A Phase 3 Study of Obexelimab in Patients With IgG4-Related Disease (INDIGO)
IgG4 Related Disease
About this trial
This is an interventional treatment trial for IgG4 Related Disease focused on measuring IgG4, IgG4-RD
Eligibility Criteria
Inclusion Criteria: Males and females, ≥ 18 years of age Clinical diagnosis of IgG4-RD Patients must meet the 2019 ACR/EULAR Classification Criteria for IgG4-RD 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 Other inclusion criteria apply Exclusion Criteria: Has disease in only 1 organ system whose primary manifestation is fibrosis Has received prednisone equivalent given orally at a dose greater than 60 mg/day within the 4 weeks prior to screening or during screening Has received a non-biologic, disease-modifying anti-rheumatological drug or immunosuppressive agent other than GCs within the 4 weeks prior to screening 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 Has received live vaccine or live therapeutic infectious agent within the 2 weeks prior to screening Active tuberculosis or high risk for tuberculosis; hepatitis C infection in absence of curative treatment; evidence of hepatitis B infection Use of B cell depleting or targeting agents within 6 months of randomization Other exclusion criteria apply
Sites / Locations
- Stanford MedicineRecruiting
- Allergy & Asthma Clinical Research- Dedicated Research FacilityRecruiting
- GI PROS Research - Dedicated Research FacilityRecruiting
- Emory UniveristyRecruiting
- Augusta University Medical CenterRecruiting
- Rush University Medical CenterRecruiting
- Massachusetts General HospitalRecruiting
- Hospital Italiano de Buenos AiresRecruiting
- Haut-Lévèque Hospital Usn Building South Hospital GroupRecruiting
- Hôpitaux Universitaires de Marseille TimoneRecruiting
- Centre Hospitalier Universitaire de NantesRecruiting
- Rheumazentrum RuhrgebietRecruiting
- Dr. med. Andreas SchwittayRecruiting
- Pécsi TudományegyetemRecruiting
- Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai KozpontRecruiting
- Policlinico San MatteoRecruiting
- Ospedale San Giovanni BoscoRecruiting
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaRecruiting
- University of VeronaRecruiting
- Hospital of University of Occupational and Environmental HealthRecruiting
- Kanazawa University HospitalRecruiting
- Shinshu University HospitalRecruiting
- Seoul National University HospitalRecruiting
- Ajou University HospitalRecruiting
- University Medical Center GroningenRecruiting
- Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Dr hab. Med. Eleonory ReicherRecruiting
- Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w BydgoszczyRecruiting
- Centrum Medyczne OporowRecruiting
- Hospital de la Santa Creu i Sant PauRecruiting
- Vall d'Hebron University HospitalRecruiting
- Bellvitge University HospitalRecruiting
- Hospital Universitario Ramón y CajalRecruiting
- Hospital Universitario 12 de OctubreRecruiting
- Skånes universitetssjukhus MalmöRecruiting
- China Medical University HospitalRecruiting
- Taipei Medical University HospitalRecruiting
- Linkou Chang Gung Memorial HospitalRecruiting
- Hacettepe University Faculty of MedicineRecruiting
- Basaksehir Cam and Sakura City HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
ZB012
Placebo
Obexelimab administered as an SC injection.
Placebo administered as an SC injection.