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

Phase 1

• Conditions: Hidradenitis suppurativa; MedDRA version: 20.0Level: LLTClassification code 10020041Term: Hidradenitis suppurativaSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2018-002757-30-NL
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-24
• Last Update Posted: 29 November 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 130

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): 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 128
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

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). 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.
Other protocol-defined exclusion criteria may apply

Study & Design

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