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Febuxostat

Phase 3

Gout | Small molecule | Musculoskeletal |Takeda Pharmaceutical Company Limited|Last Updated: Apr 27, 2016

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials7
Total Enrollment5,492
FDA Designations
No designations recorded
Clinical Trials (7)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00430248Efficacy and Safety of Oral Febuxostat in Participants With GoutPHASE3 COMPLETED 2,269 — — Feb 1, 2007Mar 1, 2008Feb 2, 2012258 United States
NCT00175019Allopurinol Versus Febuxostat in Subjects Completing the Phase 3 Trials C02-009 or C02-010PHASE3 COMPLETED 1,086 — — Jul 1, 2003Feb 1, 2007Jul 27, 2010 - —
NCT00174915Phase 3, Febuxostat, Allopurinol and Placebo-Controlled Study in Gout Subjects.PHASE3 COMPLETED 1,072 — — Feb 1, 2003Apr 1, 2004Feb 2, 2012 - —
NCT00102440Febuxostat Versus Allopurinol Control Trial in Subjects With GoutPHASE3 COMPLETED 760 — — Jul 1, 2002Feb 1, 2004Feb 2, 2012 - —
NCT00174941Long-Term Safety of Febuxostat in Subjects With Gout.PHASE2 COMPLETED 116 — — Mar 1, 2001Dec 1, 2006Jan 27, 2011 - —
NCT00174967Dose-Response, Safety and Efficacy of Febuxostat in Subjects With GoutPHASE2 COMPLETED 153 — — Jan 1, 2001Jul 1, 2001Jul 29, 2011 - —
NCT02374164Food Effect Study of Febuxostat XR in Healthy ParticipantsPHASE1 COMPLETED 36 — — Feb 1, 2015Apr 1, 2015Apr 27, 20161 United States
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Study Endpoints
Primary Endpoints
Percentage of Subjects Whose Serum Urate Level is <6.0 Milligrams Per Deciliter (mg/dL) at the Final Visit.
Last Visit on treatment (up to 6 months)

The percentage of subjects whose serum urate level was \<6.0 mg/dL at the Final Visit was summarized. The Final Visit was the last visit at which a serum urate value was collected.

Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 1.
Month 1

Serum urate values were obtained at the Month 1 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 1 visit was summarized.

Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 12.
Month 12

Serum urate values were obtained at the Month 12 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 12 visit was summarized.

Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 24.
Month 24

Serum urate values were obtained at the Month 24 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 24 visit was summarized.

Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 36.
Month 36

Serum urate values were obtained at the Month 36 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 36 visit was summarized.

Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Last Visit on Treatment.
Last Visit on treatment (up to 40 months).

The percentage of subjects whose serum urate was \<6.0 mg/dL at the last visit on treatment was summarized. The last visit on treatment was the last visit at which a serum urate value was collected prior to any changes in drug and/or dose from the initial treatment assignment.

Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL).
Last 3 visits (any last 3 visits up to week 28)

Each subject's serum urate at the last 3 visits determined the subject's response for the primary efficacy variable. A subject who prematurely discontinued without least 3 postbaseline serum urate levels was considered a nonresponder; if at least 3 serum urate were obtained postbaseline, those 3 visits were used. The last 3 visits used may have differed for each subject.

Percentage of Subjects With the Last 3 Serum Urate Levels <6.0 Milligrams Per Deciliter (mg/dL)
Last 3 Visits (up to 52 weeks)

Each subject's serum urate at the last 3 visits determined the subject's response for the primary efficacy variable. A subject who prematurely discontinued without least 3 postbaseline serum urate levels was considered a nonresponder; if at least 3 serum urate were obtained postbaseline, those 3 visits were used. The last 3 visits used may have differed for each subject.

Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 6 Visit.
Month 6

Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 6 visit was summarized.

Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 12 Visit.
Month 12

Serum urate values were obtained at the Month 12 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 12 visit was summarized.

Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 18 Visit.
Month 18

Serum urate values were obtained at the Month 18 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 18 visit was summarized.

Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 24 Visit.
Month 24

Serum urate values were obtained at the Month 24 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 24 visit was summarized.

Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 36 Visit.
Month 36

Serum urate values were obtained at the Month 36 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 36 visit was summarized.

Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 48 Visit.
Month 48

Serum urate values were obtained at the Month 48 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 48 visit was summarized.

Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 60 Visit.
Month 60

Serum urate values were obtained at the Month 60 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 60 visit was summarized.

Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Final Visit.
Last Visit on treatment (up to 66 months).

The percentage of subjects whose serum urate was \<6.0 mg/dL at the final visit was summarized. The final visit was the last visit at which a serum urate value was collected.

Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 Milligram Per Deciliter (mg/dL) at the Day 28 Visit.
Day 28.

Serum urate values were obtained at the Day 28 visit. The percentage of subjects whose serum urate decreased to \<6.0 mg/dL at the Day 28 visit was summarized.

Cmax: Maximum Observed Plasma Concentration for Febuxostat XR 80 mg in Fed (Regimen A) and Fasted (Regimen C) States
Day 1 pre-dose and at multiple timepoints (up to 48 hours) post dose

Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Participant blood samples were collected pre-dose and following a single oral dose.

Cmax: Maximum Observed Plasma Concentration for Febuxostat XR 40 mg (Regimen B) and Febuxostat XR 80 mg (Regimen C) in Fasted States
Day 1 pre-dose and at multiple time points (up to 48 hours) post dose

Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Participant blood samples were collected pre-dose and following a single oral dose.

AUCt: Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration for Febuxostat XR 80 mg in Fed (Regimen A) and Fasted (Regimen C) States
Day 1 pre-dose and at multiple timepoints (up to 48 hours) post dose

AUCt is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration. Participant blood samples were collected pre-dose and following a single oral dose.

AUCt: Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration for Febuxostat XR 40 mg (Regimen B) and Febuxostat XR 80 mg (Regimen C) in Fasted States
Day 1 pre-dose and at multiple timepoints (up to 48 hours) post dose

AUCt is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUCt) Participant blood samples were collected pre-dose and following a single oral dose.

AUCinf: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for Febuxostat XR 80 mg in Fed (Regimen A) and Fasted (Regimen C) States
Day 1 pre-dose and at multiple timepoints (up to 48 hours) post dose

AUCinf is a measure of total plasma exposure to the drug from time zero extrapolated to infinity. Participant blood samples were collected pre-dose and following a single oral dose.

AUCinf: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for Febuxostat XR 40 mg (Regimen B) and Febuxostate XR 80 mg (Regimen C) in Fasted States
Day 1 pre-dose and at multiple timepoints (up to 48 hours) post dose

AUCinf is a measure of total plasma exposure to the drug from time zero extrapolated to infinity. Participant blood samples were collected pre-dose and following a single oral dose.

Secondary Endpoints
Percentage of Renal Impairment Subjects Whose Final Visit Serum Urate Level is <6.0 mg/dl
Last Visit on treatment (up to 6 months)
Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 2 Visit.
Month 2
Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 4 Visit.
Month 4
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Febuxostat 40 mg QDEXPERIMENTAL -
Febuxostat 80 mg QDEXPERIMENTAL -
Allopurinol 200 mg or 300 mg QDACTIVE_COMPARATOR(dependent on renal function)
Febuxostat 120 mg QDEXPERIMENTAL -
Allopurinol QDACTIVE_COMPARATOR -
Febuxostat 240 mg QDEXPERIMENTAL -
Placebo QDPLACEBO_COMPARATOR -
Allopurinol 300 mg QDACTIVE_COMPARATOR -
1EXPERIMENTAL -
2EXPERIMENTAL -
3EXPERIMENTAL -
Treatment Sequence ABCEXPERIMENTALFebuxostat extended release (XR) 80 mg, capsules, orally, once on Day 1 of Period 1 after a high-fat meal, followed by a 7-day washout period, followed by febuxostat XR 40 mg, capsules, orally, once on Day 1 of Period 2 after a 10-hour fast, followed by a 7-day washout period, followed by febuxostat XR 80, capsules, orally, once on Day 1 of Period 3 after a 10-hour fast.
Treatment Sequence BCAEXPERIMENTALFebuxostat XR 40 mg, capsules, orally, once on Day 1 of Period 1 after a 10-hour fast, followed by a 7-day washout period, followed by febuxostat XR 80 mg, capsules, orally, once on Day 1 of Period 2 after a 10-hour fast, followed by a 7-day washout period, followed by Febuxostat XR 80 mg, capsules, orally, once on Day 1 of Period 3 after a high-fat meal.
Treatment Sequence CABEXPERIMENTALFebuxostat XR 80 mg, capsules, orally, once on Day 1 of Period 1 after a 10-hour fast, followed by a 7-day washout period, followed by febuxostat XR 80 mg, capsules, orally, once on Day 1 of Period 2 after a high-fat meal, followed by a 7-day washout period, followed by febuxostat XR 40 mg, capsules, orally, once on Day 1 of Period 3 after a 10-hour fast.
Interventions
NameTypeDescription
FebuxostatDRUGFebuxostat 40 mg, capsules, orally, once daily for up to 6 months.
AllopurinolDRUGAllopurinol 200 mg or 300 mg, capsules, orally, once daily for up to 6 months. Dose is dependent on the subject's renal function. Subjects with normal renal function or mild renal impairment received 300 mg once daily; subjects with moderate renal impairment received 200 mg once daily.
PlaceboDRUGPlacebo, orally, once daily for up to 28 weeks.
Febuxostat XRDRUGFebuxostat XR capsules
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Eligibility Criteria
Age Range18 Years — 85 Years
SexALL
Healthy VolunteersNo
Study Sites258

Inclusion Criteria: * Has one or more of the American Rheumatism Association criteria for the diagnosis of gout. * Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of ...

Countries:United States
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Competitive Landscape -Gout 5 trials
CompanyTickerTrialsLead PhaseDrugs
Amgen Inc.AMGN1PHASE3Pegloticase, Methotrexate
Novo Nordisk A/S Sponsored ADR Class BNVO1PHASE1NNC4004-0002
ProtalixPLX1PHASE2PRX-115, Methotrexate
TJ Biopharma Co., Ltd.IMAB1PHASE2Plonmarlimab, Compound betamethasone
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