A Clinical Study of TQH2722 Injection in the Treatment of Moderate to Severe Atopic Dermatitis
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
1 other identifier
interventional
160
1 country
32
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2023
Shorter than P25 for phase_2
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 19, 2023
CompletedFirst Submitted
Initial submission to the registry
July 24, 2023
CompletedFirst Posted
Study publicly available on registry
August 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2024
CompletedAugust 1, 2023
March 1, 2023
9 months
July 24, 2023
July 31, 2023
Conditions
Outcome Measures
Primary Outcomes (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.
Up to 16 weeks.
Secondary Outcomes (10)
Investigator's general assessment (IGA)
Up to 16 weeks.
Eczema area and severity (EASI)-90 (≥90% improvement from baseline).
Up to 16 weeks.
Eczema area and severity (EASI)
Up to 16 weeks.
Change in investigator's general assessment (IGA)
Up to 16 weeks.
Body surface area (%BSA)
Up to 16 weeks.
- +5 more secondary outcomes
Study Arms (4)
TQH2722 injection 300mg-150mg
EXPERIMENTALParticipants 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.
TQH2722 injection 600mg-300mg
EXPERIMENTALParticipants 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.
TQH2722 injection 900mg-450mg
EXPERIMENTALParticipants 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.
TQH2722 injection matching Placebo
PLACEBO COMPARATORSubjects received 900mg placebo injection subcutaneously on day 1, followed by 450mg placebo injection on days 15, 29, 43, 57, 71, 85, 99.
Interventions
TQH2722 injection is a fully human monoclonal antibody that interfering with the signal cascade.
TQH2722 injection is a fully human monoclonal antibody that thereby interfering with the signal cascade.
TQH2722 injection is a fully human monoclonal antibody that thereby interfering with the signal cascade.
Placebo without active substance.
Eligibility Criteria
You may qualify if:
- 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;
- 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);
- 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.
You may not qualify if:
- 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;
- 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)
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, 241000, China
Dermatology Hospital, Southern Medical University
Guangzhou, Guangdong, 510030, China
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510260, China
Shenzhen People's Hospital
Shenzhen, Guangdong, 518020, China
Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, 541001, China
Affiliated Hospital of Hebei Engineering University
Handan, Hebei, 056002, China
The Forth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000, China
The second affiliated hospital of harbin medical university
Harbin, Heilongjiang, 150000, China
Puyang District Hospital of Anyang City
Anyang, Henan, 455000, China
The First People's Hospital of Nanyang
Nanyang, Henan, 473000, China
People's Hospital of Henan province
Zhengzhou, Henan, 450003, China
Shiyan Renmin Hospital
Shiyan, Hubei, 442000, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430000, China
The third xiangya hospital of central south university
Changsha, Hunan, 410013, China
Qian-jin Lu
Nanjing, Jiangsu, 210042, China
Affiliated Hospital of Jiujiang University
Jiujiang, Jiangxi, 332000, China
The Second Hospital of Jilin University
Changchun, Jilin, 130041, China
Panjin Liaoyou Gem Flower Hospital
Panjin, Liaoning, 124000, China
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110000, China
Air Force Medical University
Xi'an, Shaanxi, 710032, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061, China
Shengli Oil Field Central Hospital
Dongying, Shandong, 25700, China
Shandong First Medical University Affiliated Dermatology Hospital
Jinan, Shandong, 250022, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250063, China
The Affiliated Hospital Of Qingdao University
Qingdao, Shandong, 266000, China
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200040, China
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
Tianjin, Tianjin Municipality, 300122, China
Xinjiang Uygur Autonomous Region People's Hospital
Ürümqi, Xinjiang Uygur Autonomous Region, 830000, China
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650000, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
The First People's Hospital of Wenling
Wenling, Zhejiang, 317500, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2023
First Posted
August 1, 2023
Study Start
June 19, 2023
Primary Completion
March 1, 2024
Study Completion
March 1, 2024
Last Updated
August 1, 2023
Record last verified: 2023-03