Study of TJ003234 (Anti-GM-CSF Monoclonal Antibody) in Subjects With Severe Coronavirus Disease 2019 (COVID-19)

NCT04341116 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: TJ003234COV201
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 14

Brief Summary

This is a randomized, double-blind, placebo-controlled, multi-center trial to evaluate the safety and efficacy of TJ003234 administered as an intravenous (IV) infusion in subjects with severe COVID-19 under supportive care, and to assess the effect of TJ003234 on the levels of cytokines.

Conditions

Coronavirus Disease 2019 COVID-19

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects Alive and Free of Mechanical Ventilation Among Subjects Who Are Free of Mechanical Ventilation at Baseline

  Free of mechanical ventilation was defined as proportion of subjects who scores 1 to 5 in the following 8-category ordinal scale. 8, death; 7, ventilation in addition to extracorporeal membrane oxygen (ECMO), continuous renal replacement therapy (CRRT) or pressors; 6, intubation and mechanical ventilation; 5, non-invasive mechanical ventilation (NIV) or high-flow oxygen; 4, hospitalization with oxygen by mask or nasal prongs; 3. Hospitalization without oxygen supplementation; 2, limitation of activities, discharge from hospital; and 1, no limitation of activities, discharge from hospital.

  Day 1 through Day 30

Secondary Outcomes (5)

• Percentage of Recovery by Day 14

  Day 1 through Day 14

• Percentage of Subjects Recovered on Day 30

  Day 1 through Day 30

• All-cause Mortality Rate by Day 30

  Day 1 through Day 30

• Time to Recovery Among Subjects Alive by Day 30

  Day 1 through Day 30

• Length of Hospitalization

  Day 1 through Day 30

Study Arms (4)

TJ003234 Medium Dose

EXPERIMENTAL

Drug: TJ003234

TJ003234 Low Dose

EXPERIMENTAL

Part 1 only

Drug: TJ003234

Placebo

PLACEBO COMPARATOR

Drug: Placebo

TJ003234 High Dose

EXPERIMENTAL

Part 2 Phase 3 only

Drug: TJ003234

Interventions

TJ003234 DRUG

patients receive a single infusion

TJ003234 High Dose; TJ003234 Low Dose; TJ003234 Medium Dose

Placebo DRUG

patients receive a single infusion

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 years or older (including 18 years); male or female
• Laboratory-confirmed SARS-CoV-2 or COVID-19 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay.
• Bilateral lung infection confirmed by imaging.
• Severe disease that meets one of the following conditions: (i) At rest, finger blood oxygen saturation ≤ 93% or PaO2/FiO2 ≤ 300 mmHg; (ii) Requiring non-invasive or invasive mechanical ventilation; OR (iii) Requiring high flow oxygen ≥ 15L/min
• Hospitalized for no more than 5 calendar days at the time of screening

You may not qualify if:

• Any previous and/or current clinically significant disease or condition that has not been stable within 3 months prior to enrollment, or acute illness, planned medical/ surgical procedure, or any trauma that occurred within 2 weeks prior to enrollment.
• Chronic obstructive pulmonary disease (COPD) patients requiring inhaled corticosteroid, long-acting beta-adrenergic agonists, long-acting anticholinergics, or long-term oxygen therapy (Part 1 only).
• Pulmonary interstitial disease, pulmonary alveolar proteinosis, and pulmonary granulomatosis.
• Cardiovascular event in the 3 months prior to study drug administration: acute myocardial infarction or unstable angina pectoris, severe arrhythmia (multiple sources of frequent ventricular premature beat, ventricular tachycardia and ventricular fibrillation); New York Heart Association Classification (NYHA): Class III-Class IV.
• Blood system disorders or routine blood analysis test abnormalities: Hemoglobin \< 8 g/dL; Absolute neutrophil count (ANC) \<1500 × 109/L; Platelets \< 50 × 109/L.
• Dependence on glucocorticoid treatment equivalent to methylprednisolone 2 mg/kg/ day or more or long-term use of anti-rejection or immunomodulatory drugs.
• Subjects that have been on invasive mechanical ventilation for ≥120 hours at the time of dosing
• Subjects that require ECMO.
• Pregnant or breastfeeding females.

Sponsors & Collaborators

• I-Mab Biopharma US Limited: lead

Study Sites (14)

University of Arkansas

Little Rock, Arkansas, 72205, United States

Location

Olive View-UCLA Medical Center

Sylmar, California, 91342, United States

Location

Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

The GW Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States

Location

University of Miami

Miami, Florida, 33146, United States

Location

OSF Healthcare Saint Francis Medical Center

Peoria, Illinois, 61637, United States

Location

Indiana University Health

Indianapolis, Indiana, 46202, United States

Location

Medpharmics, LLC

Metairie, Louisiana, 70006, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

University Medical Center of Southern Nevada

Las Vegas, Nevada, 89102, United States

Location

UNM Hospitals

Albuquerque, New Mexico, 87106, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

  PMID: 34473343 DERIVED

MeSH Terms

Interventions

plonmarlimab

Results Point of Contact

• Title: Claire Xu
• Organization: I-Mab Biopharma US Ltd

Claire.Xu@i-mabbiopharma.com

3177558242

Study Officials

• Claire Xu, MD, PhD

  I-Mab Biopharma US Limited

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2020
• First Posted: April 10, 2020
• Study Start: April 11, 2020
• Primary Completion: February 7, 2022
• Study Completion: February 7, 2022
• Last Updated: May 6, 2023
• Results First Posted: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)