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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-004021-33 | EudraCT Number |
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The main objectives of this study are to evaluate the efficacy, safety and tolerability of imsidolimab in adults with active GPP.
Single arm, multiple-dose study evaluating the use of imsidolimab for the treatment of GPP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imsidolimab | Experimental | Participants received imsidolimab 750 mg intravenously (IV) on Day 1 followed by administration of 3 doses of subcutaneous (SC) imsidolimab 100 mg on Days 29, 57, and 85. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imsidolimab | Biological | Humanized monoclonal antibody |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Clinical Response on the Clinical Global Impression (CGI) Scale | Clinical response was defined as "Very much improved," "Much Improved," or "Minimally Improved" on the CGI scale according to the Modified Japanese Dermatological Association Severity Index (JDA-SI) total score. The JDA-SI includes assessment of skin lesions (area of erythema with pustules, area of erythema total, and area of edema) and fever, white blood cell count, C-reactive protein and serum albumin levels. The total score ranges from 0 to 17 (severe). CGI was assessed based on the JDA-SI according to the following:
| Week 4 and Week 16 |
| Percent Change From Baseline in Body Surface Area of Erythema With Pustules at Week 1, Week 4, and Week 16 | Excluding palms and soles from 0% to 100%. The palmar surface of one hand (using the subject's hand and including the fingers) represents 1% of his or her total BSA. | Baseline, Week 1, Week 4, and Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Modified Japanese Dermatological Association - Severity Index (mJDA-SI) Total Skin Lesions Score at Week 1, Week 4, and Week 16 | The area of erythema with pustules, area of total erythema and area of edema were assessed by the Investigator and scored from 0 to 3 on the following scale:
The JDA-SI Total Skin Lesions Score is the sum of the area of erythema with pustules score, area of total erythema score and area of edema score and ranges between 0 and 9 (worst). A negative change from Baseline indicates improvement. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 102 | Encino | California | 91436 | United States | ||
| Site 105 |
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The study included a screening period of up to 42 days, a 12-week treatment period, and a 12-week safety follow-up period. A total of 12 subjects were screened, with 8 subjects being enrolled in the study.
This study was conducted at 5 centers that enrolled subjects in the United Kingdom and Poland.
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| ID | Title | Description |
|---|---|---|
| FG000 | Imsidolimab | Participants received imsidolimab 750 mg intravenously (IV) on Day 1 followed by administration of 3 doses of subcutaneous (SC) imsidolimab 100 mg on Days 29, 57, and 85. |
| 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 | Oct 29, 2019 | Feb 28, 2022 |
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| Baseline, Week 1, Week 4, and Week 16 |
| Percentage of Participants Achieving a Generalized Pustular Psoriasis Physician's Global Assessment (GPPPGA) Score of 0 or 1 at Week 1, Week 4, and Week 16 | The GPPPGA scale was used to assess the impact and severity of GPP on the following scale:
| Week 1, Week 4, and Week 16 |
| Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 1, Week 4, and Week 16 | The DLQI is a 10-item questionnaire that asks participants to evaluate the degree that their skin problem has affected their quality of life in the last week in the following 6 aspects: symptoms and feelings, daily activities, leisure, work or school activities, personal relationships and treatment related feelings. Participants answer the 10 questions on a scale from 0 (not at all) to 3 (very much). The DLQI is calculated by summing the scores of the 10 questions, resulting in a maximum of 30 and a minimum of 0 with higher scores indicating more impaired quality of life. A negative change from Baseline indicates improvement. | Baseline and Week 1, Week 4, and Week 16 |
| Largo |
| Florida |
| 33771 |
| United States |
| Site 104 | Miami | Florida | 33316 | United States |
| Site 101 | Indianapolis | Indiana | 46250 | United States |
| Site 100 | Ann Arbor | Michigan | 48109 | United States |
| Site 303 | Lodz | 90-436 | Poland |
| Site 302 | Lodz | Poland |
| Site 304 | Olsztyn | 10-229 | Poland |
| Site 301 | Rzeszów | 35-055 | Poland |
| Site 501 | Seoul | 03722 | South Korea |
| Site 201 | London | United Kingdom |
| Site 203 | Newcastle upon Tyne | United Kingdom |
| Site 202 | Salford | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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All enrolled participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Imsidolimab | Participants received imsidolimab 750 mg intravenously on Day 1 followed by administration of 3 doses of subcutaneous imsidolimab 100 mg on Days 29, 57, and 85. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Modified Japanese Dermatological Association Severity Index (JDA-SI) Total Score | The JDA-SI includes assessment of skin lesions (area of erythema with pustules, area of erythema total, and area of edema) and fever, white blood cell count, C-reactive protein and serum albumin levels. The total score ranges from 0 to 17 (severe). | Mean | Standard Deviation | score on a scale |
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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 | |||||||||||||||||||||||||||
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| Primary | Percentage of Participants Achieving Clinical Response on the Clinical Global Impression (CGI) Scale | Clinical response was defined as "Very much improved," "Much Improved," or "Minimally Improved" on the CGI scale according to the Modified Japanese Dermatological Association Severity Index (JDA-SI) total score. The JDA-SI includes assessment of skin lesions (area of erythema with pustules, area of erythema total, and area of edema) and fever, white blood cell count, C-reactive protein and serum albumin levels. The total score ranges from 0 to 17 (severe). CGI was assessed based on the JDA-SI according to the following:
| The full analysis set (FAS) included all enrolled participants. Participants with missing data were categorized as non-responders. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 4 and Week 16 |
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| Primary | Percent Change From Baseline in Body Surface Area of Erythema With Pustules at Week 1, Week 4, and Week 16 | Excluding palms and soles from 0% to 100%. The palmar surface of one hand (using the subject's hand and including the fingers) represents 1% of his or her total BSA. | Full analysis set participants with available data at each time point | Posted | Mean | Standard Deviation | percent change | Baseline, Week 1, Week 4, and Week 16 |
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| Secondary | Percent Change From Baseline in Modified Japanese Dermatological Association - Severity Index (mJDA-SI) Total Skin Lesions Score at Week 1, Week 4, and Week 16 | The area of erythema with pustules, area of total erythema and area of edema were assessed by the Investigator and scored from 0 to 3 on the following scale:
The JDA-SI Total Skin Lesions Score is the sum of the area of erythema with pustules score, area of total erythema score and area of edema score and ranges between 0 and 9 (worst). A negative change from Baseline indicates improvement. | Full analysis set participants with available data at each time point | Posted | Mean | Standard Deviation | percent change | Baseline, Week 1, Week 4, and Week 16 |
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| Secondary | Percentage of Participants Achieving a Generalized Pustular Psoriasis Physician's Global Assessment (GPPPGA) Score of 0 or 1 at Week 1, Week 4, and Week 16 | The GPPPGA scale was used to assess the impact and severity of GPP on the following scale:
| Full Analysis Set participants with GPPPGA at Baseline and at each time point | Posted | Number | 95% Confidence Interval | percentage of participants | Week 1, Week 4, and Week 16 |
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| Secondary | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 1, Week 4, and Week 16 | The DLQI is a 10-item questionnaire that asks participants to evaluate the degree that their skin problem has affected their quality of life in the last week in the following 6 aspects: symptoms and feelings, daily activities, leisure, work or school activities, personal relationships and treatment related feelings. Participants answer the 10 questions on a scale from 0 (not at all) to 3 (very much). The DLQI is calculated by summing the scores of the 10 questions, resulting in a maximum of 30 and a minimum of 0 with higher scores indicating more impaired quality of life. A negative change from Baseline indicates improvement. | Full analysis set participants with available data at each time point | Posted | Mean | Standard Deviation | score on a scale | Baseline and Week 1, Week 4, and Week 16 |
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From first dose of study treatment up to end of follow-up period; 24 weeks.
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| 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 imsidolimab 750 mg intravenously on Day 1 followed by administration of 3 doses of subcutaneous imsidolimab 100 mg on Days 29, 57, and 85. | 0 | 8 | 2 | 8 | 6 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
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| Nosocomial infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (23.1) | Systematic Assessment |
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| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (23.1) | Systematic Assessment |
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| Blood folate decreased | Investigations | MedDRA (23.1) | Systematic Assessment |
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| Blood glucose increased | Investigations | MedDRA (23.1) | Systematic Assessment |
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| C-reactive protein increased | Investigations | MedDRA (23.1) | Systematic Assessment |
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| White blood cell count increased | Investigations | MedDRA (23.1) | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
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| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (23.1) | Systematic Assessment |
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| Skin haemorrhage | Skin and subcutaneous tissue disorders | MedDRA (23.1) | Systematic Assessment |
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| Mitral valve prolapse | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
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| Myxomatous mitral valve degeneration | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
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| Peripheral swelling | General disorders | MedDRA (23.1) | Systematic Assessment |
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| Swelling face | General disorders | MedDRA (23.1) | Systematic Assessment |
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| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA (23.1) | Systematic Assessment |
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| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (23.1) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (23.1) | Systematic Assessment |
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The PI may not publish trial results until after the first multi-center publication unless such publication is not published within a period that is at least 18 months but less than or equal to 24 months after trial completion. In addition, the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vanda Pharmaceuticals | Vanda Pharmaceuticals | 202-734-3400 | clinicaltrials@vandapharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 9, 2019 | Feb 28, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Unknown or Not Reported |
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| Black or African American |
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| Native Hawaiian or Other Pacific Islander |
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| White |
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