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AMG 853

Phase 2

Asthma | Small molecule | Respiratory |Amgen Inc.|Trials Updated: Mar 23, 2016

AMG 853 development status

Highest phase Phase 2
Registered trials 3 across 1 sponsor since Nov 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment420

FDA Designations

No designations recorded

AMG 853 clinical trials

AMG 853 · 2 trials · 1 indication

Phase 2 1Phase 1 1
NCT01018550AMG 853 Phase 2 Study in Subjects With Inadequately Controlled AsthmaAsthma
COMPLETED397 Analytics
PHASE2COMPLETED
AMG 853 Phase 2 Study in Subjects With Inadequately Controlled Asthma
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Study Endpoints

Primary Endpoints

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.
Baseline to Week 12
Evaluation of treatment-emergent adverse events, safety and laboratory assessments in adolescent subjects with intermittent or mild to moderate asthma as a measure of safety and tolerability
Throughout the study duration

Secondary Endpoints

Evaluate the efficacy of AMG 853 as measured by use of rescue short-acting β-agonist (SABA)
Baseline to Week 12
Evaluate the efficacy of AMG 853 as measured by daily symptom score (aggregate/night and individual symptoms; and symptom free days)
Baseline to Week 12
Evaluate the efficacy of AMG 853 as measured by pre- and post-bronchodilator forced expiratory volume in 1 second (FEV1)
Baseline to Week 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AMG 853EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
AMG 853DRUGAMG 853 5 mg (BID)
PlaceboDRUGPlacebo
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Males or females 18 to 65 years of age * Percent of predicted FEV1 ≥ 50% and ≤ 80% * At least 12% reversibility over pre-bronchodilator FEV1 * Inhaled corticosteroid (ICS) ≥ 200 and ≤ 1000 µg/day fluticasone or equivalent. * Ongoing asthma symptoms with ACQ score ≥ 1.5 points ...

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Frequently asked questions about AMG 853

What is AMG 853 used for?

AMG 853 was studied as a treatment for asthma. It was evaluated in patients whose asthma was not adequately controlled, including a Phase 2 study in adults and a Phase 1 study in adolescents aged 12 years and older. It is an investigational small molecule and is not an approved asthma therapy.

Who makes AMG 853?

AMG 853 is developed by Amgen Inc., which trades on Nasdaq under the ticker AMGN. Amgen sponsored the clinical program for the drug in asthma, including the Phase 2 study in adults with inadequately controlled disease and the Phase 1 study in adolescents.

What phase is AMG 853 in?

AMG 853 reached Phase 2 clinical development for asthma. Two trials have been completed: a Phase 2 study in adults with inadequately controlled asthma and a Phase 1 study in adolescents. No trials are currently active, and the drug is investigational rather than approved.

What clinical trials is AMG 853 in?

AMG 853 has been studied in two completed asthma trials. NCT01018550 was a Phase 2 study in 397 adults with inadequately controlled asthma. NCT01137565 was a Phase 1 safety, tolerability, and pharmacodynamics study in 23 adolescents aged 12 years and older with asthma.

Were the AMG 853 trials randomized and placebo controlled?

Yes. The AMG 853 clinical program used randomized, double-blind, placebo-controlled designs. The two completed asthma trials together enrolled 420 participants. The Phase 2 study in adults enrolled 397 subjects, and the Phase 1 adolescent study enrolled 23 subjects.

Is AMG 853 approved by the FDA?

AMG 853 is not an approved medicine. It is an investigational small molecule that was studied in Phase 2 for asthma, and both of its completed trials have ended. No active trials are ongoing for AMG 853, and it has not been cleared for marketing.