- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04127695
A Study to Evaluate the Safety and Tolerability of ABBV-0805 in Patients With Parkinson's Disease
December 13, 2021 updated by: AbbVie
A Randomized, Double-Blind, Placebo Controlled Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of ABBV-0805 in Patients With Parkinson's Disease
This study will evaluate the safety and tolerability of ABBV-0805 in adult participants with Parkinson's Disease and results from it will help guide the design of future clinical studies.
ABBV-0805 is administered every 28 days by intravenous (IV) infusion.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Rio Piedras, Puerto Rico, 00935
- University of Puerto Rico, Medical Sciences Campus /ID# 215751
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Florida
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Gainesville, Florida, United States, 32610
- University of Florida - Archer /ID# 212823
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New York
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New York, New York, United States, 10032-3725
- Columbia Univ Medical Center /ID# 212826
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North Carolina
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Durham, North Carolina, United States, 27705-4410
- Duke University Medical Center /ID# 214435
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Washington
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Kirkland, Washington, United States, 98034-3029
- Evergreen Neuroscience Institute /ID# 212827
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Spokane, Washington, United States, 99202-1342
- Inland Northwest Research /ID# 212119
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 83 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosed with idiopathic Parkinson's Disease (PD) within 5 years and with modified Hoehn and Yahr Stage of less than 3 at Screening.
- Body Mass Index (BMI) is >= 18.0 to <=35.0 kg/m2.
- Participant must follow protocol-specific methods of contraception, if applicable.
- Participant must be in general good health (except for PD) based upon results of medical history, physical examination, vital signs, laboratory testing, neurological examination and 12-lead electrocardiogram (ECG).
Note: If participant is taking standard of care medication for treatment of PD, doses must be stable for at least 30 days prior to starting study drug and participant should not have any clinically relevant motor fluctuations.
Exclusion Criteria:
- Participant with a history of, or screening brain MRI scan indicative of significant abnormality, including, but not limited to, prior hemorrhage or infarct > 1 cm3, > 3 lacunar infarcts, cerebral contusion, encephalomalacia, aneurysm, vascular malformation, subdural hematoma, hydrocephalus, space occupying lesion (such as an abscess or brain tumor such as meningioma).
- Received any drug by injection within 30 days or within a period defined by 5 half-lives, whichever is longer, prior to study administration, unless approved by the Investigator in consultation with the AbbVie Therapeutic Area Medical Director.
- Treated with any investigational product within a time frame equal to 5 half-lives, if known, or within 6 weeks (for small molecules) or 6 months (for monoclonal antibodies or other biologics) prior to the first dose of study drug.
- Participant with recent history of drug or alcohol abuse (within 6 months prior to study drug administration) that could impact adherence to the protocol in the opinion of the investigator.
- Participant with evidence of dysplasia or history of malignancy with the exception of excised or treated cervical cancer, some indolent malignancies (such as basal cell carcinoma or squamous cell carcinomas), remission from any malignancy for more than 5 years or participants with slow growth prostatic carcinoma may be eligible to participate with the permission of the AbbVie TA MD.
- Participant with history of seizure disorder or unexplained blackouts or history of a seizure within 6 months.
- Participant with congenital structural or conduction abnormalities, cardiomyopathy, myocardial infarction, cardiac arrhythmias or other cardiac conditions.
- Participant with varicella or herpes zoster virus infection or any severe viral infection within 6 weeks before randomization.
- Received any live vaccine within 4 weeks prior to the first dose of study drug, including but not limited to: measles/mumps/rubella vaccine, varicella zoster virus vaccine, oral polio vaccine, and nasal influenza vaccine.
- Participant with symptoms of an active infection or history of prior infection (viral, fungal, or bacterial) requiring hospitalization or IV antibiotics within 8 weeks before first dose of study drug.
- Participant with history of abnormal laboratory result that, in the opinion of the investigator, are indicative of any significant cardiac, endocrine, hematological, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal, neurological, and/or other major disease.
- Participant with contraindications to lumbar puncture (such as lumbar scoliosis, coagulopathy, infected skin at needle puncture site). Use of anticoagulants may be allowed in the study but must be temporarily suspended prior to and after lumbar puncture.
- Participant with contraindications to MRI (such as aneurysm clip, metal fragments, internal electrical devices such as a cochlear implant, spinal cord stimulator or pacemaker), are allergic to gadolinium, or have claustrophobia.
- Participant currently enrolled in another interventional clinical study. Participants enrolled in non-interventional studies may be eligible to participate at the discretion of the AbbVie TA MD.
- Participant with clinically significant and/or unstable medical conditions or any other reason that the Investigator determines would interfere with participation in this study or would make the participant an unsuitable candidate to receive ABBV-0805.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ABBV-0805 Dose 1 or Placebo
Participants will receive ABBV-0805 Dose 1 or Placebo.
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ABBV-0805 administered by IV infusion.
Placebo ABBV-0805 administered by IV infusion.
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Experimental: ABBV-0805 Dose 2 or Placebo
Participants will receive ABBV-0805 Dose 2 or Placebo.
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ABBV-0805 administered by IV infusion.
Placebo ABBV-0805 administered by IV infusion.
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Experimental: ABBV-0805 Dose 3 or Placebo
Participants will receive ABBV-0805 Dose 3 or Placebo.
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ABBV-0805 administered by IV infusion.
Placebo ABBV-0805 administered by IV infusion.
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Experimental: ABBV-0805 Dose 4 or Placebo
Participants will receive ABBV-0805 Dose 4 or Placebo.
Note: This dosing group may be added after a review of data from dosing groups 1-3.
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ABBV-0805 administered by IV infusion.
Placebo ABBV-0805 administered by IV infusion.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with Adverse Events
Time Frame: Day 1 through Day 260
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An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
The investigator assesses the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related.
A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.
Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug.
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Day 1 through Day 260
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Maximum Observed Serum Concentration (Cmax)
Time Frame: Day 1 through Day 29 and Day 85 through Day 113
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Maximum Serum Concentration of ABBV-0805.
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Day 1 through Day 29 and Day 85 through Day 113
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Time to Cmax (peak time, Tmax)
Time Frame: Day 1 through Day 29 and Day 85 through Day 113
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Time to Cmax (peak time, Tmax).
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Day 1 through Day 29 and Day 85 through Day 113
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Area under the Serum Concentration Time curve (AUC)
Time Frame: Day 1 through Day 29 and Day 85 through Day 113
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Area Under the Serum Concentration Time Curve at first and final dose.
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Day 1 through Day 29 and Day 85 through Day 113
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Apparent Terminal Phase Elimination Rate Constant (Beta)
Time Frame: Day 1 through Day 176
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Apparent terminal phase elimination rate constant (Beta) for ABBV-0805.
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Day 1 through Day 176
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Ratio of ABBV-0805 concentration in cerebrospinal fluid (CSF)
Time Frame: Day 113
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Concentration of ABBV-0805 in CSF.
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Day 113
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Terminal Phase Elimination half-life (t1/2)
Time Frame: Day 1 through Day 176
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Terminal phase elimination half-life (t1/2).
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Day 1 through Day 176
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Serum Concentration (Ctrough)
Time Frame: Day 29, Day 57, Day 85, Day 113
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Ctrough concentration of ABBV-0805.
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Day 29, Day 57, Day 85, Day 113
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Total clearance (CL)
Time Frame: Day 1 through Day 176
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Clearance of ABBV-0805.
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Day 1 through Day 176
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 3, 2020
Primary Completion (Actual)
June 16, 2020
Study Completion (Actual)
June 16, 2020
Study Registration Dates
First Submitted
October 9, 2019
First Submitted That Met QC Criteria
October 14, 2019
First Posted (Actual)
October 15, 2019
Study Record Updates
Last Update Posted (Actual)
December 15, 2021
Last Update Submitted That Met QC Criteria
December 13, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- M19-304
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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