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 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT05921994
Eligibility Criteria:
Inclusion Criteria:
Patients eligible for inclusion in this study have to fulfill all of the following criteria at enrollment:
1. Patients who provide written informed consent to participate in the study
2. Male and female patients with ≥18 years of age
3. Diagnosis of clinically unequivocal moderate to severe HS
4. Patients for whom a therapy with secukinumab is medically indicated
5. Documented decision for treatment with marketed secukinumab regardless of this noninterventional study
6. Treatment with secukinumab according to the latest version of SmPC
7. Initial treatment with marketed secukinumab planned for up to 1 week before the baseline visit
Exclusion Criteria:
Patients fulfilling any of the following criteria at enrollment are not eligible for inclusion in this study. No additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible patients:
1. Patients who have any contraindications, such as a history of or active inflammatory bowel disease (Crohn´s disease, ulcerative colitis), and are not eligible for treatment with secukinumab according to the SmPC
2. Any medical or psychological condition in the treating physician's opinion which may prevent the patient from the study participation
3. Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with secukinumab
4. Previous exposure to IL-17 inhibitors
5. For biologic-naïve patients, previous exposure to another biologic drug, such as anti-TNF-α inhibitors
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT05921994
Study Brief:
Protocol Section:
NCT05921994