Status:
NOT_YET_RECRUITING
To Evaluate the Phase III Clinical Trial of TQH2722 Injection in the Treatment of Moderate to Severe Atopic Dermatitis
Lead Sponsor:
Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 Institu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06552520
Start Date
September 1 2024
End Date
June 1 2026
Last Update
August 14 2024
Active Locations (73)
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1
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China, 233004
2
Tongling People's Hospital
Tongling, Anhui, China, 244000
3
The Second Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China, 241000
4
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100050