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Open Label Extension Study to Assess the Safety and Long-Term Immunogenicity of ARCT-021

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04728347
Recruitment Status : Recruiting
First Posted : January 28, 2021
Last Update Posted : January 28, 2021
Sponsor:
Information provided by (Responsible Party):
Arcturus Therapeutics, Inc.

Brief Summary:
This is an open-label study enrolling healthy adults that participated in Study ARCT-021-01 (the Parent Study). Participants will receive either a single injection of ARCT-021 or no injection and be followed for up to 365 days.

Condition or disease Intervention/treatment Phase
SARS-CoV-2 Biological: ARCT-021 Phase 2

Detailed Description:
This is a phase 2a, open-label study enrolling up to 106 healthy adults that participated in Study ARCT-021-01 (the Parent Study). Participants will enter this study approximately 3 months after their final study visit in the Parent Study. Participants that received placebo in the Parent Study or who are seronegative for SARS-CoV-2 neutralizing antibodies at screening will receive a single dose of ARCT-021 and will be followed for 365 days. Participants that received two injections of ARCT-021 in the Parent Study will not receive any further injections of ARCT-021 and will be followed for 281 days.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2a, Open Label Extension Study to Assess the Safety and Long-Term Immunogenicity of ARCT-021
Actual Study Start Date : January 4, 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Arm Intervention/treatment
Experimental: ARCT-021
Participants will receive a single dose of ARCT-021 on Day 1
Biological: ARCT-021
ARCT-021 single dose

No Intervention: Long-term follow up from ARCT-021-01
Participants will not receive intervention but will be followed for safety.



Primary Outcome Measures :
  1. Percentages of participants reporting solicited local adverse events [ Time Frame: for 7 days following last study vaccine dose administration ]
    Adverse events reported daily in a diary that reflect common symptoms or findings at the injection site following vaccination

  2. Percentages of participants reporting solicited systemic adverse events [ Time Frame: for 7 days following last study vaccine dose administration ]
    Adverse events reported daily in a diary that reflect generalized symptoms following vaccination

  3. Percentages of participants reporting adverse events [ Time Frame: for 28 days following last study vaccine dose administration ]
    Spontaneously reported adverse events

  4. Percentages of participants reporting serious adverse events [ Time Frame: for 12 months following last study vaccine dose administration ]
    Unsolicited adverse events that meet the definition of serious

  5. Percentages of participants reporting medically attended adverse events [ Time Frame: for 12 months following last study vaccine dose administration ]
    Unsolicited adverse events that lead to healthcare provider visit

  6. Percentages of participants reporting new onset of chronic disease [ Time Frame: for 12 months following last study vaccine dose administration ]
    Unsolicited adverse events associated with new diagnosis of chronic disease

  7. Percentages of participants with abnormal safety laboratory test values [ Time Frame: for 28 days following last study vaccine dose administration ]
    Chemistry and hematology

  8. Percentages of participants with abnormal vital sign assessments [ Time Frame: for 12 months following last study vaccine dose administration ]
    Blood pressure, heart rate, respiratory rate


Secondary Outcome Measures :
  1. SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs [ Time Frame: for 12 months following last study vaccine dose administration for participants dosed in ARCT-021-02 study and for 15 months following last study vaccine dose administration for participants dose in the ARCT-021-01 study ]
    Neutralizing antibody response

  2. SARS-CoV-2 binding antibody levels, expressed as GMCs [ Time Frame: for 12 months following last study vaccine dose administration for participants dosed in ARCT-021-02 study and for 15 months following last study vaccine dose administration for participants dose in the ARCT-021-01 study ]
    Binding antibody response



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Individuals who:

  1. are able to give consent
  2. must have completed Study ARCT-021-01
  3. agree to comply with all study visits and procedures

    Only for subjects that will receive ARCT-021 in this study:

  4. are healthy and medically stable
  5. are not planning to donate blood or plasma until 28 days after the last dose of ARCT-021.
  6. are willing to refrain from strenuous exercise/activity and alcohol for at least 72 hours prior to study visits and until 28 days after the last dose of ARCT-021.
  7. are willing to adhere to contraception requirements if sexually active and/or are of child-bearing potential

Exclusion Criteria:

Individuals who:

  1. are unable to comply with the study visits or procedures in Study ARCT-021-01
  2. received placebo in the Parent Study and who are not willing to receive ARCT-021 in this study.

    Only for subjects that will receive ARCT-021 in this study:

  3. have or will receive any of the SARS CoV-2 or another experimental coronavirus during this study.
  4. have a diagnosis of new clinically significant abnormalities including but not limited to

    • Respiratory disease requiring daily medications or oxygen currently or any treatment of respiratory disease exacerbations
    • Significant heart conditions
    • Significant neurological conditions
    • Significant blood disorders
    • Newly diagnosed autoimmune disease
    • Major surgery
  5. have abnormal screening laboratory results
  6. have uncontrolled diabetes
  7. use of any prescription or over-the-counter medications within 7 days prior to vaccination
  8. have received immunoglobulins and/or any blood or blood products
  9. have a bleeding disorder
  10. have uncontrolled blood pressure
  11. have been treated with another investigational drug, biological agent, or device since completion of the Parent Study
  12. have received or plan to receive:

    • A licensed, live vaccine within 4 weeks before or after study vaccination, or
    • A licensed, inactivated vaccine within 2 weeks before or after study vaccination
  13. have traveled outside of Singapore within 30 days before the vaccination or plans to travel outside of Singapore within 60 days after vaccination.
  14. other restrictions may apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04728347


Contacts
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Contact: Arcturus Therapeutics 858-900-2660 clinicaltrials@arcturusrx.com

Locations
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Singapore
SingHealth Investigational Medicine Unit (IMU), Singapore General Hospital Recruiting
Singapore, Singapore, 169608
Contact: Michellore Aguilar    +65 6322 7544    imu@singhealth.com.sg   
Principal Investigator: Jenny Low Guek Hong, MD         
Sponsors and Collaborators
Arcturus Therapeutics, Inc.
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Responsible Party: Arcturus Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04728347    
Other Study ID Numbers: ARCT-021-02
First Posted: January 28, 2021    Key Record Dates
Last Update Posted: January 28, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes