A Phase 2 interventional study of Secukinumab in Necrobiosis Lipoidica Diabeticorum, sponsored by Beth Israel Deaconess Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years to 110 Years. Per ClinicalTrials.gov, last updated 2024-05-17.
Sponsored by Beth Israel Deaconess Medical Center · Phase 2, Interventional, and Treatment
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.
Beth Israel Deaconess Medical Center is the lead sponsor of 560 studies on the registry; 80 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 61 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Active NLD lesions, defined as
Exclusion Criteria:
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.
Drug: 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.
Also known as: cosentyx
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 1. Almost clear: very significant clearance (about 90%); however, patchy remnants of dusky erythema and/or very small ulcerations 2. Marked improvement: significant improvement (about 75%); however, a small amount of disease remaining (i.e. remaining ulcers, although have decreased in size, minimal erythema and/or active boarder) 3. Moderate improvement: intermediate between slight and marked; representing about 50% improvement 4. Slight improvement: some improvement (about 25%); however, significant disease remaining (i.e. remaining ulcers with only minor decrease in size, erythema or boarder activity) 5. No change from baseline 6. Worse
Time frame: 24 weeks
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. 1. Inflammatory infiltrate (0, none; 1, slight; 2, moderate; 3, severe) 2. collagen degeneration (0, none; 1, slight; 2, moderate; 3, severe) 3. epithelioid histiocytes, (0, none; 1, slight; 2, moderate; 3, severe) 4. qualitative expression of IL-17 (0, none; 1, slight; 2 moderate; 3, severe) Histologic analysis not performed as study was terminated prematurely.
Time frame: 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
Time frame: 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.
Time frame: Baseline and Week 24
| Milestone | Secukinumab Subcutaneous Injection |
|---|---|
| Started | 4 |
| Completed | 3 |
| Not completed | 1 |
| Withdrew: Withdrawal by subject | 1 |
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 1. Almost clear: very significant clearance (about 90%); however, patchy remnants of dusky erythema and/or very small ulcerations 2. Marked improvement: significant improvement (about 75%); however, a small amount of disease remaining (i.e. remaining ulcers, although have decreased in size, minimal erythema and/or active boarder) 3. Moderate improvement: intermediate between slight and marked; representing about 50% improvement 4. Slight improvement: some improvement (about 25%); however, significant disease remaining (i.e. remaining ulcers with only minor decrease in size, erythema or boarder activity) 5. No change from baseline 6. Worse
| score on a scale | Secukinumab Subcutaneous Injection |
|---|---|
| Mean Score of Participants Who Received Investigator Global Assessment Scores | 4 ± 0.81 |
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. 1. Inflammatory infiltrate (0, none; 1, slight; 2, moderate; 3, severe) 2. collagen degeneration (0, none; 1, slight; 2, moderate; 3, severe) 3. epithelioid histiocytes, (0, none; 1, slight; 2, moderate; 3, severe) 4. qualitative expression of IL-17 (0, none; 1, slight; 2 moderate; 3, severe) Histologic analysis not performed as study was terminated prematurely.
No measurements were reported for this outcome.
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
| score on a scale | Secukinumab Subcutaneous Injection |
|---|---|
| Week 1 | 1 ± 2 |
| Week 24 | 1 ± 1.54 |
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.
| score on a scale | Secukinumab Subcutaneous Injection |
|---|---|
| Week 1 | 6.25 ± 4.43 |
| Week 24 | 3.25 ± 4.57 |
Collected over At every visit adverse events will be registered for 36 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Secukinumab Subcutaneous Injection | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
Patient characteristics and demographic data will be presented using descriptive statistics.
| Age, Continuous(years) | Secukinumab Subcutaneous Injection |
|---|---|
| Mean | 42.3 ± 9.5 |
| Sex: Female, Male(Participants) | Secukinumab Subcutaneous Injection |
|---|---|
| Female | 4 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | Secukinumab Subcutaneous Injection |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 4 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Secukinumab Subcutaneous Injection |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 4 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Secukinumab Subcutaneous Injection |
|---|---|
| United States | 4 |
| Family history of diabetes(Participants) | Secukinumab Subcutaneous Injection |
|---|---|
| Count of participants | 2 |
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Necrobiosis Lipoidica
Beth Israel Deaconess Medical Center