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Acute Ischemic Stroke (AIS)Phase 2ARPEGGIONCT05585606

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

A Phase 2 study testing scp776 (1.9 mg/kg), scp776 (3.8 mg/kg) and scp776 (4.8 mg/kg) in people with Acute Ischemic Stroke (AIS), run by Silver Creek Pharmaceuticals at 22 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Ischemic Stroke (AIS)
What is being tested?
scp776 (1.9 mg/kg), scp776 (3.8 mg/kg) and scp776 (4.8 mg/kg)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
22 sitesUnited States
Study dates
19 Oct 2022to 15 Sep 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • Signed informed consent from subject or legally authorized representative, if required to enable inclusion by applicable national laws and regulations and the applicable independent review boards/ethics committee requirements for obtaining consent. Electronic consent is allowed in jurisdictions wherein this consent process is allowed.
  • 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:
  • 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.
  • be practicing abstinence or using an acceptable form of birth control while participating in the study through Day 90. Site personnel will provide instructions on what is an acceptable method.
  • If male, unless the subject has a same sex partner, be either sterile (surgically or biologically), commit to an acceptable double barrier method of birth control, or practice abstinence, until at least 30 days after study drug administration. Site personnel will provide instructions on what is an acceptable method.

Who cannot join

  • 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.
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  • 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.
  • 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. Examples of excluded comorbid conditions include respiratory failure because of pneumonia, chronic diseases with significant disability, or non-ambulatory status. Contact medical monitor for consultation if necessary.
  • Participation in another clinical trial of an FDA-unapproved therapeutic device or drug in the 30 days preceding study inclusion.
  • Subject was a participant in either SCP CL 0001 or SCP CL 0002 and received scp776, or previously participated in SCP-CL-0003.
  • Subject is experiencing moderate or severe hypotension as defined by CTCAE criteria (i.e., symptomatic and requiring medical intervention with fluid resuscitation and/or vasopressors) or a confirmed systolic blood pressure less than 90 mmHg.

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

United States22 sites

  • Jefferson Abington Hospital

    Abington, Pennsylvania, 19001

  • UNM Hospital

    Albuquerque, New Mexico, 87106

  • Augusta University Medical Center

    Augusta, Georgia, 30912

  • Marcus Neuroscience Institute

    Boca Raton, Florida, 33486

  • SSM Health DePaul Hospital

    Bridgeton, Missouri, 63044

  • University of Cincinnati

    Cincinnati, Ohio, 45219

  • The Ohio State University

    Columbus, Ohio, 43210

  • Hartford Hospital

    Hartford, Connecticut, 06106

  • Penn State Health - M.S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Houston Methodist Neurological Institute

    Houston, Texas, 77030

  • St. Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • Northshore University Hospital

    Manhasset, New York, 11030

  • University of Miami - Jackson Memorial Hospital

    Miami, Florida, 33136

  • Medical College of Wisconsin and Froedtert Hospital

    Milwaukee, Wisconsin, 53226

  • Lennox Hill Hospital

    New York, New York, 10075

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Oregon Stroke Center at OHSU

    Portland, Oregon, 97239

  • HonorHealth Scottsdale Osborn Medical Center

    Scottsdale, Arizona, 85251

  • Mercy Health - St Vincent Medical Center

    Toledo, Ohio, 43608

  • Banner University Medical Center /Univ of Arizona

    Tucson, Arizona, 85719

  • Providence St. Vincent Medical Center

    West Haven-Sylvan, Oregon, 97225

  • Mercy Health - St Elizabeth Youngstown Hospital

    Youngstown, Ohio, 44504

Other trials in United States

About this study

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

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

Read the 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 60 evaluable subjects will be assigned 1:1:1:3 overall to Cohort 1, Cohort 2, Cohort 3, 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

Upon completion of Part A, 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.

Being tested
Placebo, scp776 (1.9 mg/kg), scp776 (3.8 mg/kg), scp776 (4.8 mg/kg), scp776 (all dose levels)
Keywords
Stroke, Acute, Neuroprotectant
Medical subject headings
Ischemic Stroke, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Volume Matched Placebo

  • scp776 (1.9 mg/kg)Drug

    Cohort 1 dose regimen:

    Intravenous (IV) slow injection(s) over 2 minutes

    • 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 (4.8 mg/kg)Drug

    Cohort 3 dose regimen: Intravenous (IV) slow injection(s) over 2 minutes - 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.

Study groups in NCT05585606
Study groupRoleWhat they receive
PlaceboPlacebo comparatorVolume Matched Placebo (normal saline)
Receives: Drug: Placebo
scp776 (1.9 mg/kg)ExperimentalCohort 1 dose regimen: Intravenous (IV) injection(s) over 2 minutes - 1.9 mg/kg
Receives: Drug: scp776 (1.9 mg/kg); Drug: scp776 (all dose levels)
scp776 (3.8 mg/kg)ExperimentalCohort 2 dose regimen: Intravenous (IV) injection(s) over 2 minutes - 3.8 mg/kg
Receives: Drug: scp776 (3.8 mg/kg); Drug: scp776 (all dose levels)
scp776 (4.8 mg/kg)ExperimentalCohort 3 dose regimen: Intravenous (IV) injection(s) over 2 minutes - 4.8 mg/kg
Receives: Drug: scp776 (4.8 mg/kg); Drug: scp776 (all dose levels)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

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

  2. 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

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

Secondary outcomes (5)

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

    NIH Stroke Scale score assessing neurological deficits and stroke severity. Scores range from 0 (no deficits) to 42 (severe deficits).

    NIHSS at discharge will be analyzed using Analysis of Covariance (ANCOVA). Terms to be included in the model are age, baseline NIHSS, ASPECTS, reperfusion status (TICI-based reperfusion grade), and treatment.

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

  2. NIH Stroke Scale (NIHSS) Score

    NIH Stroke Scale (NIHSS) score assessing neurological deficits and stroke severity. Scores range from 0 (no deficits) to 42 (severe deficits).

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

  3. Modified Rankin Scale (mRS) Score

    Assessment of disability after stroke using the Modified Rankin Scale, ranging from 0 (no disability) to 6 (death).

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

  4. Infarct Volume by Central Imaging Review

    Infarct volume measured centrally via imaging (MRI or CT), evaluating ischemic lesion size.

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

  5. All-cause Mortality

    Incidence of death from any cause.

    Measured: By Day 30, and by Day 90.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2022
  2. Study start19 Oct 2022
  3. Primary completion15 Sep 2025
  4. Study completion15 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
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 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
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05585606
Sponsor's protocol ID
SCP-CL-0003
Acronym
ARPEGGIO
Status last verified
Feb 2026
First submitted
14 Oct 2022
Last updated
24 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing scp776 (1.9 mg/kg), scp776 (3.8 mg/kg) and scp776 (4.8 mg/kg) in people with Acute Ischemic Stroke (AIS), run by Silver Creek Pharmaceuticals at 22 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total number of SAEs recorded prior to hospital discharge (time frame: Baseline to Day 7 or at hospital discharge (whichever occurs first).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05585606.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.

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