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

Launched by SHANGHAI CHIA TAI TIANQING PHARMACEUTICAL TECHNOLOGY DEVELOPMENT CO., LTD. · Aug 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called TQH2722 injection for people with moderate to severe atopic dermatitis, also known as eczema. The trial will involve 500 participants and aims to find out how safe and effective this new treatment is compared to a placebo, which is an inactive substance. Participants will be monitored for any side effects and the severity of their eczema will be assessed using specific scoring systems.

To be eligible for this trial, participants must be between 18 and 75 years old and have been diagnosed with atopic dermatitis that meets certain criteria, including having a significant level of skin involvement and itching. Participants should not have used certain medications or treatments for their eczema in the weeks leading up to the trial. If you are chosen to participate, you will receive either the TQH2722 injection or a placebo, and there will be regular check-ups to monitor your health throughout the study. This trial is not yet recruiting, so there will be more information available soon about how to participate.

Gender

ALL

Eligibility criteria

• 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 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.