Status:
TERMINATED
A Study to Evaluate of the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Acneiform Rash
Lead Sponsor:
Vanda Pharmaceuticals
Conditions:
Acneiform Eruptions
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
This study is a Phase 2a, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of imsidolimab compared with placebo in cancer participants...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Participant has infected EGFRi/MEKi-associated acneiform rash according to investigator's evaluation.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
May 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2021
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04697069
Start Date
May 4 2021
End Date
December 13 2021
Last Update
September 22 2025
Active Locations (18)
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1
Site 102
Tampa, Florida, United States, 33620
2
Site 106
Boston, Massachusetts, United States, 02215
3
Site 101
St Louis, Missouri, United States, 63110
4
Site 105
Columbus, Ohio, United States, 43215