Status:
TERMINATED
Secukinumab for NLD (Cosentyx) in Patients With Necrobiosis Lipoidica Diabeticorum (NLD)
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Necrobiosis Lipoidica Diabeticorum
Eligibility:
All Genders
18-110 years
Phase:
PHASE2
Brief Summary
This study investigates the efficacy of secukinumab in necrobiosis lipoidica diabeticorum (NLD).
Detailed Description
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 extremi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 10 2021
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT03791060
Start Date
April 3 2019
End Date
April 10 2021
Last Update
May 17 2024
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215