A Phase 2 Study to Evaluate Axatilimab for Hospitalized Participants With Respiratory Involvement Secondary to COVID-19

NCT04415073 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: SNDX-6352-0505
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Coronavirus; COVID; ARDS; Cytokine Storm; Cytokine Release Syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 29

Secondary Outcomes (8)

• Count Of Participants With Secondary Clinical Improvement Outcomes At Day 29

  Day 29

• Time To Clinical Improvement

  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

  Baseline, Day 29

• Change From Baseline At Day 15 In Biomarkers Following Treatment With Axatilimab

  Baseline, Day 15

• Count Of Participants Experiencing Adverse Events And Serious Adverse Events

  Baseline through Day 29

Study Arms (2)

Axatilimab (SNDX-6352)

ACTIVE COMPARATOR

Axatilimab on Days 1 and 15, IV + SOC

Drug: SNDX-6352

Placebo

PLACEBO COMPARATOR

Matching placebo on Days 1 and 15, IV + SOC

Drug: Placebo

Interventions

SNDX-6352 DRUG

SNDX-6352

Also known as: Axatilimab

Axatilimab (SNDX-6352)

Placebo DRUG

Placebo comparator

Placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Syndax Pharmaceuticals: lead

Study Sites (2)

HonorHealth

Scottsdale, Arizona, 85258, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, 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

Conditions

Coronavirus Infections; Cytokine Release Syndrome

Interventions

axatilimab

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Limitations and Caveats

This study was terminated by the Sponsor given enrollment challenges, partly attributable to the constantly changing COVID-19 treatment landscape. Due to study termination and only 1 participant being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.

Results Point of Contact

• Title: Kate Madigan, MD
• Organization: Syndax Pharmaceuticals, Inc.

kmadigan@syndax.com

+1-781-419-1400

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 4, 2020
• Study Start: May 30, 2020
• Primary Completion: July 13, 2020
• Study Completion: July 13, 2020
• Last Updated: July 22, 2022
• Results First Posted: July 22, 2022

Record last verified: 2022-06

Locations

US (2)