A Multiple Dose Study of ABT-555 in Subjects With Relapsing Forms of Multiple Sclerosis

AbbVie

Status and phase: Completed; Phase 1

Conditions: Multiple Sclerosis

Treatments: Drug: ABT-555; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02601885

M14-173

Details and patient eligibility

About

This study seeks to evaluate the safety, tolerability, pharmacokinetics (PK) and immunogenicity of ABT-555 in participants with relapsing forms of multiple sclerosis (RFMS).

Enrollment: 20 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Currently receiving one of the following MS medications for at least 3 months: beta-interferon (any formulation including the pegylated form), glatiramer acetate (Copaxone®, others), teriflunomide (Aubagio®), fingolimod (Gilenya®), or dimethyl fumarate (Tecfidera®); OR
• Has not been treated with an MS immunotherapy for the past 6 months (12 months if they previously received cyclophosphamide or alemtuzumab); OR
• Treatment naïve with established MS diagnosis per criteria by a neurologist.
• Diagnosis of relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS) according to revised McDonald criteria
• Baseline Expanded Disability Status Scale (EDSS) between 0 and 6.0, inclusive.
• Brain MRI scan at Screening that did not show evidence of overt vascular lesions, masses, mass effect or other abnormalities other than those compatible with MS, which would preclude the participant from undergoing a lumbar puncture/spinal tap for CSF collection

Exclusion criteria

• Diagnosis of primary progressive MS.
• Anticipated maintenance immunomodulator change, either agent or dose
• An MS relapse that occurred within the 30 days prior to randomization AND/OR the participant has not stabilized from a previous relapse prior to randomization
• Participants for whom MRI is contraindicated
• Participants who have claustrophobia that cannot be medically managed or are unable to lie still for 1 hour or more for the imaging procedures
• Findings on brain MRI scan indicating any clinically significant brain abnormality other than MS
• Contraindication for lumbar puncture

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 3 patient groups

Group 2

Experimental group

Description:

Participants will receive multiple doses of ABT-555 or placebo

Treatment:

Drug: ABT-555

Other: Placebo

Group 3

Experimental group

Description:

Participants will receive multiple doses of ABT-555 or placebo

Treatment:

Drug: ABT-555

Other: Placebo

Group 1

Experimental group

Description:

Participants will receive multiple doses of ABT-555 or placebo

Treatment:

Drug: ABT-555

Other: Placebo