TQH2722 injection
DrugHumanized interleukin-4 receptor alpha (4Rα) monoclonal antibody
NCT Number: NCT06552520
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.
This study is active but is not currently recruiting participants.
Notify Me18 year–75 year
All sexes
Interventional
Phase 3
The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Humanized interleukin-4 receptor alpha (4Rα) monoclonal antibody
Placebo without drug substance
Time frame: 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)
Time frame: 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.
Time frame: After medication to 60 weeks
Adverse events that occur during treatment
Time frame: After medication to 60 weeks
Relatively stable concentration levels of TQH2722
Time frame: After medication to 60 weeks
The incidence and titer of drug-resistant antibodies (ADA) in subjects
Time frame: After medication to 60 weeks
Incidence of neutralizing antibodies (Nab)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: After medication to 60 weeks
Assess how much the skin problems of the last week have affected the subjects' lives
Time frame: 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.
Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.
Industry
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQH2722 Injection in the Treatment of Moderate to Severe Atopic Dermatitis in Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05559359
Atopic Dermatitis, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Birmingham, Alabama, United States
View Trial DetailsNCT06395948
Atopic Dermatitis, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Fountain Valley, California, United States
View Trial DetailsNCT07700745
Atopic Dermatitis, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Las Vegas, Nevada, United States
View Trial DetailsNCT07217015
Atopic Dermatitis, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Birmingham, Alabama, United States
View Trial Details