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Parkinson DiseasePhase 2ATLANTISNCT06055985

A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of UCB0022 in Study Participants With Advanced Parkinson's Disease

A Phase 2 study testing UCB0022 in people with Parkinson Disease, run by UCB Biopharma SRL at 61 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary purpose of this study is to demonstrate the superiority of UCB0022 as an adjunctive treatment to stable dose of standard-of-care (SoC) (including at least levodopa therapy) over placebo with regard to motor fluctuations time spent in the OFF state (OFF time) in study participants with advanced Parkinson's… Read more about this study

Who is it for?
Ages 35 to 85 years
Conditions the study is for
Parkinson Disease
What is being tested?
UCB0022
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
207 participants
Where
61 sitesUnited States
Study dates
17 Nov 2023to 11 Apr 2025
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 35 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Study participant must be 35 to 85 years of age (inclusive) at the time of signing the informed consent form (ICF)
  • Study participant is diagnosed with Parkinson's disease (PD) (based on the United Kingdom Parkinson's Disease Society Brain Bank Diagnostic criteria performed at the Screening Visit) and diagnosed ≥5 years before the Screening Visit (based on historical medical- information documented by the investigator)
  • Study participant has significant daily motor fluctuations
  • Study participant is able to complete a Hauser PD symptoms diary and differentiate between the ON and OFF states
  • Study participant is responsive to levodopa and currently receiving treatment with oral daily doses of levodopa combination (levodopa/carbidopa or levodopa/benserazide) with or without oral adjunctive antiparkinsonian therapies (based on historical clinical data)
  • Study participant has disease severity Stages I-III (modified Hoehn and Yahr staging) during ON state
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  • Study participant agrees to not post personal medical data or information related to the study on social media until study completion
  • Study participant has body weight ≥45 kg and body mass index within 18 to 30 kg/m^2 (inclusive)
  • Study participant may be male or female:
  • A male study participant must agree to use contraception during the Treatment Period and for at least 2 weeks after the last dose of study treatment and refrain from donating sperm during this period
  • A female study participant must not be a woman of childbearing potential (WOCBP)

Who cannot join

  • Study participant is diagnosed with any form of Parkinsonism other than idiopathic PD (eg, atypical or secondary Parkinsonism)
  • Study participant is diagnosed with dementia or has important cognitive dysfunction, as determined by Montreal Cognitive Assessment (MoCA) <23 at screening
  • Study participant has a history of neurosurgical intervention for PD (including DBS, thalamotomy, and experimental cell therapy or gene therapy)
  • Participant has a severe peak dose or biphasic dyskinesia at screening, defined by Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) items 4.2 score 4 or as per investigator opinion
  • Participant has a history of major depression or psychotic disorder or any other psychiatric condition within the past 5 years, that, as per investigator opinion, could jeopardize or would compromise the study participant's ability to participate in the study
  • Study participant has a history of narrow angle glaucoma
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  • Study participant has a history of melanoma
  • Study participant has current untreated hypertension
  • Study participant has a history of hypertensive crisis and/or hypertensive encephalopathy, unless the underlying cause was unequivocally identified and has been removed
  • Study participant has orthostatic hypotension requiring medication or a current history of "clinically significant" orthostatic hypotension as per the investigator's opinion (eg, recurrent orthostatic presyncope or syncope)
  • Study participant has a history over the past 12 months or between the Screening and Baseline Visits of any clinically significant arrythmia, myocardial infarction, stroke, transient ischemic attack, moderate or severe congestive heart failure (either New York Heart Association Class III or IV or known ejection fraction <40%)

Trial locations and contacts

61 sites in 1 country.

61 sites in 1 country

United States61 sites

  • Pd0060 50600

    Altamonte Springs, Florida, 32714

  • Pd0060 50110

    Ann Arbor, Michigan, 48109-0944

  • Pd0060 50075

    Augusta, Georgia, 30912

  • Pd0060 50616

    Aventura, Florida, 33180

  • Pd0060 50440

    Bellevue, Washington, 98004

  • Pd0060 50596

    Boca Raton, Florida, 33486

  • Pd0060 50615

    Boston, Massachusetts, 02118

  • Pd0060 50085

    Boston, Massachusetts, 02215

  • Pd0060 50524

    Bradenton, Florida, 34205

  • Pd0060 50087

    Centerville, Ohio, 45459

  • Pd0060 50622

    Cleveland, Ohio, 44195

  • Pd0060 50076

    Columbus, Ohio, 43221

  • Pd0060 50402

    Crab Orchard, West Virginia, 25827

  • Pd0060 50604

    Dayton, Ohio, 45449

  • Pd0060 50647

    DeLand, Florida, 32720

  • Pd0060 50577

    Doral, Florida, 33172

  • Pd0060 50545

    East Lansing, Michigan, 48824

  • Pd0060 50598

    Englewood, Colorado, 80113

  • Pd0060 50386

    Farmington Hills, Michigan, 48334

  • Pd0060 50519

    Fountain Valley, California, 92708

  • Pd0060 50428

    Fresno, California, 93710

  • Pd0060 50613

    Grand Rapids, Michigan, 49503

  • Pd0060 50143

    Henrico, Virginia, 23233

  • Pd0060 50584

    Hollywood, Florida, 33021

  • Pd0060 50595

    Indianapolis, Indiana, 46256

  • Pd0060 50319

    Iowa City, Iowa, 52242

  • Pd0060 50074

    Kansas City, Kansas, 66160

  • Pd0060 50292

    Kirkland, Washington, 98034

  • Pd0060 50561

    Lexington, Kentucky, 40536-0284

  • Pd0060 50608

    Little Rock, Arkansas, 72205

  • Pd0060 50601

    Loma Linda, California, 92354

  • Pd0060 50589

    Los Alamitos, California, 90720

  • Pd0060 50587

    Los Angeles, California, 90033

  • Pd0060 50582

    Miami, Florida, 33122

  • Pd0060 50579

    Miami, Florida, 33125

  • Pd0060 50449

    Miami, Florida, 33133

  • Pd0060 50580

    Miami, Florida, 33176

  • Pd0060 50597

    Naples, Florida, 34105

  • Pd0060 50628

    New Haven, Connecticut, 06519

  • Pd0060 50614

    New York, New York, 10021

  • Pd0060 50521

    New York, New York, 10029

  • Pd0060 50610

    Newark, Delaware, 19713

  • Pd0060 50627

    North Dartmouth, Massachusetts, 02747

  • Pd0060 50591

    Ocala, Florida, 34470

  • Pd0060 50452

    Pasadena, California, 91106

  • Pd0060 50506

    Phoenix, Arizona, 85004

  • Pd0060 50605

    Port Orange, Florida, 32127

  • Pd0060 50607

    Portland, Oregon, 97210

  • Pd0060 50612

    Raleigh, North Carolina, 27607

  • Pd0060 50619

    Rock Hill, South Carolina, 29732

  • Pd0060 50496

    Round Rock, Texas, 78681

  • Pd0060 50537

    Salt Lake City, Utah, 84108

  • Pd0060 50568

    San Antonio, Texas, 78229

  • Pd0060 50590

    Scottsdale, Arizona, 85258

  • Pd0060 50419

    Spokane, Washington, 99202

  • Pd0060 50620

    St. Petersburg, Florida, 33710

  • Pd0060 50603

    Tampa, Florida, 33609

  • Pd0060 50527

    Toledo, Ohio, 43614

  • Pd0060 50398

    Tulsa, Oklahoma, 74136

  • Pd0060 50534

    Virginia Beach, Virginia, 23456

  • Pd0060 50585

    Winter Park, Florida, 32789

Other trials in United States

About this study

Official title: A Multicenter Phase 2, Double-blind, Placebo-controlled, Randomized, Parallel-group Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of UCB0022 in Study Participants With Advanced Parkinson's Disease

The primary purpose of this study is to demonstrate the superiority of UCB0022 as an adjunctive treatment to stable dose of standard-of-care (SoC) (including at least levodopa therapy) over placebo with regard to motor fluctuations time spent in the OFF state (OFF time) in study participants with advanced Parkinson's Disease (PD).

Being tested
Placebo, UCB0022
Keywords
Parkinson Disease, Phase 2, UCB0022, wearing-off, motor fluctuations
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboOther

    Study participants will receive placebo orally administered as tablet at pre-specified time points during the study.

  • UCB0022Drug

    Study participants will receive UCB0022 dose A or B orally administered as tablet at pre-specified time points during the Treatment Period.

Study groups in NCT06055985
Study groupRoleWhat they receive
UCB0022-Dose AExperimentalStudy participants randomized to this arm will receive UCB0022 Dose A orally administered as tablet during the Treatment Period.
Receives: Drug: UCB0022
UCB0022-Dose BExperimentalStudy participants randomized to this arm will receive UCB0022 Dose B orally administered as tablet during the Treatment Period.
Receives: Drug: UCB0022
PlaceboPlacebo comparatorStudy participants randomized to this arm will receive matching placebo orally administered as tablet during the Treatment Period.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline to Visit 9 (Day 70) in the average number of hours/day of OFF time, as assessed by the study participant-completed Hauser PD symptoms diary over 3 consecutive days

    The Hauser Parkinson's disease (PD) symptoms diary is a study participant-completed diary that records the daily ON time and OFF time of study participants with PD with motor fluctuations and dyskinesia.

    Measured: From Baseline (Day 1) to Visit 9 (Day 70)

Secondary outcomes (4)

  1. Incidence of treatment-emergent adverse events (TEAEs)

    An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. TEAEs are defined as AEs starting after the time of first IMP administration up to and including 2 weeks after the final dose.

    Measured: From Baseline (Day 1) to End of Safety Follow-up (up to Week 12)

  2. Incidence of treatment-emergent serious adverse events (SAEs)

    A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose:

    • Results in death
    • Is life-threatening
    • Requires inpatient hospitalization or prolongation of existing hospitalization
    • Results in persistent disability/incapacity
    • Is a congenital anomaly/birth defect
    • Important medical events Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of investigational medicinal product (IMP).

    Measured: From Baseline (Day 1) to End of Safety Follow-up (up to Week 12)

  3. Incidence of TEAEs leading to withdrawal from the study

    An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. TEAEs are defined as AEs starting after the time of first IMP administration up to and including 2 weeks after the final dose.

    Measured: From Baseline (Day 1) to End of Safety Follow-up (up to Week 12)

  4. Average Ctrough of UCB0022 and its active N-desmethyl-UCB0022 metabolite at Visit 9 (Day 70)

    Ctrough: The predose observed plasma concentration (average, per visit) will be plotted and depicted graphically to assess trajectory to steady-state for parent and active metabolites.

    Measured: at Visit 9 (Day 70)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2023
  2. Study start17 Nov 2023
  3. Primary completion31 Mar 2025
  4. Study completion11 Apr 2025

Resources

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
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
207 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06055985
Sponsor's protocol ID
PD0060
Acronym
ATLANTIS
Status last verified
Mar 2026
First submitted
20 Sep 2023
Last updated
6 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal. This plan may change if a determination is made that the data cannot be adequately anonymized.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing UCB0022 in people with Parkinson Disease, run by UCB Biopharma SRL at 61 sites in United States.

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 11 inclusion and 11 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 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in United States. 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?

Change from Baseline to Visit 9 (Day 70) in the average number of hours/day of OFF time, as assessed by the study participant-completed Hauser PD symptoms diary over 3 consecutive days (time frame: From Baseline (Day 1) to Visit 9 (Day 70)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06055985.

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 6 Apr 2026.

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