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CCX 354-C

Phase 2

Rheumatoid Arthritis | Small molecule | Immunology |Amgen Inc.|Last Updated: Mar 6, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment183

FDA Designations

No designations recorded

Clinical trial landscape

CCX 354-C · 2 trials · 1 indication

Phase 2 1Phase 1 1
NCT01242917A Study to Evaluate the Safety and Efficacy of CCX354-C in Subjects With Rheumatoid Arthritis Partially Responsive to Methotrexate TherapyRheumatoid Arthritis
COMPLETED159 Analytics
PHASE2COMPLETED
A Study to Evaluate the Safety and Efficacy of CCX354-C in Subjects With Rheumatoid Arthritis Partially Responsive to Methotrexate Therapy
Rheumatoid ArthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

Subject incidence of adverse events
12 weeks

Secondary Endpoints

The change from baseline to week 12 of Disease Activity Score for 28 Joints using C-reactive proteine (DAS28-CRP)
12 weeks
Evaluate possible interaction with methotrexate at a number of dose levels in subjects with stable RA
14 Days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATOR -
CCX354-C 100mg twice dailyEXPERIMENTAL -
CCX354-C 200mg once dailyEXPERIMENTAL -
CCX354-CEXPERIMENTAL -

Interventions

NameTypeDescription
CCX-354-CDRUG200mg film-coated tablets once daily for 12 weeks + Methotrexate
PlaceboDRUGPlacebo film-coated tablets twice daily for 12 weeks + methotrexate
CCX354-CDRUG100mg film-coated tablets twice daily for 12 weeks + methotrexate
CCX 354-CDRUG* Cohort 1: Eight subjects will be randomized to receive 100 mg CCX354-C or placebo in a ratio of 3:1 (CCX354-C:placebo) once daily for 14 days; * Cohort 2: Eight subjects will be randomized to receive 100 mg CCX354-C or placebo in a ratio of 3:1 (CCX354-C:placebo) twice daily for 14 days; and * Cohort 3: Eight subjects will be randomized to receive 200 mg CCX354-C or placebo in a ratio of 3:1 (CCX354-C:placebo) once daily for 14 days.
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites41

Inclusion Criteria: 1. Male or female subjects, aged 18-75 years inclusive, with functional class I to III rheumatoid arthritis (RA) based on American College of Rheumatology (ACR) criteria for at least 3 months prior to screening; wheel-chair bound subjects or those with irreversible disease will ...

Countries:BelgiumCzechiaGermanyHungaryNetherlandsPolandRomaniaUkraine
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Frequently asked questions about CCX 354-C

What is CCX 354-C used for?

CCX 354-C is an investigational small molecule being developed for the treatment of rheumatoid arthritis. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities. The drug is being studied in patients with rheumatoid arthritis, including those partially responsive to methotrexate therapy.

Who makes CCX 354-C?

CCX 354-C is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for rheumatoid arthritis.

What phase is CCX 354-C in?

CCX 354-C is in Phase 2 clinical development for rheumatoid arthritis. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. Two clinical trials have been completed, including a Phase 1 study and a Phase 2 study, with a total enrollment of 183 participants.

What clinical trials is CCX 354-C in?

CCX 354-C has been studied in two completed clinical trials. NCT01027728 was a Phase 1 study evaluating safety and efficacy in 24 participants with rheumatoid arthritis in Belgium and Romania. NCT01242917 was a Phase 2 study in 159 participants with rheumatoid arthritis partially responsive to methotrexate, conducted across multiple European countries.

Is CCX 354-C the same as CCX354-C?

Yes, CCX 354-C is the same drug as CCX354-C. The name is written with and without a space in clinical trial records, but both refer to the same investigational small molecule being developed by Amgen Inc. for rheumatoid arthritis.