Clinical trial NCT05662241: A Phase 3 Study of Obexelimab in Patients with IgG4-Related Disease
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Obexelimab in Patients with IgG4-Related Disease (INDIGO)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: IgG4 Related Disease
Keywords: IgG4
IgG4-RD
Lead sponsor: Zenas BioPharma (USA), LLC
Sponsor class: INDUSTRY
First posted: 2022-12-22
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

1. Males and females, ≥ 18 years of age
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

Exclusion 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

Primary outcomes:
measure: Primary outcome measure
timeFrame: Randomization to Week 52
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Arthritis & Rheumatology Research
state: Arizona
city: Fresno
country: United States
facility: Sierra Pacific Arthritis and Rheumatology Center
state: California
city: Stanford
country: United States
facility: Stanford Medicine
state: California
city: Walnut Creek
country: United States
facility: Allergy & Asthma Clinical Research- Dedicated Research Facility
state: California
city: Naples
country: United States
facility: GI PROS Research - Dedicated Research Facility
state: Florida
city: Plantation
country: United States
facility: Integral Rheumatology & Immunology Specialists
state: Florida
city: Atlanta
country: United States
facility: Emory Univeristy
state: Georgia
city: Augusta
country: United States
facility: Augusta University Medical Center
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Córdoba
country: Argentina
facility: Consultora Integral de Salud Centro Médico Privado
city: Vancouver
country: Canada
facility: Artus Health Centre
state: British Columbia
city: Halifax
country: Canada
facility: Center for Clinical Research (Nova Scotia Health)
state: Nova Scotia
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke CHUS
state: Quebec
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Shijia Zhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Wuhai
country: China
facility: Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
city: Zhuzhou
country: China
facility: Zhuzhou Central Hospital
state: Hunan
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
city: Chang chun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
state: Shandong
city: Shanghai
country: China
facility: Renji Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
state: Shanghai
city: Taiyuan
country: China
facility: Second Hospital of Shanxi Medical University
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital
state: Shanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Pessac
country: France
facility: Haut-Lévèque Hospital Usn Building South Hospital Group
state: Bordeaux
city: Saint-Pierre
country: France
facility: Hôpitaux Universitaires de Marseille Timone
state: Marseille
city: Dijon
country: France
facility: Chu Dijon-Bourgogne
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes
city: Paris
country: France
facility: Hôpital Beaujon
city: Paris
country: France
facility: Hôpital de la Pitié Salpétrière
city: Strasbourg
country: France
facility: Nouvel Hopital Civil
city: München
country: Germany
facility: LMU Klinikum der Universität München
state: Bayern
city: Herne
country: Germany
facility: Rheumazentrum Ruhrgebiet
state: Nordrhein-Westfalen
city: Böhlen
country: Germany
facility: Dr. med. Andreas Schwittay
state: Sachsen
city: Berlin
country: Germany
facility: Charite - Universitatsmedizin Berlin Charitepatz 1
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Hong Kong
country: Hong Kong
facility: Hong Kong Sanatorium & Hospital
city: Pécs
country: Hungary
facility: Pécsi Tudományegyetem
state: Baranya
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
state: Csongrad
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Pavia
country: Italy
facility: Policlinico San Matteo
state: Milan
city: Torino
country: Italy
facility: Ospedale San Giovanni Bosco
state: Piemonte
city: Brescia
country: Italy
facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Meyer Istituto di Ricovero e Cura a Carattere Scientifico
city: Milano
country: Italy
facility: Ospedale San Raffaele S.r.l. - PPDS
city: Pisa
country: Italy
facility: Azienda Ospedaliera Universitaria Pisana
city: Verona
country: Italy
facility: University of Verona
city: Kitakyushu
country: Japan
facility: Hospital of University of Occupational and Environmental Health
state: Fukuoka
city: Kokura
country: Japan
facility: Kanazawa Medical University Hospital
state: Fukuoka
city: Kanazawa-Shi
country: Japan
facility: Kanazawa University Hospital
state: Isikawa
city: Miki
country: Japan
facility: Kagawa University Hospital
state: Kagawa
city: Sendai
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Matsumoto
country: Japan
facility: Shinshu University Hospital
state: Nagano
city: Osaka-city
country: Japan
facility: Osaka Metropolitan University Hospital
state: Osaka
city: Bunkyō-Ku
country: Japan
facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
state: Tokyo
city: Minato-ku
country: Japan
facility: The Institute of Medical Science, The University of Tokyo Hospital
state: Tokyo
city: Shinjuku-Ku
country: Japan
facility: Keio University Hospital
state: Tokyo
city: Toyama shi
country: Japan
facility: Toyama University Hospital
state: Toyama
city: Hirakata
country: Japan
facility: Kansai Medical University Hospital
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital
city: Ibaraki
country: Japan
facility: University of Tsukuba Hospital
city: Kawasaki
country: Japan
facility: St. Marianna University Hospital
city: Kobe
country: Japan
facility: Kobe University Hospital
city: Meguro
country: Japan
facility: Tokyo Medical Center Hospital
city: Nagaoka
country: Japan
facility: Nagaoka Red Cross Hospital
city: Nagasaki
country: Japan
facility: Nagasaki University Hospital
city: Neyagawa
country: Japan
facility: Kansai Medical University Kori Hospital
city: Niigata
country: Japan
facility: Niigata University Medical and Dental Hospital
city: Ono
country: Japan
facility: Kita-Harima Medical Center
city: Osaka
country: Japan
facility: National Hospital Organization Osaka Minami Medical Center
city: Osaka
country: Japan
facility: Tazuke Kofukai Medical Research Institute Kitano Hospital
city: Sapporo
country: Japan
facility: Sapporo Medical University Hospital
city: Shinjuku-Ku
country: Japan
facility: Fujita Health University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
city: San Luis Potosí
country: Mexico
facility: Centro de Alta Especialidad En Reumatologia E Investigacion Del Potosi SC
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Warszawa
country: Poland
facility: Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Dr hab. Med. Eleonory Reicher
state: Mazowieckie
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy
city: Wrocław
country: Poland
facility: Centrum Medyczne Oporow
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Vall d'Hebron University Hospital
city: Barcelona
country: Spain
facility: Bellvitge University Hospital
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Malmö
country: Sweden
facility: Skånes universitetssjukhus Malmö
city: Kaohsiung
country: Taiwan
facility: Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
city: Taichung City
country: Taiwan
facility: China Medical University Hospital
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital
city: Altındağ
country: Turkey
facility: Hacettepe University Faculty of Medicine
state: Ankara
city: Pendik
country: Turkey
facility: Marmara University Pendik Training and Research Hospital
state: Istanbul
city: Istanbul
country: Turkey
facility: Basaksehir Cam and Sakura City Hospital
city: Istanbul
country: Turkey
facility: Istanbul Universitesi - Cerrahpasa Tip Fakultesi Hastanesi (IUCTFH)
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
Study officials:
References: