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

• Status: Completed
• Trial end date: 2021-04-10
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beth Israel Deaconess Medical Center
• Collaborator: Novartis Pharmaceuticals
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion Criteria:

• Adults, age 18 and over

• Previous diagnosis of biopsy-proven NLD

• Active NLD lesions, defined as

• clinical signs of inflammation, for example erythematous margins, sensations of itch, pain, dysaesthesia

• lesions increasing in size or appearance of new lesions within the last 3 months

• ulcerations

• 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:

• History of an ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis infection as defined by a positive QuantiFERON TB-Gold test at screening.

• Are currently pregnant, breastfeeding, or planning to get pregnant during the study.

• Previous hypersensitivity reaction to secukinumab or to any of the components.

• History of Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis)

• Allergy to Latex

• Currently on any other immunosuppressant systemic medication or within 28 days of baseline visit

• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unwilling to use effective contraception during the study and for 16 weeks after stopping treatment.

• Subjects with a serum creatinine level exceeding 176.8 μmol/L (2.0 mg/dL)

• Screening total WBC count <2,500/μL, or platelets <100,000/μL or neutrophils <1,500/μL or hemoglobin <8.5 g/dL

• Known infection with HIV, hepatitis B or hepatitis C at screening or randomization. Patients who are Hepatitis B Core antibody and/or Hep B Surface Antigen positive will be excluded from this study. Patients who are Hepatitis C ab positive will also be excluded from this study.

• History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years (except for non-melanoma skin cancer and carcinoma in situ of the cervix)

• Are participating in another study using an investigational agent or procedure during participation in this study or within 28 days prior to baseline visit.

• Plans for administration of live vaccines during the study period or 6 weeks prior to randomization

• Any other procedural treatment for NLD with 28 days prior to baseline visit, including phototherapy, surgical intervention, laser therapy, or cryotherapy.

• Any other active skin disease or condition (e.g., bacterial, fungal or viral infection) that may interfere with assessment of NLD;

• Underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal) which in the opinion of the investigator significantly immunocompromises the subject and/or places the subject at unacceptable risk for receiving an immunomodulatory therapy