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Atopic DermatitisPhase 2NCT05970432

A Clinical Study of TQH2722 Injection in the Treatment of Moderate to Severe Atopic Dermatitis

A Phase 2 study testing TQH2722 injection 300mg-150mg, TQH2722 injection 600mg-300mg and TQH2722 injection 900mg-450mg in people with Atopic Dermatitis, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 32 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This phase II clinical trials is multicenter, randomized, double-blind, placebo-controlled to assess the effectiveness and safety of TQH2722 injection in the treatment of subjects with moderate to severe atopic dermatitis. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Atopic Dermatitis
What is being tested?
TQH2722 injection 300mg-150mg, TQH2722 injection 600mg-300mg and TQH2722 injection 900mg-450mg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
160 participants
Where
32 sitesChina
Study dates
19 Jun 2023to Mar 2024
Phase
Phase 2
Are there results?
None posted in the registry

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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-65 (when signing informed consent), regardless of gender;
  • Meets 2014 American Academy of Dermatology (AAD) criteria with diagnosis of atopic dermatitis (AD); In addition, history of AD prior to screening ≥ 6 months; Eczema was previously diagnosed but met the 2014 AAD criteria and can still be enrolled.
  • Patients with moderate to severe AD at screening and baseline visit (shall meet all 3 criteria as follows):
  • total area of AD lesions≥ 10% BSA;
  • IGA ≥3 points;
  • EASI ≥ 16 points;
Show all 12Show fewer
  • Baseline peak pruritus NRS ≥4 (The average peak pruritus intensity score in baseline peak pruritus NRS will be calculated based on the average of the peak pruritus intensity NRS score (daily score range 0-10) for each day during the 7 days prior to randomization. A minimum of 4 days out of 7 days of scoring is required to calculate the baseline average score. If the patient's reporting days are less than 4 days in the 7 days prior to the planned randomization date, randomization should be postponed until the requirements are met, but not beyond the maximum period of 14 days for screening);
  • 6 months prior to the screening period, insufficient response to stable (≥1 month) topical corticosteroids (TCS) or calcineurin inhibitors (TCI) (insufficient response defined as at least 28 days even if the daily regimen of moderate-high potency TCS (± topical TCI, if applicable) is at least 28 days, or to the maximum recommended course of treatment (eg, ultra-potent TCS - 14 days) in the product prescribing information (whichever is shorter), Failure to achieve or maintain disease remission or low disease activity (equivalent to IGA 0 [=none]-2 [=mild]). or patients who have received a record of systemic treatment (adequate dose, adequate course) of AD in the past 6 months are also considered to have insufficient response to topical drug therapy, and may be selected for trial after appropriate drug elution and approval by the sponsor);
  • Before the first dose, subjects must have continuously used the emollient twice a day for at least 1 week and maintained throughout the trial (Note: the emollient is provided by the sponsor);
  • Be able to read and understand, and be willing to sign informed consent forms;
  • Willingness and compliance with research visits and related procedures;
  • Female participants of childbearing age should agree that contraception (e.g., intrauterine devices, pills, or condoms) must be used during the study period and for 6 months after the end of the study; Negative serum pregnancy test within 7 days prior to first dose and must be a non-lactating subject; Male subjects should agree that contraception must be used during the study period and for 6 months after the end of the study period.

Who cannot join

  • Participants who received the following treatments within the following limited time prior to randomization:
  • Have used any of the following treatments within 4 weeks or the investigator believes that the following treatments may be required: immunosuppressants/immunomodulatory drugs (eg, systemic glucocorticosteroids, cyclosporine, mycophenolate mofetil, interferon γ (IFN-γ), azathioprine, and methotrexate); AD phototherapy;
  • Oral Janus Kinase (JAK) inhibitors (including but not limited to upadacitinib) used within 2 weeks;
  • Received systemic traditional Chinese medicine (TCM) treatment within 4 weeks; or within 1 week, topical TCM;
  • Treated with leukotriene inhibitors within 4 weeks;
  • Treated with topical preparations of TCS or TCI or phosphodiesterase 4 (PDE⁃4) inhibitors within 2 weeks;
Show all 34Show fewer
  • Treatment with the following biologics: any cell depleting agent, including but not limited to rituximab: within 6 months or until the lymphocyte count returns to normal, whichever is longer; Other biologics: 5 half-lives (if half-life known) or 12 weeks (whichever is longer); Within 4 weeks, receive regular phototherapy (including but not limited to narrow-spectrum UVB, psoralen longwave ultraviolet therapy, etc.) or use artificial sunbathing sheds/rooms;
  • Within 12 weeks, receive live (attenuated) vaccine;
  • Chronic active or acute infection requiring systemic treatment with antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks, or superficial skin infection within 1 week prior to baseline visit. After the infection resolves, screening can be renewed;
  • Antihistamines (including oral, nasal, and topical preparations) within 1 week;
  • Abnormal physical examination results during screening or any of the following laboratory tests:
  • Hemoglobin< 110 g/L
  • White blood cell (WBC) < 3.5 x 10^9/L
  • Platelet count < 125 x 10^9/L
  • Neutrophils< 1.75 x 10^9/L • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) >1.5 x upper limit of normal (ULN)
  • Total bilirubin > 1.5 x ULN (except indirect bilirubin elevation secondary to Gilbert syndrome)
  • Creatinine > 1.5 x ULN
  • Creatine phosphokinase (CPK) > 2 x ULN
  • There are cutaneous comorbidities that may interfere with the study assessment, including but not limited to scabies, seborrheic dermatitis, cutaneous T-cell lymphoma, psoriasis, etc
  • Concomitant other serious medical conditions that, at the discretion of the investigator, may adversely affect participants' participation in this study, including, but not limited to: short life expectancy, history of uncontrolled diabetes (HbA1c ≥ 9%), cardiovascular disease (eg, grade III or IV heart failure, graded according to the New York Heart Association), severe kidney disease (eg, patients on dialysis), hepatobiliary disease (e.g., Child-Pugh class B or C), neurological disease (e.g., demyelinating disease), Patients with important active autoimmune diseases (eg, lupus, inflammatory bowel disease, rheumatoid arthritis, etc.), as well as other severe endocrine, gastrointestinal, metabolic, pulmonary, or lymphatic diseases.
  • Have a history of known or suspected immunosuppression, including invasive opportunistic infections (e.g., histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, and aspergillosis), even if the infection has resolved; or unusual frequent, recurrent, or long-term infections (at the investigator's discretion);
  • 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 has been cured for more than 5 years prior to the screening period;
  • Computed Tomography (CT) of the chest shows active or occult tuberculosis or a history of contact with an open tuberculosis (TB) subject within the past 6 months. If the laboratory T cell spot test for tuberculosis infection test (or other tuberculosis diagnostic test) is positive, its activity is judged in combination with the medical history, clinical manifestations, etc., and the investigator determines whether it can be enrolled;
  • Active hepatitis during the screening period, or positive for hepatitis B surface antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb);
  • History of human immunodeficiency virus (HIV) infection, or positive HIV serological results at screening, and positive antibodies to treponema pallidum during screening
  • Positive for treponemal pallidum antibodies during screening
  • Parasitic infection related to any of the following is excluded:
  • Routine inspection of worm eggs during the screening period;
  • History of parasitic infection within 6 months prior to the screening period, except for cured trichomoniasis;
  • Have participated in clinical trials of other drugs or medical devices within 12 weeks prior to screening
  • During the period of participation in this study, participants had planned surgical procedures
  • Pregnant or lactating women
  • People who are alcoholic, drug addicts, and known drug dependents
  • In the judgment of the investigator or sponsoring medical auditor, it is believed that there are any medical or psychiatric symptoms that put the subject at risk, interfere with participation in the study, or interfere with the interpretation of the results of the study.

Trial locations and contacts

32 sites in 1 country.

Qian-jin Lu, Doctor contact

+86 13787097676

qianlu5860@gmail.com

32 sites in 1 country

China32 sites, 32 recruiting

  • Puyang District Hospital of Anyang City

    Anyang, Henan, 455000

    Xiaohan Wang, Bachelor, +86 13569009795, wangxiaohan11@hotmail.com

    Recruiting

  • The Second Hospital of Jilin University

    Changchun, Jilin, 130041

    Fuqiu Li, Doctor, +86 13039123758, Lifuqiu1234@126.com

    Recruiting

  • The third xiangya hospital of central south university

    Changsha, Hunan, 410013

    Jianyun Lu, Doctor, +86 13975130008, lujianyun888@163.com

    Recruiting

  • Shengli Oil Field Central Hospital

    Dongying, Shandong, 25700

    Min Yan, bachelor, +86 18661399259, 18661399259@163.com

    Recruiting

  • Dermatology Hospital, Southern Medical University

    Guangzhou, Guangdong, 510030

    Bin Yang, Doctor, +86 13922207231, yangbin101@hotmail.com

    Recruiting

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510260

    Wenlin Yang, Master, +86 18122256635, yangwenlin@21cn.com

    Recruiting

  • Affiliated Hospital of Guilin Medical University

    Guilin, Guangxi, 541001

    Xi Huang, Master, +86 13907731329, 1352215665@qq.com

    Recruiting

  • Affiliated Hospital of Hebei Engineering University

    Handan, Hebei, 056002

    Guoying Miao, Master, +86 18031028050, guoyingmiao_hgdfs@163.com

    Recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

    Jianjun Qiao, Doctor, +86 13735542393, qiaojianjun@126.com

    Recruiting

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009

    Xiao Yong Man, Doctor, +86 13600516219, manxy@zju.edu.cn

    Recruiting

  • The second affiliated hospital of harbin medical university

    Harbin, Heilongjiang, 150000

    Yuzhen Li, Doctor, +86 13936367628, liyuzhenyidaeryuan@126.com

    Recruiting

  • Shandong First Medical University Affiliated Dermatology Hospital

    Jinan, Shandong, 250022

    Furen Zhang, Doctor, +86 13608921718, zhangfurenlcsy@163.com

    Recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250063

    Qing Sun, Doctor, +86 18560082626, sunqing7226@163.com

    Recruiting

  • Affiliated Hospital of Jiujiang University

    Jiujiang, Jiangxi, 332000

    Qiuhe Song, Doctor, +86 15079249301, 787278405@qq.com

    Recruiting

  • The First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650000

    Li He, Doctor, +86 13577098206, drheli2662@126.com

    Recruiting

  • Qian-jin Lu

    Nanjing, Jiangsu, 210042

    Qian-jin Lu, Doctor, +86 13787097676, qianlu5860@gmail.com

    Recruiting

  • The First People's Hospital of Nanyang

    Nanyang, Henan, 473000

    Rixin Chen, Master, +86 13849795170, pfkgcpby@163.com

    Recruiting

  • Panjin Liaoyou Gem Flower Hospital

    Panjin, Liaoning, 124000

    Yingxia He, Bachelor, +86 13904273211, 3155721826@qq.com

    Recruiting

  • The Affiliated Hospital Of Qingdao University

    Qingdao, Shandong, 266000

    Guanzhi Chen, Master, +86 18661807667, Chenguanzhiqd@126.com

    Recruiting

  • Huashan Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality, 200040

    Wei Li, Doctor, +86 18629352992, liweiderma@163.com

    Recruiting

  • The First Affiliated Hospital of China Medical University

    Shenyang, Liaoning, 110000

    Li Zhang, Doctor, +86 13940023570, lizhang_1001@126.com

    Recruiting

  • Shenzhen People's Hospital

    Shenzhen, Guangdong, 518020

    Jianglin Zhang, Doctor, +86 13873143466, jianglin@szhospital.com

    Recruiting

  • The Forth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

    Wenqing Wang, Doctor, +86 15831948173, wangwqlcsy@163.com

    Recruiting

  • Shiyan Renmin Hospital

    Shiyan, Hubei, 442000

    Zudong Meng, Master, +86 13997837543, 1970547910@qq.com

    Recruiting

  • Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital

    Tianjin, Tianjin Municipality, 300122

    Litao Zhang, Doctor, 18602228122, zhanglitao@medmail.com.cn

    Recruiting

  • Xinjiang Uygur Autonomous Region People's Hospital

    Ürümqi, Xinjiang Uygur Autonomous Region, 830000

    Xiaojing Kang, Doctor, +86 13999927999, postmaster@xjrmyy.com

    Recruiting

  • The First People's Hospital of Wenling

    Wenling, Zhejiang, 317500

    Hongxia Feng, Master, +86 18648475920, fenghongxia0472@163.com

    Recruiting

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430000

    Tiechi Lei, Doctor, +86 15337173507, tiechilei@126.com

    Recruiting

  • The First Affiliated Hospital of Wannan Medical College

    Wuhu, Anhui, 241000

    Chao Ci, Bachelor, +86 13956218911, cichao8911@126.com

    Recruiting

  • Air Force Medical University

    Xi'an, Shaanxi, 710032

    Chen Yu, Doctor, +86 13571991903, 13571991903@163.com

    Recruiting

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710061

    Songmei Geng, Doctor, +86 13060423612, gsm312@yahoo.com

    Recruiting

  • People's Hospital of Henan province

    Zhengzhou, Henan, 450003

    Shoumin Zhang, Master, +86 13937168956, 1264100668@qq.com

    Recruiting

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial Evaluating the Efficacy and Safety of TQH2722 Injection in Subjects With Moderate to Severe Atopic Dermatitis

This phase II clinical trials is multicenter, randomized, double-blind, placebo-controlled to assess the effectiveness and safety of TQH2722 injection in the treatment of subjects with moderate to severe atopic dermatitis.

Being tested
TQH2722 injection 300mg-150mg, TQH2722 injection 600mg-300mg, TQH2722 injection 900mg-450mg, TQH2722 injection matching Placebo
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 injection 300mg-150mgDrug

    TQH2722 injection is a fully human monoclonal antibody that interfering with the signal cascade.

  • TQH2722 injection 600mg-300mgDrug

    TQH2722 injection is a fully human monoclonal antibody that thereby interfering with the signal cascade.

  • TQH2722 injection 900mg-450mgDrug

    TQH2722 injection is a fully human monoclonal antibody that thereby interfering with the signal cascade.

  • TQH2722 injection matching PlaceboDrug

    Placebo without active substance.

Study groups in NCT05970432
Study groupRoleWhat they receive
TQH2722 injection 300mg-150mgExperimentalParticipants received subcutaneous injection of 300 mg TQH2722 injection + 600 mg placebo on day 1, followed by subcutaneous injection of 150 mg TQH2722 injection + 300 mg placebo on days 15, 29, 43, 57, 71, 85, 99.
Receives: Drug: TQH2722 injection 300mg-150mg
TQH2722 injection 600mg-300mgExperimentalParticipants received subcutaneous injection of 600 mg TQH2722 injection + 300 mg placebo on day 1, followed by subcutaneous injection of 300 mg TQH2722 injection + 150 mg placebo on days 15, 29, 43, 57, 71, 85, 99.
Receives: Drug: TQH2722 injection 600mg-300mg
TQH2722 injection 900mg-450mgExperimentalParticipants received subcutaneous injection of 900 mg TQH2722 injection on day 1, followed by subcutaneous injection of 450 mg TQH2722 injection on days 15, 29, 43, 57, 71, 85, 99.
Receives: Drug: TQH2722 injection 900mg-450mg
TQH2722 injection matching PlaceboPlacebo comparatorSubjects received 900mg placebo injection subcutaneously on day 1, followed by 450mg placebo injection on days 15, 29, 43, 57, 71, 85, 99.
Receives: Drug: TQH2722 injection matching Placebo

What is being measured

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

  1. Eczema area and severity (EASI)-75 (≥75% improvement from baseline).

    Proportion of participants with eczema area and severity (EASI)-75 (≥75% improvement from baseline) at week 16.

    Measured: Up to 16 weeks.

Secondary outcomes (10)

  1. Investigator's general assessment (IGA)

    Proportion of subjects with, the investigator's overall assessment (IGA) of 0 or 1 (6-point in total) at week 16.

    Measured: Up to 16 weeks.

  2. Eczema area and severity (EASI)-90 (≥90% improvement from baseline).

    Proportion of participants with EASI-90 at week 16.

    Measured: Up to 16 weeks.

  3. Eczema area and severity (EASI)

    Percentage change in EASI score from baseline to week 16;

    Measured: Up to 16 weeks.

  4. Change in investigator's general assessment (IGA)

    Change (or percentage change) in IGA score from baseline to week 16;

    Measured: Up to 16 weeks.

  5. Body surface area (%BSA)

    %BSA change from baseline to week 16

    Measured: Up to 16 weeks.

  6. Treatment Emergent Adverse Events (TEAE)

    Incidence of TEAE from baseline to week 20 determined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTC AE) V5.0.

    Measured: Up to 20 weeks.

  7. Incidence of anti-drug antibodies (ADAs)

    The incidence of anti-drug antibodies (ADAs) of subjects and their titer, the incidence of neutralizing antibodies (Nab). If the subject is tested positive for ADA, a neutralizing antibody is added in the test.

    Measured: Up to 24 weeks.

  8. Incidence of neutralizing antibodies

    If the subject is tested positive for ADA, a neutralizing antibody is added.

    Measured: Up to 24 weeks.

  9. Peak Itch numerical rating scale (NRS)

    Peak Itch NRS changes from baseline to week 16. The total score is 10, with higher scores indicating more severe pruritus.

    Measured: Up to 16 weeks.

  10. Dermatology Life Quality Index (DLQI) scores

    DLQI scores change from baseline to week 16, the scores are rated as None, Not Relevant, and 0-3, with higher values representing more serious disease.

    Measured: Up to 16 weeks.

Timeline

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

  1. First posted1 Aug 2023
  2. Study start19 Jun 2023
  3. Primary completionMar 2024 (estimated)
  4. Study completionMar 2024 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05970432
Sponsor's protocol ID
TQH2722-II-01
Status last verified
Mar 2023
First submitted
24 Jul 2023
Last updated
1 Aug 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TQH2722 injection 300mg-150mg, TQH2722 injection 600mg-300mg and TQH2722 injection 900mg-450mg in people with Atopic Dermatitis, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 32 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 12 inclusion and 34 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: status not confirmed, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Qian-jin Lu, Doctor (+86 13787097676, qianlu5860@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Eczema area and severity (EASI)-75 (≥75% improvement from baseline). (time frame: Up to 16 weeks.). 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 NCT05970432.

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 1 Aug 2023.

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