A Study to Evaluate the Efficacy and Safety of Itolizumab in Subjects Hospitalized With COVID-19 (EQUINOX)

• ClinicalTrials.gov Identifier: NCT04605926
• Recruitment Status: Withdrawn
• First Posted: October 28, 2020
• Last Update Posted: January 27, 2021
• Sponsor: Equillium
• Collaborator: Biocon Limited
• Information provided by (Responsible Party): Equillium

Tracking Information

• First Submitted Date: October 21, 2020
• First Posted Date: October 28, 2020
• Last Update Posted Date: January 27, 2021
• Estimated Study Start Date: November 2020
• Estimated Primary Completion Date: April 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 27, 2020)

Proportion of subjects who have recovered at Day 28. [ Time Frame: Day 28 ]

Proportion of subjects who have recovered at Day 28.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 27, 2020)

• Proportion of subjects deceased or requiring mechanical ventilation at Day 28. [ Time Frame: Day 28 ]
  Proportion of subjects deceased or requiring mechanical ventilation at Day 28.
• Proportion of subjects deceased at Day 28. [ Time Frame: Day 28 ]
  Proportion of subjects deceased at Day 28.

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: October 27, 2020)

• Incidence of treatment-emergent adverse events (TEAEs). [ Time Frame: Day 90 ]
  Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE)
• Time to maximum itolizumab serum concentration, Tmax [ Time Frame: Day 28 ]
  Time to maximum itolizumab serum concentration, Tmax
• Maximum itolizumab serum drug concentration, Cmax [ Time Frame: Day 28 ]
  Maximum itolizumab serum drug concentration, Cmax
• Total itolizumab exposure across time, AUC (from zero to last) [ Time Frame: Day 28 ]
  Total itolizumab exposure across time, AUC (from zero to last)
• Inflammatory biomarkers [ Time Frame: Day 28 ]
  Including but not limited to IL-1, IL-6, IL-17, TNF-α.
• Pharmacodynamic markers [ Time Frame: Day 28 ]
  sCD6, sALCAM

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: A Study to Evaluate the Efficacy and Safety of Itolizumab in Subjects Hospitalized With COVID-19
• Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Itolizumab in Subjects Hospitalized With COVID-19
• Brief Summary: This is a randomized controlled trial to evaluate the efficacy and safety of itolizumab in subjects hospitalized with COVID-19.
• Detailed Description: This study will randomize up to 800 subjects in a 1:1 ratio; itolizumab vs. placebo. Subjects will receive either itolizumab or placebo administered intravenously on Day 1 and Day 8 with follow-up to Day 90. Two interim analyses of futility are planned. The first will take place when approximately 20% of the subjects have been evaluated for the primary endpoint, and the second will take place when approximately 50% of the subjects have been evaluated for the primary endpoint.
• Study Type: Interventional
• Study Phase: Phase 3

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

The study will be blinded to all study staff that has direct access to the subjects and the sponsor.

Primary Purpose: Treatment

• Condition: Coronavirus

Intervention

• Biological: EQ001
  itolizumab [Bmab600]
  Other Names:

  • itolizumab
  • Bmab600
• Biological: EQ001 Placebo
  EQ001 Placebo

Study Arms

• Experimental: EQ001
  EQ001 administered in a blinded fashion by intravenous infusion on Day 1 and Day 8 for a total of 2 doses.
  Intervention: Biological: EQ001
• Placebo Comparator: EQ001 Placebo
  Placebo administered in a blinded fashion by intravenous infusion on Day 1 and Day 8 for a total of 2 doses.
  Intervention: Biological: EQ001 Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: January 25, 2021): 0
• Original Estimated Enrollment (submitted: October 27, 2020): 800
• Estimated Study Completion Date: June 2021
• Estimated Primary Completion Date: April 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Is willing and able to, or has a legally acceptable representative who is willing and able to, provide informed consent to participate and to cooperate with all aspects of the protocol.
2. Is male or female, age ≥18 years
3. Is hospitalized with COVID-19 pneumonia with a diagnosis of SARS-CoV-2 infection confirmed by reverse transcriptase polymerase chain reaction (RT-PCR) or equivalent local test within 14 days of randomization.
4. Has PaO2/FiO2 ratio of ≤200 (or equivalent SpO2/FiO2 ratio ~235 within 24 hours before randomization. This ratio may be adjusted based on altitude.

Exclusion Criteria:

1. Has known severe allergic reactions to mAbs.
2. Has active TB or known history of inadequately treated latent or active TB.
3. Has any known active systemic or pulmonary bacterial, fungal, or viral (other than SARS-CoV-2) infection at the time of randomization.
4. Has known active, uncontrolled hepatitis B or hepatitis C or severe liver function impairment from any etiology, as defined by Child-Pugh Class C.
5. Has human immunodeficiency virus (HIV) with known CD4 counts <0.2 × 10^9/L.
6. Has a history of clinically significant cardiac abnormality within 6 months prior to randomization, such as myocardial infarction or stroke, New York Heart Association class III or IV, or clinically significant abnormalities of electrocardiogram (ECG) or cardiac function.
7. Has been on mechanical ventilation for longer than 48 hours during their first continuous episode since admission, is on their second or greater episode of mechanical ventilation at the time of randomization during the concurrent hospitalization, or has received extracorporeal membrane oxygenation (ECMO).
8. Has a declining clinical status with an expected survival <3 days in the opinion of the Investigator.
9. Has received any systemic immunomodulatory or immunosuppressant agents for any condition within 3 months prior to randomization. (Note: a stable, oral, low dose of corticosteroids [prednisone or equivalent ≤10 mg/day] for a chronic condition or any dose of systemic corticosteroids for current COVID-19 treatment are permitted. Local/topical treatments are also permitted.)
10. Has received any biologic treatment for any acute (eg, COVID-19) or chronic conditions (eg, TNFα inhibitors, anti-IL17A, tocilizumab, anti-cytokines, etc.) within 3 months prior to randomization.
11. Is participating in another clinical study of an investigational product and/or received an investigational product within 30 days or within 5 half-lives (whichever is longer) prior to randomization.
12. Is pregnant or breastfeeding, or has a positive pregnancy serum or urine test during Screening.
13. Does not agree to use contraception in the event of sexual activity for 130 days (+90 days for male subjects) after the last dose of study drug if a female of childbearing potential or a male with a partner of childbearing potential. Note: this criterion does not apply to subjects in same-sex relationships.

14. Has inadequate hematologic function during Screening defined as follows:

    • Absolute neutrophil count (ANC) <1.0 × 109/L.
    • ALC <0.5 × 109/L.
15. Requires renal dialysis, either acute or chronic, at the time of randomization.
16. Has a medical, psychiatric, or other condition or circumstance that, in the opinion of the Investigator, could affect the subject's safety, the subject's participation in the study, or the reliability of the study data.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Colombia

Administrative Information

• NCT Number: NCT04605926
• Other Study ID Numbers: EQ001-20-001
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Equillium
• Original Responsible Party: Same as current
• Current Study Sponsor: Equillium
• Original Study Sponsor: Same as current
• Collaborators: Biocon Limited

Investigators

• Study Director: Maple Fung, MD; Equillium

• PRS Account: Equillium
• Verification Date: January 2021