drugset / Trial / NCT04773678
Efficacy and Safety of CBP-201 in Patients With Moderate to Severe Persistent Asthma With Type 2 Inflammation
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study will evaluate the efficacy, safety of two dose levels of CBP-201 in patients with moderate to severe persistent asthma with Type 2 inflammation.
Timeline
- Start
- 2021-05-11
- Primary completion
- 2023-08-05
- Completion
- 2023-09-28
Outcome
Met primary endpoint
paper Prebronchodilator (trough) forced expiratory volume in 1 second (FEV1) at Week 12 (primary endpoint) improved with rademikibart at 150 mg and 300 mg: PMID 39998473 ↗
paper Least squares mean changes (95% confidence interval), above placebo, were 140 ml (44-236 ml; P = 0.005) and 189 ml (92-286 ml; P < 0.001), respectively. PMID 39998473 ↗
Publications
- Wechsler ME, Quart B, Collazo R. Eosinophil Counts in Adults With Asthma Treated with Anti-IL-4Ralpha Rademikibart: Exploratory Analyses in a Randomized Trial. Chest. 2026 Apr 28:S0012-3692(26)00563-5. doi: 10.1016/j.chest.2026.04.019. Online ahead of print.
- Kerwin E, Yang T, Su N, Guo J, Adivikolanu R, Longphre M, Wang J, Yun J, Pan W, Wei Z, Collazo R. Rademikibart Treatment for Moderate-to-Severe Uncontrolled Asthma: A Phase 2B Randomized Clinical Trial. Am J Respir Crit Care Med. 2025 May;211(5):749-758. doi: 10.1164/rccm.202409-1708OC.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CBP-201 | Unknown | 150 mg | Subcutaneous |
| Subject | CBP-201 | Unknown | 300 mg | Subcutaneous |