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AMG 853

Phase 2

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

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

Clinical trial landscape

AMG 853 · 3 trials · 2 indications

Phase 2 1Phase 1 2
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
AsthmaUnlock trial analytics

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
Pharmacokinetic parameters
throughout 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 is an investigational small molecule being studied for the treatment of asthma. It has been evaluated in clinical trials involving adults and adolescents with inadequately controlled asthma, as well as in healthy volunteers for pharmacokinetic studies. The drug is being developed by Amgen Inc. and is currently in Phase 2 clinical development.

What does AMG 853 target?

AMG 853 is a small molecule developed by Amgen Inc. for respiratory conditions, specifically asthma. While the specific molecular target has not been disclosed in the available information, the drug is being investigated for its ability to treat asthma in clinical trials. It is currently in Phase 2 development.

Who makes AMG 853?

AMG 853 is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The drug is an investigational small molecule intended for the treatment of asthma and has completed Phase 2 clinical trials.

What phase is AMG 853 in?

AMG 853 is in Phase 2 clinical development for asthma. It has completed two Phase 1 trials and one Phase 2 trial, all of which are finished. The drug is not yet approved and remains investigational, with no active trials currently ongoing.

What clinical trials is AMG 853 in?

AMG 853 has been studied in three completed clinical trials. NCT01018550 was a Phase 2 study in 397 adults with inadequately controlled asthma. NCT01124279 was a Phase 1 pharmacokinetic study in 43 healthy volunteers. NCT01137565 was a Phase 1 safety and pharmacodynamics study in 23 adolescents with asthma.

Is AMG 853 the same as other asthma drugs?

AMG 853 is a distinct investigational small molecule developed by Amgen Inc. for asthma. No alternative names have been reported for this drug. It is being studied as a potential treatment for asthma and has completed clinical trials, but it is not yet approved by regulatory authorities.