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: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2018-002757-30-HU
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 245
-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), C (MAS825 and E (VAY736): 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
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 236
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4
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 administration and until 5 months after the final dose (Day 225 to Day 253), when a pregnancy test will be conducted.In Cohort E, WoCBP will be required to adhere to highly effective contraception for 6 months after the final dose (Day 253 to Day 281).
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 Main Objective: To assess the efficacy of the investigational treatments when compared to placebo, in moderate to severe inflammatory HS Patients;Secondary Objective: To assess the safety and tolerability of the investigational treatments in Patients with moderate to severe hidradenitis suppurativa (HS);Primary end point(s): Proportion of patients achieving hidradenitis suppurativa clinical response after 16 weeks of treatment;Timepoint(s) of evaluation of this end point: 16 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Number and severity of adverse events<br>- Physical exam, vital signs, safety laboratory measurements, ECGs;Timepoint(s) of evaluation of this end point: At baseline and repeatedly until study completion