A Study to Evaluate of the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Acneiform Rash
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Acneiform Eruptions
In brief
Efficacy and Safety of imsidolimab in participants with epidermal growth factor receptor inhibitor (EGFRi)/mitogen-activated protein (MAP)/extracellular signal-regulated kinase (ERK) kinase inhibitor (MEKi)-associated acneiform Rash
Key facts
- Study ID
- NCT04697069
- Run by
- Vanda Pharmaceuticals
- People needed
- 4
- Starts
- 2021-05-04
- Expected to finish
- 2021-12-13
- Last updated by the study team
- 2025-09-22
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Participant has cancer
- Participant is treated with an oral or injectable Food and Drug Administration (FDA)-approved EGFRi or MEKi therapy
- Participant has EGFRi/MEKi-related acneiform rash of Grade ≥ 2 as per common terminology criteria for adverse events (CTCAE) version 5.0, and ≥ 20 inflammatory lesions on the face at screening and Day 1.
You may not qualify if…
- Participant has infected EGFRi/MEKi-associated acneiform rash according to investigator's evaluation.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Where it is running
- Site 102 — Tampa, Florida, United States
- Site 106 — Boston, Massachusetts, United States
- Site 101 — St Louis, Missouri, United States
- Site 105 — Columbus, Ohio, United States
- Site 103 — Houston, Texas, United States
- Site 302 — New Town, Praha 2, Czechia
- Site 303 — Brno, Czechia
- Site 301 — Olomouc, Czechia
- Site 304 — Plzen-Bory, Czechia
- Site 404 — Batumi, Georgia
- Site 402 — Tbilisi, Georgia
- Site 403 — Tbilisi, Georgia
- Site 405 — Tbilisi, Georgia
- Site 401 — Tbilisi, Georgia
- Site 601 — Riga, Latvia
- Site 204 — Gliwice, Poland
- Site 203 — Poznan, Poland
- Site 201 — Szczecin, Poland
Full record on ClinicalTrials.gov
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