Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants with Parkinson’s Disease

• Register: EUCTR
• Last refreshed on: 14 June 2021
• Main ID: EUCTR2016-004610-95-DE
• Date of registration: 27/02/2018
• Prospective Registration: Yes
• Primary sponsor: Biogen Idec Research Limited
• Public title: Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants with Parkinson’s Disease
• Scientific title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, with an Active-Treatment Dose-Blinded Period, to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects with Parkinson’s Disease - SPARK
• Date of first enrolment: 01/10/2018
• Target sample size: 357
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-004610-95
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 4
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Canada, France, Germany, Israel, Italy, Spain, United Kingdom, United States

Contacts

• Name: Medical Director
• Affiliation: Biogen

• Name: Medical Director
• Affiliation: Biogen

Key inclusion & exclusion criteria

Inclusion criteria:
- Diagnosed with Parkinson's disease (PD) within a maximum of 3 years prior to Screening.
- Score of =2.5 on the Modified Hoehn and Yahr Scale.
- Has not received any medication for the treatment of the motor symptoms of PD for at least 12 weeks prior to Day 1 and, in the opinion of the investigator, is not expected to require PD treatment for at least 6 months following Day 1. Maximum total duration of prior PD regimens should not exceed 30 days. Stable (at least 8 weeks) dosages of medications that are used to treat conditions other than PD tremot are allowed. Further guidance will be provided by the study's Medical Monitor on a case by case basis.
-Screening dopamine transporter (DaT)/ single-photon emission computed tomography (SPECT) results consistent with
neurodegenerative Parkinsonism (central reading).
- All women of childbearing potential and all men must practice highly effective contraception during the study and for 6 months after their last dose of study treatment.
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 203
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 154

Exclusion criteria:
- Presence of freezing of gait.
- Montreal cognitive assessment (MOCA) score <23 or other significant cognitive impairment or clinical dementia that, in the opinion of the Investigator, would interfere with study evaluation.
- History of or screening brain magnetic resonance imaging (MRI) scan indicative of clinically significant abnormality, as read by central reader.
- History of severe allergic or anaphylactic reactions, or history of hypersensitivity to BIIB054 or any of the inactive ingredients in the drug product or to radioligands or iodine used in the study.
- Participation in any active immunotherapy study targeting alpha-synuclein.
- Use of allowed medications not previously specified at doses that have not been stable for at least 8 weeks before Day 1, and/or that are not expected to remain stable for the duration of the study.
- Clinically significant abnormal laboratory test values at Screening, as determined by the Investigator.
- Blood donation (1 unit or more) within 8 weeks before Day 1 (must also refrain from donating blood for the duration of the study).


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

Health Condition(s) or Problem(s) studied

Parkinson's Disease
MedDRA version: 20.0 Level: PT Classification code 10061536 Term: Parkinson's disease System Organ Class: 10029205 - Nervous system disorders

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

Intervention(s)

Product Code: BIIB054
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: n/a
Current Sponsor code: BIIB054
Other descriptive name: BIIB054
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Main Objective: To evaluate the clinical efficacy of BIIB054 via dose response using the
change from baseline in Movement Disorder Society-Unified Parkinson's
Disease Rating Scale (MDS-UPDRS) Total Score.

Primary end point(s): Change From Baseline in Movement Disorder Society-Unified Parkinson's
Disease Rating Scale (MDS-UPDRS) Total Score (Sum of Parts I, II, and
III) at Week 52 and Week 72

Timepoint(s) of evaluation of this end point: Baseline, Week 52, Week 72

Secondary Objective: - To evaluate the dose-related safety of BIIB054,
-To evaluate the clinical efficacy of BIIB054 via MDS-UPDRS total score,
-To assess the pharmacokinetic (PK) profile of BIIB054,
-To evaluate the clinical efficacy of BIIB054 based on MDS-UPDRS
subparts,
-To evaluate the pharmacodynamic effects of BIIB054 on the integrity of
nigrostriatal dopaminergic nerve terminals, and
-To evaluate the immunogenicity of BIIB054.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: - Up to 178 weeks
- Baseline, Week 178
- Baseline up to Week 144
- Baseline, Week 52, Week 72 and Week 178
- Baseline, Week 52
- Baseline up to Week 144

Secondary end point(s): - Percentage of Participants With Adverse Event (AEs) and Serious
Adverse Event (SAEs)
- Change From Baseline in Movement Disorder Society-Unified
Parkinson's Disease Rating Scale MDS-UPDRS Total Score (Sum of Parts
I, II, and III) at End of Study
- Serum Concentration of BIIB054
- Change From Baseline in Movement Disorder Society-Unified
Parkinson's Disease Rating Scale MDS-UPDRS Subparts I, II and III at
Week 52, Week 72 and End of Study
- Change From Baseline in Striatal Binding Ratio (SBR) in Putamen,
Striatum, and Caudate
- Percentage of Participants With Anti-BIIB054 Antibodies in the Serum

Secondary ID(s)

228PD201

2016-004610-95-GB

NCT03318523

Source(s) of Monetary Support

Biogen Idec Research Limited

Ethics review

Status: Approved
Approval date: 01/10/2018
Contact: