SIM0718 Treatment of Asthma Clinical Study

NCT ID: NCT06488755

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 418 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-23
• Study Completion Date: 2027-09-30

Brief Summary

Phase III clinical study of SIM0718 asthma

Detailed Description

A multicenter, randomized, double-blind, parallel-group, placebo-controlled phase III clinical study evaluating the efficacy and safety of SIM0718 in adults and adolescents with asthma

Conditions

Asthma; Eosinophilic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

SIM0718 injection of placebo

Intervention Type: DRUG

Dosage form: injection Specification: 2ml/bottle Dosage: 4ml subcutaneously on day 1, followed by 2ml of placebo subcutaneously every two weeks.

Duration of medication: 52 weeks

SIM0718 injection

SIM0718 injection

Group Type: EXPERIMENTAL

SIM0718 injection

Intervention Type: DRUG

Dosage form: injection Specification: 300mg/2ml/bottle Dosage: A loading dose of 600 mg is injected subcutaneously on day 1, followed by 300 mg SIM0718 subcutaneously every two weeks.

Duration of medication: 52 weeks

Interventions

SIM0718 injection

Dosage form: injection Specification: 300mg/2ml/bottle Dosage: A loading dose of 600 mg is injected subcutaneously on day 1, followed by 300 mg SIM0718 subcutaneously every two weeks.

Duration of medication: 52 weeks

Intervention Type: DRUG

SIM0718 injection of placebo

Dosage form: injection Specification: 2ml/bottle Dosage: 4ml subcutaneously on day 1, followed by 2ml of placebo subcutaneously every two weeks.

Duration of medication: 52 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age 12 to 75 years, weight ≥ 40 kg, diagnosed with asthma for at least 12 months；
• Currently receiving medium- to high-dose inhaled corticosteroids (ICS) in combination with 1 or 2 control medications and have been on a stable dose for at least 28 days prior to randomization；
• Pre-bronchodilator (trough) FEV1 ≤ 80% of predicted normal for adults and ≤90% of predicted normal for adolescents ；
• Positive bronchodilator response within 12 months prior to randomization or during the screening period;
• Asthma Control Questionnaire (ACQ-5) score ≥ 1.5;
• At least one severe asthma exacerbation within 12 months prior to the screening visit and no occurrence within 28 days prior to randomization;
• Based on the investigator judgment, the subject demonstrates acceptable inhaler, peak flow meter, and spirometry techniques;
• Compliance with usual asthma controller use ≥ 80% based on the patient diary in 7 days prior to dosing;
• Voluntarily participate in this clinical study and sign the informed consent form and be able to comply with the clinical visit schedule and study-related procedures;
• Female subjects of childbearing potential who are sexually active with non-sterilized male partners, male subjects, and their female partners of childbearing potential agree to use adequate and effective contraception throughout the study;

Exclusion Criteria

• Current respiratory disease that may impair lung function as judged by the investigator;
• Diagnosis of helminth parasitic infection within 24 weeks prior to randomization and who have not received or have not responded to standard therapy;
• Within 28 days prior to randomization, with acute or chronic infection; or have a severe viral infection;
• Has a known or suspected history of immunosuppression or frequent, recurrent, or long-term infection;
• History of active tuberculosis; or untreated latent tuberculosis or tuberculosis not receiving standard treatment, unless the investigator judges that the patient has been adequately treated;
• People with hepatitis B, hepatitis C, or HIV infection;
• History of malignancy;
• Major surgery within 8 weeks prior to signing the informed;
• Bronchial thermoplasty within 12 months prior to randomization;
• Treatment of systemic glucocorticoid during 4 weeks prior to signing informed to randomization;
• Previous use or ongoing use of systemic immunosuppressants or biologics for the treatment of autoimmune or inflammatory diseases in 8 weeks or 5 half-lives prior to randomization;
• Within 16 weeks or 5 half-lives prior to randomization, received a biologic agent with the same therapeutic purpose;
• Participated in an interventional clinical trial of any drug or medical device within 3 months or 5 half-lives prior to randomization;
• Poor response to or intolerance to prior anti-IL-4Rα antibody therapy;
• Within 3 months prior to randomization, received specific immunotherapy；
• Receipt of intravenous human immunoglobulin (IVIG) or blood products within 30 days prior to randomization;
• Vaccination with live(attenuated) vaccine within 30 days prior to randomization or plan to receive live (attenuated) vaccine during the study;
• Are using concomitant medications or treatments that are prohibited in the protocol;
• The following laboratory abnormalities occurred during the screening period: eosinophils≥1500 cells/mm3 or 1.5×109/L; Platelets≤80,000 cells/mm3 or 80×109/L; phosphocreatine kinase (CPK) ≥5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) ≥3-fold ULN; aspartate aminotransferase (AST)≥ 3-fold ULN; Bilirubin ≥ 2x ULN;
• History of alcohol abuse or drug abuse within 12 months prior to randomization;
• Current smokers, or those who have been smoking in recent 6 months, or former smokers who have not been smoking for 6 months with a smoking history of ≥10 pack years;
• Allergy to L-histidine, trehalose, or Tween 80, or history of systemic hypersensitivity to any biologic products;
• Females of childbearing potential have a positive pregnancy test result during the screening period; Females planning to become pregnant or breastfeeding;
• Any clinically significant examination abnormality or serious and/or uncontrolled disease that, in the opinion of the investigator, may affect the subject safety, or affect the evaluation of efficacy, or preclude the subject completion of the entire study.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Simcere Pharmaceutical Co., Ltd

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

L I hong zhuang

Role: STUDY_DIRECTOR

Simcere Pharmaceutical Co., Ltd

Locations

China Japan Friendship Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yi Wang

Role: CONTACT

wangyi4@simcere.com

+8615805160455

wei wang

Role: CONTACT

Facility Contacts

Ting yang, doctor

Role: primary

Other Identifiers

SIM0718-301

Identifier Type: -

Identifier Source: org_study_id