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-ES
• Lead Sponsor: ovartis Farmacéutica, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-06
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

- Male or female, age 18-65 years, at least 50 kg body weight with moderate to severe HS
- Clinically diagnosed HS for at least 12 months prior to screening
- For Cohort A (iscalimab): at least 5 inflammatory lesions, no more than 10 fistulae and at least two anatomical area involved with HS lesions
- For Cohort B (LYS006): at least 3 inflammatory lesions; no more than 10 fistulae and at least two anatomical areas 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 89
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

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; or
longer if required by local regulations
- Women of childbearing potential, 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).
- Pregnant or nursing (lactating) women at screening or randomization

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