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

Phase 1

Active, not recruiting

• 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-CZ
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-21
• Last Update Posted: 7 September 2020

Recruitment & Eligibility

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

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): 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 both 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 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.
- Use/receipt of the following treatments during the specified time frames:
? Use of IL12 and IL23 blocking biologics such as ustekinumab or guselkumab within the last 6 months prior to randomization.
? Use of B-cell targeting or B-cell depleting biologics or similar such as rituximab or belilumab within 12 months prior to randomization; For patients who received these drugs earlier, B cell count must be within normal range at screening.
? Use of biological immunomodulating agents other than above (e.g., adalimumab, secukinumab, etanercept, infliximab, etc.) within 3 months or 5 half-lives (whichever is longer) prior to randomization.
? If spironolactone or other antiandrogens (finasteride, cyproterone acetate, etc.) are used (for HS or other conditions, such as PCOS), only patients who have been on a stable dose for the last 3 months prior to randomization and who are planning to continue for the duration of the study are eligible.
? Use of systemic antibiotics for HS in the last week prior to randomization.
? Surgical treatment for HS in the last 4 weeks prior to randomization. Surgical treatment does not include sporadic excisional biopsies.
? Use of any other systemic treatment for HS in the last 4 weeks prior to randomization (such as retinoids or other immunmodulating therapies, e.g., methotrexate, cyclosporine A, corticosteroids).
? Receipt of any high-dose injected corticosteroid bolus (>1mg/kg) within 3 months prior to randomization.
? Use of cyclophosphamide within the last 6 months prior to 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