A Phase 2 interventional study of Imsidolimab and Placebo in Acneiform Eruptions, sponsored by Vanda Pharmaceuticals. Terminated at 18 sites in 5 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-09-22.
Sponsored by Vanda Pharmaceuticals · Phase 2, Interventional, and Treatment
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
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.
Vanda Pharmaceuticals is the lead sponsor of 81 studies on the registry; 18 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 22 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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.
Biological: Imsidolimab
Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by subcutaneous injection.
Biological: Placebo
Humanized monoclonal antibody
Also known as: ANB019
Placebo
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.
Time frame: Baseline, Week 8
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.
Time frame: 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
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.
Time frame: Baseline, Week 8
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.
Time frame: 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
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).
Time frame: Baseline, Week 8
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.
Time frame: Baseline to 55 days
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.
Time frame: Baseline, Week 8
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.
Time frame: Baseline to 55 days
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.
Time frame: Baseline, Week 8
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.
Time frame: Baseline, Week 8
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.
Time frame: Baseline, Week 8
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.
Time frame: Baseline, Week 8
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).
Time frame: Baseline, Week 8
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.
Time frame: From first dose to 55 days
Participants with neoplasms who were receiving epidermal growth factor inhibitors or mitogen-activated protein/extracellular signal regulated kinase inhibitor were enrolled into the study.
| Milestone | Imsidolimab | Placebo |
|---|---|---|
| Started | 2 | 2 |
| Completed | 0 | 0 |
| Not completed | 2 | 2 |
| Withdrew: Withdrew consent due to possible/perceived lack of efficacy by participants | 0 | 1 |
| Withdrew: Study termination | 2 | 1 |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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).
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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).
No measurements were reported for this outcome.
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.
| Participants | Imsidolimab | Placebo |
|---|---|---|
| Any TEAEs | 0 | 2 |
| Serious TEAEs | 0 | 0 |
Collected over From first dose to 55 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Imsidolimab | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Placebo | 0/2 (0%) | 0/2 (0%) | 2/2 (100%) |
| Event | Imsidolimab | Placebo |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 0/2 | 1/2 |
| Electrocardiogram T wave inversionInvestigations | 0/2 | 1/2 |
| HypokalaemiaMetabolism and nutrition disorders | 0/2 | 1/2 |
Intent-to-Treat (ITT) analysis set included all randomized participants.
| Age, Continuous(years) | Imsidolimab | Placebo | Total |
|---|---|---|---|
| Mean | 50.0 ± 9.90 | 65.0 ± 2.83 | 57.5 ± 10.50 |
| Sex: Female, Male(Participants) | Imsidolimab | Placebo | Total |
|---|---|---|---|
| Female | 1 | 0 | 1 |
| Male | 1 | 2 | 3 |
| Ethnicity (NIH/OMB)(Participants) | Imsidolimab | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 2 | 2 | 4 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Imsidolimab | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 2 | 2 | 4 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
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Acneiform Eruptions
Vanda Pharmaceuticals