A Phase 3 Study of Obexelimab in Patients with IgG4-Related Disease

JRCT ID: jRCT2031230189

Registered date:28/06/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Active IgG4 related disease
• Date of first enrollment: 30/06/2023
• Target sample size: 20
• Countries of recruitment: ARGENTINA,Japan,CANADA,Japan,CHINA,Japan,FRANCE,Japan,GERMANY,Japan,HONG KONG,Japan,HUNGARY,Japan,ITALY,Japan,KOREA,Japan,MEXICO,Japan,NETHERLANDS,Japan,POLAND,Japan,SPAIN,Japan,SWEDEN,Japan,TAIWAN,Japan,TURKEY,Japan,UNITED KINGDOM,Japan,UNITED STATES,Japan
• Study type: Interventional
• Intervention(s): Obexelimab or placebo is administered as SC injections every 7 days during the Randomized Controlled Period. Obexelimab is administered as SC injections every 7 days during the open-label extension period.

Outcome(s)

• Primary Outcome: Time to first IgG4-RD flare, defined as the reappearance of previous signs/symptoms or appearance of new signs/symptoms of IgG4-RD that requires initiation of rescue therapy in the opinion of the investigator and the Adjudication Committee (AC), from randomization to Week 52.

Key inclusion & exclusion criteria

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

Include criteria

1.Males and females, 18 years of age and over
2.Clinical diagnosis of IgG4-RD
3.Patients must meet the 2019 ACR/EULAR Classification Criteria for IgG4-RD
4.Patients must have active IgG4-RD signs/symptoms (i.e., flare) that require the initiation of GC therapy or the increase in background long-term GC therapy
5.Other inclusion criteria apply

Exclude criteria

1.Has disease in only 1 organ system whose primary manifestation is fibrosis.
2.Has received prednisone equivalent given orally at a dose greater than 60 mg/day within the 4 weeks prior to screening or during screening
3.Has received a non-biologic, disease-modifying anti-rheumatological drug or immunosuppressive agent other than GCs within the 4 weeks prior to screening
4.Has received an investigational treatment or direct medical intervention on another clinical study within 12 weeks or < 5 half-lives of the investigational treatment, whichever is shorter, prior to screening
5.Has received live vaccine or live therapeutic infectious agent within the 2 weeks prior to screening
6.Active tuberculosis or high risk for tuberculosis; hepatitis C infection in absence of curative treatment; evidence of hepatitis B infection
7.Use of B-cell depleting or targeting agents within 6 months of randomization.
8.Other exclusion criteria apply

Related Information

• Primary Sponsor: Yamaji Hideomi
• Secondary ID(s): NCT05662241