Study of the Safety and Neuroprotective Capacity of Scp776 in Acute Ischemic Stroke

NCT05585606 | Completed Phase 2 FDA Drug

• 1 other identifier: SCP-CL-0003
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 22

Brief Summary

A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study of the Safety and Neuroprotective Capacity of Scp776 in Subjects Undergoing Endovascular Thrombectomy for Acute Ischemic Stroke

Conditions

Acute Ischemic Stroke (AIS)

Keywords

Stroke, Acute; Neuroprotectant

Outcome Measures

Primary Outcomes (2)

• Total number of SAEs recorded prior to hospital discharge

  Generalized linear models will be fit assuming a Poisson family with log link. The regression model will include a term for the duration of hospitalization. The regression models may also be adjusted for any or all of the following utilizing a stepwise approach: Time from LKW or stroke onset to reperfusion; Reperfusion Status (eTICI score from central read); Age; and, ASPECTS (raw score from central read).

  Baseline to Day 7 or at hospital discharge (whichever occurs first).

• Proportion of subjects experiencing adverse events of special interest (AESIs)

  Proportion of subjects experiencing adverse events of special interest (AESIs): * Hypoglycemia * Tachycardia * Bleeding events: * Symptomatic intracranial hemorrhage as per the central imaging review * Asymptomatic intracranial hemorrhage as per the central imaging review * Extracranial hemorrhage

  Baseline to Day 7 or at hospital discharge (whichever occurs first).

Secondary Outcomes (5)

• NIH Stroke Scale (NIHSS) Score at Day 7 / Discharge (whichever comes first)

  Baseline to Day 7 or at hospital discharge (whichever occurs first).

• NIH Stroke Scale (NIHSS) Score

  Daily from Days 1 through 7, Day 30, and Day 90.

• Modified Rankin Scale (mRS) Score

  Day 7 or discharge (whichever occurs first), Day 30, and Day 90.

• Infarct Volume by Central Imaging Review

  At 24 hours, and 72 - 96 hours or discharge (whichever occurs first).

• All-cause Mortality

  By Day 30, and by Day 90.

Other Outcomes (13)

• Duration of Hospitalization

  Baseline to Day 90 or at hospital discharge (whichever occurs first).

• Barthel Index Score at Day 90

  Day 90.

• Proportion of Patients Achieving Barthel Index Score ≥90

  Day 90.

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Volume Matched Placebo (normal saline)

Drug: Placebo

scp776 (1.9 mg/kg)

EXPERIMENTAL

Cohort 1 dose regimen: Intravenous (IV) injection(s) over 2 minutes \- 1.9 mg/kg

Drug: scp776 (1.9 mg/kg); Drug: scp776 (all dose levels)

scp776 (3.8 mg/kg)

EXPERIMENTAL

Cohort 2 dose regimen: Intravenous (IV) injection(s) over 2 minutes \- 3.8 mg/kg

Drug: scp776 (3.8 mg/kg); Drug: scp776 (all dose levels)

scp776 (4.8 mg/kg)

EXPERIMENTAL

Cohort 3 dose regimen: Intravenous (IV) injection(s) over 2 minutes - 4.8 mg/kg

Drug: scp776 (4.8 mg/kg); Drug: scp776 (all dose levels)

Interventions

Placebo DRUG

Volume Matched Placebo

Placebo

scp776 (1.9 mg/kg) DRUG

Cohort 1 dose regimen: Intravenous (IV) slow injection(s) over 2 minutes \- 1.9 mg/kg

scp776 (1.9 mg/kg)

scp776 (3.8 mg/kg) DRUG

Cohort 2 dose regimen: Intravenous (IV) slow injection(s) over 2 minutes \- 3.8 mg/kg

scp776 (3.8 mg/kg)

scp776 (4.8 mg/kg) DRUG

Cohort 3 dose regimen: Intravenous (IV) slow injection(s) over 2 minutes - 4.8 mg/kg

scp776 (4.8 mg/kg)

scp776 (all dose levels) DRUG

A composite group encompassing all participants who received any dose level of the investigational drug under evaluation.

scp776 (1.9 mg/kg); scp776 (3.8 mg/kg); scp776 (4.8 mg/kg)

Eligibility Criteria

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

You may qualify if:

• Aged 18 years or older.
• Body weight of less than 150 kg.
• AIS intended for immediate endovascular treatment.
• Disabling stroke defined as a baseline NIHSS ≥6 at the time of randomization.
• Confirmed symptomatic intracranial occlusion, based on qualifying imaging, at one or more of the following locations: intracranial carotid artery and/or M1 or M2 middle cerebral artery.
• Onset of AIS (last time subject seen well) to randomization is ≤24 hours.
• Intended endovascular treatment with an approved endovascular device.
• Pre-AIS (24 hours before stroke onset) independent functional status in activities of daily living with Modified Rankin Scale score of 0, 1, or 2. Subject must be living in their own home, apartment, or seniors' lodge where no nursing care is required.
• Treating team and subject family are committed to full medical support for the subject.
• Biologically female subjects must meet the following:
• Subject must be surgically sterile or be at least 1 year postmenopausal, OR
• Subjects of child-bearing potential must:
• i. have a negative serum or urine pregnancy test at Screening, AND ii. have no plans to become pregnant or to breast feed during the study, AND iii. at least one of the following must apply:
• have a monogamous partner who is surgically sterile.
• have a monogamous same sex partner.

You may not qualify if:

• Evidence of acute intra-cerebral hemorrhage on qualifying imaging, per radiology lab manual.
• Poor/no collateral circulation in the opinion of the investigator (e.g., collateral score of 0 or 1 if data available).
• ASPECT score of 0-4.
• Current AIS is being treated with IV thrombolytic therapy (e.g., alteplase, tenecteplase), or the subject has received thrombolytic therapy within the previous 24 hours.
• Intent to use any endovascular device that is not Food and Drug Administration (FDA)-approved.
• Planned use of intra arterial thrombolytic therapy.
• Known severe contrast allergy or absolute contraindication to iodinated contrast preventing endovascular intervention.
• Clinical history, past imaging, or clinical judgment suggests that the intracranial occlusion is chronic or there is suspected intracranial dissection such that there is a predicted lack of success with endovascular intervention.
• Known arterial condition that would prevent the mechanical device from achieving reperfusion (e.g., aortic dissection, carotid stent).
• Subjects with end stage kidney disease.
• Part A Cohort 1: Subjects taking a chronic anticoagulant (e.g., apixaban, warfarin) are excluded. Chronic use of anti-platelet drugs is acceptable.
• Part A Cohort 2: Subjects taking a chronic anticoagulant (e.g., apixaban, warfarin) are excluded unless subject has both a STAT international normalized ratio (INR) \< 1.7, and a platelet count \> 100K/µL prior to randomization. Chronic use of anti-platelet drugs is acceptable.
• Part A Cohort 3 and Part B: With SRC approval, subjects in Part A Cohort 3 and Part B taking a chronic anticoagulant (e.g., apixaban, warfarin) are excluded unless subject has both a STAT international normalized ratio (INR) \< 1.7, and a platelet count \> 100K/µL prior to randomization.
• (If the SRC does not approve expansion of this criterion, then subjects taking a chronic anticoagulant (e.g., apixaban, warfarin) are excluded, as in Cohort 1. Chronic use of anti-platelet drugs is acceptable in either case.)
• Known metastatic malignancy with poor prognosis.

Sponsors & Collaborators

• Silver Creek Pharmaceuticals: lead

Study Sites (22)

HonorHealth Scottsdale Osborn Medical Center

Scottsdale, Arizona, 85251, United States

Location

Banner University Medical Center /Univ of Arizona

Tucson, Arizona, 85719, United States

Location

Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

Marcus Neuroscience Institute

Boca Raton, Florida, 33486, United States

Location

University of Miami - Jackson Memorial Hospital

Miami, Florida, 33136, United States

Location

Augusta University Medical Center

Augusta, Georgia, 30912, United States

Location

SSM Health DePaul Hospital

Bridgeton, Missouri, 63044, United States

Location

St. Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

UNM Hospital

Albuquerque, New Mexico, 87106, United States

Location

Northshore University Hospital

Manhasset, New York, 11030, United States

Location

Lennox Hill Hospital

New York, New York, 10075, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Mercy Health - St Vincent Medical Center

Toledo, Ohio, 43608, United States

Location

Mercy Health - St Elizabeth Youngstown Hospital

Youngstown, Ohio, 44504, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Oregon Stroke Center at OHSU

Portland, Oregon, 97239, United States

Location

Providence St. Vincent Medical Center

West Haven-Sylvan, Oregon, 97225, United States

Location

Jefferson Abington Hospital

Abington, Pennsylvania, 19001, United States

Location

Penn State Health - M.S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Houston Methodist Neurological Institute

Houston, Texas, 77030, United States

Location

Medical College of Wisconsin and Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Condition Hierarchy (Ancestors)

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

Study Design

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

Model Details: This is a Phase 2 randomized, placebo-controlled, double-blind study that will be conducted in 2 parts: sequential dose escalation in Part A, followed by dose expansion in Part B. In Part A, approximately 60 evaluable subjects will be assigned 1:1:1:3 overall to Cohort 1, Cohort 2, Cohort3, or placebo. Doses of scp776 will be tested sequentially in 3 cohorts, each in parallel with a volume-matched placebo randomized as 1:1 scp776:placebo within each cohort, to maintain the overall 1:1:1:3 ratio. Subjects will receive doses of either normal saline (placebo) or scp776, approximately 24 hours apart. * Cohort 1 dose regimen: \- 1.9 mg/kg * Cohort 2 dose regimen: \- 3.8 mg/kg * Cohort 3 dose regimen: * 4.8 mg/kg The study will proceed into Part B (dose expansion), in which approximately 40 subjects will be randomized 3:1 to the chosen scp776 therapeutic dose from Part A or volume-matched placebo: Cohort 3: Therapeutic dose scp776:placebo

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: October 19, 2022
• Study Start: October 19, 2022
• Primary Completion: September 15, 2025
• Study Completion: September 15, 2025
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (22)