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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-003494-22 | EudraCT Number |
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Administrative Reason
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ANB019 | Experimental | 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. |
|
| Placebo | Placebo Comparator | Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by subcutaneous injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imsidolimab | Biological | Humanized monoclonal antibody |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 102 | Tampa | Florida | 33620 | United States | ||
| Site 106 |
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11 participants were screened for eligibility and 4 participants were randomized into the study.
Participants with neoplasms who were receiving epidermal growth factor inhibitors or mitogen-activated protein/extracellular signal regulated kinase inhibitor were enrolled into the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Imsidolimab | 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. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 5, 2021 | Dec 14, 2022 |
Not provided
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| Placebo | Biological | Placebo |
|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by subcutaneous injection.
| COMPLETED |
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| NOT COMPLETED |
|
|
Intent-to-Treat (ITT) analysis set included all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Imsidolimab | Participants received a starting dose of 400 mg of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by subcutaneous injection. |
| BG001 | Placebo | Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by subcutaneous injection. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Due to early study termination, no participant was evaluated in the imsidolimab group and 1 participant was evaluated in the placebo group. Since only 1 participant was evaluated, results were not reported for the protection of personal data and to avoid re-identification. | Posted | 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. | Due to early study termination, no participant was evaluated in the imsidolimab group and 1 participant was evaluated in the placebo group. Since only 1 participant was evaluated, results were not reported for the protection of personal data and to avoid re-identification. | Posted | 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. | Due to early study termination, no participant was evaluated in the imsidolimab group and 1 participant was evaluated in the placebo group. Since only 1 participant was evaluated, results were not reported for the protection of personal data and to avoid re-identification. | Posted | 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. | Due to early study termination, no participant was evaluated in the imsidolimab group and 1 participant was evaluated in the placebo group. Since only 1 participant was evaluated, results were not reported for the protection of personal data and to avoid re-identification. | Posted | 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). | Due to early study termination, no participant was evaluated in the imsidolimab group and 1 participant was evaluated in the placebo group. Since only 1 participant was evaluated, results were not reported for the protection of personal data and to avoid re-identification. | Posted | Baseline, Week 8 |
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| 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. | Due to early study termination, no participant was evaluated in the imsidolimab group and 1 participant was evaluated in the placebo group. Since only 1 participant was evaluated, results were not reported for the protection of personal data and to avoid re-identification. | Posted | Baseline to 55 days |
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| 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. | Due to early study termination, no participant was evaluated in the imsidolimab group and 1 participant was evaluated in the placebo group. Since only 1 participant was evaluated, results were not reported for the protection of personal data and to avoid re-identification. | Posted | Baseline, Week 8 |
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| 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. | Due to early study termination, no participant was evaluated in the imsidolimab group and 1 participant was evaluated in the placebo group. Since only 1 participant was evaluated, results were not reported for the protection of personal data and to avoid re-identification. | Posted | Baseline to 55 days |
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| 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. | Due to early study termination, no participant was evaluated in the imsidolimab group and 1 participant was evaluated in the placebo group. Since only 1 participant was evaluated, results were not reported for the protection of personal data and to avoid re-identification. | Posted | Baseline, Week 8 |
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| 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. | Due to early study termination, no participant was evaluated in the imsidolimab group and 1 participant was evaluated in the placebo group. Since only 1 participant was evaluated, results were not reported for the protection of personal data and to avoid re-identification. | Posted | Baseline, Week 8 |
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| 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. | Due to early study termination, no participant was evaluated in the imsidolimab group and 1 participant was evaluated in the placebo group. Since only 1 participant was evaluated, results were not reported for the protection of personal data and to avoid re-identification. | Posted | Baseline, Week 8 |
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| 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. | Due to early study termination, no participant was evaluated in the imsidolimab group and 1 participant was evaluated in the placebo group. Since only 1 participant was evaluated, results were not reported for the protection of personal data and to avoid re-identification. | Posted | Baseline, Week 8 |
|
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| 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). | Due to early study termination, no participant was evaluated in the imsidolimab group and 1 participant was evaluated in the placebo group. Since only 1 participant was evaluated, results were not reported for the protection of personal data and to avoid re-identification. | Posted | 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. | Safety analysis set included all randomized participants who received at least 1 dose of imsidolimab or placebo. | Posted | Count of Participants | Participants | No | From first dose to 55 days |
|
From first dose to 55 days
Safety analysis set included all randomized participants who received at least 1 dose of imsidolimab or placebo.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Imsidolimab | Participants received a starting dose of 400 mg of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by subcutaneous injection. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG001 | Placebo | Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by subcutaneous injection. | 0 | 2 | 0 | 2 | 2 | 2 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Electrocardiogram T wave inversion | Investigations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vanda Pharmaceuticals | Vanda Pharmaceuticals | 202-734-3400 | clinicaltrials@vandapharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 11, 2022 | Dec 14, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG001 | Placebo | Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by subcutaneous injection. |
|
|
| OG001 |
| Placebo |
Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by subcutaneous injection. |
|
| Participants |
|
Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by subcutaneous injection.
|
| Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by subcutaneous injection.
|
|