CTIS2023-509296-16-00
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 - CCFZ533H12201BC
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Moderate to severe hidradenitis suppurativa
- Sponsor
- ovartis Pharma AG
- Enrollment
- 348
- Status
- Recruiting
- Last Updated
- last year
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), 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.
Exclusion Criteria
- •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., Use/receipt of some specific treatments during specified time frames, depending on the cohort., 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 D (remibrutinib). In Cohort C, 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\).
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 2
A randomized, subject and investigator blinded, placebo-controlled, multicenter study in parallel groups to assess the efficacy and safety of LYS006 in patients with moderate to severe inflammatory acneAcne10040790NL-OMON50746ovartis8
Active, not recruiting
Phase 1
A study to assess different investigational drugs for the treatment of hidradenitis suppurativaEUCTR2018-002757-30-FRovartis Pharma AG90
Active, not recruiting
Phase 1
A study to assess if CMK389 is effective, safe and tolerable in patients with moderate to severe Atopic Dermatitis (AD)EUCTR2020-003406-31-ESovartis Farmacéutica, S.A.64
Active, not recruiting
Phase 1
A study to assess different investigational drugs for the treatment of hidradenitis suppurativaHidradenitis suppurativaMedDRA version: 20.0Level: LLTClassification code 10020041Term: Hidradenitis suppurativaSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]EUCTR2018-002757-30-NLovartis Pharma AG130
Active, not recruiting
Phase 1
A study to assess if CMK389 is effective, safe and tolerable in patients with moderate to severe Atopic Dermatitis (AD)Moderate to Severe Atopic DermatitisMedDRA version: 21.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]EUCTR2020-003406-31-HUovartis Pharma AG64