NCT03469934Phase 2Completed

Proof of Concept Study to Investigate Etokimab (ANB020) Activity in Adult Participants With Severe Eosinophilic Asthma

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2018-10-30Actual

Enrollment · participants25Actual

Source updated2023-08-16Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Eosinophilic Asthma

Treatments or interventions studied

EtokimabBiologicalAlso known as ANB020
PlaceboDrug

Primary outcomes · main study measures

Read the study measures

measure: Change From Baseline in Peripheral Eosinophil Count at Day 22; timeFrame: Baseline, Day 22; measure: Number of Participants With Treatment-Emergent Adverse Events; description: An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE was considered "serious" if there was any of the following outcomes: death, life-threatening, Inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of ability to conduct normal life functions, congenital anomaly/birth defect, other important medical events. Treatment-emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the date and time of the study drug infusion.; timeFrame: From first dose to Day 127; measure: Number of Asthma Exacerbations; description: Asthma exacerbation was defined as follows: 1. Use of systemic corticosteroids (or a temporary increase in a stable oral corticosteroid background dose) for at least 3 days; a single depo-injectable dose of corticosteroids was considered equivalent to a 3-day course of systemic corticosteroids. OR 2. An emergency room/urgent care visit (defined as evaluation and treatment for \<24 hours in an emergency department or urgent care center) due to asthma that required systemic corticosteroids (as per above). OR 3. An inpatient hospitalization (defined as admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for ≥24 hours due to asthma).; timeFrame: From first dose to Day 127; measure: Number of Participants With Positive Anti-drug Antibody; timeFrame: Day 1, Day 8, Day 36, Day 85, Day 106, end of study (up to Day 127)

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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