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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02601885
• Date of registration: 05/11/2015
• Prospective Registration: Yes
• Primary sponsor: AbbVie
• Public title: A Multiple Dose Study of ABT-555 in Subjects With Relapsing Forms of Multiple Sclerosis
• Scientific title: An Escalating Multiple Dose Study of ABT-555 in Subjects With Relapsing Forms of Multiple Sclerosis
• Date of first enrolment: October 18, 2016
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02601885
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: AbbVie Inc.
• Affiliation: AbbVie

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Other: Placebo

Drug: ABT-555

Primary Outcome(s)

Area under the concentration curve (AUC) of ABT-555 [Time Frame: Day 1 to Day 176]

Time to Maximum observed plasma concentration (Tmax) of ABT-555 [Time Frame: Day 1 to Day 176]

Concentration of anti-drug antibody (ADA) titers of ABT-555 [Time Frame: Day 1 to Day 176]

Number and percentage of participants reporting adverse events [Time Frame: Throughout study from Day 1 to Day 176]

Maximum observed plasma concentration (Cmax) of ABT-555 [Time Frame: Day 1 to Day 176]

Secondary Outcome(s)

Number of new, newly-enlarging T2 hyperintense lesions [Time Frame: Throughout study from Day 0 to Day 113]

Lesion volume of new, newly enlarging T2 hyperintense lesions [Time Frame: Throughout study from Day 0 to Day 113]

Percentage of participants who experience relapse and disability progression [Time Frame: Throughout the study to Day 176]

Total number of new Gadolinium-enhancing T1 lesions [Time Frame: Throughout study from Day 0 to Day 113]

Secondary ID(s)

M14-173

Source(s) of Monetary Support

Please refer to primary and secondary sponsors