NCT03791060

Secukinumab for NLD (Cosentyx) in Patients With Necrobiosis Lipoidica Diabeticorum (NLD)

Terminated Phase 2 Results posted Last updated 17 May 2024

What this trial tests

Phase 2 trial testing Secukinumab in Necrobiosis Lipoidica Diabeticorum in 4 participants. Terminated before completion.

Timeline

3 April 2019

Primary endpoint
17 January 2021

10 April 2021

Quick facts

Lead sponsor	Beth Israel Deaconess Medical Center
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	4
Start date	3 April 2019
Primary completion	17 January 2021
Estimated completion	10 April 2021
Sites	1 location across United States

Drugs / interventions tested

• Secukinumab (secukinumab) — full drug profile →

Conditions studied

• Necrobiosis Lipoidica Diabeticorum — all drugs for Necrobiosis Lipoidica Diabeticorum →

Sponsor

Beth Israel Deaconess Medical Center

Who can join

Adults 18 to 110, any sex, with Necrobiosis Lipoidica Diabeticorum. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Score of Participants Who Received Investigator Global Assessment Scores Primary · 24 weeks

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 si

Group	Value	95% CI
Secukinumab Subcutaneous Injection	4	± 0.81

Pain Score Baseline and Week 24 Secondary · 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

Week 1

Group	Value	95% CI
Secukinumab Subcutaneous Injection	1	± 2

Week 24

Group	Value	95% CI
Secukinumab Subcutaneous Injection	1	± 1.54

Dermatology Life Quality Index Secondary · Baseline and Week 24

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 calc

Week 1

Group	Value	95% CI
Secukinumab Subcutaneous Injection	6.25	± 4.43

Week 24

Group	Value	95% CI
Secukinumab Subcutaneous Injection	3.25	± 4.57

Sponsor's own description

This study investigates the efficacy of secukinumab in necrobiosis lipoidica diabeticorum (NLD).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Interactions between neutrophils and T-helper 17 cells.
   Fan X, Shu P, Wang Y, Ji N, et al · · 2023 · cited 51× · PMID 37920459 · DOI 10.3389/fimmu.2023.1279837
2. Molecularly Targeted Therapies for Inflammatory Cutaneous Granulomatous Disorders: A Review of the Evidence and Implications for Understanding Disease Pathogenesis.
   Hwang E, Abdelghaffar M, Shields BE, Damsky W. · · 2023 · cited 5× · PMID 37719661 · DOI 10.1016/j.xjidi.2023.100220