A study to assess different investigational drugs for the treatment if hidradenitis suppurativa

Phase 1

Recruiting

• Conditions: Moderate to severe hidradenitis suppurativa; MedDRA version: 20.0Level: LLTClassification code: 10020041Term: Hidradenitis suppurativa Class: 10040785; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: CTIS2023-509296-16-00
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-04
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 348

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified