A Phase 3b open-label, randomised study of IPX203 in subjects with advanced Parkinson’s disease and motor fluctuations - ADIP study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Zambon Biotech S.A.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

6 Nov 2025 → ongoing

Decision date (initial)

2025-10-06

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Zambon Biotech SA

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

The primary objective is to investigate the efficacy of IPX203 in comparison to immediate-release (IR) levodopa (LD)/aromatic L-amino acid decarboxylase inhibitor (AAADI) regimen in improving the ON time in relation to its dosing interval and dosing frequency.

Secondary objectives 4

1. 1. The key secondary objective is to investigate the efficacy of IPX203 in comparison to IR LD/AAADI regimen in reducing the OFF time in relation to its dosing interval and dosing frequency.
2. 2. To investigate the efficacy of IPX203 in comparison to IR LD/AAADI regimen in increasing the ON times (overall and with/without dyskinesia) in relation to its dosing interval and dosing frequency
3. 3. To investigate the efficacy of IPX203 in comparison to IR LD/AAADI regimen with validated questionnaires in relation to its dosing interval and dosing frequency
4. 4. To investigate safety using a different dosing frequency of IPX203 in comparison to IR LD/AAADI regimen

Conditions and MedDRA coding

Motor fluctuations in advanced Parkinson’s disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. 1. Male or female (assigned at birth, inclusive of all gender identities) subjects age ≥40 years, inclusive, at the time of informed consent.
2. 2. Patients with PD consistent with the United Kingdom Parkinson’s Disease Society Brain Bank Diagnostic Criteria, who are being treated with stable regimens of LD/AAADI since 3 months prior to screening but experiencing motor fluctuations.
3. 3. Patients with Hoehn and Yahr Stages 2.5 to 4 in the ON-state at screening.
4. 4. By history, for the 4 weeks (28 days) prior to screening, the patient experiences the following: - Daily predictable “wearing-OFF” episodes with periods of worsening motor symptoms - An average of at least 3 cumulative hours per day of OFF time, during the hours the patient is awake
5. 5. Patients needed to be on a documented stable LD/AAADI and optimised dosing schedule within the last 3 months prior to screening.
6. 6. Taking ≥5 LD doses/day and a minimal total daily dose of 500 mg LD/AAADI. If a patient is using IR LD/AAADI or controlled-release (CR) LD/AAADI in combination with a COMT inhibitor, then the dosing frequency must be 3 to 6 times daily.

Exclusion criteria 4

1. 1. PD patients taking a single individual dose of IR LD/AAADI above 250 mg.
2. 2. Patients who received any of the medications listed below or are planning to take them during participation in the clinical study: - Within 4 weeks prior to screening, any doses of a CR LD apart from a single daily bedtime dose - Any doses of Rytary or considered IPX066 or Rytary failures for reasons of efficacy or safety or considered IPX203 failure in previous clinical studies for reasons of efficacy or safety - Any additional doses of CD (eg, Lodosyn) or benserazide (eg, Serazide) - Nonselective monoamine oxidase B (MAO-B) inhibitors, apomorphine, or antidopaminergic agents, including antiemetics - Within 4 weeks prior to screening, rescue medication used to treat OFF episodes (eg, apomorphine or inhaled LD [Inbrija]) - Within 2 years prior to screening, any doses of dopamine antagonist antipsychotic agents for the purposes of psychosis or bipolar disorder
3. 3. Patient had a prior neurosurgical treatment for PD (eg, deep brain stimulation surgery or neurosurgical ablation treatment procedures) or if such procedure is planned or anticipated prior to Visit 5 (Week 12) of the study.
4. 4. PD patient has received LD/CD enteral suspension, or any other PD medication as continuous daily infusion, whether commercially available or investigational, within the last 3 months prior to screening.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 1. The primary endpoint is the change in good ON time at Week 12 compared to baseline for IPX203 versus IR LD/AAADI (>1 hour; ≤1 hour)

Secondary endpoints 3

1. 1. Change from baseline in OFF time at Week 12 (key secondary)
2. 2. Change from baseline in good ON time, ON time, change from baseline in ON time with dyskinesia, change from baseline in ON time with troublesome dyskinesia, change from baseline in ON time with non-troublesome dyskinesia, and change from baseline in ON time without dyskinesia (all derived from the Parkinson’s disease diary) up to Visit 5
3. 3. Change from baseline scores for the clinical outcome assessments listed in the protocol.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Zambon Biotech S.A.

Sponsor organisation

Zambon Biotech S.A.

Address

Via Industria 13

City

Cadempino

Postcode

6814

Country

Switzerland

Scientific contact point

Organisation

Zambon Biotech S.A.

Contact name

Jaakko Kopra

Public contact point

Organisation

Zambon Biotech S.A.

Contact name

Dr Doris Greiling

Third parties 4

Locations

3 EU/EEA countries · 20 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 32 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications