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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
500
Humanized interleukin-4 receptor alpha (4Rα) monoclonal antibody
Placebo without drug substance
Participants who achieved EASI-75 (≥75% improvement from baseline) on the eczema Area and Severity score (EASI)
Percentage of participants who achieved EASI-75 (≥75% improvement from baseline) on the eczema Area and Severity score (EASI)
Time frame: Baseline to 16 weeks after treatment
Subjects with an Investigator's Overall Rating (IGA) score (5-scale) of 0 or 1 and ≥2 points decline from baseline
Percentage of subjects with an Investigator's Overall Rating (IGA) score (5-scale) of 0 or 1 and ≥2 points decline from baseline.
Time frame: Baseline to 16 weeks after treatment
The incidence of adverse events
Adverse events that occur during treatment
Time frame: After medication to 60 weeks
Steady valley concentration of TQH2722
Relatively stable concentration levels of TQH2722
Time frame: After medication to 60 weeks
The incidence and titer of drug-resistant antibodies (ADA) in subjects
The incidence and titer of drug-resistant antibodies (ADA) in subjects
Time frame: After medication to 60 weeks
Incidence of neutralizing antibodies (Nab)
Incidence of neutralizing antibodies (Nab)
Time frame: After medication to 60 weeks
Eczema area and severity score (EASI) change from baseline
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.
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The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Tongling People's Hospital
Tongling, Anhui, China
The Second Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of the Chinese People's Liberation Army Army Medical University
Chongqing, Chongqing Municipality, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Chongqing Three Gorges Medical College affiliated People's Hospital
Chongqing, Chongqing Municipality, China
The Second Affiliated Hospital of Xiamen Medical College
Xiamen, Fujian, China
Dermatology Hospital of Southern Medical UniversityDermatology Hospital of Southern Medical University
Guangzhou, Guangdong, China
...and 63 more locations
Time frame: From baseline to week 60
Rate of change from baseline in the Investigator's overall Score (IGA)
The researchers assessed the form of the dermatitis using a 5-point scale (0-5), with higher scores being more severe.
Time frame: After medication to 60 weeks
Change of body surface area from baseline in moderate to severe atopic dermatitis
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.
Time frame: After medication to 60 weeks
Change rate of atopic dermatitis score (SCORAD) from baseline
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.
Time frame: After medication to 60 weeks
Change in daily Peak Itch Digital Rating Scale (NRS) score from baseline
Rate the most severe itching in the past 24 hours on a scale of 0-10, with higher numbers being more severe.
Time frame: After medication to 60 weeks
Rate of change in dermatological quality of life (DLQI) score from baseline
Assess how much the skin problems of the last week have affected the subjects' lives
Time frame: After medication to 60 weeks
Change in patients' self-assessment of eczema (POEM) from baseline
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.
Time frame: After medication to 60 weeks