Clinical trial NCT06773962: A Phase 2a Multicenter Clinical Trial of TB006 in Participants With Parkinson's Disease
Official title: A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of TB006 in Participants With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Parkinson's Disease (PD)
Keywords: PD
TB006
Monoclonal Antibody
Parkinson's Disease
Lead sponsor: TrueBinding, Inc.
Sponsor class: INDUSTRY
First posted: 2025-01-14
Enrollment: 62
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objectives of this study are to assess the efficacy of TB006 in improving motor function and to assess the safety of TB006 in participants with Parkinson's Disease (PD).


Eligibility criteria: Inclusion Criteria:

1. Participants voluntarily agree to participate in this study and sign an Institutional Review Board (IRB)-approved informed consent form (ICF) prior to performing any of the screening procedures.

   Parkinson's Disease Related Criteria:
2. Diagnosis of Parkinson's disease (PD) with motor symptom improvement from levodopa, if applicable.
3. Less than 5 years from the initial PD diagnosis, at the time of ICF.
4. Early-stage PD, with mild symptoms based on standard clinical staging in OFF state.
5. Participants who are on immediate-release levodopa-carbidopa/benserazide.

   Other Health Related Criteria
6. No active cancer, unless in remission for ≥10 years without ongoing treatment, except fully removed basal cell carcinoma.
7. Free of significant health issues that might interfere with study participation.

   Other Criteria/Social Circumstances
8. Negative screening for illegal drugs (excluding cannabis), with willingness to abstain during the study and avoid cannabis or alcohol effects during visits.

Exclusion Criteria:

Parkinsons's Disease Related Criteria

1. History of sudden, unexpected PD medication OFF episodes.
2. Severe motor complications or disabling symptoms that may impact study involvement.

   Other Health Related Criteria
3. Any condition or health concern deemed a safety risk or likely to interfere with study results.
4. Severe psychiatric disorders, including psychosis or substance addiction.
5. Allergies or sensitivities to specific study-related treatments or substances.
6. Any prior history of a severe infusion reaction.

   Other Criteria/Social Circumstances
7. Pregnancy, breastfeeding, or plans for pregnancy or ova donation during or shortly after the study.
8. Recent use of investigational drugs or therapeutic antibodies.

Primary outcomes:
measure: Change from Baseline in Parkinson's Disease Rating Scale Score
timeFrame: Baseline to 28 weeks
measure: Number of Participants Experiencing Adverse Events
timeFrame: 28 weeks
measure: Number of Participants Experiencing Serious Adverse Events
timeFrame: 28 weeks
Secondary outcomes:
measure: Change from Baseline in Parkinson's Disease Rating Scale Sub-score
timeFrame: Baseline to 28 weeks
measure: Change from Baseline in Patient Perceived Severity of Disease
timeFrame: Baseline to 28 weeks
measure: Change from Baseline in Clinician Perceived Severity of Disease
timeFrame: Baseline to 28 weeks
Other outcomes:
Locations:
city: Aliso Viejo
country: United States
facility: Parkinson's Research Centers of America - Orange County
state: California
city: Boca Raton
country: United States
facility: Parkinson's Disease and Movement Disorders Center of Boca Raton
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Northbrook
country: United States
facility: Consultants in Neurology, Ltd
state: Illinois
city: Indianapolis
country: United States
facility: Josephson Wallack Munshower Neurology - Southeast
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Farmington Hills
country: United States
facility: Quest Research Institute
state: Michigan
city: Round Rock
country: United States
facility: Central Texas Neurology Consultants
state: Texas
Study officials:
References: