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Atopic DermatitisPhase 3NCT06552520

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

A Phase 3 study testing TQH2722 injection in people with Atopic Dermatitis, run by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. at 73 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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 Institute to evaluate the adverse events of the drugs, and the effectiveness evaluation used the eczema area and severity… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Atopic Dermatitis
What is being tested?
TQH2722 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
500 participants
Where
73 sitesChina
Study dates
8 Oct 2024to Jun 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 21Show fewer
  • 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.

Trial locations and contacts

73 sites in 1 country.

73 sites in 1 country

China73 sites

  • Anyang District Hospital, Puyang City

    Anyang, Henan, 455001

  • Baoji Central Hospital

    Baoji, Shanxi, 721008

  • The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology

    Baotou, Inner Mongolia, 14017

  • Baotou Central Hospital

    Baotou, Inner Mongolia, 14040

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui, 233004

  • Cangzhou Central Hospital

    Cangzhou, Hebei, 061012

  • Second Hospital of Jilin University

    Changchun, Jilin, 130041

  • The Second Xiangya Hospital, Central South University

    Changsha, Hunan, 410011

  • Xiangya Third Hospital, Central South University

    Changsha, Hunan, 410013

  • Changzhou First People's Hospital

    Changzhou, Jiangsu, 213000

  • The Affiliated Hospital of Chengde Medical College

    Chengde, Hebei, 067000

  • Chengdu Second People's Hospital

    Chengdu, Sichuan, 610000

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610000

  • Chengdu Second People's Hospital

    Chengdu, Sichuan, 610072

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400010

  • The First Affiliated Hospital of the Chinese People's Liberation Army Army Medical University

    Chongqing, Chongqing Municipality, 400038

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400072

  • Chongqing Three Gorges Medical College affiliated People's Hospital

    Chongqing, Chongqing Municipality, 404100

  • Dezhou People's Hospital

    Dezhou, Shandong, 277102

  • Dermatology Hospital of Southern Medical UniversityDermatology Hospital of Southern Medical University

    Guangzhou, Guangdong, 510000

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510000

  • Hangzhou First People's Hospital

    Hangzhou, Zhejiang, 310006

  • Hangzhou Third People's Hospital

    Hangzhou, Zhejiang, 310009

  • Heilongjiang Provincial Hospital

    Harbin, Heilongjiang, 150036

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 151100

  • The First Affiliated Hospital of University of South China

    Hengyang, Hunan, 421001

  • Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia, 10000

  • Hunan Medical University General Hospital

    Huaihua, Hunan, 418000

  • Jiaxing second Hospital

    Jiaxing, Zhejiang, 545006

  • Shandong University Qilu Hospital

    Jinan, Shandong, 250012

  • Jingzhou Central Hospital

    Jingzhou, Hubei, 434000

  • Jinhua Central Hospital

    Jinhua, Zhejiang, 321000

  • The First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650032

  • Liaocheng People's Hospital

    Liaocheng, Shandong, 252000

  • Liuzhou People's Hospital

    Liuzhou, Guangxi, 545006

  • The Second Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan, 471000

  • Affiliated Hospital of Southwest Medical University

    Luzhou, Sichuan, 646000

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • Nanyang city first People's Hospital

    Nanyang, Henan, 473000

  • The First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang, 315211

  • Panjin Liao oil precious stone flower hospital

    Panjin, Liaoning, 124120

  • Qiqihar Hospital of Traditional Chinese Medicine

    Qiqihar, Heilongjiang, 161005

  • Sanmenxia Central Hospital

    Sanmenxia, Henan, 472000

  • Shanghai Dermatology Hospital

    Shanghai, Shanghai Municipality, 545006

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong, 518036

  • Suining Central Hospital

    Suining, Sichuan, 629000

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215000

  • Suzhou Municipal Hospital

    Suzhou, Jiangsu, Weiling

  • Shanxi Provincial People's Hospital

    Taiyuan, Shanxi, 030000

  • Peking University First Hospital Taiyuan Hospital

    Taiyuan, Shanxi, 030009

  • Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital

    Tianjin, Tianjin Municipality, 300120

  • Tianjin First Central Hospital

    Tianjin, Tianjin Municipality, 300190

  • Tongling People's Hospital

    Tongling, Anhui, 244000

  • People's Hospital of Xinjiang Uygur Autonomous Region

    Ürümqi, Xinjiang, 830002

  • Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine

    Ürümqi, Xinjiang, 830002

  • Wuhan University People's Hospital

    Wuhan, Hubei, 430060

  • The Second Affiliated Hospital of Wannan Medical College

    Wuhu, Anhui, 241000

  • The Second Affiliated Hospital of Xi 'an Jiaotong University

    Xi’an, Shanxi, 710004

  • The First Affiliated Hospital of PLA Air Force Medical University

    Xi’an, Shanxi, 710032

  • The First Affiliated Hospital of Xi 'an Medical College

    Xi’an, Shanxi, 710032

  • The Second Affiliated Hospital of the Chinese People's Liberation Army Air Force Medical University

    Xi’an, Shanxi, 710032

  • The Second Affiliated Hospital of Xiamen Medical College

    Xiamen, Fujian, 361021

  • Affiliated Hospital of Qinghai University

    Xining, Qinghai, 810000

  • Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221132

  • Yancheng First People's Hospital

    Yancheng, Jiangsu, 224005

  • Yantai Yuhuangding Hospital

    Yantai, Shandong, 264000

  • Yichang Central People's Hospital

    Yichang, Hubei, 443003

  • Yinchuan First People's Hospital

    Yinchuan, Ningxia, 750010

  • Zaozhuang Municipal Hospital

    Zaozhuang, Shandong, 277102

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, 450000

  • The First Affiliated Hospital of Henan University of Science and Technology

    Zhengzhou, Henan, 471000

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu, 210039

Other trials in China

About this study

Official 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

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.

Being tested
TQH2722 injection, Placebo of TQH2722 injection
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TQH2722 injectionDrug

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

  • Placebo of TQH2722 injectionDrug

    Placebo without drug substance

Study groups in NCT06552520
Study groupRoleWhat they receive
TQH2722 injectionExperimentalTQH2722 injection, 14 days for a treatment cycle
Receives: Drug: TQH2722 injection
Placebo of TQH2722 injectionPlacebo comparatorPlacebo of TQH2722 injection, 14 days for a treatment cycle
Receives: Drug: Placebo of TQH2722 injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Baseline to 16 weeks after treatment

  2. 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.

    Measured: Baseline to 16 weeks after treatment

Secondary outcomes (11)

  1. The incidence of adverse events

    Adverse events that occur during treatment

    Measured: After medication to 60 weeks

  2. Steady valley concentration of TQH2722

    Relatively stable concentration levels of TQH2722

    Measured: After medication to 60 weeks

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

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

    Measured: After medication to 60 weeks

  4. Incidence of neutralizing antibodies (Nab)

    Incidence of neutralizing antibodies (Nab)

    Measured: After medication to 60 weeks

  5. 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.

    Measured: From baseline to week 60

  6. 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.

    Measured: After medication to 60 weeks

  7. 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.

    Measured: After medication to 60 weeks

  8. 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.

    Measured: After medication to 60 weeks

  9. 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.

    Measured: After medication to 60 weeks

  10. 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

    Measured: After medication to 60 weeks

  11. 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.

    Measured: After medication to 60 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2024
  2. Study start8 Oct 2024
  3. Primary completion11 Sep 2025
  4. Study completionJun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06552520
Sponsor's protocol ID
TQH2722-III-01
Status last verified
Apr 2026
First submitted
8 Aug 2024
Last updated
20 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TQH2722 injection in people with Atopic Dermatitis, run by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. at 73 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06552520.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.

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