EUCTR2018-002757-30-DK
Active, not recruiting
Phase 1
A randomized, subject and investigator blinded, placebo controlled and multi-center platform study, to assess efficacy and safety of different investigational drugs in patients with moderate to severe hidradenitis suppurativa - Efficacy and safety of different investigational drugs for the treatment of hidradenitis suppurativa
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Hidradenitis suppurativa
- Sponsor
- ovartis Pharma AG
- Enrollment
- 200
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Male and female patients, 18 to 65 years of age (inclusive), with
- •clinically diagnosed HS for at least 12 months prior to Screening.
- •\- For Cohort A (iscalimab) and C (MAS825\): A total of at least 5
- •inflammatory lesions, i.e., abscesses and/or inflammatory nodules.
- •\- For Cohort B (LYS006\) and D (LOU064\): A total of at least 3 inflammatory lesions, i.e.,
- •abscesses and/or inflammatory nodules.
- •\- For all Cohorts: No more than 15 fistulae and at least two anatomical
- •areas need to be involved with HS lesions.
- •Other protocol\-defined inclusion criteria may apply
- •Are the trial subjects under 18? no
Exclusion Criteria
- •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.
- •2\. Use/receipt of some specific treatments during specified time frames
- •3\. WOCBP, defined as all women physiologically capable of becoming
- •pregnant, unless they are using highly effective methods of
- •contraception during dosing and for the subsequent 14 weeks after the
- •last study drug administration for Cohort A (iscalimab) and the
- •subsequent 2 weeks after the last study drug administration for Cohort B (LYS006\) and cohort D (LOU064\). In Cohort C (MAS825\), WoCBP will be asked to adhere to
- •highly effective contraception from at least 3 months prior to first drug
Outcomes
Primary Outcomes
Not specified
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