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AMG 108

Phase 2

Rheumatoid Arthritis | Small molecule | Immunology |Amgen Inc.|Last Updated: Dec 13, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials2
Total Enrollment1,503

FDA Designations

No designations recorded

Clinical trial landscape

AMG 108 · 2 trials · 1 indication

Phase 2 2
NCT00369473Long-Term Assessment of Safety and Physical Function With AMG 108 in RARheumatoid Arthritis
COMPLETED690 Analytics
NCT00293826A Multiple Dose Study to Evaluate Subcutaneous AMG 108 in Subjects With Rheumatoid ArthritisRheumatoid Arthritis
COMPLETED813 Analytics
PHASE2COMPLETED
Long-Term Assessment of Safety and Physical Function With AMG 108 in RA
Rheumatoid ArthritisUnlock trial analytics
PHASE2COMPLETED
A Multiple Dose Study to Evaluate Subcutaneous AMG 108 in Subjects With Rheumatoid Arthritis
Rheumatoid ArthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

To assess long-term safety of AMG 108 SC in subjects with RA previously enrolled in study 20050168
144 Weeks
ACR20 response
24 Weeks

Secondary Endpoints

To determine whether long-term use of AMG 108 improves function in subjects with RA
144 Weeks
Change in subject reported outcomes
24 Weeks
ACRn, AUC ACRn, ACR50, ACR70, and DAS28
24 Weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL350
2EXPERIMENTAL350
3EXPERIMENTAL196 subjects
4PLACEBO_COMPARATOR196 subjects

Interventions

NameTypeDescription
AMG 108DRUG125 mg via SC (subcutaneous) injection every 4 weeks
PlaceboDRUGPlacebo via SC (subcutaneous) injection every 4 weeks
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Only subjects eligible for and completing 24 weeks of study 20050168 will be permitted to enroll. Exclusion Criteria: * Subjects not eligible for or not completing 24 weeks of study 20050168 will be excluded.

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Frequently asked questions about AMG 108

What is AMG 108 used for?

AMG 108 is an investigational small molecule being developed for the treatment of rheumatoid arthritis. It is currently in Phase 2 clinical development and has been studied in clinical trials for this condition.

Who makes AMG 108?

AMG 108 is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN.

What phase is AMG 108 in?

AMG 108 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 2 clinical trials for rheumatoid arthritis have been completed.

What clinical trials is AMG 108 in?

AMG 108 has been studied in two completed Phase 2 clinical trials for rheumatoid arthritis. These are NCT00293826, which enrolled 813 participants, and NCT00369473, which enrolled 690 participants. Both trials were randomized, double-blind, and controlled.

Is AMG 108 the same as any other drug?

AMG 108 is the primary name used for this investigational drug. No alternative names have been reported for this compound.