A Study of Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)

Lilly

Status and phase: Completed; Phase 2

Conditions: Relapsing-Remitting Multiple Sclerosis

Treatments: Drug: Placebo; Drug: LY2127399

Study type: Interventional

Funder types: Industry

Identifiers

NCT00882999

12778

H9B-MC-BCDJ (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 245 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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245 participants in 7 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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).

Treatment:

Drug: Placebo

4 mg LY2127399 / 4 weeks

Experimental group

Description:

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

Treatment:

Drug: LY2127399

40 mg LY2127399 / 4 weeks

Experimental group

Description:

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

Treatment:

Drug: LY2127399

120 mg LY2127399 / 4 weeks

Experimental group

Description:

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

Treatment:

Drug: LY2127399

4 mg LY2127399 / 12 weeks

Experimental group

Description:

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).

Treatment:

Drug: Placebo

Drug: LY2127399

120 mg LY2127399 / 12 weeks

Experimental group

Description:

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).

Treatment:

Drug: Placebo

Drug: LY2127399

12 mg LY2127399 / 4 weeks

Experimental group

Description:

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

Treatment:

Drug: LY2127399