A Study to Assess Disease Activity and Safety of Subcutaneous Lutikizumab (ABT-981) in Adult Participants with Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-Tumor Necrosis Factor (TNF) Therapy

JRCT ID: jRCT2071220012

Registered date:28/05/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: hidradenitis suppurativa
• Date of first enrollment: 04/10/2022
• Target sample size: 5
• Countries of recruitment: United states of America,Japan,Spain,Japan,Germany,Japan,Australia,Japan,Canada,Japan,Greece,Japan
• Study type: Interventional

Intervention(s)

Lutikizumab Dose A every week
Lutikizumab Dose B every other week
Lutikizumab Dose C every other week
Placebo

Outcome(s)

• Primary Outcome: Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR) at week16.
• Secondary Outcome: Percentage of Participants Achieving Numeric Rating Scale (NRS) 30 among Participants with Baseline NRS >=3 at week16.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- A clinical diagnosis of hidradenitis suppurativa (HS) for at least 1 year prior to Baseline as determined by the investigator.
- A total abscess and inflammatory nodule (AN) count of >= 5 at Baseline
- HS lesions must be present in at least 2 distinct anatomic areas.
- Must have failed anti-TNF treatment for HS.

• Exclude criteria: - History of active skin disease other than HS that could interfere with the assessment of HS, including skin infections (e.g., bacterial, fungal, or viral) requiring systemic treatment within 4 weeks of the Baseline visit.

Related Information

• Primary Sponsor: Otani Tetsuya
• Secondary ID(s): NCT05139602