Multiple-dose IBI3002 injections for adults with eosinophilic asthma

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dose of IBI3002 in Patients With Asthma - a Randomized, Double-Blind, Placebo-Controlled Study

This trial will test whether multiple subcutaneous injections of IBI3002 are safe and well tolerated in adults with asthma who have high FeNO and elevated blood eosinophils.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Soochow University (Academic / other)
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT07015749 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 18–65 with physician-confirmed asthma for ≥12 months, weight ≥40 kg, on stable inhaled therapy, FeNO ≥25 ppb, elevated blood eosinophils (≥300/μL historically or ≥150/μL at screening), and pre-BD FEV1 ≤80% predicted are the intended participants.

Not a fit: People without elevated FeNO or blood eosinophils, those with well-controlled asthma, significant comorbidities, or who cannot attend the Suzhou study site are unlikely to benefit from or be eligible for this study.

Why it matters

Potential benefit: If safe and tolerable, IBI3002 could become an additional injectable option to reduce airway inflammation and improve control in eosinophilic asthma.

How similar studies have performed: Other biologic antibodies targeting type 2 inflammation (for example anti-IL-5 and anti-IL-4R therapies) have shown benefit in eosinophilic asthma, but IBI3002 itself is novel and has not been tested in large clinical trials.

Eligibility criteria

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 this trial is running

Suzhou, Jiangsu

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

Study contacts

• Study coordinator: Wensheng Zang

Conditions Asthma