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

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.32 sites in 1 country160 target enrollmentJune 19, 2023

InterventionsTQH2722 injection 300mg-150mg TQH2722 injection 600mg-300mg TQH2722 injection 900mg-450mg TQH2722 injection matching Placebo

DrugsTQH2722 injection 300mg-150mg TQH2722 injection 600mg-300mg TQH2722 injection 900mg-450mg TQH2722 injection matching Placebo

Overview

Phase: Phase 2
Intervention: TQH2722 injection 300mg-150mg
Conditions: Atopic Dermatitis
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Enrollment: 160
Locations: 32
Primary Endpoint: Eczema area and severity (EASI)-75 (≥75% improvement from baseline).
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 19, 2023

End Date

March 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Responsible Party

Sponsor

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;

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;

Arms & Interventions

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.

Intervention: TQH2722 injection 300mg-150mg

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.

Intervention: TQH2722 injection 600mg-300mg

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.

Intervention: TQH2722 injection 900mg-450mg

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.

Intervention: TQH2722 injection matching Placebo

Outcomes

Primary Outcomes

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

Time Frame: Up to 16 weeks.

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

Secondary Outcomes

Eczema area and severity (EASI)(Up to 16 weeks.)
Peak Itch numerical rating scale (NRS)(Up to 16 weeks.)
Investigator's general assessment (IGA)(Up to 16 weeks.)
Eczema area and severity (EASI)-90 (≥90% improvement from baseline).(Up to 16 weeks.)
Dermatology Life Quality Index (DLQI) scores(Up to 16 weeks.)
Change in investigator's general assessment (IGA)(Up to 16 weeks.)
Incidence of neutralizing antibodies(Up to 24 weeks.)
Body surface area (%BSA)(Up to 16 weeks.)
Treatment Emergent Adverse Events (TEAE)(Up to 20 weeks.)
Incidence of anti-drug antibodies (ADAs)(Up to 24 weeks.)