Study to Test Effects and Safety of RO7568282 in Early Parkinson's Disease (TARBELA-PD)

August 20, 2026 updated by: Hoffmann-La Roche

A Phase II, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of RO7568282 in Participants With Early-stage Parkinson's Disease

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of RO7568282 compared with placebo in participants with early-stage Parkinson's disease (PD) on stable symptomatic monotherapy with levodopa.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

474

Phase

  • Phase 2
  • 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 Contact

  • Name: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Study Contact Backup

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Must be aged 40 to 85 years inclusive
  • Diagnosis of idiopathic PD
  • Has received stable doses of monotherapy treatment with levodopa for at least 2 months prior to baseline
  • Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV score of 0 at screening and prior to randomization at baseline
  • Hoehn and Yahr (H&Y) Stage ≤ 3 (assessed in off medication state) at screening and prior to randomization at baseline
  • Able to swallow whole capsules

Exclusion Criteria:

  • Medical history indicating a parkinsonian syndrome other than idiopathic PD
  • Diagnosis of PD dementia
  • Diagnosis of a significant neurologic disease other than PD
  • Within the last year, unstable or clinically significant cardiovascular disease
  • Chronic uncontrolled hypertension
  • History or presence of brain magnetic resonance imaging (MRI) scan showing evidence of structural abnormalities, other than related to PD

Note: Other protocol-defined inclusion/exclusion criteria also apply

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: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RO7568282 High Dose
RO7568282 will be administered as per the schedule specified in the protocol.
Drug: RO7568282
RO7568282 will be administered as per the schedule specified in the protocol.
Experimental: RO7568282 Low Dose
RO7568282 will be administered as per the schedule specified in the protocol.
Drug: RO7568282
RO7568282 will be administered as per the schedule specified in the protocol.
Placebo Comparator: Placebo
Placebo will be administered as per the schedule specified in the protocol.
Drug: Placebo
Placebo will be administered as per the schedule specified in the protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to a Confirmed Motor Progression Event From the Randomization Date, as Measured by the MDS-UPDRS Part III Score
Time Frame: Up to at least Week 104
Up to at least Week 104

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Motor Signs From Baseline at Week 104, as Measured by the MDS-UPDRS Part III Score
Time Frame: Baseline and Week 104
Baseline and Week 104
Time to Worsening of Participants' Motor Function, as Reported by the Participant in the Presence of a Confirmed Motor Progression Event
Time Frame: Up to at least Week 104
Up to at least Week 104
Incidence of Adverse Events (AEs)
Time Frame: Up to at least Week 104
Up to at least Week 104
Change From Baseline in Columbia-suicide Severity Rating Scale (C-SSRS)
Time Frame: Up to at least Week 104
Up to at least Week 104
Plasma Concentrations of RO7568282
Time Frame: Up to at least Week 104
Up to at least Week 104

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 (Estimated)

September 30, 2026

Primary Completion (Estimated)

December 15, 2028

Study Completion (Estimated)

April 15, 2032

Study Registration Dates

First Submitted

August 20, 2026

First Submitted That Met QC Criteria

August 20, 2026

First Posted (Actual)

August 24, 2026

Study Record Updates

Last Update Posted (Actual)

August 24, 2026

Last Update Submitted That Met QC Criteria

August 20, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BP46441
  • 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-524064-37-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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