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

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05970432

Collaborator

(none)

160

Enrollment

Locations

Arms

8.4

Anticipated Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis	Drug: TQH2722 injection 300mg-150mg Drug: TQH2722 injection 600mg-300mg Drug: TQH2722 injection 900mg-450mg Drug: TQH2722 injection matching Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 19, 2023

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TQH2722 injection 300mg-150mg 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.	Drug: TQH2722 injection 300mg-150mg TQH2722 injection is a fully human monoclonal antibody that interfering with the signal cascade.
Experimental: TQH2722 injection 600mg-300mg 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.	Drug: TQH2722 injection 600mg-300mg TQH2722 injection is a fully human monoclonal antibody that thereby interfering with the signal cascade.
Experimental: TQH2722 injection 900mg-450mg 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.	Drug: TQH2722 injection 900mg-450mg TQH2722 injection is a fully human monoclonal antibody that thereby interfering with the signal cascade.
Placebo Comparator: TQH2722 injection matching Placebo Subjects received 900mg placebo injection subcutaneously on day 1, followed by 450mg placebo injection on days 15, 29, 43, 57, 71, 85, 99.	Drug: TQH2722 injection matching Placebo Placebo without active substance.

Outcome Measures

Primary Outcome Measures

Eczema area and severity (EASI)-75 (≥75% improvement from baseline). [Up to 16 weeks.]
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) [Up to 16 weeks.]
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). [Up to 16 weeks.]
Proportion of participants with EASI-90 at week 16.
Eczema area and severity (EASI) [Up to 16 weeks.]
Percentage change in EASI score from baseline to week 16;
Change in investigator's general assessment (IGA) [Up to 16 weeks.]
Change (or percentage change) in IGA score from baseline to week 16;
Body surface area (%BSA) [Up to 16 weeks.]
%BSA change from baseline to week 16
Treatment Emergent Adverse Events (TEAE) [Up to 20 weeks.]
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) [Up to 24 weeks.]
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 [Up to 24 weeks.]
If the subject is tested positive for ADA, a neutralizing antibody is added.
Peak Itch numerical rating scale (NRS) [Up to 16 weeks.]
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 [Up to 16 weeks.]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Wannan Medical College	Wuhu	Anhui	China	241000
2	Dermatology Hospital, Southern Medical University	Guangzhou	Guangdong	China	510030
3	The Second Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong	China	510260
4	Shenzhen People's Hospital	Shenzhen	Guangdong	China	518020
5	Affiliated Hospital of Guilin Medical University	Guilin	Guangxi	China	541001
6	Affiliated Hospital of Hebei Engineering University	Handan	Hebei	China	056002
7	The Forth Hospital of Hebei Medical University	Shijiazhuang	Hebei	China	050000
8	The second affiliated hospital of harbin medical university	Harbin	Heilongjiang	China	150000
9	Puyang District Hospital of Anyang City	Anyang	Henan	China	455000
10	The First People's Hospital of Nanyang	Nanyang	Henan	China	473000
11	People's Hospital of Henan province	Zhengzhou	Henan	China	450003
12	Shiyan Renmin Hospital	Shiyan	Hubei	China	442000
13	Renmin Hospital of Wuhan University	Wuhan	Hubei	China	430000
14	The third xiangya hospital of central south university	Changsha	Hunan	China	410013
15	Qian-jin Lu	Nanjing	Jiangsu	China	210042
16	Affiliated Hospital of Jiujiang University	Jiujiang	Jiangxi	China	332000
17	The Second Hospital of Jilin University	Changchun	Jilin	China	130041
18	Panjin Liaoyou Gem Flower Hospital	Panjin	Liaoning	China	124000
19	The First Affiliated Hospital of China Medical University	Shenyang	Liaoning	China	110000
20	Air Force Medical University	Xi'an	Shaanxi	China	710032
21	The Second Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi	China	710061
22	Shengli Oil Field Central Hospital	Dongying	Shandong	China	25700
23	Shandong First Medical University Affiliated Dermatology Hospital	Jinan	Shandong	China	250022
24	Qilu Hospital of Shandong University	Jinan	Shandong	China	250063
25	The Affiliated Hospital Of Qingdao University	Qingdao	Shandong	China	266000
26	Huashan Hospital Affiliated to Fudan University	Shanghai	Shanghai	China	200040
27	Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital	Tianjin	Tianjin	China	300122
28	Xinjiang Uygur Autonomous Region People's Hospital	Ürümqi	Xinjiang Uygur Autonomous Region	China	830000
29	The First Affiliated Hospital of Kunming Medical University	Kunming	Yunnan	China	650000
30	The First Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang	China	310003
31	The Second Affiliated Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang	China	310009
32	The First People's Hospital of Wenling	Wenling	Zhejiang	China	317500

Sponsors and Collaborators

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

ClinicalTrials.gov Identifier:

NCT05970432

Other Study ID Numbers:

TQH2722-II-01

First Posted:

Aug 1, 2023

Last Update Posted:

Aug 1, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dermatitis, Atopic

Dermatitis

Eczema

Study Results

No Results Posted as of Aug 1, 2023