- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04697069
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Brno, Czechia, 656-91
- Site 303
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Olomouc, Czechia, 779 00
- Site 301
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Plzen-Bory, Czechia, 305 99
- Site 304
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Praha 2
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Nové Město, Praha 2, Czechia, 128 00
- Site 302
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Batumi, Georgia, 6000
- Site 404
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Tbilisi, Georgia, 0144
- Site 402
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Tbilisi, Georgia, 0160
- Site 403
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Tbilisi, Georgia, 0160
- Site 405
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Tbilisi, Georgia, 0186
- Site 401
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Riga, Latvia, 1038
- Site 601
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Gliwice, Poland, 44-102
- Site 204
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Poznań, Poland, 60-569
- Site 203
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Szczecin, Poland, 70-784
- Site 201
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Florida
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Tampa, Florida, United States, 33620
- Site 102
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Site 106
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Missouri
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Saint Louis, Missouri, United States, 63110
- Site 101
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Ohio
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Columbus, Ohio, United States, 43215
- Site 105
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Texas
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Houston, Texas, United States, 77030
- Site 103
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: ANB019
Participants 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.
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Humanized monoclonal antibody
Other Names:
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Placebo Comparator: Placebo
Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by subcutaneous injection.
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Placebo
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change From Baseline in Facial Inflammatory Lesion Count (Papules and Pustules) at Week 8
Time Frame: Baseline, Week 8
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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.
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Baseline, Week 8
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Change From Baseline in Facial Inflammatory Lesion Count (Papules and Pustules) at Week 8
Time Frame: Baseline, Week 8
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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.
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Baseline, Week 8
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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
Time Frame: Baseline, Week 8
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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
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Time to First Response of 1 Grade Improvement From Baseline on the Acneiform Rash CTCAE Grading Scale
Time Frame: Baseline up to 55 days
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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.
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Baseline up to 55 days
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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
Time Frame: Baseline, Week 8
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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
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Time to First Response of 1 Grade Improvement From Baseline on the Acneiform Rash Modified MESTT Grading Scale (Total Score)
Time Frame: Baseline to 55 days
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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.
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Baseline to 55 days
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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
Time Frame: Baseline, Week 8
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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
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Time to First Response of 1 Grade Improvement From Baseline on the Acneiform Rash Modified MESTT Grading Scale (Facial Assessment)
Time Frame: Baseline to 55 days
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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.
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Baseline to 55 days
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Change From Baseline in Pruritus Numeric Rating Scale (NRS) at Week 8
Time Frame: Baseline, Week 8
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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.
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Baseline, Week 8
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Percent Change From Baseline in Pruritus NRS at Week 8
Time Frame: Baseline, Week 8
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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.
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Baseline, Week 8
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Change From Baseline in Pain NRS at Week 8
Time Frame: Baseline, Week 8
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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.
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Baseline, Week 8
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Percent Change From Baseline in Pain NRS at Week 8
Time Frame: Baseline, Week 8
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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.
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Baseline, Week 8
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Change From Baseline in Functional Assessment of Cancer Therapy - Epidermal Growth Factor Receptor Inhibitor 18 (FACT-EGFRi-18) at Week 8
Time Frame: Baseline, Week 8
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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
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Number of Participants With Treatment-Emergent Adverse Events
Time Frame: From first dose to 55 days
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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.
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From first dose to 55 days
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ANB019-207
- 2020-003494-22 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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