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Asthma; EosinophilicPhase 3NCT06488755

SIM0718 Treatment of Asthma Clinical Study

A Phase 3 study testing SIM0718 injection in people with Asthma; Eosinophilic, run by Simcere Pharmaceutical Co., Ltd at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Phase III clinical study of SIM0718 asthma Read more about this study

Who is it for?
Ages 12 to 75 years
Conditions the study is for
Asthma; Eosinophilic
What is being tested?
SIM0718 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
418 participants
Where
1 siteChina
Study dates
23 Jun 2024to 19 Feb 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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;
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  • 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;

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • China Japan Friendship Hospital

    Beijing, Beijing Municipality, 100000

Other trials in China

About this study

Official title: 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

Phase III clinical study of SIM0718 asthma

Read the 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

Being tested
SIM0718 injection, SIM0718 injection of placebo
Medical subject headings
Pulmonary Eosinophilia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SIM0718 injectionDrug

    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 of placeboDrug

    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

Study groups in NCT06488755
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo
Receives: Drug: SIM0718 injection of placebo
SIM0718 injectionExperimentalSIM0718 injection
Receives: Drug: SIM0718 injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Annualized rate of severe asthma exacerbation events

    Annualized rate of severe asthma exacerbation events within 52 weeks

    Measured: 52 weeks

Secondary outcomes (18)

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

    Change from baseline in forced expiratory volume in the first second before within 12 weeks

    Measured: 12 weeks

  2. Change from baseline in Forced Vital Capacity (FVC)

    Change from baseline in Forced Vital Capacity (FVC) of during the 52-week treatment period

    Measured: During the 52-week treatment period

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

    Change from baseline in pre-bronchodilator forced expiratory volume in 1 second of during the 52-week treatment period

    Measured: During the 52-week treatment period

  4. Change from baseline in Peak Expiratory Flow (PEF)

    Change from baseline in Peak Expiratory Flow (PEF) of during the 52-week treatment period

    Measured: During the 52-week treatment period

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

    subjects with ≥ 1 severe asthma exacerbation of during the 52-week treatment period

    Measured: During the 52-week treatment period

  6. Annualized rate of "loss of asthma control" events, time from baseline to "loss of asthma control"event

    Annualized rate of "loss of asthma control" events, time from baseline to "loss of asthma control"event of during the 52-week treatment period

    Measured: During the 52-week treatment period

  7. Change from baseline in annualized rate of hospitalization or emergency department visits, utilization of medical resources

    Change from baseline in annualized rate of hospitalization or emergency department visits, utilization of medical resources of during the 52-week treatment period

    Measured: During the 52-week treatment period

  8. Change from baseline in ASTHMA CONTROL QUESTIONNAIRE(ACQ-5) score

    Change from baseline in ASTHMA CONTROL QUESTIONNAIRE(ACQ-5) score (5 questions, 0-6 score, higher score indicated lower asthma control) of during the 52-week treatment period

    Measured: During the 52-week treatment period

  9. Asthma symptom score

    Asthma symptom score (0-4 score, higher score indicated worse asthma symptom) during the 52-week treatment period

    Measured: During the 52-week treatment period

  10. Use of rescue medication

    Use of rescue medication of during the 52-week treatment period

    Measured: During the 52-week treatment period

  11. Number of days of awakenings due to asthma and number of awakenings due to asthma

    Number of days of awakenings due to asthma and number of awakenings due to asthma of during the 52-week treatment period

    Measured: During the 52-week treatment period

  12. Change from baseline in standardized asthma quality of life questionnaire score ASTHMA QUALITY OF LIFE QUESTIONNAIRES(AQLQ(S))

    Change from baseline in standardized asthma quality of life questionnaire score(AQLQ(S)) (32 questions, 1-7 score, higher scores indicate better quality of life) of during the 52-week treatment period

    Measured: During the 52-week treatment period

  13. Adverse events

    Adverse events during 64 week study period

    Measured: during the 64 week study period

  14. Vital signs

    Vital signs during 64 week study period

    Measured: during the 64 week study period

  15. Electrocardiograph (12-ECG)

    Electrocardiograph (12-ECG) during 64 week study period

    Measured: during the 64 week study period

  16. Laboratory tests

    Laboratory tests during 64-week study period. Lab tests include hematology, biochemistry

    Measured: during the 64 week study period

  17. SIM0718 blood concentration

    SIM0718 blood concentration of during the 52-week treatment period

    Measured: During the 52-week treatment period

  18. Positive rate and titer of anti-drug antibodies, positive rate of neutralizing antibodies

    Positive rate and titer of anti-drug antibodies, positive rate of neutralizing antibodies of 64 weeks during the study

    Measured: 64 weeks during the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2024
  2. Study start23 Jun 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion19 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
418 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06488755
Sponsor's protocol ID
SIM0718-301
Status last verified
Mar 2026
First submitted
24 Jun 2024
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SIM0718 injection in people with Asthma; Eosinophilic, run by Simcere Pharmaceutical Co., Ltd at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Annualized rate of severe asthma exacerbation events (time frame: 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06488755.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.

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