NIPH Clinical Trials Search

JRCT ID: jRCT2071220012

Registered date:28/05/2022

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

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedhidradenitis suppurativa
Date of first enrollment04/10/2022
Target sample size5
Countries of recruitmentUnited states of America,Japan,Spain,Japan,Germany,Japan,Australia,Japan,Canada,Japan,Greece,Japan
Study typeInterventional
Intervention(s)Lutikizumab Dose A every week Lutikizumab Dose B every other week Lutikizumab Dose C every other week Placebo


Primary OutcomePercentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR) at week16.
Secondary OutcomePercentage 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 maximumNot applicable
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


Public contact
Name Contact for Patients and HCP
Address 3-1-21 Shibaura, Minato-ku, Tokyo Tokyo Japan 108-0023
Telephone +81-120-587-874
Affiliation AbbVie G.K.
Scientific contact
Name Tetsuya Otani
Address 3-1-21, Shibaura, Minato-ku, Tokyo Tokyo Japan 108-0023
Telephone +81-120-587-874
Affiliation AbbVie G.K.