- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04415073
A Phase 2 Study to Evaluate Axatilimab for Hospitalized Participants With Respiratory Involvement Secondary to COVID-19
A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Axatilimab for the Treatment of Hospitalized Patients With Respiratory Signs and Symptoms Secondary to Novel Coronavirus Disease (COVID-19)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Axatilimab (SNDX-6352) is a humanized immunoglobin G4 monoclonal antibody with high affinity against colony stimulating factor-1 receptor (CSF-1R) under investigation for the prevention or treatment of respiratory signs and symptoms secondary to COVID-19.
This was a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety and tolerability of axatilimab as an add-on to SOC therapy in hospitalized participants with respiratory signs and symptoms secondary to COVID-19 compared to SOC treatment.
Eligible participants were to be randomized in a 1:1 ratio to 1 of 2 treatment groups, active or control. All participants were to receive axatilimab or matching placebo intravenously (IV) as an add-on to SOC on Day 1, within 8 hours of randomization and on Day 15. Participants were to be followed for at least 28 days (+3 days) after the first dose of study intervention (Day 29).
The primary objective of the study was to assess the proportion of participants alive and free of respiratory failure at Day 29.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Arizona
-
Scottsdale, Arizona, United States, 85258
- HonorHealth
-
-
New York
-
Bronx, New York, United States, 10467
- Montefiore Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Type of Participant and Disease Characteristics -
- Documented or confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection by an FDA-approved polymerase chain reaction test of nasopharyngeal swab or stool less than 72 hours before randomization
- Hospitalized for COVID-19
Illness of any duration with at least 1 of the following:
- Clinical assessment (evidence of rales/crackles on exam) and peripheral capillary oxygen saturation less than or equal to 94% on room air, or
- Requiring mechanical ventilation and/or supplemental oxygen, or
Radiographic evidence (chest x-ray or computed tomography scan) of 1 of the following:
- Ground-glass opacities, or
- Local or bilateral patchy infiltrates, or
- Interstitial pulmonary infiltrates
If the participant was intubated, must have been intubated less than 24 hours prior to randomization
Sex and Contraception Guidelines -
Contraceptive use by men or women should have been consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Informed Consent -
- Capable of giving signed informed consent or by a designated representative, which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol
Exclusion Criteria:
Medical Conditions -
- Active bacterial pneumonia defined: based on either lobar consolidation on x-ray, positive sputum cultures, or leukocytosis with a left shift
- Known active tuberculosis
- Participants with acquired immune deficiency syndrome
- It is not in the best interest of the participants to participate, in the opinion of the treating Investigator.
- In the opinion of the investigator, progression to death was imminent and inevitable within the next 24 hours, irrespective of the provision of treatments.
Female participants who were pregnant or breastfeeding or expecting to conceive within the projected duration of the study, starting with the screening visit through 90 days after the last dose of study intervention
Excluded Prior/Concomitant Therapy -
- Prior treatment with other agents with actual or possible direct acting anti-inflammatory activity against SARS-CoV-2 in the past 30 days (for example, chloroquine, hydroxychloroquine)
- Treatment with convalescent plasma
- Treatment with high doses of corticosteroids (greater than 20 milligrams daily, prednisone equivalent) prior to randomization
- Treatment with immunomodulators including anti-interleukin (IL)-6, anti-IL-6 receptor antagonists, or with Janus kinase inhibitors in the past 30 days or plans to receive during the study period
- Previous exposure to study intervention or any other agent targeting colony stimulating factor-1 or CSF-1R or known allergy/sensitivity to study intervention
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Axatilimab (SNDX-6352)
Axatilimab on Days 1 and 15, IV + SOC
|
SNDX-6352
Other Names:
|
Placebo Comparator: Placebo
Matching placebo on Days 1 and 15, IV + SOC
|
Placebo comparator
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Count Of Participants Alive And Free Of Respiratory Failure At Day 29
Time Frame: Day 29
|
Respiratory failure was defined by need for mechanical ventilation, extracorporeal membrane oxygenation, non-invasive ventilation >6 liters oxygen/minute, or clinical diagnosis of respiratory failure with initiation of none of these measures only when clinical decision-making was driven solely by resource limitation.
|
Day 29
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Count Of Participants With Secondary Clinical Improvement Outcomes At Day 29
Time Frame: Day 29
|
Participants achieving a ≥2 category improvement on a 7-point ordinal score relative to the baseline on Day 28 as collected on Day 29 are reported.
|
Day 29
|
Time To Clinical Improvement
Time Frame: Baseline through Day29
|
The time to clinical improvement is defined as a national early warning score of ≤2 maintained for 24 hours.
|
Baseline through Day29
|
Change From Baseline At Day 29 In Oxygenation In Hospitalized Adults With Respiratory Signs And Symptoms Secondary To COVID-19 Treated With Axatilimab
Time Frame: Baseline, Day 29
|
The change from baseline at Day 29 or hospital discharge or death, if sooner, in the ratio of peripheral hemoglobin oxygen saturation to fraction of inspired oxygen is evaluated.
|
Baseline, Day 29
|
Change From Baseline At Day 15 In Biomarkers Following Treatment With Axatilimab
Time Frame: Baseline, Day 15
|
The change from baseline at Day 15 in serum concentrations of interleukin 6 and c-reactive protein or hospital discharge or death is evaluated.
|
Baseline, Day 15
|
Count Of Participants Experiencing Adverse Events And Serious Adverse Events
Time Frame: Baseline through Day 29
|
This outcome measure evaluates the safety and tolerability of axatilimab within the same population.
A summary of all serious adverse events and other adverse events (nonserious) regardless of causality is located in the 'Reported Adverse Events' section.
|
Baseline through Day 29
|
Count Of Participants Requiring Ventilation Support
Time Frame: Baseline through Day 29
|
Participants who required initiation of mechanical ventilation after study entry are analyzed.
|
Baseline through Day 29
|
Count Of Participants Considered Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Free By Day 15
Time Frame: Day 15
|
This outcome measure evaluates the antiviral effects of axatilimab in hospitalized adults by Day 15 or hospital discharge, whichever was sooner, with recently diagnosed SARS-CoV-2 infection.
|
Day 15
|
Pharmacokinetics: Serum Concentration Of Axatilimab And Anti-drug Antibodies
Time Frame: Day 29
|
The serum concentration of axatilimab and presence of anti-drug antibodies is evaluated.
|
Day 29
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SNDX-6352-0505
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on COVID
-
European Institute of OncologyFondazione I.R.C.C.S. Istituto Neurologico Carlo Besta; Azienda Ospedaliera... and other collaboratorsCompleted
-
Owlstone LtdCambridge University Hospitals NHS Foundation TrustCompleted
-
Erasmus Medical CenterDa Vinci Clinic; HGC RijswijkNot yet recruitingPost-COVID-19 Syndrome | Long COVID | Long Covid19 | Post COVID-19 Condition | Post-COVID Syndrome | Post COVID-19 Condition, Unspecified | Post-COVID ConditionNetherlands
-
Sultan Qaboos UniversityCompletedCOVID-19 | Non-CovidOman
-
Assiut UniversityRecruiting
-
Jilin UniversityUnknown
-
Indonesia UniversityRecruitingPost-COVID-19 Syndrome | Long COVID | Post COVID-19 Condition | Post-COVID Syndrome | Long COVID-19Indonesia
-
University of Roma La SapienzaQueen Mary University of London; Università degli studi di Roma Foro Italico; Bios Prevention SrlCompletedPost Acute Sequelae of COVID-19 | Post COVID-19 Condition | Long-COVID | Chronic COVID-19 SyndromeItaly
-
Miami VA Healthcare SystemNot yet recruiting
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States