Study Stopped
Administrative Reason
A Study to Evaluate of the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Acneiform Rash
A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ANB019 in the Treatment of Acneiform Rash in Subjects With Neoplasm Receiving EGFRi or MEKi Therapy
2 other identifiers
interventional
4
5 countries
18
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 (MEKi)-associated acneiform Rash
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started May 2021
Shorter than P25 for phase_2
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 23, 2020
CompletedFirst Posted
Study publicly available on registry
January 6, 2021
CompletedStudy Start
First participant enrolled
May 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 13, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 13, 2021
CompletedResults Posted
Study results publicly available
January 9, 2023
CompletedSeptember 22, 2025
December 1, 2022
7 months
December 23, 2020
December 14, 2022
September 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Facial Inflammatory Lesion Count (Papules and Pustules) at Week 8
The number of facial inflammatory lesions (papules and pustules) on the face (excluding the neck and scalp area) was counted. Papule was a small, solid elevation 5 millimeters (mm) or less in diameter. Pastule was a small, circumscribed elevation of the skin that contains yellow-white exudate.
Baseline, Week 8
Secondary Outcomes (13)
Percent Change From Baseline in Facial Inflammatory Lesion Count (Papules and Pustules) at Week 8
Baseline, Week 8
Percentage of Participants With an Improvement of at Least 1 Grade From Baseline in Acneiform Rash Common Terminology Criteria for Adverse Events (CTCAE) Grading Scale at Week 8
Baseline, Week 8
Time to First Response of 1 Grade Improvement From Baseline on the Acneiform Rash CTCAE Grading Scale
Baseline up to 55 days
Percentage of Participants With an Improvement of at Least 1 Grade From Baseline in Acneiform Rash Modified Multinational Association for Supportive Care in Cancer (MASCC) EGFRi Skin Toxicity Tool (MESTT) Grading Scale (Total Score) at Week 8
Baseline, Week 8
Time to First Response of 1 Grade Improvement From Baseline on the Acneiform Rash Modified MESTT Grading Scale (Total Score)
Baseline to 55 days
- +8 more secondary outcomes
Study Arms (2)
ANB019
EXPERIMENTALParticipants received a starting dose of 400 milligrams (mg) of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by subcutaneous injection.
Placebo
PLACEBO COMPARATORParticipants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by subcutaneous injection.
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Site 102
Tampa, Florida, 33620, United States
Site 106
Boston, Massachusetts, 02215, United States
Site 101
St Louis, Missouri, 63110, United States
Site 105
Columbus, Ohio, 43215, United States
Site 103
Houston, Texas, 77030, United States
Site 302
New Town, Praha 2, 128 00, Czechia
Site 303
Brno, 656-91, Czechia
Site 301
Olomouc, 779 00, Czechia
Site 304
Plzen-Bory, 305 99, Czechia
Site 404
Batumi, 6000, Georgia
Site 402
Tbilisi, 0144, Georgia
Site 403
Tbilisi, 0160, Georgia
Site 405
Tbilisi, 0160, Georgia
Site 401
Tbilisi, 0186, Georgia
Site 601
Riga, 1038, Latvia
Site 204
Gliwice, 44-102, Poland
Site 203
Poznan, 60-569, Poland
Site 201
Szczecin, 70-784, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vanda Pharmaceuticals
- Organization
- Vanda Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 23, 2020
First Posted
January 6, 2021
Study Start
May 4, 2021
Primary Completion
December 13, 2021
Study Completion
December 13, 2021
Last Updated
September 22, 2025
Results First Posted
January 9, 2023
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share