 x 10^9/L • Aspartate aminotransferase (AST)/alanineaminotransferase (ALT) >1.5 x upper limit of normal (ULN)
5. Total bilirubin > 1.5 x ULN (except indirect bilirubin elevation secondary toGilbert syndrome)
6. Creatinine > 1.5 x ULN
7. Creatine phosphokinase (CPK) > 2 x ULN

• There are cutaneous comorbidities that may interfere with the study assessment,including but not limited to scabies, seborrheic dermatitis, cutaneous T-celllymphoma, psoriasis, etc
• Concomitant other serious medical conditions that, at the discretion of theinvestigator, may adversely affect participants' participation in this study,including, but not limited to: short life expectancy, history of uncontrolled diabetes (HbA1c ≥ 9%), cardiovascular disease (eg, grade III or IV heart failure, gradedaccording to the New York Heart Association), severe kidney disease (eg, patients ondialysis), hepatobiliary disease (e.g., Child-Pugh class B or C), neurological disease (e.g., demyelinating disease), Patients with important active autoimmune diseases (eg,lupus, inflammatory bowel disease, rheumatoid arthritis, etc.), as well as othersevere endocrine, gastrointestinal, metabolic, pulmonary, or lymphatic diseases.
• Have a history of known or suspected immunosuppression, including invasiveopportunistic infections (e.g., histoplasmosis, listeriosis, coccidioidomycosis,pneumocystosis, and aspergillosis), even if the infection has resolved; or unusualfrequent, recurrent, or long-term infections (at the investigator's discretion);
• Subjects with any type of active malignancy or a history of malignancy (exceptcervical cancer or non-metastatic cutaneous squamous cell carcinoma, basal cellcarcinoma and papillary thyroid carcinoma) that has been cured for more than 5 yearsprior to the screening period;
• Computed Tomography (CT) of the chest shows active or occult tuberculosis or a historyof contact with an open tuberculosis (TB) subject within the past 6 months. If thelaboratory T cell spot test for tuberculosis infection test (or other tuberculosisdiagnostic test) is positive, its activity is judged in combination with the medicalhistory, clinical manifestations, etc., and the investigator determines whether it canbe enrolled;
• Active hepatitis during the screening period, or positive for hepatitis B surfaceantigen (HBsAg), or positive for hepatitis B core antibody (HBcAb);
• History of human immunodeficiency virus (HIV) infection, or positive HIV serologicalresults at screening, and positive antibodies to treponema pallidum during screening
• Positive for treponemal pallidum antibodies during screening
• Parasitic infection related to any of the following is excluded:

1. Routine inspection of worm eggs during the screening period;
2. History of parasitic infection within 6 months prior to the screening period,except for cured trichomoniasis;

• Have participated in clinical trials of other drugs or medical devices within 12 weeksprior to screening
• During the period of participation in this study, participants had planned surgicalprocedures
• Pregnant or lactating women
• People who are alcoholic, drug addicts, and known drug dependents
• In the judgment of the investigator or sponsoring medical auditor, it is believed thatthere are any medical or psychiatric symptoms that put the subject at risk, interferewith participation in the study, or interfere with the interpretation of the resultsof the study.