Last reviewed · How we verify

NCT04415073

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

Terminated Phase 2 Results posted Last updated 22 July 2022
What this trial tests

Phase 2 trial testing SNDX-6352 in Coronavirus in 1 participant. Terminated before completion.

Timeline
30 May 2020
Primary endpoint
13 July 2020
13 July 2020

Quick facts

Lead sponsorSyndax Pharmaceuticals
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment1
Start date30 May 2020
Primary completion13 July 2020
Estimated completion13 July 2020
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Syndax Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Coronavirus or COVID. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19.
    Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, et al · · 2021 · cited 126× · PMID 34473343 · DOI 10.1002/14651858.cd013825.pub2
  2. Recent updates in the clinical trials of therapeutic monoclonal antibodies targeting cytokine storm for the management of COVID-19.
    Patel S, Saxena B, Mehta P. · · 2021 · cited 39× · PMID 33553708 · DOI 10.1016/j.heliyon.2021.e06158
  3. Therapeutic antibodies for COVID-19: is a new age of IgM, IgA and bispecific antibodies coming?
    Zhang J, Zhang H, Sun L. · · 2022 · cited 21× · PMID 35220888 · DOI 10.1080/19420862.2022.2031483
  4. COVID-19 associated complications and potential therapeutic targets.
    Monpara JD, Sodha SJ, Gupta PK. · · 2020 · cited 21× · PMID 32926918 · DOI 10.1016/j.ejphar.2020.173548
  5. Therapeutic Antibodies for the Treatment of Respiratory Tract Infections-Current Overview and Perspectives.
    Mayor A, Chesnay A, Desoubeaux G, Ternant D, et al · · 2021 · cited 9× · PMID 33668613 · DOI 10.3390/vaccines9020151
  6. Immunomodulatory Therapeutic Proteins in COVID-19: Current Clinical Development and Clinical Pharmacology Considerations.
    Ji P, Chen J, Golding A, Nikolov NP, et al · · 2020 · cited 6× · PMID 32779201 · DOI 10.1002/jcph.1729

Verify or expand the search:

Other trials of SNDX-6352

Trials testing the same drug.

Other recruiting trials for Coronavirus

Currently open trials in the same condition.

Other Syndax Pharmaceuticals trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04415073.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing