CoronavirusPhase 2NCT04415073
A Phase 2 Study to Evaluate Axatilimab for Hospitalized Participants With Respiratory Involvement Secondary to COVID-19
A Phase 2 study testing SNDX-6352 in people with Coronavirus and COVID, run by Syndax Pharmaceuticals at 2 sites in United States.
Trial summary
This was a randomized, double-blind, placebo-controlled, 29-day study to assess the efficacy and safety of axatilimab plus standard of care (SOC), compared with placebo plus SOC, in participants with respiratory signs and symptoms secondary to COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus, COVID, ARDS
- What is being tested?
- SNDX-6352
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 May 2020to 13 Jul 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
HonorHealth
Scottsdale, Arizona, 85258
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: 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)
This was a randomized, double-blind, placebo-controlled, 29-day study to assess the efficacy and safety of axatilimab plus standard of care (SOC), compared with placebo plus SOC, in participants with respiratory signs and symptoms secondary to COVID-19.
Read the 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.
- Conditions
- Coronavirus, COVID, ARDS, Cytokine Storm, Cytokine Release Syndrome
- Being tested
- SNDX-6352, Placebo
- Medical subject headings
- Coronavirus Infections, Cytokine Release Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNDX-6352Drug
Also called Axatilimab
SNDX-6352
PlaceboDrug
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| Axatilimab (SNDX-6352) | Active comparator | Axatilimab on Days 1 and 15, IV + SOC Receives: Drug: SNDX-6352 |
| Placebo | Placebo comparator | Matching placebo on Days 1 and 15, IV + SOC Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Count Of Participants Alive And Free Of Respiratory Failure At 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.
Measured: Day 29
Secondary outcomes (8)
Count Of Participants With Secondary Clinical Improvement Outcomes At 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.
Measured: Day 29
Time To Clinical Improvement
The time to clinical improvement is defined as a national early warning score of ≤2 maintained for 24 hours.
Measured: 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
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.
Measured: Baseline, Day 29
Change From Baseline At Day 15 In Biomarkers Following Treatment With Axatilimab
The change from baseline at Day 15 in serum concentrations of interleukin 6 and c-reactive protein or hospital discharge or death is evaluated.
Measured: Baseline, Day 15
Count Of Participants Experiencing Adverse Events And Serious Adverse Events
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.
Measured: Baseline through Day 29
Count Of Participants Requiring Ventilation Support
Participants who required initiation of mechanical ventilation after study entry are analyzed.
Measured: Baseline through Day 29
Count Of Participants Considered Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Free By 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.
Measured: Day 15
Pharmacokinetics: Serum Concentration Of Axatilimab And Anti-drug Antibodies
The serum concentration of axatilimab and presence of anti-drug antibodies is evaluated.
Measured: Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start30 May 2020
- Primary completion13 Jul 2020
- Study completion13 Jul 2020
Why it stopped: Given enrollment challenges, partly attributable to the constantly changing COVID-19 treatment landscape, the trial has been closed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CoronavirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syndax Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04415073
- Sponsor's protocol ID
- SNDX-6352-0505
- Status last verified
- Jun 2022
- First submitted
- 29 May 2020
- Last updated
- 22 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 34473343
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT04415073
- Acronym / sponsor ID
- SNDX-6352-0505
- Conditions
- Coronavirus, COVID, ARDS, Cytokine Storm, Cytokine Release Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Given enrollment challenges, partly attributable to the constantly changing COVID-19 treatment landscape, the trial has been closed.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Syndax PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 30 May 2020 (actual)
- Primary completion
- 13 Jul 2020 (actual)
- Study completion
- 13 Jul 2020 (actual)
- First posted
- 4 Jun 2020 (actual)
- Results
- Posted 22 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a randomized, double-blind, placebo-controlled, 29-day study to assess the efficacy and safety of axatilimab plus standard of care (SOC), compared with placebo plus SOC, in participants with respiratory signs and symptoms secondary to COVID-19.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Axatilimab (SNDX-6352) | Active comparator | Drug: SNDX-6352Axatilimab on Days 1 and 15, IV + SOC |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo on Days 1 and 15, IV + SOC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
- If the participant was intubated, must have been intubated less than 24 hours prior to randomization
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SNDX-6352Also: AxatilimabSNDX-6352 | Drug | Axatilimab (SNDX-6352) |
| PlaceboPlacebo comparator | Drug | Placebo |
Primary outcome
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.
8 secondary outcomes
Count Of Participants With Secondary Clinical Improvement Outcomes At Day 29
Time frame: Day 29
Time To Clinical Improvement
Time frame: 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
Change From Baseline At Day 15 In Biomarkers Following Treatment With Axatilimab
Time frame: Baseline, Day 15
Count Of Participants Experiencing Adverse Events And Serious Adverse Events
Time frame: Baseline through Day 29
Count Of Participants Requiring Ventilation Support
Time frame: Baseline through Day 29
Count Of Participants Considered Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Free By Day 15
Time frame: Day 15
Pharmacokinetics: Serum Concentration Of Axatilimab And Anti-drug Antibodies
Time frame: Day 29
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34473343Kreuzberger 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SNDX-6352 in people with Coronavirus and COVID, run by Syndax Pharmaceuticals at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Count Of Participants Alive And Free Of Respiratory Failure At Day 29 (time frame: Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04415073, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2022.