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

IgG4 Related Disease Clinical Trial

— INDIGO  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05662241
• Other study ID #: ZB012-03-001
• Status: Recruiting
• Phase: Phase 3
• Start date: September 30, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2024
• Source: Zenas BioPharma (USA), LLC
• Contact: Patient and Medical Information
• Phone: 833-269-4696
• Email: Clinicaltrialsinfo[@]zenasbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to examine the efficacy and safety of obexelimab for the prevention of flare of IgG4-related disease (IgG4-RD)

Description:

This study consists of a 1-year randomized control period (RCP), followed by an additional 1-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 116 weeks (i.e., 28-day screening, 52-week RCP, 52-week OLE, and an 8-week follow-up).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2026
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• IgG4 Related Disease

Intervention

Drug:
• Obexelimab
Obexelimab is a monoclonal antibody that simultaneously binds CD19 and Fc?RIIb, resulting in down regulation of B cell activity.

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
Argentina	Hospital Italiano de Buenos Aires	Buenos Aires
Argentina	Consultora Integral de Salud Centro Médico Privado	Córdoba
Canada	Artus Health Centre	Vancouver	British Columbia
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	Peking University First Hospital	Beijing	Beijing
China	The First Hospital of Jilin University	Chang chun	Jilin
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	The First Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Anhui Provincial Hospital	Hefei	Anhui
China	Renji Hospital, Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	The Second Hospital of Hebei Medical University	Shijia Zhuang	Hebei
China	Second Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Shanxi Bethune Hospital	Taiyuan	Shanxi
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology	Wuhai	Hubei
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi
China	Yantai Yuhuangding Hospital	Yantai	Shandong
China	Zhuzhou Central Hospital	Zhuzhou	Hunan
France	Chu Dijon-Bourgogne	Dijon
France	Centre Hospitalier Universitaire de Nantes	Nantes
France	Haut-Lévèque Hospital Usn Building South Hospital Group	Pessac	Bordeaux
France	Hôpitaux Universitaires de Marseille Timone	Saint-Pierre	Marseille
Germany	Dr. med. Andreas Schwittay	Böhlen	Sachsen
Germany	Rheumazentrum Ruhrgebiet	Herne	Nordrhein-Westfalen
Germany	LMU Klinikum der Universität München	München	Bayern
Hong Kong	Hong Kong Sanatorium & Hospital	Hong Kong
Hungary	Semmelweis Egyetem	Budapest
Hungary	Pécsi Tudományegyetem	Pécs	Baranya
Hungary	Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont	Szeged	Csongrad
Italy	Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia	Brescia
Italy	Ospedale San Raffaele S.r.l. - PPDS	Milano
Italy	Policlinico San Matteo	Pavia	Milan
Italy	Azienda Ospedaliera Universitaria Pisana	Pisa
Italy	Ospedale San Giovanni Bosco	Torino	Piemonte
Italy	University of Verona	Verona
Japan	Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital	Bunkyo-Ku	Tokyo
Japan	Kansai Medical University Hospital	Hirakata
Japan	Kanazawa University Hospital	Kanazawa-Shi	Isikawa
Japan	Hospital of University of Occupational and Environmental Health	Kitakyushu	Fukuoka
Japan	Kobe University Hospital	Kobe
Japan	Kanazawa Medical University Hospital	Kokura	Fukuoka
Japan	Shinshu University Hospital	Matsumoto	Nagano
Japan	Kagawa University Hospital	Miki	Kagawa
Japan	Nagaoka Red Cross Hospital	Nagaoka
Japan	Kansai Medical University Kori Hospital	Neyagawa
Japan	Niigata University Medical and Dental Hospital	Niigata
Japan	Kita-Harima Medical Center	Ono
Japan	Sapporo Medical University Hospital	Sapporo
Japan	Fujita Health University Hospital	Shinjuku-Ku
Japan	Keio University Hospital	Shinjuku-Ku	Tokyo
Japan	Toyama University Hospital	Toyama shi	Toyama
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon
Mexico	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	Mexico City
Mexico	Centro de Alta Especialidad En Reumatologia E Investigacion Del Potosi SC	San Luis Potosí
Netherlands	University Medical Center Groningen	Groningen
Poland	Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy	Bydgoszcz
Poland	Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Dr hab. Med. Eleonory Reicher	Warszawa	Mazowieckie
Poland	Centrum Medyczne Oporow	Wroclaw
Spain	Bellvitge University Hospital	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Vall d'Hebron University Hospital	Barcelona
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital Universitario Virgen del Rocio	Sevilla
Sweden	Skånes universitetssjukhus Malmö	Malmö
Taiwan	China Medical University Hospital	Taichung City
Taiwan	Taipei Medical University Hospital	Taipei
Taiwan	Linkou Chang Gung Memorial Hospital	Taoyuan
Turkey	Hacettepe University Faculty of Medicine	Altindag	Ankara
Turkey	Basaksehir Cam and Sakura City Hospital	Istanbul
Turkey	Istanbul Universitesi - Cerrahpasa Tip Fakultesi Hastanesi (IUCTFH)	Istanbul
United Kingdom	John Radcliffe Hospital	Oxford
United States	Emory Univeristy	Atlanta	Georgia
United States	Augusta University Medical Center	Augusta	Georgia
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	Rush University Medical Center	Chicago	Illinois
United States	Sierra Pacific Arthritis and Rheumatology Center	Fresno	California
United States	GI PROS Research - Dedicated Research Facility	Naples	Florida
United States	Stanford Medicine	Stanford	California
United States	Allergy & Asthma Clinical Research- Dedicated Research Facility	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Zenas BioPharma (USA), LLC

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  China,  France,  Germany,  Hong Kong,  Hungary,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Poland,  Spain,  Sweden,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcome measure	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.	Randomization to Week 52

External Links

•   For more information or to see if you may qualify, click here.