Last reviewed · How we verify
NCT04082754
A Clinical Study to Test the Safety, Exposure, and Pharmacodynamic Markers of CSL311 in Patients With Mild-to-moderate Asthma and in Healthy Volunteers
Phase 1 trial testing Human beta common receptor antagonist monoclonal antibody in Asthma in 78 participants. Completed in 14 November 2023.
14 November 2023
Quick facts
| Lead sponsor | CSL Behring |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 78 |
| Start date | 28 November 2019 |
| Primary completion | 14 November 2023 |
| Estimated completion | 14 November 2023 |
| Sites | 3 locations across United Kingdom, Germany |
Drugs / interventions tested
- Human beta common receptor antagonist monoclonal antibody — full drug profile →
- Placebo
Conditions studied
- Asthma — all drugs for Asthma →
Sponsor
CSL Behring — full company profile →
Who can join
Adults 18 to 65, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a phase 1, first-in-human (FIH), multi-center, randomized, double-blind, placebo-controlled study of CSL311 in patients with mild-to-moderate asthma. The primary objective of this study is to assess the safety and tolerability of single ascending doses (SAD) and multiple ascending doses (MAD) of CSL311.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Targeting GM-CSF in COVID-19 Pneumonia: Rationale and Strategies.
Bonaventura A, Vecchié A, Wang TS, Lee E, et al · · 2020 · cited 112× · PMID 32719685 · DOI 10.3389/fimmu.2020.01625 -
Regulation of Eosinophilia in Asthma-New Therapeutic Approaches for Asthma Treatment.
Cusack RP, Whetstone CE, Xie Y, Ranjbar M, et al · · 2021 · cited 22× · PMID 33917396 · DOI 10.3390/cells10040817
Verify or expand the search:
- PubMed search for NCT04082754
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Asthma
Currently open trials in the same condition.
- NCT07525375 — A Phase II Study to Investigate Lung Function With 2 Different Doses of Inhaled Glycopyrronium Taken With BFF Compared t · Phase 2 · recruiting
- NCT07536256 — Community Connections Through Native Hawaiian Cultural Values to Strengthen Youth Resilience, Health, and Well-Being · NA · recruiting
- NCT07556159 — A Study Evaluating Disease Characteristics and Outcomes in Participants With Asthma in Routine Clinical Practice · recruiting
- NCT07282886 — VENTURI (VENTilation Using Respiratory Imaging) · Phase 2 · recruiting
- NCT07433569 — A Study to Investigate How Budesonide and Formoterol Move Through the Body (Pharmacokinetics) When Delivered With Differ · Phase 1 · recruiting
Other CSL Behring trials
Trials by the same sponsor.
- NCT07326592 — Phase 4, Double-blind Study Evaluating the Response on Computed Tomography (CT) Lung Density Decline Rates of Respreeza · Phase 4 · not yet recruiting
- NCT07224360 — Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease (SCD) · Phase 2 · recruiting
- NCT07332091 — Efficacy and Safety of Vamifeport in Adult Participants With Homeostatic Iron Regulator Gene (HFE)-Related Hereditary He · Phase 2 · recruiting
- NCT07094087 — Efficacy and Safety of 4F-PCC (4-Factor Prothrombin Complex Concentrate) in Adult Patients Undergoing Complex Cardiovasc · Phase 3 · recruiting
- NCT07048262 — Dose Range Finding, Efficacy, and Safety Study of Nebulized CSL787 in Adults With Non-cystic Fibrosis Bronchiectasis (NC · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04082754 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by CSL Behring
- Last refreshed: 10 January 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04082754.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing