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Systemic AMG 108

Phase 2

Osteoarthritis | Small molecule | Musculoskeletal |Amgen Inc.|Last Updated: Jun 23, 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment160

FDA Designations

No designations recorded

Clinical trial landscape

Systemic AMG 108 · 1 trial · 1 indication

Phase 2 1
NCT00110942Treatment for Patients With Osteoarthritis (OA)Osteoarthritis
COMPLETED160 Analytics
PHASE2COMPLETED
Treatment for Patients With Osteoarthritis (OA)
OsteoarthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in WOMAC pain score
Week 6

Secondary Endpoints

Change in WOMAC pain score
Week 12
Change in WOMAC composite score and function and stiffness index scores
Weeks 6 and 12
Achieving 50% or more improvement from Day 1 in the WOMAC
Weeks 6 and 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Minor sub-study AMG 108ACTIVE_COMPARATORN = 15
Minor sub-study placeboPLACEBO_COMPARATORN = 15
Main sub-study AMG 108ACTIVE_COMPARATORN = 73
Main sub-study placeboPLACEBO_COMPARATORN = 73

Interventions

NameTypeDescription
Systemic AMG 108DRUG300 mg SC AMG 108 Q4W for 3 doses
PlaceboOTHERSC placebo injection Q4W for 3 doses
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Eligibility Criteria

Age Range30 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Diagnosed with knee OA as determined by American College of Rheumatology (ACR) criteria * Pain defined by a level of greater than or equal to 30 mm on a 100 mm Visual Analogue Scale (VAS) * If currently taking any over the counter nutritional supplements, must be on stable dos...

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Frequently asked questions about Systemic AMG 108

What is AMG 108 used for?

AMG 108 is an investigational small molecule being developed for the treatment of osteoarthritis, a degenerative joint disease. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who is developing AMG 108?

AMG 108 is being developed by Amgen Inc., a biotechnology company listed on NASDAQ under the ticker symbol AMGN. The drug is currently in Phase 2 clinical trials for osteoarthritis.

What phase is AMG 108 in?

AMG 108 is in Phase 2 clinical development. It is an investigational drug and has not been approved for any use. A Phase 2 clinical trial for osteoarthritis has been completed.

What clinical trials is AMG 108 in?

AMG 108 has one completed Phase 2 clinical trial, identified as NCT00110942, titled "Treatment for Patients With Osteoarthritis (OA)." The trial enrolled 160 participants aged 30 years and older with osteoarthritis.

Is AMG 108 the same as another drug?

AMG 108 is the drug name used in clinical trials for this investigational treatment. No alternative names have been reported for this compound in the available clinical trial information.