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

Primary Purpose

Atopic Dermatitis

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
TQH2722 injection 300mg-150mg
TQH2722 injection 600mg-300mg
TQH2722 injection 900mg-450mg
TQH2722 injection matching Placebo
Sponsored by
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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); 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. Exclusion Criteria: 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) 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.

Sites / Locations

  • The First Affiliated Hospital of Wannan Medical CollegeRecruiting
  • Dermatology Hospital, Southern Medical UniversityRecruiting
  • The Second Affiliated Hospital of Guangzhou Medical UniversityRecruiting
  • Shenzhen People's HospitalRecruiting
  • Affiliated Hospital of Guilin Medical UniversityRecruiting
  • Affiliated Hospital of Hebei Engineering UniversityRecruiting
  • The Forth Hospital of Hebei Medical UniversityRecruiting
  • The second affiliated hospital of harbin medical universityRecruiting
  • Puyang District Hospital of Anyang CityRecruiting
  • The First People's Hospital of NanyangRecruiting
  • People's Hospital of Henan provinceRecruiting
  • Shiyan Renmin HospitalRecruiting
  • Renmin Hospital of Wuhan UniversityRecruiting
  • The third xiangya hospital of central south universityRecruiting
  • Qian-jin LuRecruiting
  • Affiliated Hospital of Jiujiang UniversityRecruiting
  • The Second Hospital of Jilin UniversityRecruiting
  • Panjin Liaoyou Gem Flower HospitalRecruiting
  • The First Affiliated Hospital of China Medical UniversityRecruiting
  • Air Force Medical UniversityRecruiting
  • The Second Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting
  • Shengli Oil Field Central HospitalRecruiting
  • Shandong First Medical University Affiliated Dermatology HospitalRecruiting
  • Qilu Hospital of Shandong UniversityRecruiting
  • The Affiliated Hospital Of Qingdao UniversityRecruiting
  • Huashan Hospital Affiliated to Fudan UniversityRecruiting
  • Tianjin Academy of Traditional Chinese Medicine Affiliated HospitalRecruiting
  • Xinjiang Uygur Autonomous Region People's HospitalRecruiting
  • The First Affiliated Hospital of Kunming Medical UniversityRecruiting
  • The First Affiliated Hospital, Zhejiang University School of MedicineRecruiting
  • The Second Affiliated Hospital Zhejiang University School of MedicineRecruiting
  • The First People's Hospital of WenlingRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

TQH2722 injection 300mg-150mg

TQH2722 injection 600mg-300mg

TQH2722 injection 900mg-450mg

TQH2722 injection matching Placebo

Arm Description

Participants 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.

Participants 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.

Participants 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.

Subjects received 900mg placebo injection subcutaneously on day 1, followed by 450mg placebo injection on days 15, 29, 43, 57, 71, 85, 99.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Eczema area and severity (EASI)-90 (≥90% improvement from baseline).
Proportion of participants with EASI-90 at week 16.
Eczema area and severity (EASI)
Percentage change in EASI score from baseline to week 16;
Change in investigator's general assessment (IGA)
Change (or percentage change) in IGA score from baseline to week 16;
Body surface area (%BSA)
%BSA change from baseline to week 16
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.
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.
Incidence of neutralizing antibodies
If the subject is tested positive for ADA, a neutralizing antibody is added.
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.
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.

Full Information

First Posted
July 24, 2023
Last Updated
July 31, 2023
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05970432
Brief Title
A Clinical Study of TQH2722 Injection in the Treatment of Moderate to Severe Atopic Dermatitis
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 19, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TQH2722 injection 300mg-150mg
Arm Type
Experimental
Arm Description
Participants 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.
Arm Title
TQH2722 injection 600mg-300mg
Arm Type
Experimental
Arm Description
Participants 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.
Arm Title
TQH2722 injection 900mg-450mg
Arm Type
Experimental
Arm Description
Participants 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.
Arm Title
TQH2722 injection matching Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects received 900mg placebo injection subcutaneously on day 1, followed by 450mg placebo injection on days 15, 29, 43, 57, 71, 85, 99.
Intervention Type
Drug
Intervention Name(s)
TQH2722 injection 300mg-150mg
Intervention Description
TQH2722 injection is a fully human monoclonal antibody that interfering with the signal cascade.
Intervention Type
Drug
Intervention Name(s)
TQH2722 injection 600mg-300mg
Intervention Description
TQH2722 injection is a fully human monoclonal antibody that thereby interfering with the signal cascade.
Intervention Type
Drug
Intervention Name(s)
TQH2722 injection 900mg-450mg
Intervention Description
TQH2722 injection is a fully human monoclonal antibody that thereby interfering with the signal cascade.
Intervention Type
Drug
Intervention Name(s)
TQH2722 injection matching Placebo
Intervention Description
Placebo without active substance.
Primary Outcome Measure Information:
Title
Eczema area and severity (EASI)-75 (≥75% improvement from baseline).
Description
Proportion of participants with eczema area and severity (EASI)-75 (≥75% improvement from baseline) at week 16.
Time Frame
Up to 16 weeks.
Secondary Outcome Measure Information:
Title
Investigator's general assessment (IGA)
Description
Proportion of subjects with, the investigator's overall assessment (IGA) of 0 or 1 (6-point in total) at week 16.
Time Frame
Up to 16 weeks.
Title
Eczema area and severity (EASI)-90 (≥90% improvement from baseline).
Description
Proportion of participants with EASI-90 at week 16.
Time Frame
Up to 16 weeks.
Title
Eczema area and severity (EASI)
Description
Percentage change in EASI score from baseline to week 16;
Time Frame
Up to 16 weeks.
Title
Change in investigator's general assessment (IGA)
Description
Change (or percentage change) in IGA score from baseline to week 16;
Time Frame
Up to 16 weeks.
Title
Body surface area (%BSA)
Description
%BSA change from baseline to week 16
Time Frame
Up to 16 weeks.
Title
Treatment Emergent Adverse Events (TEAE)
Description
Incidence of TEAE from baseline to week 20 determined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTC AE) V5.0.
Time Frame
Up to 20 weeks.
Title
Incidence of anti-drug antibodies (ADAs)
Description
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.
Time Frame
Up to 24 weeks.
Title
Incidence of neutralizing antibodies
Description
If the subject is tested positive for ADA, a neutralizing antibody is added.
Time Frame
Up to 24 weeks.
Title
Peak Itch numerical rating scale (NRS)
Description
Peak Itch NRS changes from baseline to week 16. The total score is 10, with higher scores indicating more severe pruritus.
Time Frame
Up to 16 weeks.
Title
Dermatology Life Quality Index (DLQI) scores
Description
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.
Time Frame
Up to 16 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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); 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. Exclusion Criteria: 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) 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qian-jin Lu, Doctor
Phone
+86 13787097676
Email
qianlu5860@gmail.com
Facility Information:
Facility Name
The First Affiliated Hospital of Wannan Medical College
City
Wuhu
State/Province
Anhui
ZIP/Postal Code
241000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chao Ci, Bachelor
Phone
+86 13956218911
Email
cichao8911@126.com
Facility Name
Dermatology Hospital, Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bin Yang, Doctor
Phone
+86 13922207231
Email
yangbin101@hotmail.com
Facility Name
The Second Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510260
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenlin Yang, Master
Phone
+86 18122256635
Email
yangwenlin@21cn.com
Facility Name
Shenzhen People's Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianglin Zhang, Doctor
Phone
+86 13873143466
Email
jianglin@szhospital.com
Facility Name
Affiliated Hospital of Guilin Medical University
City
Guilin
State/Province
Guangxi
ZIP/Postal Code
541001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xi Huang, Master
Phone
+86 13907731329
Email
1352215665@qq.com
Facility Name
Affiliated Hospital of Hebei Engineering University
City
Handan
State/Province
Hebei
ZIP/Postal Code
056002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guoying Miao, Master
Phone
+86 18031028050
Email
guoyingmiao_hgdfs@163.com
Facility Name
The Forth Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenqing Wang, Doctor
Phone
+86 15831948173
Email
wangwqlcsy@163.com
Facility Name
The second affiliated hospital of harbin medical university
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuzhen Li, Doctor
Phone
+86 13936367628
Email
liyuzhenyidaeryuan@126.com
Facility Name
Puyang District Hospital of Anyang City
City
Anyang
State/Province
Henan
ZIP/Postal Code
455000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaohan Wang, Bachelor
Phone
+86 13569009795
Email
wangxiaohan11@hotmail.com
Facility Name
The First People's Hospital of Nanyang
City
Nanyang
State/Province
Henan
ZIP/Postal Code
473000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rixin Chen, Master
Phone
+86 13849795170
Email
pfkgcpby@163.com
Facility Name
People's Hospital of Henan province
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shoumin Zhang, Master
Phone
+86 13937168956
Email
1264100668@qq.com
Facility Name
Shiyan Renmin Hospital
City
Shiyan
State/Province
Hubei
ZIP/Postal Code
442000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zudong Meng, Master
Phone
+86 13997837543
Email
1970547910@qq.com
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tiechi Lei, Doctor
Phone
+86 15337173507
Email
tiechilei@126.com
Facility Name
The third xiangya hospital of central south university
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianyun Lu, Doctor
Phone
+86 13975130008
Email
lujianyun888@163.com
Facility Name
Qian-jin Lu
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210042
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qian-jin Lu, Doctor
Phone
+86 13787097676
Email
qianlu5860@gmail.com
Facility Name
Affiliated Hospital of Jiujiang University
City
Jiujiang
State/Province
Jiangxi
ZIP/Postal Code
332000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiuhe Song, Doctor
Phone
+86 15079249301
Email
787278405@qq.com
Facility Name
The Second Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fuqiu Li, Doctor
Phone
+86 13039123758
Email
Lifuqiu1234@126.com
Facility Name
Panjin Liaoyou Gem Flower Hospital
City
Panjin
State/Province
Liaoning
ZIP/Postal Code
124000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yingxia He, Bachelor
Phone
+86 13904273211
Email
3155721826@qq.com
Facility Name
The First Affiliated Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Zhang, Doctor
Phone
+86 13940023570
Email
lizhang_1001@126.com
Facility Name
Air Force Medical University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chen Yu, Doctor
Phone
+86 13571991903
Email
13571991903@163.com
Facility Name
The Second Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Songmei Geng, Doctor
Phone
+86 13060423612
Email
gsm312@yahoo.com
Facility Name
Shengli Oil Field Central Hospital
City
Dongying
State/Province
Shandong
ZIP/Postal Code
25700
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Yan, bachelor
Phone
+86 18661399259
Email
18661399259@163.com
Facility Name
Shandong First Medical University Affiliated Dermatology Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Furen Zhang, Doctor
Phone
+86 13608921718
Email
zhangfurenlcsy@163.com
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250063
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qing Sun, Doctor
Phone
+86 18560082626
Email
sunqing7226@163.com
Facility Name
The Affiliated Hospital Of Qingdao University
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guanzhi Chen, Master
Phone
+86 18661807667
Email
Chenguanzhiqd@126.com
Facility Name
Huashan Hospital Affiliated to Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Li, Doctor
Phone
+86 18629352992
Email
liweiderma@163.com
Facility Name
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300122
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Litao Zhang, Doctor
Phone
18602228122
Email
zhanglitao@medmail.com.cn
Facility Name
Xinjiang Uygur Autonomous Region People's Hospital
City
Ürümqi
State/Province
Xinjiang Uygur Autonomous Region
ZIP/Postal Code
830000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaojing Kang, Doctor
Phone
+86 13999927999
Email
postmaster@xjrmyy.com
Facility Name
The First Affiliated Hospital of Kunming Medical University
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li He, Doctor
Phone
+86 13577098206
Email
drheli2662@126.com
Facility Name
The First Affiliated Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianjun Qiao, Doctor
Phone
+86 13735542393
Email
qiaojianjun@126.com
Facility Name
The Second Affiliated Hospital Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiao Yong Man, Doctor
Phone
+86 13600516219
Email
manxy@zju.edu.cn
Facility Name
The First People's Hospital of Wenling
City
Wenling
State/Province
Zhejiang
ZIP/Postal Code
317500
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongxia Feng, Master
Phone
+86 18648475920
Email
fenghongxia0472@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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