A Study of TAK-341 in Treatment of Multiple System Atrophy
Purpose
The main aim is to see how TAK-341 works after 52 weeks in participants with multiple system atrophy as measured by the Unified Multiple System Atrophy Rating Scale Part I (UMSARS). The study will enroll approximately 138 patients. Participants will receive a total of 13 intravenous infusions every 4 weeks approximately, these may be either of TAK-341 or placebo, after each infusion some blood samplings will be taken and other assessments completed. This trial will be conducted in North America, Europe and Asia.
Condition
- Multiple System Atrophy
Eligibility
- Eligible Ages
- Over 40 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
Diagnostic: 1. The participant has a diagnosis of possible or probable MSA using the modified Gilman et al, 2008 diagnostic criteria. 2. The participant's onset of first MSA symptoms occurred ≤4 years before screening, as assessed by the investigator. 3. Evidence of MSA specific symptoms and deficits as measured by the UMSARS scale.
Exclusion Criteria
Medical History: 1. The participant has any contraindication to study procedures. Diagnostic Assessments: 1. Presence of confounding diagnosis and/or conditions that could affect participant's safety during the study per investigator judgement. 2. The participant's participation in a previous study of a disease-modifying therapy (with proven receipt of active treatment) will compromise the interpretability of the data from the present study, per consultation with medical monitor or designee. Other: 1. The participant has participated in another study investigating active or passive immunization against α-synuclein (αSYN) for progressive disease (PD) or MSA, or has had immunoglobulin G therapy, within 6 months before screening.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Early PK Cohort: TAK-341 |
Participants will be randomized to receive TAK-341 at 4-week intervals for up to 52 weeks. |
|
|
Placebo Comparator Early PK Cohort: Placebo |
Participants will be randomized to receive placebo at 4-week intervals for up to 52 weeks. |
|
|
Experimental Main Cohort: TAK-341 |
Participants will be randomized to receive TAK-341 at 4-week intervals for up to 52 weeks. |
|
|
Placebo Comparator Main Cohort: Placebo |
Participants will be randomized to receive placebo at 4-week intervals for up to 52 weeks. |
|
Recruiting Locations
More Details
- NCT ID
- NCT05526391
- Status
- Active, not recruiting
- Sponsor
- Takeda
Detailed Description
The drug being tested in this study is called TAK-341. The study will evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of intravenous (IV) TAK-341 in participants with multiple system atrophy (MSA). The study will enroll approximately 138 participants. The study comprises a screening period of up to 42 days (6 weeks), a 52-week double-blind treatment period, and a follow-up safety visit. Participants will be randomly assigned (by chance, like flipping a coin) to one of the treatment schedules-which will remain undisclosed to the participant, care provider and investigator during the study: - Early PK Cohort: TAK-341 - Early PK Cohort: Placebo - Main Cohort: TAK-341 - Main Cohort: Placebo The change from baseline in UMSARS will be measured at Week 52 post-dose. This multi-center trial will be conducted worldwide. The duration of treatment in this study will be 52 weeks. Participants will make a follow-up visit to the site after approximately 90 days after the last dose of study treatment.