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dirucotide

Phase 2

Relapsing Remitting Multiple Sclerosis | Small molecule | Neurology |Eli Lilly and Company|Trials Updated: Sep 9, 2010

dirucotide development status

Highest phase Phase 2
Registered trials 3 across 1 sponsor since Mar 2009

dirucotide target and mechanism

Target class-Tide (Peptide)
ModalitySmall molecule

Also known as MBP8298, LY2820671

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment814

FDA Designations

No designations recorded

dirucotide clinical trials

dirucotide · 2 trials · 2 indications

Phase 2 2
NCT00869986A Study for Patients With Relapsing Remitting Multiple SclerosisRelapsing Remitting Multiple Sclerosis
COMPLETED218 Analytics
NCT00869726A Study for Patients With Secondary Progressive Multiple SclerosisSecondary Progressive Multiple Sclerosis
COMPLETED596 Analytics
PHASE2COMPLETED
A Study for Patients With Relapsing Remitting Multiple Sclerosis
Relapsing Remitting Multiple SclerosisUnlock trial analytics
PHASE2COMPLETED
A Study for Patients With Secondary Progressive Multiple Sclerosis
Secondary Progressive Multiple SclerosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Annualized relapse rate
15 months
Increase in the time to worsening of disability by Kurtzke Expended Disability Status (EDSS).
baseline, 3mos, 6mos, 9mos, 12mos, 15mos,18mos, 21mos, 24mos

Secondary Endpoints

Time to confirmed worsening of disability by Expanded Disability Status Scale (EDSS)
baseline, 15, 24 and 27 months
Time to confirmed worsening of disability by Multiple Sclerosis Functional Composite (MSFC)
baseline, 15, 24 and 27 months
Proportion of patients relapse-free
15, 24, and 27 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
DirucotideEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
dirucotideDRUG500mg, intravenous, every 6 months for 15 months
placeboDRUGintravenous, once every six months for 15 months
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: 1. Male or female subjects, 18-50 years of age 2. Relapsing-remitting multiple sclerosis (RRMS) according to "Diagnostic criteria for multiple sclerosis: 2005 revisions to the McDonald Criteria" (Annals of Neurology 58: 840-846) 3. At least 2 years history of MS before trial ent...

Countries:BulgariaPolandRussiaSerbiaSlovakiaUkraineCanadaDenmarkEstoniaFinlandGermanyLatviaNetherlandsSpainSwedenUnited Kingdom
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Frequently asked questions about dirucotide

What is dirucotide used for?

Dirucotide was studied for relapsing remitting multiple sclerosis and secondary progressive multiple sclerosis, two forms of MS. It is a small molecule peptide developed by Eli Lilly and Company. Both Phase 2 trials in these indications have been completed, and no active trials are currently listed.

What does dirucotide target?

Dirucotide is a peptide, classified as a -tide, developed for multiple sclerosis. It is a small molecule modality. The supplied information identifies its target class as peptide but does not name a specific molecular target, so its precise mechanism of action is not described here.

Who makes dirucotide?

Dirucotide is developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly sponsored the Phase 2 clinical program evaluating dirucotide in relapsing remitting and secondary progressive multiple sclerosis.

What phase is dirucotide in?

Dirucotide is in Phase 2 development. It has not been approved by the FDA and remains investigational. Two Phase 2 trials have been completed, one in relapsing remitting multiple sclerosis and one in secondary progressive multiple sclerosis, and no active trials are listed.

What clinical trials is dirucotide in?

Dirucotide has been evaluated in two completed Phase 2 trials. NCT00869986 studied relapsing remitting multiple sclerosis with 218 participants across Bulgaria, Poland, Russia, Serbia, Slovakia, and Ukraine. NCT00869726 studied secondary progressive multiple sclerosis with 596 participants across Canada, Denmark, Estonia, Finland, Germany, Latvia, Netherlands, Spain, Sweden, and the United Kingdom.

Were the dirucotide trials randomized and placebo controlled?

Yes. The dirucotide Phase 2 program used randomized, double blind, placebo controlled designs. The relapsing remitting multiple sclerosis trial, NCT00869986, enrolled 218 participants, and the secondary progressive multiple sclerosis trial, NCT00869726, enrolled 596 participants. Both studies are completed and enrolled adults aged 18 years and older.