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VX-509

Phase 2

Rheumatoid Arthritis | Small molecule | Immunology |Vertex Pharmaceuticals Incorporated|Last Updated: Nov 20, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials4
Total Enrollment647

FDA Designations

No designations recorded

Clinical trial landscape

VX-509 · 6 trials · 3 indications

Phase 2 4Phase 1 2
NCT01830985A Phase 2/3 Open-label Extension Study to Evaluate Long-Term Safety and Efficacy With VX-509 in Subjects With Rheumatoid ArthritisRheumatoid Arthritis
COMPLETED39 Analytics
NCT01754935A Magnetic Resonance Imaging Study and Arthroscopic Biopsy Substudy in Subjects With Active Rheumatoid Arthritis Receiving VX-509, an Oral JAK3 InhibitorRheumatoid Arthritis
COMPLETED43 Analytics
NCT0159045924-week Study With Open Label Extension of VX-509, an Oral JAK3 Inhibitor, in Subjects Taking MethotrexateRheumatoid Arthritis
COMPLETED359 Analytics
NCT01052194A 12-week Study of 4 Doses of VX-509 in Subjects With Active Rheumatoid ArthritisRheumatoid Arthritis
COMPLETED206 Analytics
PHASE2COMPLETED
A Phase 2/3 Open-label Extension Study to Evaluate Long-Term Safety and Efficacy With VX-509 in Subjects With Rheumatoid Arthritis
Rheumatoid Arthritis
NCT0183098539
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PHASE2COMPLETED
A Magnetic Resonance Imaging Study and Arthroscopic Biopsy Substudy in Subjects With Active Rheumatoid Arthritis Receiving VX-509, an Oral JAK3 Inhibitor
Rheumatoid Arthritis
NCT0175493543
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PHASE2COMPLETED
24-week Study With Open Label Extension of VX-509, an Oral JAK3 Inhibitor, in Subjects Taking Methotrexate
Rheumatoid Arthritis
NCT01590459359
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PHASE2COMPLETED
A 12-week Study of 4 Doses of VX-509 in Subjects With Active Rheumatoid Arthritis
Rheumatoid Arthritis
NCT01052194206
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Study Endpoints

Primary Endpoints

Long-term safety and tolerability of VX-509 treatment
Baseline through 104 weeks

Measured by clinical laboratory tests

Proportion of subjects achieving a ≥20% improvement in disease severity according to the American College of Rheumatology criteria (ACR20), using C reactive protein (CRP) (ACR20 CRP)
Week 12
Change from baseline in Disease Activity Score 28 using CRP (4-component) (DAS28-4[CRP])
Week 12
Change from baseline in OMERACT RAMRIS synovitis score in designated hand wrist
Week 12
Change from baseline in OMERACT RAMRIS bone marrow edema (osteitis) in designated hand wrist
Week 12
Change from baseline in OMERACT RAMRIS erosion score in designated hand wrist
Week 12
Proportion of subjects who achieve a 20% improvement in disease severity according to the American College of Rheumatology criteria, assessed using the C-reactive protein level (ACR20-CRP) response
Week 12
Change from baseline in Disease Activity Score 28 using C-reactive protein (DAS28- CRP)
Week 12
Safety and tolerability
Week 12

Measured by incidence of treatment-emergent adverse events

Proportion of subjects who achieve an ACR20 response
Week 12
Change from baseline in DAS28
Week 12
PK parameters including Cmax, area under the concentration-time curve from the time of dosing extrapolated to infinity (AUC0 ∞), and AUC0-last for prednisone and its metabolite prednisolone with or without VX-509
Multiple blood samples will be obtained over the 10 day open-label treatment phase
PK parameters including Cmax, area under the concentration-time curve from the time of dosing extrapolated to infinity (AUC0 ∞), and AUC0-last for methylprednisolone with or without VX-509
Multiple blood samples will be obtained over the 10 day open-label treatment phase
Safety and Tolerability as measured by adverse events (AEs) and clinically relevant changes in laboratory values, vital signs, electrocardiograms (ECGs), and physical examination variables
Specified timepoints in the protocol

Secondary Endpoints

Proportion of subjects who achieve CDAI LDA (≤10) or CDAI remission (≤2.8)
Baseline through 104 weeks
Proportion of subjects who achieve ≥20% (50%, 70%) improvement in disease severity according to the ACR criteria, using CRP (ACR20 CRP, ACR50 CRP, ACR70 CRP)
Baseline through 104 weeks
Change from baseline in DAS28 using CRP (4-component) (DAS28 4[CRP])
Baseline through 104 weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Single Arm VX-509EXPERIMENTAL -
VX-509 100 mg qd ArmEXPERIMENTAL -
VX-509 200 mg qd ArmEXPERIMENTAL -
VX-509 300 mg qd ArmEXPERIMENTAL -
Placebo ArmPLACEBO_COMPARATOR -
VX-509 150 mg qd ArmEXPERIMENTAL -
VX-509 100 mg bid ArmEXPERIMENTAL -
25 mg b.i.d. VX-509EXPERIMENTAL -
50 mg b.i.d. VX-509EXPERIMENTAL -
100 mg b.i.d. VX-509EXPERIMENTAL -
150 mg b.i.d. VX-509EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Cohort 1EXPERIMENTALPrednisone 10 mg tablet on Day 1 and 7; VX-509 200 mg tablets on Days 2 thru 7
Cohort 2EXPERIMENTALMethylprednisolone 8 mg tablet on Day 1 and 7; VX-509 200 mg tablets on Days 2 thru 7

Interventions

NameTypeDescription
VX-509DRUGVX-509 dose may be increased every 8 weeks in a stepwise fashion from 100 to 150 mg and from 150 to 200 mg, as needed (determined by ongoing disease activity by CDAI)
VX-509 matching placeboDRUG0 mg oral tablet
PlaceboDRUGtablet, placebo b.i.d. for 12 weeks
PrednisoneDRUG -
MethylprednisoloneDRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites22

Inclusion Criteria: * Subjects must have completed the assigned study drug treatment phase of a previous VX-509 study (e.g., Study 103). * Subjects must voluntarily sign and date the Study 104 informed consent document. * Subject must be willing and able to comply with the scheduled visits, treatme...

Countries:United StatesEstoniaLithuaniaSouth AfricaDenmarkNetherlandsArgentinaBulgariaCzechiaGermanyHungaryMexicoPolandRomaniaRussiaSerbiaSlovakiaUkraineBelgiumCroatiaPuerto Rico
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Competitive Landscape -Rheumatoid Arthritis 92 trials

Top 20 of 28 competitors

CompanyTickerTrialsLead PhaseDrugs
AbbVie, Inc.ABBV5PHASE3Adalimumab, Upadacitinib
Bristol-Myers Squibb CompanyBMY6PHASE3Abatacept, Adalimumab, Methotrexate
Eli Lilly and CompanyLLY4PHASE3Baricitinib, Tocilizumab
Johnson & JohnsonJNJ1PHASE3Guselkumab
AstraZeneca PLCAZN4PHASE2AZD1163
Novartis AG Sponsored ADRNVS3PHASE2VAY736 PFS, VAY736 AI
Merck & Co., Inc.MRK2PHASE2Tulisokibart, Methotrexate
AnaptysBio, Inc.ANAB1PHASE2Rosnilimab
Spyre Therapeutics, IncSYRE1PHASE2SPY002-072
Sanofi SA Sponsored ADRSNY2PHASE2Sarilumab SAR153191
Immunovant IncIMVT1PHASE2IMVT-1402
XBiotech, Inc.XBIT1PHASE2Natrunix, Methotrexate
Amgen Inc.AMGN1PHASE2Inebilizumab, Blinatumomab
Artiva Biotherapeutics, Inc.ARTV2PHASE2Allogeneic NK Cells
Gilead Sciences, Inc.GILD1PHASE1GS-0151
Zenas BioPharma, Inc.ZBIO1PHASE1ZB002
Stryker CorporationSYK5N/AUndisclosed
Zimmer Biomet Holdings, Inc.ZBH29N/AUndisclosed
Cullinan Therapeutics, Inc.CGEM1PHASE1CLN-978
Sonoma Pharmaceuticals, Inc.SNOA2PHASE1SBT777101
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Frequently asked questions about VX-509

What is VX-509 used for?

VX-509 is an investigational small molecule being developed by Vertex Pharmaceuticals for rheumatoid arthritis. It has been studied in healthy volunteers, in patients with active rheumatoid arthritis, and in drug interaction studies with corticosteroids. Clinical development has focused on evaluating its safety, efficacy, and pharmacokinetics in these populations.

Who makes VX-509?

VX-509 is being developed by Vertex Pharmaceuticals Incorporated, a biopharmaceutical company traded on the NASDAQ under the ticker VRTX. The company has sponsored clinical trials of VX-509 in healthy subjects and in patients with rheumatoid arthritis.

What phase is VX-509 in?

VX-509 has completed Phase 1 and Phase 2 clinical trials. It is not approved by the FDA and remains an investigational drug. All four clinical trials listed for VX-509 are completed, with no active trials currently ongoing.

What clinical trials is VX-509 in?

VX-509 has been studied in four completed clinical trials. NCT00789126 was a Phase 1 dose escalation study in healthy subjects. NCT01754935 was a Phase 2 MRI and biopsy study in rheumatoid arthritis. NCT01830985 was a Phase 2/3 open-label extension in rheumatoid arthritis. NCT01886209 was a Phase 1 drug interaction study with prednisone or methylprednisolone.

Is VX-509 the same as a JAK3 inhibitor?

VX-509 is described as an oral JAK3 inhibitor in the title of one of its clinical trials. The trial NCT01754935, which studied VX-509 in patients with active rheumatoid arthritis, explicitly refers to VX-509 as an oral JAK3 inhibitor.