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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
Phase 2 trial testing AMG 853 in Asthma in 397 participants. Completed in 1 March 2011.
1 December 2010
Quick facts
| Lead sponsor | Amgen |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 397 |
| Start date | 1 October 2009 |
| Primary completion | 1 December 2010 |
| Estimated completion | 1 March 2011 |
Drugs / interventions tested
- AMG 853 — full drug profile →
- AMG 853 — full drug profile →
- AMG 853 — full drug profile →
- AMG 853 — full drug profile →
- Placebo
Conditions studied
- Asthma — all drugs for Asthma →
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.
-
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.
Time frame: Baseline to Week 12
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):
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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 -
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:
- PubMed search for NCT01018550
- 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.
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Other Amgen trials
Trials by the same sponsor.
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- NCT06987539 — A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Gen · Phase 2 · recruiting
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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 NCT01018550 (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 Amgen
- Last refreshed: 23 February 2016
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