An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)

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Brief Title

An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)

Official Title

An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)

Brief Summary

      The purpose of this study was to assess the long-term safety and efficacy of ABBV-8E12
      (tilavonemab) in participants with progressive supranuclear palsy (PSP).
    

Detailed Description

      This study (M15-563) was a Phase 2, randomized, double-blind, multiple-dose, multicenter,
      long-term extension of NCT 02985879 (Study M15-562) in participants with progressive
      supranuclear palsy (PSP). Those who completed the 52-week Treatment Period in Study M15-562
      and met all entry criteria were eligible for enrollment into this study. This study planned
      for a Treatment Period of up to 5 years and a post-treatment follow-up visit approximately 20
      weeks after the last dose of study drug (including participants who prematurely discontinued
      treatment). All participants received ABBV-8E12 as follows: those who received placebo in
      Study M15-562 were randomized, in a 1:1 ratio, to either 2000 or 4000 mg; those who received
      ABBV-8E12 at a dose of either 2000 or 4000 mg in Study M15-562 continued on the same dose in
      this study.

      This study was prematurely discontinued because the program for progressive supranuclear
      palsy was discontinued due to lack of efficacy.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Change in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score From Baseline to Week 52

Secondary Outcome

 Mean Change From Baseline to Week 52 in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living)

Condition

Progressive Supranuclear Palsy (PSP)

Intervention

ABBV-8E12

Study Arms / Comparison Groups

 M15-562 ABBV-8E12 2000 mg/M15-563 ABBV-8E12 2000 mg
Description:  Intravenous (IV) infusions of 2000 mg ABBV-8E12 at Day 1 and Day 29, then every 28 days for up to 5 years; administered at 300 mg/15 mL and 1000 mg/10 mL strength. Placebo IV infusion was administered on Day 15 in Study M15-563 (to maintain the blind in Study M15-562).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

142

Start Date

January 24, 2018

Completion Date

December 13, 2019

Primary Completion Date

December 13, 2019

Eligibility Criteria

        Inclusion Criteria:

          -  Participant completed the 52-week treatment period in Study M15-562 (NCT02985879)

          -  In the opinion of the investigator, the participant was compliant during participation
             in Study M15-562 (NCT02985879)

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

        Exclusion Criteria:

          -  Participants who weigh less than 44 kg (97 lbs) at the time of study entry

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

          -  Participant has any significant change in his/her medical condition that could
             interfere with the subject's participation in the study, could place the subject at
             increased risk, or could confound interpretation of study results

          -  More than 8 weeks have elapsed since the participant received his/her last dose of
             study drug in Study M15-562 (NCT02985879)

          -  Participant is considered by the investigator, for any reason, to be an unsuitable
             candidate to receive ABBV-8E12 or the participant is considered by the investigator to
             be unable or unlikely to comply with the dosing schedule or study evaluations
      

Gender

All

Ages

40 Years - N/A

Accepts Healthy Volunteers

No

Contacts

AbbVie Inc., , 

Location Countries

Australia

Location Countries

Australia

Administrative Informations


NCT ID

NCT03391765

Organization ID

M15-563

Secondary IDs

2017-001590-16

Responsible Party

Sponsor

Study Sponsor

AbbVie


Study Sponsor

AbbVie Inc., Study Director, AbbVie


Verification Date

February 2021