A Trial of Lu AF28996 in Participants With Parkinson's Disease (PD)

March 31, 2026 updated by: H. Lundbeck A/S

Interventional, Open-label, Trial Investigating the Safety, Tolerability, and Pharmacokinetic Properties of Lu AF28996 in Chinese Men and Women With Parkinson's Disease

The purpose of this study is to investigate the safety of Lu AF28996, how well it is tolerated and what the body does to the drug in participants with Parkinson's disease.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

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 Contact

Study Locations

  • China
      • Beijing, China, 100053
        • Xuanwu Hospital Capital Medical University
      • Beijing, China, 100070
        • Beijing Tiantan Hospital, Capital Medical University
      • Chengdu, China, 610041
        • West China Hospital, Sichuan University
      • Shanghai, China, 200040
        • Huashan Hospital, Fudan University

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

Key Inclusion Criteria:

  • The participant is Chinese, defined as having four Chinese grandparents being born in China.
  • The participant is diagnosed with idiopathic Parkinson's disease (consistent with the United Kingdom PD Society Brain Bank Criteria for the Diagnosis of PD).
  • The participant's Modified Hoehn and Yahr score is ≥2 and ≤4 (in OFF) and ≤3 in the ON state.
  • The participant experiences well recognizable and predictable motor fluctuations in the awake time including predictable morning OFF episodes causing clinically significant disability during the last 3 months prior to screening, as evaluated by the investigator.

Key Exclusion Criteria:

  • The participant has received oral or transdermal dopamine agonist treatment ≤4 weeks prior to screening.
  • The participant has undergone a neurosurgical intervention for Parkinson's disease (such as pallidotomy, thalamotomy, foetal or stem cell transplantation or deep brain stimulation).
  • The participant has any other disorder for which the treatment takes priority over treatment of Parkinson's disease or is likely to interfere with trial treatment or impair treatment compliance.
  • The participant has received Traditional Chinese Medicine treatment ≤4 weeks prior to screening.

Note: Other protocol-defined inclusion and exclusion criteria may 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lu AF28996
Participants will receive oral doses of Lu AF28996 twice daily (BID) as add-on to the participant's usual PD treatment (levodopa and allowed PD medications) during the Up-titration treatment period, whereafter the participants will initiate down-titration of Lu AF28996.
Drug: Lu AF28996
Capsule administered orally per schedule specified in the arm description.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time Frame: Up to 60 days
Up to 60 days
Area Under the Plasma Concentration-time Curve From Zero to Last Quantifiable Concentration (AUC0-tlast) of Lu AF28996
Time Frame: Days 1, 21 or 31, and 41
Days 1, 21 or 31, and 41
Maximum Observed Plasma Concentration (Cmax) of Lu AF28996
Time Frame: Days 1, 21 or 31, and 41
Days 1, 21 or 31, and 41
Time to Reach Cmax (Tmax) of Lu AF28996
Time Frame: Days 1, 21 or 31, and 41
Days 1, 21 or 31, and 41

Collaborators and Investigators

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

Sponsor

H. Lundbeck A/S

Investigators

  • Study Director: Email contact via H. Lundbeck A/S, LundbeckClinicalTrials@Lundbeck.com

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)

March 31, 2026

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2027

Study Registration Dates

First Submitted

March 31, 2026

First Submitted That Met QC Criteria

March 31, 2026

First Posted (Actual)

April 7, 2026

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20501A

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

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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