Phase 2 Study of TXA127 in Post-ischemic Stroke Patients

NCT06135103 | Unknown Phase 2 FDA Drug

• 1 other identifier: TXA127-STRK-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is a 50-patient, Phase 2, double-blind, randomized, placebo-controlled, hybrid decentralized study to evaluate the safety and efficacy of daily subcutaneous (SC) injection of TXA127 in post-ischemic stroke patients. Subjects will receive either TXA127 0.5mg/kg or placebo for 12 weeks started 6 to 24 months post ischemic stroke, and they will have a 12 week follow up visit after treatment has ended. The primary efficacy outcome measure is individual patient absolute change from baseline in motor and sensory functions as measured by the Fugl-Meyer Assessment of Upper Extremity (FMA-UE) 12 weeks after start of treatment.

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (2)

• Fugl-Meyer Assessment of Upper Extremity (FM-UE)

  Individual patient absolute change from baseline in motor and sensory functions as measured by the Fugl-Meyer Assessment of Upper Extremity (FMA-UE) 12 weeks after start of treatment.

  12 weeks

• Adverse Events

  Incidence of adverse events (AEs) assessed according to CTCAE v5.0

  12 weeks

Secondary Outcomes (6)

• Fugl-Meyer Assessment of Lower Extremity (FMA-LE)

  12 weeks

• Time Up and Go

  12 weeks

• Stroke Impact Scale

  12 weeks

• Durability of Fugl-Meyer

  24 weeks

• Durability of Time Up and Go

  24 weeks

Other Outcomes (2)

• Brain-derived neurotrophic factor (BDNF)

  12 weeks

• Neurofilament light chain (NfL)

  12 weeks

Study Arms (2)

talfirastide (TXA127)

EXPERIMENTAL

TXA127 will be given daily for 12 weeks at a dose of 0.5.mg/kg via SC injection.

Drug: talfirastide

placebo

PLACEBO COMPARATOR

Placebo will be given daily for 12 weeks via SC injection.

Drug: Placebo

Interventions

talfirastide DRUG

TXA127, a pharmaceutically formulated angiotensin (1-7) heptapeptide, identical to the endogenously produced, non-hypertensive derivative of angiotensin II (Ang II) is a sterile solution containing angiotensin (1-7) \[A(1-7)\], supplied in a 3 mL, single-use, stoppered vial.

Also known as: TXA127

talfirastide (TXA127)

Placebo DRUG

Placebo is a sterile solution containing supplied in a 3 mL, single-use, stoppered vial.

placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-85 years
• BMI: 18.0-35.0 kg/m2
• Patient suffered an ischemic stroke (caused by blockage of the middle cerebral artery) 6-24 months prior to enrollment and with no additional symptomatic stroke incidents since then.
• Patient resides in Israel between Hedera and Gedera
• Fugl-Meyer Assessment of Upper Extremity: 20-50 without reflex items
• Patient suffers from hemiparesis as assessed by the study investigator
• Premorbid disability does not impact physical and cognitive function to a degree that would limit completion of study activities and assessments, as assessed by the study investigator
• Patient agrees to participate in two physical therapy or occupational therapy sessions per week
• Patient is able to use a device for telemedicine meetings with a physician and to record study-related events in an electronic diary, either alone or with caregiver's assistance

You may not qualify if:

• Woman of childbearing potential who is pregnant or planning to become pregnant, or not using birth control
• Aphasia or dementia limiting ability of patient to comply with instructions as assessed by the study investigator
• Current diagnosis of severe depression (NOTE: In case of doubt, a patient who is currently taking or has taken within the last 30 days second-line anti-depressants OR who has scored 12-15 points using the Geriatric Depression Scale, will be considered severely depressed and will not be eligible to participate in the study.)
• Drug or alcohol abuse within the last year
• Current or planned Botox administration for upper limb spasticity, strabismus, overactive bladder, migraine prevention, blepharospasm, cervical dystonia or other off-label uses including but not limited to: sialorrhea, post-herpetic neuralgia, Raynaud's disease, achalasia, or any use the investigator believes may interfere with an accurate neurological exam. Permitted uses - cosmetic (wrinkles), hyperhidrosis
• Participation in a transcranial magnetic stimulation and/or other interventional stroke studies within 6 months of screening
• History of cancer within three years of screening, with the exception of fully excised non-melanoma skin cancers or non-metastatic prostate cancer that has been stable for at least 6 months
• Any medical condition that, in the opinion of the investigator, would preclude patient participation in the study and/or analysis of results
• Significant disability prior to stroke that would impact execution of any of the functional assessments in the protocol

Sponsors & Collaborators

• Constant Therapeutics LLC: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

angiotensin I (1-7)

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Richard L Franklin, MD, PhD

CONTACT

1-617-245-0289; rfranklin@constanttherapeutics.com

Elizabeth Wagner, MS, MBA

CONTACT

1-617-245-0289; ewagner@constanttherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 18, 2023
• Study Start: November 26, 2023
• Primary Completion: December 1, 2024
• Study Completion: September 1, 2025
• Last Updated: December 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)