A study to assess different investigational drugs for the treatment of hidradenitis suppurativa
- Conditions
- Hidradenitis suppurativaMedDRA version: 20.0Level: LLTClassification code 10020041Term: Hidradenitis suppurativaSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2018-002757-30-FR
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 90
- Male or female, age 18-65 years, at least 50 kg body weight with moderate to severe HS
- Clinically diagnosed HS for at least 12 months prior to screening
- For Cohort A (iscalimab): at least 5 inflammatory lesions, no more than 10 fistulae and at least two anatomical area involved with HS lesions
- For Cohort B (LYS006): at least 3 inflammatory lesions; no more than 10 fistulae and at least two anatomical areas involved with HS lesions
Other protocol-defined inclusion criteria may apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 89
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1
- Use of other investigational drugs at the time of screening, or within 30 days or 5 half-lives of randomization, whichever is longer; or
longer if required by local regulations
- Women of childbearing potential, unless they are using highly effective methods of contraception during dosing and for a minimum of 12 weeks after stopping medication for cohort A (iscalimab) and a minimum of 2 weeks after the last study drug administration for cohort B (LYS006).
- Pregnant or nursing (lactating) women
Other protocol-defined exclusion criteria may apply
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
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