A Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Subjects With Progressive Supranuclear Palsy (PSP)

• Status: Terminated
• Trial end date: 2019-11-20
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to assess efficacy, safety, tolerability, and pharmacokinetics of ABBV-8E12 in participants with progressive supranuclear palsy (PSP).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Treatments: Tilavonemab

Criteria

Key Inclusion Criteria:

• Male or female participant with age 40 years or greater at the time of signed consent

• Meets the criteria for possible or probable progressive supranuclear palsy (PSP; Steele-Richardson-Olszewski Syndrome)

• Presence of PSP symptoms for less than 5 years

• Participant is able to walk 5 steps with minimal assistance (stabilization of one arm or use of cane/walker)

• Participant has an identified, reliable, study partner (e.g., caregiver, family member, social worker, or friend)

Key Exclusion Criteria:

• Participants who weigh less than 44 kg (97 lbs) at screening

• Mini-Mental State Examination (MMSE) score less than 15 at screening

• Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI)

• Participant resides at a skilled nursing or dementia care facility, or admission to such a facility is planned during the study period

• Evidence of any clinically significant neurological disorder other than PSP

• The participant has a history of or currently has schizophrenia, schizoaffective disorder or bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) or International Classification of Diseases (ICD-10) criteria

• Participant has had a significant illness or infection requiring medical intervention in the past 30 days