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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04697069
Other study ID # ANB019-207
Secondary ID 2020-003494-22
Status Terminated
Phase Phase 2
First received
Last updated
Start date May 4, 2021
Est. completion date December 13, 2021

Study information

Verified date December 2022
Source AnaptysBio, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Terminated
Enrollment 4
Est. completion date December 13, 2021
Est. primary completion date December 13, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Imsidolimab
Humanized monoclonal antibody
Placebo
Placebo

Locations

Country Name City State
Czechia Site 303 Brno
Czechia Site 302 Nové Mesto Praha 2
Czechia Site 301 Olomouc
Czechia Site 304 Plzen-Bory
Georgia Site 404 Batumi
Georgia Site 401 Tbilisi
Georgia Site 402 Tbilisi
Georgia Site 403 Tbilisi
Georgia Site 405 Tbilisi
Latvia Site 601 Riga
Poland Site 204 Gliwice
Poland Site 203 Poznan
Poland Site 201 Szczecin
United States Site 106 Boston Massachusetts
United States Site 105 Columbus Ohio
United States Site 103 Houston Texas
United States Site 101 Saint Louis Missouri
United States Site 102 Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
AnaptysBio, Inc.

Countries where clinical trial is conducted

United States,  Czechia,  Georgia,  Latvia,  Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Percent 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 mm or less in diameter. Pastule was a small, circumscribed elevation of the skin that contains yellow-white exudate. Baseline, Week 8
Secondary 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 The acneiform rash CTCAE grading scale of severity was 6-point scale ranging from 0-5.
Scale 0=no evidence of rash. Scale 1= papules and/or pustules covering <10% body surface area (BSA), which may or may not be associated with symptoms of pruritus or tenderness.
Scale 2=papules and/or pustules covering 10-30% BSA, which may or may not be associated with symptoms of pruritus or tenderness; associated with psychosocial impact; limiting instrumental activities of daily living (ADL); papules and/or pustules covering >30% BSA with or without mild symptoms.
Scale 3=papules and/or pustules covering >30% BSA with moderate or severe symptoms; limiting self-care ADL; associated with local superinfection with oral antibiotics.
Scale 4=life-threatening consequences; papules and/or pustules covering any %BSA, which may or may not be associated with symptoms of pruritus or tenderness and are associated with extensive superinfection with intravenous (IV) antibiotics indicated.
Scale 5=death.
Baseline, Week 8
Secondary Time to First Response of 1 Grade Improvement From Baseline on the Acneiform Rash CTCAE Grading Scale Time to first response of 1 grade improvement from baseline on the acneiform rash CTCAE grading scale: Date of the first response of 1 grade improvement from baseline on the acneiform rash CTCAE grading scale - Date of the first dose of study treatment (or from randomization for any participant randomized but not treated) + 1. Baseline up to 55 days
Secondary 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 The MESTT grading scale of the acneiform rash severity was a 3-point scale ranging from 1 to 3:
Scale 1 = 1A: papules or pustules =5; OR 1 area of erythema or edema <1 centimeter (cm) in size. 1B: papules or pustules =5; OR 1 area of erythema or edema <1 cm in size; AND pain or pruritus.
Scale 2 = 2A: papules or pustules 6-20; OR 2-5 areas of erythema or edema <1 cm in size. 2B: Papules or pustules 6-20; OR 2-5 areas of erythema or edema <1 cm in size; AND pain, pruritus, or effect on emotions or functioning.
Scale 3 = 3A: papules or pustules > 20; OR more than 5 areas of erythema or edema <1 cm in size. 3B: papules or pustules > 20; OR more than 5 areas of erythema or edema <1 cm in size; AND pain, pruritus, or effect on emotions or functioning.
Grading was performed individually for the face, scalp, chest, and back. The sum of all body region scores yielded the total score (range: 4 to 12).
Baseline, Week 8
Secondary Time to First Response of 1 Grade Improvement From Baseline on the Acneiform Rash Modified MESTT Grading Scale (Total Score) Time to first response of 1 grade improvement from baseline on the acneiform rash modified MESTT grading scale (total score): Date of onset of the first response of 1 grade improvement from baseline on the acneiform rash modified MESTT grading scale (total score) - Date of the first dose of study treatment (or from randomization for any participant randomized but not treated) + 1. Baseline to 55 days
Secondary 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 The MESTT grading scale of the acneiform rash severity was a 3-point scale ranging from 1 to 3:
Scale 1 = 1A: papules or pustules =5; OR 1 area of erythema or edema <1cm in size. 1B: papules or pustules =5; OR 1 area of erythema or edema <1 cm in size; AND pain or pruritus.
Scale 2 = 2A: papules or pustules 6-20; OR 2-5 areas of erythema or edema <1 cm in size. 2B: Papules or pustules 6-20; OR 2-5 areas of erythema or edema <1 cm in size; AND pain, pruritus, or effect on emotions or functioning.
Scale 3 = 3A: papules or pustules > 20; OR more than 5 areas of erythema or edema <1 cm in size. 3B: papules or pustules > 20; OR more than 5 areas of erythema or edema <1 cm in size; AND pain, pruritus, or effect on emotions or functioning.
Grading was performed individually for the face. The score ranged from 1 to 3.
Baseline, Week 8
Secondary Time to First Response of 1 Grade Improvement From Baseline on the Acneiform Rash Modified MESTT Grading Scale (Facial Assessment) Time to first response of 1 grade improvement from baseline on the acneiform rash modified MESTT grading scale (facial assessment): Date of onset of the first response of 1 grade improvement from baseline on the acneiform rash modified MESTT grading scale (facial assessment) - Date of the first dose of study treatment (or from randomization for any participant randomized but not treated) + 1. Baseline to 55 days
Secondary Change From Baseline in Pruritus Numeric Rating Scale (NRS) at Week 8 The intensity of pruritus was evaluated by asking participants to assign a numerical score representing the worst intensity over the last 24 hours of their symptoms on a scale from 0 to 10, with 0 indicating no itch and 10 indicating the worst imaginable itch. Baseline, Week 8
Secondary Percent Change From Baseline in Pruritus NRS at Week 8 The intensity of pruritus was evaluated by asking participants to assign a numerical score representing the worst intensity over the last 24 hours of their symptoms on a scale from 0 to 10, with 0 indicating no itch and 10 indicating the worst imaginable itch. Baseline, Week 8
Secondary Change From Baseline in Pain NRS at Week 8 The intensity of pain was evaluated by asking participants to assign a numerical score representing the worst intensity over the last 24 hours of their symptoms on a scale from 0 to 10, with 0 indicating no pain and 10 indicating the worst imaginable pain. Baseline, Week 8
Secondary Percent Change From Baseline in Pain NRS at Week 8 The intensity of pain was evaluated by asking participants to assign a numerical score representing the worst intensity over the last 24 hours of their symptoms on a scale from 0 to 10, with 0 indicating no pain and 10 indicating the worst imaginable pain. Baseline, Week 8
Secondary Change From Baseline in Functional Assessment of Cancer Therapy - Epidermal Growth Factor Receptor Inhibitor 18 (FACT-EGFRi-18) at Week 8 The FACT-EGFRi-18 was an 18-item likert-scaled questionnaire, arranged in three dimensions: physical (seven items), social/emotional (six items), and functional well-being (five items). The response scores ranged from 0 (not at all) to 4 (very much).
The total score was obtained by multiplying the sum of the subscale by the number of items in the scale (18), and then dividing by the number of items actually answered.
The total score ranged from 0-72 with a higher score represented a high level of symptomatology (problems).
Baseline, Week 8
Secondary Number of Participants With Treatment-Emergent Adverse Events An adverse event (AE) was any untoward medical occurrence in a participant temporally associated with the use of a study treatment, whether or not considered related to study treatment. An AE could therefore be any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with use of study treatment that did not necessarily have a causal relationship with this treatment. An AE was considered "serious" if there was any of the following outcomes: death, life-threatening, Inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of ability to conduct normal life functions, congenital anomaly/birth defect, other important medical events. An AE was considered treatment-emergent if the date of onset was during or after first dose of study treatment, or if the AE present at baseline worsened in either intensity or frequency after first dose of study treatment. From first dose to 55 days
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