Parkinson DiseasePhase 2EXISTNCT06671938
Safety, Tolerability, and Pharmacokinetics of Exidavnemab in Patients With Parkinson's Disease and Patients With Multiple System Atrophy
A Phase 2 study testing exidavnemab in people with Parkinson Disease and Multiple System Atrophy, run by BioArctic AB at 7 sites in 2 countries.
Trial summary
The primary objective of this study is to assess the safety and tolerability of exidavnemab after multiple dosing versus placebo. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Parkinson Disease, Multiple System Atrophy
- What is being tested?
- exidavnemab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 24 Oct 2024to 10 Aug 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female participants 40 to 85 years of age.
- Body weight more than or equal to 50 kg and less than or equal to 120 kg.
- Have clinically established or clinically probable MSA (either MSA-P or MSA-C), as per the Movement Disorder Society criteria for the diagnosis of MSA (Wenning, et al. 2022).
- Classified as Stage 1 to 3 on the modified Hoehn and Yahr scale for the staging of MSA severity.
- Participants must have cognition inconsistent with dementia as confirmed by a score of more than or equal to 22 on the MoCA.
- Negative urine or serum pregnancy test at the Screening Visit and Baseline for premenopausal women, and for women who have experienced menopause onset less than 12 months prior to the first planned dose of trial medication.
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- Males and POCBP must agree to practice an effective means of birth control during their participation in the trial and until 3 months after their last dose of the trial medication. See specific guidelines regarding contraceptive methods in Section 14.1.
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and trial procedures.
- Exclusion Criteria for Cohorts 1 and 2a (Parkinson's Disease):
- Known hypersensitivity to trial medication, the infusion solution, or excipients.
- More than 5 years of symptomatic treatment for PD.
- History of neurosurgical intervention for PD including implantation of brain stimulation.
- Diagnosis of PD dementia or another dementia.
- Any psychiatric diagnosis or symptoms (e.g., hallucinations, major depression, or delusions) that could interfere with trial procedures.
- Freezing episodes occurring on a weekly basis or more frequently.
- Motor fluctuations occurring on a weekly basis or more frequently.
- Levodopa-induced troublesome dyskinesia of a severity that would significantly interfere with the participant's ability to participate or perform trial procedures as determined by the Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Subscale IV.
Who cannot join
- Known hypersensitivity to the trial medication, the infusion solution, or excipients.
- Any psychiatric diagnosis or symptoms (e.g., hallucinations, major depression, or delusions) that could interfere with trial procedures.
- History of significant cardiovascular disease or arrhythmia within 6 months of Screening.
- Abnormal ECG that is or may be clinically significant in the Investigator's opinion and after consultation with the Medical Monitor, including left bundle branch block, atrial fibrillation, QTcF more than 450 msec for males and more than 470 msec for females at the Screening Visit or Baseline.
- History of transient ischemic attacks, stroke, or seizures within 12 months of Screening.
- Abnormal liver function tests: GGT, TBil, ALP, ALT, and AST higher than the ULN and regarded as potentially clinically significant by the Investigator.
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- Note: Gilbert's syndrome is not exclusionary.
- Poorly controlled diabetes as defined by hemoglobin A1C of more than 8%.
- Contraindication, condition, or concomitant medication incompatible with lumbar puncture (e.g., lumbar scoliosis, coagulopathy, and infected skin at needle puncture site), 1.5T or 3T MRI (e.g., aneurysm clip, metal fragments [e.g., in-skull and cardiac devices other than those approved as safe for use in MRI scanners], and internal electrical devices such as a cochlear implant, spinal cord stimulator, or cardiac pacemaker/defibrillator).
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Spain5 sites
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona, 08035
Hospital Universitario Ramón y Cajal
Madrid, Madrid, 28034
Policlínica Gipuzkoa
San Sebastián, 20014
Hospital Universitari General de Catalunya
Sant Cugat del Vallès, Barcelona, 08195
Hospital Universitario Virgen del Rocío
Seville, Andalusia, 41013
Poland2 sites
Centrum Medyczyne Neuromed Sp. z o.o.
Bydgoszcz, 85-163
Krakowska Akademia Neurologii Sp. Z o.o
Krakow, 31-505
About this study
Official title: A Phase 2a, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Dosing of Exidavnemab in Patients With Mild to Moderate Parkinson's Disease on Stable Symptomatic Parkinson's Disease Medication and in Patients With Multiple System Atrophy
The primary objective of this study is to assess the safety and tolerability of exidavnemab after multiple dosing versus placebo.
Read the detailed description
This Phase 2a, randomized, double-blind, placebo-controlled, multicenter, multinational, multiple ascending dose (MAD) trial is designed to investigate the safety, tolerability, and pharmacokinetics (PK) of exidavnemab in participants with mild to moderate Parkinson's Disease (PD) on stable symptomatic PD medication and Patients With Multiple System Atrophy.
The trial will evaluate two dose cohorts versus placebo. Participants in each cohort will be randomly allocated in a 2:1 ratio to receive either exidavnemab or placebo. There will be approximately 12 evaluable participants with PD in Cohort 1 and approximately 24 evaluable participants in Cohort 2 (approximately 12 participants in each of Cohorts 2a and 2b), resulting in approximately 36 participants, 24 with PD and 12 with MSA, randomized in total.
- Conditions
- Parkinson Disease, Multiple System Atrophy
- Being tested
- exidavnemab, Placebo Comparator
- Keywords
- Parkinson Disease, Exidavnemab, EXIST, BAN-0805, ABBV-0805, alfa-synuclein
- Medical subject headings
- Parkinson Disease, Multiple System Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exidavnemabDrug
The trial medication will be administered as an intravenous (IV) infusion (dose 1; dose 2)
Placebo ComparatorDrug
The trial medication will be administered as an intravenous (IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| exidavnemab | Experimental | exidavnemab (cohort 1 - dose 1; cohort 2 - dose 2) Receives: Drug: exidavnemab |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs) and serious adverse events (SAEs).
Number of participants with adverse events (AEs) and serious adverse events (SAEs).
Measured: From first dose to Day 176
Secondary outcomes (3)
Pharmacokinetic (Plasma): Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (Clast)
PK parameters (AUClast) following single dose, as calculated by the linear trapezoidal method
Measured: Day 1 and Day 85
Establishment of an appropriate dose range for proof-of-concept trial
The recommended maximal dose will be defined by the safety and tolerability profile and PK data
Measured: From first dose to Day 176
Assessment of systemic immunogenicity effects of exidavnemab
Determination of ADAs in serum by using a tier-based approach followed by determination of NAbs if relevant.
Measured: From first dose to Day 176
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start24 Oct 2024
- Primary completion10 Aug 2026
- Study completion10 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The trial will evaluate 2 dose cohorts, dose 1 exidavnemab versus placebo (Cohort 1) and dose 2 exidavnemab versus placebo (Cohort 2). Cohort 2 will consist of a PD cohort (Cohort 2a) and an MSA cohort (Cohort 2b).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioArctic AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Worldwide Clinical Trials
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06671938
- Sponsor's protocol ID
- BAN0805-201
- Other IDs
- 2024-511222-30-00
- Acronym
- EXIST
- Status last verified
- Aug 2026
- First submitted
- 19 Sep 2024
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Dosing of Exidavnemab in Patients With Mild to Moderate Parkinson's Disease on Stable Symptomatic Parkinson's Disease Medication and in Patients With Multiple System Atrophy
- ClinicalTrials.gov ID
- NCT06671938
- Acronym / sponsor ID
- EXIST / BAN0805-201
- Conditions
- Parkinson Disease, Multiple System Atrophy
- Keywords
- Parkinson Disease, Exidavnemab, EXIST, BAN-0805, ABBV-0805, alfa-synuclein
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- BioArctic ABIndustry (pharma, biotech, devices)
- Collaborators
- Worldwide Clinical Trials
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- 10 Aug 2026 (actual)
- Study completion
- 10 Aug 2026 (actual)
- First posted
- 4 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to assess the safety and tolerability of exidavnemab after multiple dosing versus placebo.
Detailed description
This Phase 2a, randomized, double-blind, placebo-controlled, multicenter, multinational, multiple ascending dose (MAD) trial is designed to investigate the safety, tolerability, and pharmacokinetics (PK) of exidavnemab in participants with mild to moderate Parkinson's Disease (PD) on stable symptomatic PD medication and Patients With Multiple System Atrophy.
The trial will evaluate two dose cohorts versus placebo. Participants in each cohort will be randomly allocated in a 2:1 ratio to receive either exidavnemab or placebo. There will be approximately 12 evaluable participants with PD in Cohort 1 and approximately 24 evaluable participants in Cohort 2 (approximately 12 participants in each of Cohorts 2a and 2b), resulting in approximately 36 participants, 24 with PD and 12 with MSA, randomized in total.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The trial will evaluate 2 dose cohorts, dose 1 exidavnemab versus placebo (Cohort 1) and dose 2 exidavnemab versus placebo (Cohort 2). Cohort 2 will consist of a PD cohort (Cohort 2a) and an MSA cohort (Cohort 2b).
| Arm | Type | Receives |
|---|---|---|
| exidavnemab | Experimental | Drug: exidavnemabexidavnemab (cohort 1 - dose 1; cohort 2 - dose 2) |
| Placebo | Placebo comparator | Drug: Placebo Comparator |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Male and female participants 40 to 85 years of age.
- Body weight more than or equal to 50 kg and less than or equal to 120 kg.
- Have clinically established or clinically probable MSA (either MSA-P or MSA-C), as per the Movement Disorder Society criteria for the diagnosis of MSA (Wenning, et al. 2022).
- Classified as Stage 1 to 3 on the modified Hoehn and Yahr scale for the staging of MSA severity.
- Participants must have cognition inconsistent with dementia as confirmed by a score of more than or equal to 22 on the MoCA.
Key exclusion criteria (9 listed)
- Known hypersensitivity to the trial medication, the infusion solution, or excipients.
- Any psychiatric diagnosis or symptoms (e.g., hallucinations, major depression, or delusions) that could interfere with trial procedures.
- History of significant cardiovascular disease or arrhythmia within 6 months of Screening.
- Abnormal ECG that is or may be clinically significant in the Investigator's opinion and after consultation with the Medical Monitor, including left bundle branch block, atrial fibrillation, QTcF more than 450 msec for males and more than 470 msec for females at the Screening Visit or Baseline.
- History of transient ischemic attacks, stroke, or seizures within 12 months of Screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exidavnemabThe trial medication will be administered as an intravenous (IV) infusion (dose 1; dose 2) | Drug | exidavnemab |
| Placebo ComparatorThe trial medication will be administered as an intravenous (IV) infusion | Drug | Placebo |
Primary outcome
Number of participants with adverse events (AEs) and serious adverse events (SAEs).
Time frame: From first dose to Day 176
Number of participants with adverse events (AEs) and serious adverse events (SAEs).
3 secondary outcomes
Pharmacokinetic (Plasma): Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (Clast)
Time frame: Day 1 and Day 85
Establishment of an appropriate dose range for proof-of-concept trial
Time frame: From first dose to Day 176
Assessment of systemic immunogenicity effects of exidavnemab
Time frame: From first dose to Day 176
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing exidavnemab in people with Parkinson Disease and Multiple System Atrophy, run by BioArctic AB at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Spain, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (AEs) and serious adverse events (SAEs). (time frame: From first dose to Day 176). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.