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BIIB074

Phase 2

Lumbosacral Radiculopathy | Small molecule | Neurology |Biogen Inc.|Last Updated: Sep 25, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment502

FDA Designations

No designations recorded

Clinical trial landscape

BIIB074 · 7 trials · 7 indications

Phase 2 2Phase 1 5
NCT02935608Study to Evaluate the Efficacy and Safety of BIIB074 in Neuropathic Pain From Lumbosacral RadiculopathyLumbosacral Radiculopathy
COMPLETED502 Analytics
NCT02917187A Phase 2a Study of BIIB074 in the Treatment of ErythromelalgiaPrimary Inherited Erythromelalgia
COMPLETED8 Analytics
PHASE2COMPLETED
Study to Evaluate the Efficacy and Safety of BIIB074 in Neuropathic Pain From Lumbosacral Radiculopathy
Lumbosacral Radiculopathy
NCT02935608502
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PHASE2COMPLETED
A Phase 2a Study of BIIB074 in the Treatment of Erythromelalgia
Primary Inherited Erythromelalgia
NCT029171878
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Study Endpoints

Primary Endpoints

Change from Baseline to Week 14 in the weekly average of the daily neuropathic pain score on the 11-point Pain Intensity Numerical Rating Scale (PI-NRS)
Week 14

Participants will be asked every evening to rate their overall neuropathic pain for the last 24-hour period. PI-NRS is an 11-point pain intensity numerical rating scale (PI-NRS), where 0=no pain and 10=pain as bad as you can imagine.

Weekly average severity of paroxysms
Day 1 to Week 12

11-point Pain Intensity Numerical Rating Scale (PI-NRS) is used to assess EM paroxysmal pain. PI-NRS is an 11-point pain intensity numerical rating scale, where 0=no pain and 10=worst possible pain. Weekly average is defined as the total of severity scores during a week divided by the total number of paroxysms during that week.

Area Under the Concentration-Time Curve from Hour 0 to Hour 8 (AUC8) for BIIB074
Day 7, 32
Area Under the Concentration-Time Curve from Hour 0 to Hour 24 (AUC24) for OC
Day 25, 32
Maximum Observed Concentration (Cmax) for BIIB074
Day 7, 32
Maximum Observed Concentration (Cmax) for OC
Day 25, 32
Time to Reach Maximum Observed Concentration (Tmax) for BIIB074
Day 7, 32
Terminal Elimination Half-Life (t1/2) of BIIB074
Day 7, 32
Apparent Clearance (CL/F) for BIIB074
Day 7, 32
Apparent Volume of Distribution at Steady State (Vss/F) for BIIB074
Day 7, 32
Time to Maximum Observed Concentration (Tmax) for OC
Day 25, 32
Terminal Elimination Half-Life (t1/2) of OC
Day 25, 32
Apparent Clearance (CL/F) for OC
Day 25, 32
Apparent Volume of Distribution at Steady State (Vss/F) for OC
Day 25, 32
Maximum Observed Concentration (Cmax) of BIIB074
Day 1 through Day 8, Day 16 through Day 23
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUCinf) of BIIB074
Day 1 through Day 8, Day 16 through Day 23
Area Under the Concentration-Time Curve from Time Zero to Time of the Last Measurable Concentration (AUClast) of BIIB074
Day 1 through Day 8, Day 16 through Day 23
Time of Last Measured Serum Concentration (Tlast) of BIIB074
Day 1 through Day 8, Day 16 through Day 23
Elimination Half-Life (T 1/2) of BIIB074
Day 1 through Day 8, Day 16 through Day 23
Apparent Clearance (CL/F) of BIIB074
Day 1 through Day 8, Day 16 through Day 23
Apparent Volume of Distribution (V/F) of BIIB074
Day 1 through Day 8, Day 16 through Day 23
Part 1: PK of BIIB074 single oral dose as assessed by maximum observed concentration (Cmax )
15 minutes prior to dosing up to 96 hours post dose
Part 1: PK of BIIB074 single oral dose as assessed by time to reach Cmax (tmax)
15 minutes prior to dosing up to 96 hours post dose
Part 1: PK of BIIB074 single oral dose as assessed by area under the concentration time curve from time 0 extrapolated to infinity (AUCinf)
15 minutes prior to dosing up to 96 hours post dose
Part 1: PK of BIIB074 single oral dose as assessed by area under the concentration time curve from time 0 to time of the last measurable drug concentration (AUC0-t)
15 minutes prior to dosing up to 96 hours post dose
Part 1: PK of BIIB074 single oral dose as assessed by terminal elimination half-life (t1/2)
15 minutes prior to dosing up to 96 hours post dose
Part 1: PK of BIIB074 single oral dose as assessed by apparent volume of distribution (Vd/F)
15 minutes prior to dosing up to 96 hours post dose
Part 1: PK of BIIB074 single oral dose as assessed by apparent total body clearance (CL/F)
15 minutes prior to dosing up to 96 hours post dose
Part 1: PK of BIIB074 single oral dose as assessed by metabolite to parent ratio in AUC (MRAUC)
15 minutes prior to dosing up to 96 hours post dose
Part 2: PK of BIIB074 repeated oral dose as assessed by Cmax
15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
Part 2: PK of BIIB074 repeated oral dose as assessed by tmax
15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
Part 2: PK of BIIB074 repeated oral dose as assessed by area under the concentration time curve within a dosing interval (AUCtau)
15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
Part 2: PK of BIIB074 repeated oral dose as assessed by trough concentration after repeated doses (Ctrough)
15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
Part 2: PK of BIIB074 repeated oral dose as assessed by t1/2
15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
Part 2: PK of BIIB074 repeated oral dose as assessed by apparent volume of distribution at steady state (Vss/F)
15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
Part 2: PK of BIIB074 repeated oral dose as assessed by apparent clearance at steady state (CLss/F)
15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
Part 2: PK of BIIB074 repeated oral dose as assessed by accumulation ratio (Rac)
15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
Part 2: PK of BIIB074 repeated oral dose as assessed by MRAUC
15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
Urinary amount excreted per sampling interval (Aeu)
12 hours prior to dosing up to Day 9
Fecal amount excreted per sampling interval (Aef)
Prior to dosing up to Day 9
Cumulative urinary amount excreted per sampling interval (Cum Aeu)
12 hours prior to dosing up to Day 9
Cumulative fecal amount excreted per sampling interval (Cum Aef)
Prior to dosing up to Day 9
Percentage of radioactive urinary dose excreted per sampling interval (%Feu)
12 hours prior to dosing up to Day 9
Percentage of radioactive fecal dose excreted per sampling interval (%Fef)
Prior to dosing up to Day 9
Cumulative percentage of radioactive urinary dose excreted per sampling interval (Cum %Feu)
12 hours prior to dosing up to Day 9
Cumulative percentage of radioactive fecal dose excreted per sampling interval (Cum %Fef)
Prior to dosing up to Day 9
Urinary amount of BIIB074 and its known metabolites excreted per sampling interval (Aeu)
12 hours prior to dosing up to Day 9
Cumulative urinary amount of BIIB074 and its known metabolites excreted per sampling interval (Cum Aeu)
12 hours prior to dosing up to Day 9
Percentage of BIIB074 dose excreted per sampling interval (%Feu)
12 hours prior to dosing up to Day 9
Cumulative percentage of BIIB074 dose excreted (Cum %Feu)
12 hours prior to dosing up to Day 9
Maximum observed concentration (Cmax)
2 hours post dose up to Day 9
Time to reach Cmax (Tmax)
2 hours post dose up to Day 9
Area under the concentration-time curve from time 0 to time of the last measurable drug concentration (AUC0-t)
2 hours post dose up to Day 9
Area under the concentration-time curve from time 0 extrapolated to infinity (AUCinf)
2 hours post dose up to Day 9
Terminal elimination half-life (t1/2)
2 hours post dose up to Day 9
Apparent total body clearance (CL/F)
2 hours post dose up to Day 9
Apparent volume of distribution (Vd/F)
2 hours post dose up to Day 9
Renal clearance (CLR)
2 hours post dose up to Day 9
Metabolite-to-parent ratio at Cmax (MRCmax)
2 hours post dose up to Day 9
Metabolite-to-parent ratio in AUC (MRAUC)
2 hours post dose up to Day 9
Exposure of BIIB074 as measured by area under the concentration-time curve from time zero to infinity (AUCinf)
Prior to dosing up to 96 hours post dose

Secondary Endpoints

50% neuropathic daily pain reduction response
At Week 14
30% neuropathic daily pain reduction response
At Week 14
Change from Baseline to Week 14 in the weekly average of the daily neuropathic pain score at each visit
Week 14
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BIIB074 high doseEXPERIMENTALAdministered twice daily (BID)
BIIB074 low doseEXPERIMENTALAdministered BID
PlaceboPLACEBO_COMPARATORPlacebo administered BID
Randomized Group 1EXPERIMENTALAfter two week run-in, BIIB074 three times a day (TID) followed by placebo (TID) after two week washout period
Randomized Group 2EXPERIMENTALAfter two week run-in, Placebo three times a day (TID) followed by BIIB074 (TID) after two week washout period
BIIB074 150 mg and Oral ContraceptiveEXPERIMENTALParticipants will receive BIIB074 in tablet form in 150 mg doses every 8 hours on prescription (TID) on days 1-7 and on days 26-32. OC will be taken in tablet form (ethinyl estradiol 30 micrograms and levonorgestrel 150 micrograms) once daily (QD) on days 12-32.
BIIB074 150 mg and Valproic Acid 500 mgEXPERIMENTALParticipants will receive BIIB074 in tablet form in 150 mg doses. BIIB074 will be taken once daily (QD) on Days 1-16 after an 8-hour fast. Valproic Acid will be given in capsule form in 500 mg doses on prescription (TID) every 8 hours on Days 8-22. The morning dose on Day 16 will be coadministered with BIIB074 following an 8-hour fast.
Part 1EXPERIMENTAL48 participants: Cohorts 1,2 and 3 (Single Ascending Dose of BIIB074 or placebo) in a 6:2 ratio
Part 2EXPERIMENTAL16 participants: Multiple Ascending Dosing of BIIB074 or placebo in a 6:2 ratio; 3 times daily \[TID\] in cohort 4 for 6 days and one time (QD) for 1 day and 2 times daily \[BID\] in cohort 5 for 6 days and QD for 1 day
BIIB074EXPERIMENTALSingle oral dose on Day 1

Interventions

NameTypeDescription
BIIB074DRUGAdministered as specified in the treatment arm
PlaceboDRUGMatched placebo
OC (ethinyl estradiol and levonorgestrel)DRUGOC is administered as specified in the treatment arm.
Valproic AcidDRUGAdministered as specified in the treatment arm
ItraconazoleDRUG200 mg twice daily \[BID\] on Day 8 and once daily (QD) from Day 9 to Day 15 inclusive
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites56

Key Inclusion Criteria: * Has body weight ≥50 kg for men and ≥45 kg for women * Must have diagnosis of neuropathic PLSR * Has duration of neuropathic (leg) pain of at least 6 months before Screening * Has an intensity of ≥4 and ≤9 on the Numerical Rating Scale based on a paper-based question at Scr...

Countries:AustriaBelgiumBulgariaCzechiaFranceGeorgiaItalyLatviaNetherlandsRomaniaSerbiaSlovakiaSpainUnited KingdomUnited States
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Frequently asked questions about BIIB074

What is BIIB074 used for?

BIIB074 is an investigational small molecule being studied for neuropathic pain, primary inherited erythromelalgia, and lumbosacral radiculopathy. It has also been evaluated in healthy volunteers for drug interaction studies. BIIB074 is not approved and remains in clinical development.

Who makes BIIB074?

BIIB074 is being developed by Biogen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol BIIB. The drug is an investigational small molecule in clinical development.

What phase is BIIB074 in?

BIIB074 has completed Phase 1 and Phase 2 clinical trials. The completed studies include Phase 1 pharmacokinetic and drug interaction trials, as well as a Phase 2a study in primary inherited erythromelalgia. BIIB074 remains investigational.

What clinical trials has BIIB074 been in?

BIIB074 has been studied in several completed trials. NCT02698267 and NCT02751905 were Phase 1 pharmacokinetic studies in healthy volunteers. NCT02917187 was a Phase 2a study in primary inherited erythromelalgia. NCT03385525 evaluated a drug interaction with valproic acid.

Is BIIB074 FDA approved?

BIIB074 is not FDA approved. It is an investigational drug that has completed early-stage clinical trials, including Phase 1 and Phase 2 studies. The drug remains in clinical development and has not been approved for any indication.

What conditions has BIIB074 been studied for?

BIIB074 has been studied for neuropathic pain, primary inherited erythromelalgia, and lumbosacral radiculopathy. It has also been evaluated in healthy volunteers for drug interaction and pharmacokinetic studies. These studies were conducted in the United States and the United Kingdom.