A Study to Evaluate the Efficacy, Safety , Tolerability and Pharmacokinetics of ABBV-8E12 in Subjects with Progressive Supranuclear Palsy.

• Register: EUCTR
• Last refreshed on: 10 December 2019
• Main ID: EUCTR2016-001635-12-ES
• Date of registration: 10/05/2018
• Prospective Registration: Yes
• Primary sponsor: AbbVie Deutschland GmbH & Co. KG
• Public title: A Study to Evaluate the Efficacy, Safety , Tolerability and Pharmacokinetics of ABBV-8E12 in Subjects with Progressive Supranuclear Palsy.
• Scientific title: A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Progressive Supranuclear Palsy
• Date of first enrolment: 04/07/2018
• Target sample size: 330
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-001635-12
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Canada, Germany, Italy, Spain, United States

Contacts

• Name: EU Clinical Trials Helpdesk
• Affiliation: AbbVie Ltd

• Name: EU Clinical Trials Helpdesk
• Affiliation: AbbVie Ltd

Key inclusion & exclusion criteria

Inclusion criteria:
• Male or female subject with age 40 years or greater at the time of signed consent.
• Meets the following criteria for possible or probable progressive supranuclear palsy (Steele-Richardson-Olszewski Syndrome)
- gradually progressive disorder, with age at disease onset greater than or equal to 40 years
- either or both of the following two items are met:
1. vertical supranuclear gaze palsy
2. slowing of vertical saccades AND postural instability with falls within the first 3 years of PSP symptoms
• Presence of PSP symptoms for less than 5 years.
• Subject is able to walk 5 steps with minimal assistance (stabilization of one arm or use of cane/walker).
• Subject has an identified, reliable, study partner (e.g., caregiver, family member, social worker, or friend).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 92
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 238

Exclusion criteria:
• Subjects who weigh less than 44 kg (97 lbs) at screening.
• MMSE score less than 15 at screening
• Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI)
• Subject 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 subject has a history of or currently has schizophrenia, schizoaffective disorder or bipolar disorder according to DSM-V or ICD-10 criteria.
• Subject has had a significant illness or infection requiring medical intervention in the past 30 days.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Progressive Supranuclear Palsy
MedDRA version: 20.0 Level: PT Classification code 10036813 Term: Progressive supranuclear palsy System Organ Class: 10029205 - Nervous system disorders

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

Product Code: ABBV-8E12
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: ABBV-8E12
Current Sponsor code: ABBV-8E12
Other descriptive name: ABBV-8E12
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Product Code: ABBV-8E12
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: ABBV-8E12
Current Sponsor code: ABBV-8E12
Other descriptive name: ABBV-8E12
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Main Objective: - To assess the efficacy of ABBV-8E12 in slowing disease progression in subjects with progressive supranuclear palsy as measured by the PSP Rating Scale (PSP-RS).
- To assess the long term safety and tolerability of ABBV-8E12 for up to 52 weeks in subjects with progressive supranuclear palsy.

Timepoint(s) of evaluation of this end point: Weeks 12, 24, 36 and 52

Primary end point(s): The change from baseline to Week 52 on the PSP-RS total score.

Secondary Objective: - To assess the pharmacokinetics of ABBV-8E12 in subjects with PSP.
- To assess the efficacy of ABBV-8E12 in slowing disease progression and functional impairment in subjects with PSP as measured by secondary endpoints.
- To assess the efficacy of ABBV-8E12 in slowing regional and/or whole brain atrophy in subjects with PSP as measured by volumetric MRI.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1. Day 1, Day 5 (C1), Day 15, Day 29, Day 57 (C1), Day 85, Day 89 (C1), Day 99 (C1), Week 16 (C1), Week 24, Week 36, Week 52, Week 60, Week 68
2. SEADL, UPDRS, – Screen, Day 1, Week 12, Week 24, Week 36, Week 52
CGI-S-SV1, SV2, Day 1, Week 8, Week 12, Week 20, Week 24, Week 32, Week 36, Week 48 and Week 52
CGI-C-Weeks 8, Week 12, Week 20, Week 24, Week 32, Week 36, Week 48 and Week 52
PSP-QoL-SV1, Day 1, Week 12, Week 24, Week 36, Week 52
3. Screen, Day 15 (C1), Week 12, Week 24, Week 52

Secondary end point(s): 1. To assess the pharmacokinetics of ABBV-8E12 in subjects with progressive supranuclear palsy.
2. To assess the efficacy of ABBV-8E12 in slowing disease progression and functional impairment in subjects with progressive supranuclear palsy as measured by the SEADL, UPDRS Part II, CGI-S, CGI-C, and PSP-QoL.
3. To assess the efficacy of ABBV-8E12 in slowing regional and/or whole brain atrophy in subjects with progressive supranuclear palsy as measured by volumetric MRI.

Secondary ID(s)

NCT02985879

2016-001635-12-DE

M15-562

Source(s) of Monetary Support

AbbVie Inc.

Ethics review

Status: Approved
Approval date:
Contact: