Clinical trial NCT04697069: A Study to Evaluate of the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Acneiform Rash
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acneiform Eruptions
Keywords: IL-36 receptor
Interleukin 36
Imsidolimab
Lead sponsor: AnaptysBio, Inc.
Sponsor class: INDUSTRY
First posted: 2021-01-06
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 with EGFRi/MEKi-associated acneiform rash. This study will also characterize the pharmacokinetic (PK) profile of imsidolimab and explore the immune response to imsidolimab in participants with EGFRi/MEKi-associated acneiform rash.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* Participant has infected EGFRi/MEKi-associated acneiform rash according to investigator's evaluation.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Change From Baseline in Facial Inflammatory Lesion Count (Papules and Pustules) at Week 8
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: Percent Change From Baseline in Facial Inflammatory Lesion Count (Papules and Pustules) at Week 8
timeFrame: Baseline, Week 8
measure: 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
timeFrame: Baseline, Week 8
measure: Time to First Response of 1 Grade Improvement From Baseline on the Acneiform Rash CTCAE Grading Scale
timeFrame: Baseline up to 55 days
measure: 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
timeFrame: Baseline, Week 8
measure: Time to First Response of 1 Grade Improvement From Baseline on the Acneiform Rash Modified MESTT Grading Scale (Total Score)
timeFrame: Baseline to 55 days
measure: Percentage of Participants With an Improvement of at Least 1 Grade From Baseline in Acneiform Rash Modified MESTT Grading Scale (Facial Assessment) at Week 8
timeFrame: Baseline, Week 8
measure: Time to First Response of 1 Grade Improvement From Baseline on the Acneiform Rash Modified MESTT Grading Scale (Facial Assessment)
timeFrame: Baseline to 55 days
measure: Change From Baseline in Pruritus Numeric Rating Scale (NRS) at Week 8
timeFrame: Baseline, Week 8
measure: Percent Change From Baseline in Pruritus NRS at Week 8
timeFrame: Baseline, Week 8
measure: Change From Baseline in Pain NRS at Week 8
timeFrame: Baseline, Week 8
measure: Percent Change From Baseline in Pain NRS at Week 8
timeFrame: Baseline, Week 8
measure: Change From Baseline in Functional Assessment of Cancer Therapy - Epidermal Growth Factor Receptor Inhibitor 18 (FACT-EGFRi-18) at Week 8
timeFrame: Baseline, Week 8
measure: Number of Participants With Treatment-Emergent Adverse Events
timeFrame: From first dose to 55 days
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Site 102
state: Florida
city: Boston
country: United States
facility: Site 106
state: Massachusetts
city: Saint Louis
country: United States
facility: Site 101
state: Missouri
city: Columbus
country: United States
facility: Site 105
state: Ohio
city: Houston
country: United States
facility: Site 103
state: Texas
city: Nové Město
country: Czechia
facility: Site 302
state: Praha 2
city: Brno
country: Czechia
facility: Site 303
city: Olomouc
country: Czechia
facility: Site 301
city: Plzen-Bory
country: Czechia
facility: Site 304
city: Batumi
country: Georgia
facility: Site 404
city: Tbilisi
country: Georgia
facility: Site 402
city: Tbilisi
country: Georgia
facility: Site 403
city: Tbilisi
country: Georgia
facility: Site 405
city: Tbilisi
country: Georgia
facility: Site 401
city: Riga
country: Latvia
facility: Site 601
city: Gliwice
country: Poland
facility: Site 204
city: Poznań
country: Poland
facility: Site 203
city: Szczecin
country: Poland
facility: Site 201
Study officials:
affiliation: AnaptysBio, Inc.
name: Bruce Randazzo, MD
role: STUDY_DIRECTOR
References: