Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa.
- Conditions
- Health Condition 1: L988- Other specified disorders of the skin and subcutaneous tissue
- Registration Number
- CTRI/2019/02/017864
- Lead Sponsor
- ovartis Healthcare Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Written informed consent must be obtained before any assessment is performed.
1)Male and female patients greater than equal to 18 years of age.
2)Diagnosis of HS greater than equal to 1 year prior to baseline.
3)Patients with moderate to severe HS defined as:
4)A total of at least 5 inflammatory lesions, i.e. abscesses and/or inflammatory nodules AND
5)Inflammatory lesions should affect at least 2 distinct anatomic areas
6)Patients agree to daily use of topical over-the-counter antiseptics on the areas affected by HS lesions while on study treatment.
1)Total fistulae count greater than equal to 20 at baseline.
2)Any other active skin disease or condition that may interfere with assessment of HS.
3)Active ongoing inflammatory diseases other than HS that require treatment with prohibited medications.
4)Use or planned use of prohibited treatment. Washout periods detailed in the protocol have to be adhered to.
5)History of hypersensitivity to any of the study drug constituents.
6)History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system treated or untreated within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
7)Pregnant or lactating women.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method