BRIGHT - A Phase II, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Multiple Doses of LT3001 Drug Product in Subjects with Acute Ischemic Stroke (AIS)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Lumosa Therapeutics Co. Ltd.

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 Dec 2023 → 24 May 2025

Decision date (initial)

2023-09-05

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Lumosa Therapeutics Co, Ltd.

External identifiers

EU CT number

2022-502001-15-00

ClinicalTrials.gov

NCT05403866

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To determine the safety of multiple doses of LT3001 drug product in subjects with AIS.

Secondary objectives 1

1. To determine the efficacy of multiple doses of LT3001 drug product in subjects with AIS.

Conditions and MedDRA coding

Acute Ischemic Stroke (AIS)

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 1. Subject has been diagnosed with AIS. 2. Subject or if applicable subject’s legally acceptable representative/ legally designated representative consents to participation by signing the informed consent form after receiving full information about the study. 3. Subject from the US and Taiwan is aged 18 to 90 years (inclusive) and subject from the EU and UK is aged 18 to 80 years (inclusive) at the time of Screening (Visit 1). 4. Subject has an NIHSS of 4 to 25. 5. Subject comes to the study site 6 hours after the stroke symptoms onset and is able to receive the 1st IP within 24 hours after stroke symptoms onset. If any subject comes to the study site within 6 hours of stroke symptoms onset and is ineligible to receive endovascular thrombectomy (EVT) and/or intravenous thrombolytic treatment (e.g., recombinant tissue-type plasminogen activator) based on the Investigator's assessment of its potential benefit. 6. Subjects who are women of childbearing potential, or men whose sexual partners are women of childbearing potential, are able and willing to use at least 1 highly effective method of contraception during the study until 3 months after the last dosing of IP administration.

Exclusion criteria 1

1. 1. During the current AIS episode, the subject has received or is scheduled to receive EVT and/or intravenous thrombolytic (e.g., recombinant tissue-type plasminogen activator) treatment based on the investigator's assessment of its potential benefit. 2. Subject has a pre-stroke disability (mRS >2). 3. Subject has Alberta Stroke Program Early CT Score of ≤5. 4. Subject has symptoms of suspected subarachnoid hemorrhage, even if CT is normal. 5. In the opinion of the Investigator, the subject is not appropriate for the study for any other reason.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The proportion of subjects with Adverse Events (AEs), judged to be probably or definitely related to the investigational product (IP) within 90 days after the 1st IP administration.

Investigational products

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

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Lumosa Therapeutics Co. Ltd.

Sponsor organisation

Lumosa Therapeutics Co. Ltd.

Address

4 F, No 3-2 Park St., Nangang Dist. No 3-2 Park St. Nangang Dist.

City

Taipei City

Postcode

115603

Country

Taiwan

Scientific contact point

Organisation

Lumosa Therapeutics Co. Ltd.

Contact name

Sabrina Yeh

Public contact point

Organisation

Lumosa Therapeutics Co. Ltd.

Contact name

Sabrina Yeh

Third parties 7

Locations

6 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

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 45 files

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

Application history

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