Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT03791060
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
110 Years
Study:
NCT03791060
Study Brief:
Protocol Section:
NCT03791060