NCT00882999

Brief Summary

To look at the ability of LY2127399 to reduce magnetic resonance imaging (MRI) lesions at 12, 16, 20, and 24 weeks compared to placebo.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
245

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2009

Typical duration for phase_2

Geographic Reach
13 countries

63 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 17, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
6.5 years until next milestone

Results Posted

Study results publicly available

November 15, 2018

Completed
Last Updated

November 15, 2018

Status Verified

November 1, 2018

Enrollment Period

1.8 years

First QC Date

April 16, 2009

Results QC Date

March 24, 2018

Last Update Submit

November 10, 2018

Conditions

Relapsing-Remitting Multiple Sclerosis

Keywords

RelapsingRemittingMultiple SclerosisMultipleSclerosisMSLY2127399

Outcome Measures

Primary Outcomes (1)

  • Total Number of Gd-Enhancing T1-Weighted MRI Lesions Per Scan Averaged During Weeks 12, 16, 20, and 24

    Lesions were measured using Gd-enhancing T1-weighted MRI scans. The number of T1-weighted lesions per scan was obtained from the number of T1-weighted lesions observed during a specified week divided by the number of scans performed that same week. To obtain the number of T1-weighted lesions per scan averaged during Weeks 12, 16, 20, and 24, the number of lesions per scan at each week was summed and then divided by the number of visits with non-missing lesion counts.

    Weeks 12, 16, 20, and 24

Secondary Outcomes (15)

  • Change From Baseline in Number of Gd-Enhancing T1-Weighted MRI Lesions Per Scan

    Baseline, Weeks 4, 8, 12, 16, 20, 24, 36, and 48

  • Total Number of New Gd-Enhancing T1-Weighted MRI Lesions Per Scan

    Weeks 4, 8, 12, 16, 20, 24, 36, and 48

  • Total Number of New or Newly Enlarging T2-Weighted MRI Lesions

    Weeks 4, 8, 12, 16, 20, 24, 36, and 48

  • Total Volume of T2-Weighted MRI Lesions

    Weeks 4, 8, 12, 16, 20, 24, 36, and 48

  • Expanded Disability Status Scale (EDSS)

    Weeks 12, 24, and 48

  • +10 more secondary outcomes

Study Arms (7)

Placebo

PLACEBO COMPARATOR

Injection: Every 4 weeks in the placebo arm for 24 weeks (Weeks 0, 4, 8, 12, 16, and 20) for a total of 6 doses. Every 4 weeks in the LY2127399 arms \[4 milligrams (mg) LY2127399 / 12 weeks and 120 mg LY2127399 / 12 weeks\] for 24 weeks (except Week 0 and Week 12).

Drug: Placebo

4 mg LY2127399 / 4 weeks

EXPERIMENTAL

Injection: 6 doses, one every 4 weeks for 24 weeks.

Drug: LY2127399

40 mg LY2127399 / 4 weeks

EXPERIMENTAL

Injection: 6 doses, one every 4 weeks for 24 weeks.

Drug: LY2127399

120 mg LY2127399 / 4 weeks

EXPERIMENTAL

Injection: 6 doses, one every 4 weeks for 24 weeks.

Drug: LY2127399

4 mg LY2127399 / 12 weeks

EXPERIMENTAL

Drug: LY2127399 Injection: 2 doses, one every 12 weeks for 24 weeks. Drug: Placebo Injection: Every 4 weeks for 24 weeks (except Week 0 and Week 12).

Drug: LY2127399Drug: Placebo

120 mg LY2127399 / 12 weeks

EXPERIMENTAL

Drug: LY2127399 Injection: 2 doses, one every 12 weeks for 24 weeks. Drug: Placebo Injection: Every 4 weeks for 24 weeks (except Week 0 and Week 12).

Drug: LY2127399Drug: Placebo

12 mg LY2127399 / 4 weeks

EXPERIMENTAL

Injection: 6 doses, one every 4 weeks for 24 weeks.

Drug: LY2127399

Interventions

LY2127399DRUG

Administered via Injection

12 mg LY2127399 / 4 weeks120 mg LY2127399 / 12 weeks120 mg LY2127399 / 4 weeks4 mg LY2127399 / 12 weeks4 mg LY2127399 / 4 weeks40 mg LY2127399 / 4 weeks
PlaceboDRUG

Administered via Injection

120 mg LY2127399 / 12 weeks4 mg LY2127399 / 12 weeksPlacebo

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • through 64 years of age diagnosed with RRMS, who can walk without aid or rest for at least 200 meters (approximately 1/10 of a mile).
  • Women who can become pregnant must use birth control.

You may not qualify if:

  • Have had a live vaccination within 12 weeks before randomization, or intend to have a live vaccination during the course of the study.
  • Have had had recent surgery or are scheduled to have surgery during the study.
  • Are immunocompromised or have evidence of active infection \[such as hepatitis, tuberculosis or, human immunodeficiency virus (HIV)\].
  • Have been on certain drugs that are being studied for RRMS or have recently received prescription drugs to treat RRMS.
  • Have had a recent serious infection.
  • Have serious or uncontrolled illnesses other than RRMS.
  • Have clinically significant blood test values.
  • Have multiple or severe drug allergies.
  • Have contraindications for MRI "scanning" or claustrophobia (fear of an enclosed space) that cannot be managed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (63)

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Phoenix, Arizona, 85013, United States

Location

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Tucson, Arizona, 85741, United States

Location

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Fullerton, California, 92835, United States

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Denver, Colorado, 80220, United States

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Naples, Florida, 34102, United States

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Plantation, Florida, 33324, United States

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Sarasota, Florida, 34239, United States

Location

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Northbrook, Illinois, 60062, United States

Location

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Indianapolis, Indiana, 46202, United States

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Kansas City, Kansas, 66160, United States

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Lexington, Kentucky, 40513, United States

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Biddeford, Maine, 04005, United States

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Farmington Hills, Michigan, 48334, United States

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Toms River, New Jersey, 08755, United States

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Schenectady, New York, 12308, United States

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Charlotte, North Carolina, 28207, United States

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Raleigh, North Carolina, 27607, United States

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Akron, Ohio, 44320, United States

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Green, Ohio, 44685, United States

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Greensburg, Pennsylvania, 15601, United States

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Greenville, South Carolina, 29615, United States

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Franklin, Tennessee, 37064, United States

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Memphis, Tennessee, 38120, United States

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Lubbock, Texas, 79410, United States

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Round Rock, Texas, 78681, United States

Location

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Newport News, Virginia, 23601, United States

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Roanoke, Virginia, 24018, United States

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Sofia, 1407, Bulgaria

Location

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Brno, 62500, Czechia

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Pardubice, 500 05, Czechia

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Prague, 140 59, Czechia

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Caen, 14033, France

Location

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Montpellier, 34295, France

Location

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Nîmes, 30900, France

Location

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Strasbourg, 67091, France

Location

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Berlin, 13156, Germany

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Ulm, 89075, Germany

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Budapest, 1095, Hungary

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Győr, 9023, Hungary

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Gyula, 5700, Hungary

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Tel Litwinsky, 52621, Israel

Location

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Gdansk, 80-952, Poland

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Gliwice, 44-100, Poland

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Grodzisk Mazowiecki, 05-825, Poland

Location

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Krakow-Nowa Huta, PL-31-826, Poland

Location

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Lodz, 90-549, Poland

Location

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Lublin, 20-090, Poland

Location

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Târgu Mureş, 540136, Romania

Location

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Kazan', 4420029, Russia

Location

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Kemerovo, 650066, Russia

Location

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Moscow, 119435, Russia

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Belgrade, 11000, Serbia

Location

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Niš, 18000, Serbia

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Bratislava, 833 05, Slovakia

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Košice, 04011, Slovakia

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Spišská Nová Ves, 05201, Slovakia

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Žilina, 01001, Slovakia

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Dnipro, 49027, Ukraine

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Donetsk, 83037, Ukraine

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Ivano-Frankivsk, 76008, Ukraine

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Kharkiv, 61000, Ukraine

Location

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Vinnytsia, 21005, Ukraine

Location

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Zaporizhzhya, 69057, Ukraine

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-RemittingRecurrenceMultiple SclerosisSclerosis

Interventions

tabalumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon- Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2009

First Posted

April 17, 2009

Study Start

April 1, 2009

Primary Completion

February 1, 2011

Study Completion

June 1, 2012

Last Updated

November 15, 2018

Results First Posted

November 15, 2018

Record last verified: 2018-11

Locations

US(27)RO(1)RU(3)BU(1)SL(4)CZ(3)UA(6)PL(6)DE(2)SE(2)IL(1)FR(4)HU(3)