Multiple-dose IBI3002 injections for adults with eosinophilic asthma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 1 trial that will enroll 9–27 adults with asthma and assign them in a 1:1:1 ratio across three dose cohorts to receive subcutaneous IBI3002 or matching placebo. The primary focus is safety and tolerability, with secondary measurements of pharmacokinetics, pharmacodynamics, immunogenicity, and exploratory clinical endpoints. The study includes a 4-week screening period, a 12-week treatment period with multiple doses, and an 8-week safety follow-up, with serial blood tests and lung function assessments. Eligible participants must be 18–65 years old, on stable inhaled therapy, have FeNO ≥25 ppb, elevated blood eosinophils, and pre-bronchodilator FEV1 ≤80% predicted.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged between 18 and 65 years old (inclusive).
2. Weight ≥40kg.
3. Diagnosed with Asthma for ≥12 months in accordance with the Global Initiative for Asthma (GINA) and confirmed by the Investigator.
4. Receiving inhaled treatment with or without inhaled corticosteroids (ICS), which has been stablized for ≥ 1 month and confirmed by the Investigator.
5. FeNO ≥25ppb at screening and randomization.
6. Elevated peripheral blood eosinophils, defined as ≥300/μL in within 6 months prior to screening; OR ≥150/μL at screening.
7. Pre-bronchodilator forced expiratory volume in 1 second (pre-BD FEV) ≤ 80% of prediction.

Exclusion Criteria:

1. Co-exsiting diseases that may have an impact on the participant's own safety or participation in the study, in the opinion of the Investigator. Including but not limited to mental disorders, diseases of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system or metabolic system.
2. A known history of active tuberculosis or clinically suspected manifestations of tuberculosis (including but not limited to pulmonary tuberculosis, lymph node tuberculosis, tuberculous pleurisy, etc.); Or chest imaging suggests the existence of suspected evidence of tuberculosis. Those with positive T-SPOT.TB need to receive preventive anti-tuberculosis treatment from 4 weeks before the first administration until the end of the study.
3. The peripheral blood white blood cells or neutrophils are lower than the lower limit of the normal value at screening or randomization.
4. Experience of life-threatening asthma attacks requiring mechanical ventilation and/or asthma attacks related to hypercapnia, respiratory failure or hypoxic epilepsy within the 5 years prior to randomization.
5. History of other lung diseases besides asthma, including but not limited to chronic obstructive pulmonary disease, interstitial lung disease, etc, in the opinion of the Investigator.

The above information is not intended to contain all considerations relevant to a participant's potential participation in this trial.

Where it's running

• The First Affiliated Hospital of Soochow University
  Suzhou, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Wensheng Zang
• Email: wensheng.zang@innoventbio.com
• Phone: 15210342569

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.