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

Recruiting in Palo Alto (17 mi)

+65 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: AbbVie

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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

Research Team

AbbVie Inc.

Principal Investigator

AbbVie

Eligibility Criteria

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

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Treatment Details

Interventions

ABBV-8E12 (Monoclonal Antibodies)

Participant Groups

3Treatment groups

Experimental Treatment

Placebo Group

Group I: ABBV-8E12 4000 mgExperimental Treatment1 Intervention

Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)

Group II: ABBV-8E12 2000 mgExperimental Treatment1 Intervention

Group III: PlaceboPlacebo Group1 Intervention

0.9% Sodium Chloride Injection/Solution for Infusion; intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks