Hidradenitis Suppurativa Phase 3 Study of Izokibep

JRCT ID: jRCT2031230501

Registered date:09/12/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Moderate to Severe Hidradenitis Suppurativa
• Date of first enrollment: 13/03/2024
• Target sample size: 40
• Countries of recruitment: Canada,Japan,France,Japan,Germany,Japan,Hungary,Japan,Poland,Japan,Spain,Japan,The United States,Japan
• Study type: Interventional

Intervention(s)

Group 1: placebo QW from Day 1/Week 0 to Week 15, then Izokibep 160mg QW from Week 16 to Week 51
Group 2: Izokibep 160 mg QW from Day 1/Week 0 to Week 51

Outcome(s)

• Primary Outcome: HiSCR75 at Week 16

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

General
1.Subject has provided signed informed consent including consenting to comply with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
2.18 to 75 years of age
Type of Subject and Disease Characteristics
3.Diagnosis of HS for >= 6 months prior to first dose of study drug
4.Hidradenitis suppurativa lesions present in >= 2 distinct anatomic areas, one of which is Hurley Stage II or Hurley Stage III
5.A total abscess and inflammatory nodule (AN) count of >= 5 at screening and Day 1 prior to enrollment/randomization
6.Subject must have had an inadequate response to oral antibiotics OR exhibited recurrence after discontinuation to, OR demonstrated intolerance to, OR have a contraindication to oral antibiotics for treatment of their HS
7.Must agree to use daily over-the-counter topical antiseptics
8.Subject must be willing to complete a daily skin pain diary
Other protocol defined Inclusion criteria may apply

Exclude criteria

Medical Conditions
1.Draining fistula count of > 20
2.Outpatient surgery <= 8 weeks prior or inpatient surgery <= 12 weeks prior to enrollment/randomization
3.Other active skin disease or condition that could interfere with study assessments
4.History of active inflammatory bowel disease (IBD) OR symptoms within the last year that may be suggestive of IBD
5.Chronic pain not associated with HS
6.Uncontrolled, clinically significant system disease
7.History of demyelinating disease or neurological symptoms suggestive of demyelinating disease
8.Malignancy within 5 years
9.The subject is at risk of self-harm or harm to others
10.Active infection or history of certain infections
11.Tuberculosis or fungal infection seen on available chest x-ray taken within 3 months prior to first dose of study drug or at screening (Exception: documented evidence of completed treatment and clinically resolved)
12.Known history of human immunodeficiency virus (HIV)
Other protocol defined Exclusion criteria may apply

Related Information

• Primary Sponsor: Benner Saskia
• Secondary ID(s): NCT05905783