[M20-465] A Phase 3 Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lutikizumab in Adult and Adolescent Subjects with Moderate to Severe Hidradenitis Suppurativa

JRCT ID: jRCT2041240080

Registered date:29/08/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hidradenitis suppurativa
• Date of first enrollment: 29/08/2024
• Target sample size: 1280
• Countries of recruitment: the United States of America,Japan,Puerto Rico,Japan
• Study type: Interventional
• Intervention(s): In Period 1, participants will receive subcutaneous injections of lutikizumab or placebo every week for 16 weeks. In Period 2, participants that were randomized to lutikizumab in Period 1 will receive subcutaneous injections of lutikizumab every week or every other week for 36-weeks. Participants that were randomized to the placebo arm in Period 1 will receive subcutaneous injections of lutikizumab every week for 16 weeks, then either every week or every other week for 20 weeks

Outcome(s)

Primary Outcome

- Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR) 75 (Time frame: Week 16)
- Number of Participants with Adverse Events (AEs) (Time frame: Up to Approximately Week 62)

Secondary Outcome

- Percentage of Participants Achieving Numeric Rating Scale (NRS) 30 among Participants with Baseline NRS >=3 (Time frame: Week 8)
- Change from Baseline in Dermatology Life Quality Index (DLQI) (Time frame: Week 16)
- Change from Baseline in Hidradenitis Suppurativa Impact Assessment (HSIA) (Time frame: Week 16)
- Change from Baseline in Hidradenitis Suppurativa Symptom Assessment (HSSA) Worst Drainage Score (Time frame: Week 16)
- Change from Baseline in Draining Fistula Count (Time frame: Week 16)
- Percentage of Participants Achieving HiSCR 90 (Time frame: Week 16)
- Change from Baseline in the Patient's Global Assessment of HS-related Skin Pain (NRS) (Time frame: Week 8)
- Change from Baseline in HSSA (Time frame: Week 16)
- Change from Baseline in the Patient's Global Assessment of HS-related Odor (smell), based on the HSSA Question 8 (Time frame: Week 16)
- Percentage of Participants with an Occurrence of HS Flare in Period 1 (Time frame: Baseline to Week 16)

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Diagnosis of moderate to severe HS for at least 6 months prior to Baseline as determined by the investigator (i.e., through medical history and interview of participant).
- Total abscess and inflammatory nodule (AN) count of >= 5 at Baseline
- Hidradenitis suppurativa (HS) lesions present in at least two distinct anatomic areas at Baseline.
- At least 1 anatomic area of HS involvement characterized as Hurley Stage II or higher at Baseline.

Exclude criteria

- Any evidence of Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Confirmed positive anti-HIV antibody (HIV Ab) test.
- Evidence of active tuberculosis or meets tuberculosis exclusionary parameter

Related Information

• Primary Sponsor: Otani Tetsuya
• Secondary ID(s): NCT06468228