An Open-Label Extension, Multi-Centered, Phase 2 Trial of TEV-56286 (Emrusolmin) for 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

5 Mar 2026 → ongoing

Decision date (initial)

2026-02-16

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

Teva Branded Pharmaceutical Products R&D LLC

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacogenomic, Pharmacodynamic, Pharmacokinetic, Efficacy

The primary objective of the trial is to describe the long-term safety and tolerability of TEV 56286 administered orally for the treatment of adult participants with MSA

Conditions and MedDRA coding

Multiple System Atrophy

Regulatory references

Scientific advice from competent authorities

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 7

1. 1. Completion of the treatment period and the week 48 (V9) visit of the DB trial whilst remaining compliant with trial requirements.
2. 2. Is able to swallow the IMP, as determined by a dysphagia evaluation during the OLE baseline visit; and is willing to swallow the IMP capsules whole, and as scheduled, throughout the duration of the OLE trial
3. 3. In the investigator’s opinion, the participant and where applicable, participant’s caregiver(s), has (have) the ability to understand the nature of the OLE trial and its procedures, and is (are) able and willing to comply with the requirements of the OLE trial
4. 4. Participant must provide consent, either by signature, spoken word, or gesture. If participant is physically unable to provide written informed consent, the completed ICF must be signed by one of the following in accordance with local regulation: (1) legally acceptable representative (LAR) or (2) acknowledgement of participant’s consent by an impartial witness. The process for consent should follow the local regulatory requirements. Caregiver consent will also be obtained in the circumstances where caregiver participation is applicable.
5. 5. Females of childbearing potential (CBP) may be included only if they have a negative pregnancy test at the OLE baseline visit
6. 6. Females of CBP whose male partners are potentially fertile (ie, no vasectomy) must use highly effective birth control methods for the duration of the OLE trial and for 28 days after the last dose of IMP
7. 7. Males who are potentially fertile/reproductively competent (not surgically [eg, vasectomy] or congenitally sterile) and their female partners who are of CBP must use, together with their female partners, highly effective birth control methods for the duration of the OLE trial and for 28 days after the last dose of IMP

Exclusion criteria 7

1. 1. Has any clinically significant uncontrolled medical or psychiatric condition (treated or untreated), or any findings from vital signs, imaging, physical examination, electrocardiogram (ECG), or clinical laboratory, other than MSA related that could jeopardize or compromise the participant’s ability to participate in the OLE trial. The investigator should consult with the medical monitor or trial physician as needed.
2. 2. Is a female participant who is pregnant, plans to become pregnant, or is breastfeeding during the OLE trial.
3. 3. Has moderate to severe renal impairment as assessed by estimated glomerular filtration rate <60 mL/min/1.73m2. Minor deviations or borderline results (up to 10 mL/minute/1.73m2) may be acceptable for eligibility at the discretion of the Principal Investigator.
4. 4. Current or history of chronic liver or biliary disease, >2.5x the upper limit of normal (ULN) for alanine aminotransferase (ALT) or aspartate aminotransferase (AST), or 1.5x ULN total bilirubin (isolated bilirubin >1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
5. 5. Has any clinically significant disorder that may interfere with absorption, distribution, metabolism, or excretion of IMP (including relevant gastrointestinal surgery, malabsorption syndrome) that makes the participant unsuitable for the trial.
6. 6. Is of a vulnerable population (eg, people kept in detention or jail).
7. 7. Is regularly using or consuming any prohibited concomitant medications within the specified exclusionary windows of this trial

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. The primary safety and tolerability endpoints are as follows: • number (%) of participants experiencing an adverse event
2. The primary safety and tolerability endpoints are as follows: • number (%) of participants who withdraw from the trial due to an adverse event

Investigational products

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

Test 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 LLC

Contact name

Medical Information

Public contact point

Organisation

Teva Branded Pharmaceutical Products R&D LLC

Contact name

Medical Information

Third parties 11

Locations

4 EU/EEA countries · 28 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 34 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