A Phase 3 Study of Obexelimab in Patients with IgG4-Related Disease
- Conditions
- IgG4 Related Disease
- Interventions
- Drug: ObexelimabOther: Placebo
- Registration Number
- NCT05662241
- Lead Sponsor
- Zenas BioPharma (USA), LLC
- Brief Summary
This study aims to examine the efficacy and safety of obexelimab for the prevention of flare of IgG4-related disease (IgG4-RD)
- Detailed Description
This study consists of a 1-year randomized control period (RCP), followed by an additional 2-year open label extension (OLE) period.
To enter the Screening Period (Day -28 to Day -1), patients must have active IgG4-RD signs/symptoms (i.e., flare) that require steroid therapy. On Day 1, patients will be randomized in a ratio of 1:1 to receive either obexelimab or placebo administered as subcutaneous (SC) injections. All patients will begin a steroid taper on Day 1 to discontinuation by Week 8.
Patients will be monitored for flares during scheduled in clinic visits and any unscheduled visits. The primary endpoint is time to first IgG4-RD flare that requires initiation of rescue therapy in the opinion of the investigator and the Adjudication Committee (AC).
Following the 52-week RCP, patients will have the opportunity to continue in an OLE period where all patients will receive obexelimab. Patients who do not wish to enroll into the OLE period will return for an in-clinic safety follow-up visit 8 weeks after the Week 52 visit (i.e., Week 60).
Including screening and follow-up, the maximum duration of participation in this study for an individual patient is 172 weeks (i.e., 28-day screening, 52-week RCP, 104-week OLE, and an 12-week follow-up).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 194
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ZB012 Obexelimab Obexelimab administered as an SC injection. Placebo Placebo Placebo administered as an SC injection.
- Primary Outcome Measures
Name Time Method Primary outcome measure Randomization to Week 52 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (111)
Consultora Integral de Salud Centro Médico Privado
🇦🇷Córdoba, Argentina
Artus Health Centre
🇨🇦Vancouver, British Columbia, Canada
Anhui Provincial Hospital
🇨🇳Hefei, Anhui, China
Beijing Friendship Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
The Second Hospital of Hebei Medical University
🇨🇳Shijia Zhuang, Hebei, China
Peking University First Hospital
🇨🇳Beijing, Beijing, China
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
🇨🇳Wuhai, Hubei, China
Zhuzhou Central Hospital
🇨🇳Zhuzhou, Hunan, China
Nanjing Drum Tower Hospital
🇨🇳Nanjing, Jiangsu, China
Yantai Yuhuangding Hospital
🇨🇳Yantai, Shandong, China
Second Hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China
The First Hospital of Jilin University
🇨🇳Chang chun, Jilin, China
Renji Hospital, Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Shanxi Bethune Hospital
🇨🇳Taiyuan, Shanxi, China
West China Hospital of Sichuan University
🇨🇳Chengdu, Sichuan, China
The First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shanxi, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, Tianjin, China
The First Affiliated Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Chu Dijon-Bourgogne
🇫🇷Dijon, France
Centre Hospitalier Universitaire de Nantes
🇫🇷Nantes, France
LMU Klinikum der Universität München
🇩🇪München, Bayern, Germany
Rheumazentrum Ruhrgebiet
🇩🇪Herne, Nordrhein-Westfalen, Germany
Charite - Universitatsmedizin Berlin Charitepatz 1
🇩🇪Berlin, Germany
Universitätsklinikum Essen
🇩🇪Essen, Germany
Hong Kong Sanatorium & Hospital
🇭🇰Hong Kong, Hong Kong
Policlinico San Matteo
🇮🇹Pavia, Milan, Italy
Ospedale San Giovanni Bosco
🇮🇹Torino, Piemonte, Italy
Azienda Ospedaliera Universitaria Meyer Istituto di Ricovero e Cura a Carattere Scientifico
🇮🇹Firenze, Italy
Ospedale San Raffaele S.r.l. - PPDS
🇮🇹Milano, Italy
Azienda Ospedaliera Universitaria Pisana
🇮🇹Pisa, Italy
Kanazawa Medical University Hospital
🇯🇵Kokura, Fukuoka, Japan
Shinshu University Hospital
🇯🇵Matsumoto, Nagano, Japan
Osaka Metropolitan University Hospital
🇯🇵Osaka-city, Osaka, Japan
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
🇯🇵Bunkyō-Ku, Tokyo, Japan
Keio University Hospital
🇯🇵Shinjuku-Ku, Tokyo, Japan
Toyama University Hospital
🇯🇵Toyama shi, Toyama, Japan
University of Tsukuba Hospital
🇯🇵Ibaraki, Japan
Kansai Medical University Hospital
🇯🇵Hirakata, Japan
Hiroshima University Hospital
🇯🇵Hiroshima, Japan
Kobe University Hospital
🇯🇵Kobe, Japan
Tokyo Medical Center Hospital
🇯🇵Meguro, Japan
St. Marianna University Hospital
🇯🇵Kawasaki, Japan
Nagaoka Red Cross Hospital
🇯🇵Nagaoka, Japan
Nagasaki University Hospital
🇯🇵Nagasaki, Japan
Niigata University Medical and Dental Hospital
🇯🇵Niigata, Japan
Kita-Harima Medical Center
🇯🇵Ono, Japan
National Hospital Organization Osaka Minami Medical Center
🇯🇵Osaka, Japan
Sapporo Medical University Hospital
🇯🇵Sapporo, Japan
Tazuke Kofukai Medical Research Institute Kitano Hospital
🇯🇵Osaka, Japan
Fujita Health University Hospital
🇯🇵Shinjuku-Ku, Japan
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon, Korea, Republic of
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
🇲🇽Mexico City, Mexico
Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy
🇵🇱Bydgoszcz, Poland
Centrum Medyczne Oporow
🇵🇱Wrocław, Poland
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Vall d'Hebron University Hospital
🇪🇸Barcelona, Spain
Bellvitge University Hospital
🇪🇸Barcelona, Spain
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Skånes universitetssjukhus Malmö
🇸🇪Malmö, Sweden
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
🇨🇳Kaohsiung, Taiwan
Taipei Medical University Hospital
🇨🇳Taipei, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Linkou Chang Gung Memorial Hospital
🇨🇳Taoyuan, Taiwan
Marmara University Pendik Training and Research Hospital
🇹🇷Pendik, Istanbul, Turkey
Basaksehir Cam and Sakura City Hospital
🇹🇷Istanbul, Turkey
Istanbul Universitesi - Cerrahpasa Tip Fakultesi Hastanesi (IUCTFH)
🇹🇷Istanbul, Turkey
John Radcliffe Hospital
🇬🇧Oxford, United Kingdom
Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital
🇬🇧London, United Kingdom
Haut-Lévèque Hospital Usn Building South Hospital Group
🇫🇷Pessac, Bordeaux, France
GI PROS Research - Dedicated Research Facility
🇺🇸Naples, Florida, United States
Integral Rheumatology & Immunology Specialists
🇺🇸Plantation, Florida, United States
Centre Hospitalier Universitaire de Sherbrooke CHUS
🇨🇦Sherbrooke, Quebec, Canada
Hôpitaux Universitaires de Marseille Timone
🇫🇷Saint-Pierre, Marseille, France
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
🇮🇹Brescia, Italy
The Institute of Medical Science, The University of Tokyo Hospital
🇯🇵Minato-ku, Tokyo, Japan
Kansai Medical University Kori Hospital
🇯🇵Neyagawa, Japan
Hospital Italiano de Buenos Aires
🇦🇷Buenos Aires, Argentina
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
🇭🇺Szeged, Csongrad, Hungary
University of Verona
🇮🇹Verona, Italy
Hospital of University of Occupational and Environmental Health
🇯🇵Kitakyushu, Fukuoka, Japan
Kanazawa University Hospital
🇯🇵Kanazawa-Shi, Isikawa, Japan
Semmelweis Egyetem
🇭🇺Budapest, Hungary
Dr. med. Andreas Schwittay
🇩🇪Böhlen, Sachsen, Germany
Universitätsklinikum Ulm
🇩🇪Ulm, Germany
University Medical Center Groningen
🇳🇱Groningen, Netherlands
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Dr hab. Med. Eleonory Reicher
🇵🇱Warszawa, Mazowieckie, Poland
Nouvel Hopital Civil
🇫🇷Strasbourg, France
Kagawa University Hospital
🇯🇵Miki, Kagawa, Japan
Tohoku University Hospital
🇯🇵Sendai, Miyagi, Japan
Centro de Alta Especialidad En Reumatologia E Investigacion Del Potosi SC
🇲🇽San Luis Potosí, Mexico
China Medical University Hospital
🇨🇳Taichung City, Taiwan
Hôpital Beaujon
🇫🇷Paris, France
Hôpital de la Pitié Salpétrière
🇫🇷Paris, France
Pécsi Tudományegyetem
🇭🇺Pécs, Baranya, Hungary
Hacettepe University Faculty of Medicine
🇹🇷Altındağ, Ankara, Turkey
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Sierra Pacific Arthritis and Rheumatology Center
🇺🇸Fresno, California, United States
Stanford Medicine
🇺🇸Stanford, California, United States
Allergy & Asthma Clinical Research- Dedicated Research Facility
🇺🇸Walnut Creek, California, United States
Emory Univeristy
🇺🇸Atlanta, Georgia, United States
Augusta University Medical Center
🇺🇸Augusta, Georgia, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Arizona Arthritis & Rheumatology Research
🇺🇸Phoenix, Arizona, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Center for Clinical Research (Nova Scotia Health)
🇨🇦Halifax, Nova Scotia, Canada
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