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

• Sponsor: I-Mab Biopharma Co. Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04341116
• Collaborator: (none)
• Enrollment: 152
• Locations: 14
• Arms: 4
• Actual Duration (Months): 21.9
• Patients Per Site: 10.9
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronavirus Disease 2019 COVID-19	Drug: TJ003234; Drug: Placebo	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 152 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of TJ003234 in Subjects With Severe Coronavirus Disease 2019 (COVID-19)
• Actual Study Start Date: Apr 11, 2020
• Actual Primary Completion Date: Feb 7, 2022
• Actual Study Completion Date: Feb 7, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TJ003234 Medium Dose	Drug: TJ003234; patients receive a single infusion
Experimental: TJ003234 Low Dose Part 1 only	Drug: TJ003234; patients receive a single infusion
Placebo Comparator: Placebo	Drug: Placebo; patients receive a single infusion
Experimental: TJ003234 High Dose Part 2 Phase 3 only	Drug: TJ003234; patients receive a single infusion

Outcome Measures

Primary Outcome Measures

1. Proportion (%) of subjects alive and free of mechanical ventilation among subjects who are free of mechanical ventilation at baseline [Day 1 through Day 30]

Secondary Outcome Measures

1. Proportion (%) of subjects recovered by Day 14 [Day 1 through Day 14]

2. Proportion (%) of subjects recovered on Day 30 [Day 1 through Day 30]

3. All-cause mortality rate by Day 30 [Day 1 through Day 30]

4. Time to recovery among subjects alive by Day 30 [Day 1 through Day 30]

5. Length of hospitalization [Day 1 through Day 30]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arkansas	Little Rock	Arkansas	United States	72205
2	Olive View-UCLA Medical Center	Sylmar	California	United States	91342
3	Georgetown University Hospital	Washington	District of Columbia	United States	20007
4	The GW Medical Faculty Associates	Washington	District of Columbia	United States	20037
5	University of Miami	Miami	Florida	United States	33146
6	OSF Healthcare Saint Francis Medical Center	Peoria	Illinois	United States	61637
7	Indiana University Health	Indianapolis	Indiana	United States	46202
8	Medpharmics, LLC	Metairie	Louisiana	United States	70006
9	Ochsner Medical Center	New Orleans	Louisiana	United States	70121
10	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
11	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216
12	University Medical Center of Southern Nevada	Las Vegas	Nevada	United States	89102
13	UNM Hospitals	Albuquerque	New Mexico	United States	87106
14	Houston Methodist Hospital	Houston	Texas	United States	77030

Sponsors and Collaborators

• I-Mab Biopharma Co. Ltd.

Investigators

• Study Director: Claire Xu, MD, PhD, I-Mab Biopharma US Limited

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: I-Mab Biopharma Co. Ltd.
• ClinicalTrials.gov Identifier: NCT04341116
• Other Study ID Numbers: TJ003234COV201
• First Posted: Apr 10, 2020
• Last Update Posted: May 25, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19; Coronavirus Infections; Plonmarlimab

Study Results

No Results Posted as of May 25, 2022