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-DK
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-14
• Last Update Posted: 23 May 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

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
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 197
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

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
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

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