SIM0718 Treatment of Asthma Clinical Study

NCT06488755 | Recruiting Phase 3

• 1 other identifier: SIM0718-301
• Study Type: interventional
• Target: 418
• Locations: 1 country
• Sites: 1

Brief Summary

Phase III clinical study of SIM0718 asthma

Conditions

Asthma; Eosinophilic

Outcome Measures

Primary Outcomes (1)

• Annualized rate of severe asthma exacerbation events

  Annualized rate of severe asthma exacerbation events within 52 weeks

  52 weeks

Secondary Outcomes (18)

• Change from baseline in forced expiratory volume in the first second before bronchodilator use

  12 weeks

• Change from baseline in Forced Vital Capacity (FVC)

  During the 52-week treatment period

• Change from baseline in pre-bronchodilator forced expiratory volume in 1 second

  During the 52-week treatment period

• Change from baseline in Peak Expiratory Flow (PEF)

  During the 52-week treatment period

• Time from baseline to the first severe asthma exacerbation event, proportion of subjects with ≥ 1 severe asthma exacerbation

  During the 52-week treatment period

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: SIM0718 injection of placebo

SIM0718 injection

EXPERIMENTAL

SIM0718 injection

Drug: SIM0718 injection

Interventions

SIM0718 injection of placebo 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

Placebo

SIM0718 injection 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

SIM0718 injection

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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；

Sponsors & Collaborators

• Simcere Pharmaceutical Co., Ltd: lead

Study Sites (1)

China Japan Friendship Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Eosinophilia

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypereosinophilic Syndrome; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• L I hong zhuang

  Simcere Pharmaceutical Co., Ltd

  STUDY DIRECTOR

Central Study Contacts

Yi Wang

CONTACT

+8615805160455; wangyi4@simcere.com

wei wang

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: July 5, 2024
• Study Start: June 23, 2024
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)