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Study halted prematurely due COVID-19 pandemic and did not resume; participants are no longer being examined or receiving intervention.
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| Name | Class |
|---|---|
| Novartis Pharmaceuticals | INDUSTRY |
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This study investigates the efficacy of secukinumab in necrobiosis lipoidica diabeticorum (NLD).
Necrobiosis lipoidica diabeticorum (NLD) is a rare granulomatous condition of the skin often presenting with papules and eventually atrophic plaques, most commonly on the distal extensor lower extremities, which can be painful and disfiguring. Currently no FDA-approved treatment exists, and no well-established treatment algorithm has been described. Reports on successful therapeutic interventions have generally been small and inconsistent.
Recent literature expanding on the previously poorly understood pathogenesis of NLD has suggested a potential role for IL-17 in the development of this condition. Thus blockade of IL-17 may be a potential therapeutic strategy in patients with NLD. Secukinumab (Cosentyx) is a human monoclonal antibody that targets IL-17a and is FDA approved for the treatment of psoriasis.
This open-label, proof of concept study regarding the use of Secukinumab in patients with NLD may be a first step in elucidating and defining a treatment for this chronic and potentially debilitating condition for which no FDA approved treatment currently exists.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Secukinumab Subcutaneous Injection | Experimental | 300 mg q weekly for 5 weeks followed by 300 mg q 4 weeks. Each subject will receive 300mg of Secukinumab by using 2 syringes of 150mg each as a subcutaneous injection at weeks 0,1,2,3,4 then every 4 weeks for a total of 9 doses over 24 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Secukinumab | Drug | Secukinumab is selective for human IL-17A and potently neutralizes the bioactivity of this cytokine. IL-17A is the central cytokine in multiple autoimmune and inflammatory processes. It is being recognized as one of the principal pro-inflammatory cytokines in autoimmune diseases such as psoriasis, PsA and AS, uveitis and is thought to play a role in other inflammatory conditions. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Score of Participants Who Received Investigator Global Assessment Scores | Number of patients who received Investigator Global Assessment Scores rating their remission or clinical improvement as measured at week 24. The minimum score is zero and the maximum score is 6. A larger score is worse. Score Descriptions: 0. Completely clear: except for possible residual hyperpigmentation
| 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Histology | Number of subjects achieving improvement based upon histological score. The score is calculated by adding subscores as listed below, which will be evaluated by the dermatopathologist. Average of pre and post scores and overall change in score will be calculated and compared using a paired T-test.
Histologic analysis not performed as study was terminated prematurely. |
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Inclusion Criteria:
Adults, age 18 and over
Previous diagnosis of biopsy-proven NLD
Active NLD lesions, defined as
Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study related activity is performed.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexa Kimball, MD MPH | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
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No screenfailures for the study
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| ID | Title | Description |
|---|---|---|
| FG000 | Secukinumab Subcutaneous Injection | 300 mg q weekly for 5 weeks followed by 300 mg q 4 weeks. Each subject will receive 300mg of Secukinumab by using 2 syringes of 150mg each as a subcutaneous injection at weeks 0,1,2,3,4 then every 4 weeks for a total of 9 doses over 24 weeks. Secukinumab: Secukinumab is selective for human IL-17A and potently neutralizes the bioactivity of this cytokine. IL-17A is the central cytokine in multiple autoimmune and inflammatory processes. It is being recognized as one of the principal pro-inflammatory cytokines in autoimmune diseases such as psoriasis, PsA and AS, uveitis and is thought to play a role in other inflammatory conditions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Patient characteristics and demographic data will be presented using descriptive statistics.
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| ID | Title | Description |
|---|---|---|
| BG000 | Secukinumab Subcutaneous Injection | 300 mg q weekly for 5 weeks followed by 300 mg q 4 weeks. Each subject will receive 300mg of Secukinumab by using 2 syringes of 150mg each as a subcutaneous injection at weeks 0,1,2,3,4 then every 4 weeks for a total of 9 doses over 24 weeks. Secukinumab: Secukinumab is selective for human IL-17A and potently neutralizes the bioactivity of this cytokine. IL-17A is the central cytokine in multiple autoimmune and inflammatory processes. It is being recognized as one of the principal pro-inflammatory cytokines in autoimmune diseases such as psoriasis, PsA and AS, uveitis and is thought to play a role in other inflammatory conditions. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Mean Score of Participants Who Received Investigator Global Assessment Scores | Number of patients who received Investigator Global Assessment Scores rating their remission or clinical improvement as measured at week 24. The minimum score is zero and the maximum score is 6. A larger score is worse. Score Descriptions: 0. Completely clear: except for possible residual hyperpigmentation
| Posted | Mean | Standard Deviation | score on a scale | 24 weeks |
|
At every visit adverse events will be registered for 36 weeks
Adverse events are defined as any undesirable experience occurring to a subject during the study, associated to the investigational treatment. All adverse events observed by investigator or staff members or reported by the subject will be recorded.
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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 | Secukinumab Subcutaneous Injection | 300 mg q weekly for 5 weeks followed by 300 mg q 4 weeks. Each subject will receive 300mg of Secukinumab by using 2 syringes of 150mg each as a subcutaneous injection at weeks 0,1,2,3,4 then every 4 weeks for a total of 9 doses over 24 weeks. Secukinumab: Secukinumab is selective for human IL-17A and potently neutralizes the bioactivity of this cytokine. IL-17A is the central cytokine in multiple autoimmune and inflammatory processes. It is being recognized as one of the principal pro-inflammatory cytokines in autoimmune diseases such as psoriasis, PsA and AS, uveitis and is thought to play a role in other inflammatory conditions. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Co-Director Clinical Laboratory for Epidemiology and Applied Research in Skin (CLEARS) | Beth Israel Deaconess Medical Center | 6176675834 | mporter3@bidmc.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 10, 2020 | Aug 18, 2022 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 18, 2020 | Nov 17, 2023 | ICF_005.pdf |
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| ID | Term |
|---|---|
| D009335 | Necrobiosis Lipoidica |
| ID | Term |
|---|---|
| D017441 | Necrobiotic Disorders |
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C555450 | secukinumab |
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|
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| 26 weeks |
| Pain Score Baseline and Week 24 | Number of patients who completed the self-reported pain and stinging intensity during and directly after treatment with Secukinumab injections A Pain Score will be calculated based upon the Wong-Baker Faces Pain rating Scale (10-point pain score), which has been widely used to rate pain in both children and adults and has also been used in dermatology clinical trials. Scale score 0-10, higher score means worse outcome: 0 = No hurt 2 = Hurts a little bit 4 = Hurts a little bit more 6 = Hurts even more 8 = Hurts whole lot 10 = Hurts worst Response based on an improvement from baseline in the Wong-Baker pain score at all scheduled time points will be calculated. We will compare pre and post treatment pain values and categorize patients as (i) Resolved (ii) Improved (iii) Stable (iv) Worsened | Baseline and Week 24 |
| Dermatology Life Quality Index | Number of subjects improving based upon patient-reported outcomes The Dermatology Life Quality Index (DLQI) is a validated general dermatology questionnaire that consists of 10 items that assess subject health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment) The scoring of each question is as follows: Very much scored = 3 points, A lot scored = 2 points, A little scored = 1, Not at all scored = 0 points, Not relevant scored = 0 points, Question 7, 'prevented work or studying' scored = 3 points. The DLQI is calculated by adding the score of each question, resulting in a maximum of 30 (meaning maximum impact on quality of life) and a minimum of 0 (meaning no impact of skin disease on quality of life). The higher the score, the more quality of life is impaired. 0-1 = No effect on patient's life, 2-5 = Small effect, 6-10 = Moderate effect, 11-20 = Very large effect, 21-30 = Extremely large effect. | Baseline and Week 24 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Family history of diabetes | Count of Participants | Participants |
|
| Secukinumab Subcutaneous Injection |
300 mg q weekly for 5 weeks followed by 300 mg q 4 weeks. Each subject will receive 300mg of Secukinumab by using 2 syringes of 150mg each as a subcutaneous injection at weeks 0,1,2,3,4 then every 4 weeks for a total of 9 doses over 24 weeks. Secukinumab: Secukinumab is selective for human IL-17A and potently neutralizes the bioactivity of this cytokine. IL-17A is the central cytokine in multiple autoimmune and inflammatory processes. It is being recognized as one of the principal pro-inflammatory cytokines in autoimmune diseases such as psoriasis, PsA and AS, uveitis and is thought to play a role in other inflammatory conditions. |
|
|
| Secondary | Histology | Number of subjects achieving improvement based upon histological score. The score is calculated by adding subscores as listed below, which will be evaluated by the dermatopathologist. Average of pre and post scores and overall change in score will be calculated and compared using a paired T-test.
Histologic analysis not performed as study was terminated prematurely. | Histologic analysis was not performed on any subjects. Study was terminated prematurely and performing histology analysis for 4 subjects would not have reflected appropriate results. Dermatopathologist didnt evaluate biopsies, only confirm diagnosis for eligibility. | Posted | 26 weeks |
|
|
| Secondary | Pain Score Baseline and Week 24 | Number of patients who completed the self-reported pain and stinging intensity during and directly after treatment with Secukinumab injections A Pain Score will be calculated based upon the Wong-Baker Faces Pain rating Scale (10-point pain score), which has been widely used to rate pain in both children and adults and has also been used in dermatology clinical trials. Scale score 0-10, higher score means worse outcome: 0 = No hurt 2 = Hurts a little bit 4 = Hurts a little bit more 6 = Hurts even more 8 = Hurts whole lot 10 = Hurts worst Response based on an improvement from baseline in the Wong-Baker pain score at all scheduled time points will be calculated. We will compare pre and post treatment pain values and categorize patients as (i) Resolved (ii) Improved (iii) Stable (iv) Worsened | Analyzed mean scores for Baseline and Week 24 | Posted | Mean | Standard Deviation | score on a scale | Baseline and Week 24 |
|
|
|
| Secondary | Dermatology Life Quality Index | Number of subjects improving based upon patient-reported outcomes The Dermatology Life Quality Index (DLQI) is a validated general dermatology questionnaire that consists of 10 items that assess subject health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment) The scoring of each question is as follows: Very much scored = 3 points, A lot scored = 2 points, A little scored = 1, Not at all scored = 0 points, Not relevant scored = 0 points, Question 7, 'prevented work or studying' scored = 3 points. The DLQI is calculated by adding the score of each question, resulting in a maximum of 30 (meaning maximum impact on quality of life) and a minimum of 0 (meaning no impact of skin disease on quality of life). The higher the score, the more quality of life is impaired. 0-1 = No effect on patient's life, 2-5 = Small effect, 6-10 = Moderate effect, 11-20 = Very large effect, 21-30 = Extremely large effect. | DLQI data analyzed for Baseline and Week 24 only | Posted | Mean | Standard Deviation | score on a scale | Baseline and Week 24 |
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| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
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| D012871 | Skin Diseases |
| D012875 | Skin Diseases, Metabolic |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |