A Multi-centered, Double-blind, Randomized, Placebo-controlled Study of TEV-56286 for the Treatment of Multiple System Atrophy

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Teva Branded Pharmaceutical Products R&D LLC

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

30 Jan 2025 → ongoing

Decision date (initial)

2024-08-28

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

Teva Branded Pharmaceutical Products R&D LLC

External identifiers

EU CT number

2023-505320-54-00

ClinicalTrials.gov

NCT06568237

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Pharmacodynamic, Safety, Others, Pharmacogenomic, Efficacy

The primary objective of the trial is to evaluate the efficacy of TEV-56286 administered orally for the treatment of adult participants with MSA.

Secondary objectives 2

1. A secondary objective of the trial is to evaluate specific efficacy parameters of TEV 56286 beyond the measure of the primary objective.
2. A secondary objective of the trial is to evaluate the safety and tolerability of TEV 56286.

Conditions and MedDRA coding

Multiple System Atrophy

Study design 1 period

Regulatory references

Scientific advice from competent authorities

Medicines And Healthcare Products Regulatory Agency, Pharmaceuticals And Medical Devices Agency, Federal Institute For Drugs And Medical Devices, National Authority Of Medicines And Health Products, European Medicines Agency, Food And Drug Administration

EMA paediatric investigation plan (PIP)

EMEA-003252-PIP01-22

Plan to share IPD

Yes

IPD plan description

Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please visit www.clinicalstudydatarequest.com to make your request.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Is a male or female aged ≥30 to ≤75 years old at screening
2. Is considered to be “clinically possible” or “clinically probable” MSA as determined by the Gilman criteria.
3. Is able to ambulate at least 10 meters without the assistance of another person. Use of an assistive device (cane only, not walker) is allowed during this assessment. Apart from the 10-meter walk at screening, use of any assistive device is allowed during the trial.

Exclusion criteria 3

1. Has any clinically significant uncontrolled medical or psychiatric condition (treated or untreated), or any findings from vital signs, imaging, physical examination, electrocardiogram (QTcF >450 msec), or clinical laboratory, other than MSA related, that could jeopardize or compromise the participant’s safety, ability to participate, or integrity of the trial. The investigator should consult with the medical monitor or trial physician as needed.
2. Is severely affected with a UMSARS part IV score of > 3
3. Is suspected of having a neurodegenerative disease other than MSA

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary efficacy endpoint (TEV-56286 versus placebo, change from baseline to week 48) is as follows: • For non-EU: modified UMSARS part I score (excluding item 11, item scoring rescaled 0-3) • For EU: total UMSARS score (part I and part II combined)

Secondary endpoints 8

1. The key secondary endpoints (TEV-56286 versus placebo, change from baseline to week 48) are as follows:•For non-EU:total UMSARS score(part I and part II combined)•For EU:modified UMSARS part I score(excluding item 11, item scoring rescaled 0-3)•UMSARS part I score•Lateral ventricle volume measured by MRI•CGI-S•NfL concentrations in CSF•PGI-S
2. Safety endpoints include the following: 1. number (%) of participants per adverse event from baseline
3. Safety endpoints include the following: 2. number (%) of participants who withdraw from the trial due to an adverse event from baseline
4. Safety endpoints include the following: 4. number (%) of participants with potentially clinically significant vital sign values from baseline
5. Safety endpoints include the following: 5. number (%) of participants with potentially clinically significant laboratory tests values (hematology and chemistry) from baseline
6. Safety endpoints include the following: 6. number (%) of participants with potentially clinically significant 12-lead ECG measurements from baseline
7. Safety endpoints include the following: 3. number (%) of participants who withdraw from treatment due to an adverse event from baseline
8. The other secondary efficacy endpoints (TEV-56286 versus placebo, change from baseline to week 48) are as follows: • Pons volume measured by MRI • Cerebellar volume measured by MRI • UMSARS part II score • UMSARS part IV score • Two-minute walk test as part of gait assessment • MSA-QoL

Investigational products

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

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Teva Branded Pharmaceutical Products R&D LLC

Sponsor organisation

Teva Branded Pharmaceutical Products R&D LLC

Address

145 Brandywine Parkway

City

West Chester

Postcode

19380-4245

Country

United States

Scientific contact point

Organisation

Teva Branded Pharmaceutical Products R&D Inc.

Contact name

Medical Information

Public contact point

Organisation

Teva Branded Pharmaceutical Products R&D Inc.

Contact name

Medical Information

Third parties 11

Locations

4 EU/EEA countries · 33 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 114 files

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

Application history

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