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Phase 2 Study of the Safety and Neuroprotective Capacity of Scp776 in Acute Ischemic Stroke (Arpeggio)

Primary Purpose

Acute Ischemic Stroke (AIS)

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Placebo

scp776 (1.9 mg/kg)

scp776 (3.8 mg/kg)

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke (AIS) focused on measuring Stroke, Acute, Neuroprotectant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 middle cerebral artery.
Onset of AIS (last time subject seen well) to randomization is ≤16 hours.
Intended endovascular treatment with an approved endovascular device.

Exclusion Criteria:

Evidence of acute intra-cerebral hemorrhage on qualifying imaging, per radiology lab manual.
Poor/no collateral circulation. (e.g. collateral score of 0 or 1).
ASPECT score of 0-4.
Current AIS is being treated with IV thrombolytic therapy (eg, alteplase, tenecteplase), or the subject has received thrombolytic therapy within the previous 24 hours.
Intent to use any endovascular thrombectomy device that is not 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 (eg, aortic dissection, carotid stent).
Subjects with end-stage kidney disease.
Subjects taking a chronic anticoagulant (eg, warfarin, apixaban).
Known metastatic malignancy with poor prognosis.
Subjects with any comorbid disease, condition, or situation that would confound the neurologic and functional evaluations, prevent improvement, or render the subject unable to complete follow-up treatment, in the opinion of the investigator.
Participation in another clinical trial of an FDA-unapproved therapeutic device or drug in the 30 days preceding study inclusion.
Subject has previously received scp776 in another clinical trial.

Sites / Locations

The Ohio State UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

scp776 (1.9 mg/kg)

scp776 (3.8 mg/kg)

Arm Description

Volume Matched Placebo (normal saline)

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

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

Outcomes

Primary Outcome Measures

Change in NIHSS from baseline to Day 7 or at hospital discharge (whichever occurs first).

Change from baseline in NIHSS will be assessed with Analyses of Variance performed on the FAS and PPAS. Terms to be included in the model are baseline NIHSS, treatment, and ASPECT score (ASPECT score ≤6 versus ASPECT score >6).

Secondary Outcome Measures

Change in NIHSS from baseline to Day 3

Change in Modified Rankin Scale score at Day 30 from baseline

Change in Modified Rankin Scale score at Day 90 from baseline

Change in NIHSS from baseline to Day 1

Change in NIHSS from baseline to Day 2

Change in Barthel Index score at Day 90 from baseline

Full Information

NCT ID

NCT05585606

First Posted

October 14, 2022

Last Updated

January 17, 2023

Sponsor

Silver Creek Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT05585606

Brief Title

Phase 2 Study of the Safety and Neuroprotective Capacity of Scp776 in Acute Ischemic Stroke

Acronym

Arpeggio

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 19, 2022 (Actual)

Primary Completion Date

March 2024 (Anticipated)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Silver Creek Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

Detailed Description

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Ischemic Stroke (AIS)

Keywords

Stroke, Acute, Neuroprotectant

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Sequential Assignment

Model Description

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 40 evaluable subjects will be assigned 1:1:2 overall to Cohort 1, Cohort 2 or placebo. Doses of scp776 will be tested sequentially in 2 cohorts, each in parallel with a volume-matched placebo randomized as 1:1 scp776:placebo within each cohort, to maintain the overall 1:1:2 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 The study will proceed into Part B (dose expansion), in which approximately 40 subjects will be randomized 1:1 to the chosen scp776 therapeutic dose from Part A or volume-matched placebo: Cohort 3: Therapeutic dose scp776:placebo

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Volume Matched Placebo (normal saline)

Arm Title

scp776 (1.9 mg/kg)

Arm Type

Experimental

Arm Description

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

Arm Title

scp776 (3.8 mg/kg)

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Volume Matched Placebo

Intervention Type

Drug

Intervention Name(s)

scp776 (1.9 mg/kg)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

scp776 (3.8 mg/kg)

Intervention Description

Cohort 1 dose regimen: Intravenous (IV) slow injection(s) over 2 minutes - 3.8 mg/kg

Primary Outcome Measure Information:

Title

Change in NIHSS from baseline to Day 7 or at hospital discharge (whichever occurs first).

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Change in NIHSS from baseline to Day 3

Time Frame

Baseline through Day 3

Title

Change in Modified Rankin Scale score at Day 30 from baseline

Time Frame

Baseline through Day 30

Title

Change in Modified Rankin Scale score at Day 90 from baseline

Time Frame

Baseline through Day 90

Title

Change in NIHSS from baseline to Day 1

Time Frame

Baseline through Day 1

Title

Change in NIHSS from baseline to Day 2

Time Frame

Baseline through Day 2

Title

Change in Barthel Index score at Day 90 from baseline

Time Frame

Baseline through Day 90

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 middle cerebral artery. Onset of AIS (last time subject seen well) to randomization is ≤16 hours. Intended endovascular treatment with an approved endovascular device. Exclusion Criteria: Evidence of acute intra-cerebral hemorrhage on qualifying imaging, per radiology lab manual. Poor/no collateral circulation. (e.g. collateral score of 0 or 1). ASPECT score of 0-4. Current AIS is being treated with IV thrombolytic therapy (eg, alteplase, tenecteplase), or the subject has received thrombolytic therapy within the previous 24 hours. Intent to use any endovascular thrombectomy device that is not 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 (eg, aortic dissection, carotid stent). Subjects with end-stage kidney disease. Subjects taking a chronic anticoagulant (eg, warfarin, apixaban). Known metastatic malignancy with poor prognosis. Subjects with any comorbid disease, condition, or situation that would confound the neurologic and functional evaluations, prevent improvement, or render the subject unable to complete follow-up treatment, in the opinion of the investigator. Participation in another clinical trial of an FDA-unapproved therapeutic device or drug in the 30 days preceding study inclusion. Subject has previously received scp776 in another clinical trial.

Facility Information:

Facility Name

The Ohio State University

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Silver Creek Investigative Site

Phone

614-366-6703

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Phase 2 Study of the Safety and Neuroprotective Capacity of Scp776 in Acute Ischemic Stroke

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