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NCT Number: NCT06552520

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TQH2722 injection

Drug

Humanized interleukin-4 receptor alpha (4Rα) monoclonal antibody

Placebo of TQH2722 injection

Drug

Placebo without drug substance

Primary outcomes

  1. 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 participants who achieved EASI-75 (≥75% improvement from baseline) on the eczema Area and Severity score (EASI)

  2. 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

    Percentage of subjects with an Investigator's Overall Rating (IGA) score (5-scale) of 0 or 1 and ≥2 points decline from baseline.

Secondary outcomes

  1. The incidence of adverse events

    Time frame: After medication to 60 weeks

    Adverse events that occur during treatment

  2. Steady valley concentration of TQH2722

    Time frame: After medication to 60 weeks

    Relatively stable concentration levels of TQH2722

  3. The incidence and titer of drug-resistant antibodies (ADA) in subjects

    Time frame: After medication to 60 weeks

    The incidence and titer of drug-resistant antibodies (ADA) in subjects

  4. Incidence of neutralizing antibodies (Nab)

    Time frame: After medication to 60 weeks

    Incidence of neutralizing antibodies (Nab)

  5. Eczema area and severity score (EASI) change from baseline

    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.

  6. Rate of change from baseline in the Investigator's overall Score (IGA)

    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.

  7. Change of body surface area from baseline in moderate to severe atopic dermatitis

    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.

  8. Change rate of atopic dermatitis score (SCORAD) from baseline

    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.

  9. Change in daily Peak Itch Digital Rating Scale (NRS) score from baseline

    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.

  10. Rate of change in dermatological quality of life (DLQI) score from baseline

    Time frame: After medication to 60 weeks

    Assess how much the skin problems of the last week have affected the subjects' lives

  11. Change in patients' self-assessment of eczema (POEM) from baseline

    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.

Sponsors and collaborators

Lead sponsor

Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 14, 2024
Registry last updated
Apr 20, 2026

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.

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