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AMG 317

Phase 2

Asthma | Monoclonal antibody | Respiratory |Amgen Inc.|Last Updated: Mar 23, 2016

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment294

FDA Designations

No designations recorded

Clinical trial landscape

AMG 317 · 1 trial · 1 indication

Phase 2 1
NCT00436670Phase II Study to Evaluate the Efficacy of AMG 317Asthma
COMPLETED294 Analytics
PHASE2COMPLETED
Phase II Study to Evaluate the Efficacy of AMG 317
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

The primary objective is to evaluate the efficacy of AMG 317 compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) symptom scores from baseline to week 12.
12 weeks

Secondary Endpoints

Change from baseline in frequency of rescue beta agonist use during week 12
12 weeks
Change from baseline PEFR during week 12 (morning/evening, diurnal and inter-day variation)
12 weeks
Change in pre and post bronchodilator FEV1 at week 12 from baseline
12 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AMG 317 75 mgEXPERIMENTAL75 subjects
Placebo ArmPLACEBO_COMPARATOR75 subjects
AMG 317 300 mgEXPERIMENTAL75 subjects
AMG 317 150 mgEXPERIMENTAL75 subjects

Interventions

NameTypeDescription
AMG 317 75 mgBIOLOGICAL75 mg SC weekly injection
AMG 317 150 mgBIOLOGICAL150 mg SC once weekly injection
AMG 317 300 mgBIOLOGICAL300 mg weekly SC injection
PlaceboBIOLOGICALPlacebo SC once weekly injection
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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 at the time of screening * Baseline percent of predicted FEV1 ≥ 50% to ≤ 80% at screening * At least 12% reversibility over baseline FEV1 with beta agonist inhalation, which can be demonstrated in the office or documented by medical recor...

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Frequently asked questions about AMG 317

What is AMG 317 used for?

AMG 317 is an investigational monoclonal antibody being developed for the treatment of asthma. It is intended for use in patients with asthma, as studied in a Phase 2 clinical trial. The drug is not yet approved and remains in clinical development.

What does AMG 317 target?

AMG 317 is a monoclonal antibody, but its specific molecular target has not been disclosed in the available information. As a monoclonal antibody, it is designed to bind to a specific protein involved in the disease process, but the exact target is not specified.

Who makes AMG 317?

AMG 317 is being developed by Amgen Inc., a biotechnology company traded on the NASDAQ under the ticker symbol AMGN. Amgen is responsible for the clinical development of this investigational drug for asthma.

What phase is AMG 317 in?

AMG 317 is in Phase 2 clinical development. It has completed a Phase 2 trial, and there are no active trials currently listed. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is AMG 317 in?

AMG 317 has been studied in one completed Phase 2 clinical trial, identified as NCT00436670. This trial was a randomized, double-blind, placebo-controlled study that enrolled 294 participants with asthma. The trial has been completed, and no active trials are currently ongoing.