Atopic Dermatitis
Conditions
Brief summary
This is a randomized, double-blind, placebo-controlled clinical trial with 500 participants. In this study, the safety evaluation used the common toxic reaction criteria of the National Cancer Institute to evaluate the adverse events of the drugs, and the effectiveness evaluation used the eczema area and severity score and the overall investigator score to confirm the efficacy.
Interventions
Humanized interleukin-4 receptor alpha (4Rα) monoclonal antibody
DRUGPlacebo of TQH2722 injection
Placebo without drug substance
Sponsors
Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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. * There are skin comorbidities that may interfere with study evaluation. * 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. * 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. * Pregnant or lactating women. * Alcohol, drug abuse and known drug dependence. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants who achieved EASI-75 (≥75% improvement from baseline) on the eczema Area and Severity score (EASI) | Baseline to 16 weeks after treatment | Percentage of participants who achieved EASI-75 (≥75% improvement from baseline) on the eczema Area and Severity score (EASI) |
| Subjects with an Investigator's Overall Rating (IGA) score (5-scale) of 0 or 1 and ≥2 points decline from baseline | Baseline to 16 weeks after treatment | Percentage of subjects with an Investigator's Overall Rating (IGA) score (5-scale) of 0 or 1 and ≥2 points decline from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of adverse events | After medication to 60 weeks | Adverse events that occur during treatment |
| Steady valley concentration of TQH2722 | After medication to 60 weeks | Relatively stable concentration levels of TQH2722 |
| The incidence and titer of drug-resistant antibodies (ADA) in subjects | After medication to 60 weeks | The incidence and titer of drug-resistant antibodies (ADA) in subjects |
| Incidence of neutralizing antibodies (Nab) | After medication to 60 weeks | Incidence of neutralizing antibodies (Nab) |
| Eczema area and severity score (EASI) change from baseline | From baseline to week 60 | The affected area of each site was assessed. According to the percentage of the affected area, the corresponding Region score was 0 to 6. The higher the score, the more severe the involvement. |
| Rate of change from baseline in the Investigator's overall Score (IGA) | After medication to 60 weeks | The researchers assessed the form of the dermatitis using a 5-point scale (0-5), with higher scores being more severe. |
| Change of body surface area from baseline in moderate to severe atopic dermatitis | After medication to 60 weeks | The researchers used a nine-point scale to assess the percentage of AD affected area in the whole body (0-100%), with the larger the value, the more severe the involvement. |
| Change rate of atopic dermatitis score (SCORAD) from baseline | After medication to 60 weeks | According to the involvement of skin surface area, the severity of skin lesions and the subjective symptom score, the higher the value, the more severe the dermatitis. |
| Change in daily Peak Itch Digital Rating Scale (NRS) score from baseline | After medication to 60 weeks | Rate the most severe itching in the past 24 hours on a scale of 0-10, with higher numbers being more severe. |
| Rate of change in dermatological quality of life (DLQI) score from baseline | After medication to 60 weeks | Assess how much the skin problems of the last week have affected the subjects' lives |
| Change in patients' self-assessment of eczema (POEM) from baseline | After medication to 60 weeks | The number of days in the past 7 days to assess whether eczema caused skin problems such as itching and bleeding, 0 indicates no days, 1 indicates 1-2 days, 2 indicates 3-4 days, 3 indicates 5-6 days, and 4 indicates all days. |
Countries
China
Outcome results
None listed