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NCT01018550

A Randomized, Double-Blind, Placebo Controlled, Multiple Dose Phase 2 Study to Determine the Safety and Efficacy of AMG 853 in Subjects With Inadequately Controlled Asthma

Completed Phase 2 Last updated 23 February 2016
What this trial tests

Phase 2 trial testing AMG 853 in Asthma in 397 participants. Completed in 1 March 2011.

Timeline
1 October 2009
Primary endpoint
1 December 2010
1 March 2011

Quick facts

Lead sponsorAmgen
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment397
Start date1 October 2009
Primary completion1 December 2010
Estimated completion1 March 2011

Drugs / interventions tested

Conditions studied

Sponsor

Amgen — full company profile →

Who can join

Adults 18 to 65, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

The primary objective is to determine if AMG 853 is effective compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) composite symptoms scores from baseline to week 12.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Biomarker Profiles in Asthma With High vs Low Airway Reversibility and Poor Disease Control.
    Busse WW, Holgate ST, Wenzel SW, Klekotka P, et al · · 2015 · cited 57× · PMID 26226215 · DOI 10.1378/chest.14-2457
  2. Effects of non-steroidal anti-inflammatory drugs and other eicosanoid pathway modifiers on antiviral and allergic responses: EAACI task force on eicosanoids consensus report in times of COVID-19.
    Sokolowska M, Rovati GE, Diamant Z, Untersmayr E, et al · · 2022 · cited 13× · PMID 35174512 · DOI 10.1111/all.15258

Verify or expand the search:

Other recruiting trials for Asthma

Currently open trials in the same condition.

Other Amgen trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT01018550.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing