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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02601885
• Other study ID #: M14-173
• Status: Completed
• Phase: Phase 1
• Start date: October 18, 2016
• Est. completion date: April 20, 2018

Study information

• Verified date: May 2018
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 20, 2018
• Est. primary completion date: April 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• ABT-555
Intravenous Infusion

Other:
• Placebo
Intravenous Infusion

Locations

Country	Name	City	State
United States	Integrated Neurology Services	Alexandria	Virginia
United States	Parexel International	Baltimore	Maryland
United States	Duke Univ Med Ctr	Durham	North Carolina
United States	MIND	Farmington Hills	Michigan
United States	Clinical Trial Network	Houston	Texas
United States	Tri-State Mountain Neurology	Johnson City	Tennessee
United States	Rowe Neurology Institute	Lenexa	Kansas
United States	Compass Research LLC	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and percentage of participants reporting adverse events		Throughout study from Day 1 to Day 176
Primary	Concentration of anti-drug antibody (ADA) titers of ABT-555		Day 1 to Day 176
Primary	Time to Maximum observed plasma concentration (Tmax) of ABT-555		Day 1 to Day 176
Primary	Maximum observed plasma concentration (Cmax) of ABT-555		Day 1 to Day 176
Primary	Area under the concentration curve (AUC) of ABT-555		Day 1 to Day 176
Secondary	Percentage of participants who experience relapse and disability progression		Throughout the study to Day 176
Secondary	Lesion volume of new, newly enlarging T2 hyperintense lesions		Throughout study from Day 0 to Day 113
Secondary	Number of new, newly-enlarging T2 hyperintense lesions		Throughout study from Day 0 to Day 113
Secondary	Total number of new Gadolinium-enhancing T1 lesions		Throughout study from Day 0 to Day 113