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

• ClinicalTrials.gov Identifier: NCT05585606
• Recruitment Status: Recruiting
• First Posted: October 19, 2022
• Last Update Posted: January 19, 2023
• Sponsor: Silver Creek Pharmaceuticals
• Information provided by (Responsible Party): Silver Creek Pharmaceuticals

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

Condition or disease	Intervention/treatment	Phase
Acute Ischemic Stroke (AIS)	Drug: Placebo; Drug: scp776 (1.9 mg/kg); Drug: scp776 (3.8 mg/kg)	Phase 2

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment

Intervention 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: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: October 19, 2022
• Estimated Primary Completion Date: March 2024
• Estimated Study Completion Date: June 2024

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo; Volume Matched Placebo (normal saline)	Drug: Placebo; Volume Matched Placebo
Experimental: scp776 (1.9 mg/kg); Cohort 1 dose regimen: Intravenous (IV) slow injection(s) over 2 minutes - 1.9 mg/kg	Drug: scp776 (1.9 mg/kg); Cohort 1 dose regimen: Intravenous (IV) slow injection(s) over 2 minutes - 1.9 mg/kg
Experimental: scp776 (3.8 mg/kg); Cohort 2 dose regimen: Intravenous (IV) injection(s) over 2 minutes - 3.8 mg/kg	Drug: scp776 (3.8 mg/kg); Cohort 1 dose regimen: Intravenous (IV) slow injection(s) over 2 minutes - 3.8 mg/kg

Outcome Measures

Primary Outcome Measures :

1. Change in NIHSS from baseline to Day 7 or at hospital discharge (whichever occurs first). [ Time Frame: 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 :

1. Change in NIHSS from baseline to Day 3 [ Time Frame: Baseline through Day 3 ]
2. Change in Modified Rankin Scale score at Day 30 from baseline [ Time Frame: Baseline through Day 30 ]
3. Change in Modified Rankin Scale score at Day 90 from baseline [ Time Frame: Baseline through Day 90 ]
4. Change in NIHSS from baseline to Day 1 [ Time Frame: Baseline through Day 1 ]
5. Change in NIHSS from baseline to Day 2 [ Time Frame: Baseline through Day 2 ]
6. Change in Barthel Index score at Day 90 from baseline [ Time Frame: Baseline through Day 90 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Ohio

The Ohio State University; Recruiting

Columbus, Ohio, United States, 43210

Contact: Silver Creek Investigative Site 614-366-6703

Sponsors and Collaborators

Silver Creek Pharmaceuticals

More Information

• Responsible Party: Silver Creek Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT05585606
• Other Study ID Numbers: SCP-CL-0003
• First Posted: October 19, 2022
• Last Update Posted: January 19, 2023
• Last Verified: January 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Silver Creek Pharmaceuticals:

Stroke, Acute; Neuroprotectant

Additional relevant MeSH terms:

Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Brain Infarction; Brain Ischemia; Infarction; Necrosis