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

Primary Purpose

IgG4 Related Disease

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Obexelimab
Placebo
Sponsored by
Zenas BioPharma (USA), LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IgG4 Related Disease focused on measuring IgG4, IgG4-RD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Placebo Comparator

Arm Label

ZB012

Placebo

Arm Description

Obexelimab administered as an SC injection.

Placebo administered as an SC injection.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 14, 2022
Last Updated
October 24, 2023
Sponsor
Zenas BioPharma (USA), LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05662241
Brief Title
A Phase 3 Study of Obexelimab in Patients With IgG4-Related Disease
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2022 (Actual)
Primary Completion Date
October 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zenas BioPharma (USA), LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IgG4 Related Disease
Keywords
IgG4, IgG4-RD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ZB012
Arm Type
Experimental
Arm Description
Obexelimab administered as an SC injection.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered as an SC injection.
Intervention Type
Drug
Intervention Name(s)
Obexelimab
Intervention Description
Obexelimab is a monoclonal antibody that simultaneously binds CD19 and FcγRIIb, resulting in down regulation of B cell activity.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Primary outcome measure
Description
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.
Time Frame
Randomization to Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patient and Medical Information
Phone
833-269-4696
Email
Clinicaltrialsinfo@zenasbio.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zenas Patient Center
Phone
213-459-2979
Email
zenas@patientwing.com
Facility Information:
Facility Name
Stanford Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Name
Allergy & Asthma Clinical Research- Dedicated Research Facility
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Individual Site Status
Recruiting
Facility Name
GI PROS Research - Dedicated Research Facility
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Individual Site Status
Recruiting
Facility Name
Emory Univeristy
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Name
Augusta University Medical Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Individual Site Status
Recruiting
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Name
Hospital Italiano de Buenos Aires
City
Buenos Aires
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Haut-Lévèque Hospital Usn Building South Hospital Group
City
Pessac
State/Province
Bordeaux
ZIP/Postal Code
33604
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpitaux Universitaires de Marseille Timone
City
Saint-Pierre
State/Province
Marseille
ZIP/Postal Code
13005
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire de Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Name
Rheumazentrum Ruhrgebiet
City
Herne
State/Province
Nordrhein-Westfalen
Country
Germany
Individual Site Status
Recruiting
Facility Name
Dr. med. Andreas Schwittay
City
Böhlen
State/Province
Sachsen
Country
Germany
Individual Site Status
Recruiting
Facility Name
Pécsi Tudományegyetem
City
Pécs
State/Province
Baranya
ZIP/Postal Code
7632
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
City
Szeged
State/Province
Csongrad
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Policlinico San Matteo
City
Pavia
State/Province
Milan
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale San Giovanni Bosco
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10128
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Recruiting
Facility Name
University of Verona
City
Verona
ZIP/Postal Code
37134
Country
Italy
Individual Site Status
Recruiting
Facility Name
Hospital of University of Occupational and Environmental Health
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
807-8555
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kanazawa University Hospital
City
Kanazawa-Shi
State/Province
Isikawa
Country
Japan
Individual Site Status
Recruiting
Facility Name
Shinshu University Hospital
City
Matsumoto
State/Province
Nagano
ZIP/Postal Code
390-8621
Country
Japan
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Ajou University Hospital
City
Suwon
ZIP/Postal Code
206
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9713
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Dr hab. Med. Eleonory Reicher
City
Warszawa
State/Province
Mazowieckie
Country
Poland
Individual Site Status
Recruiting
Facility Name
Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy
City
Bydgoszcz
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne Oporow
City
Wrocław
ZIP/Postal Code
52-416
Country
Poland
Individual Site Status
Recruiting
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Individual Site Status
Recruiting
Facility Name
Vall d'Hebron University Hospital
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Bellvitge University Hospital
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Skånes universitetssjukhus Malmö
City
Malmö
ZIP/Postal Code
21428
Country
Sweden
Individual Site Status
Recruiting
Facility Name
China Medical University Hospital
City
Taichung City
ZIP/Postal Code
404327
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Medical University Hospital
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Linkou Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Hacettepe University Faculty of Medicine
City
Altındağ
State/Province
Ankara
ZIP/Postal Code
06230
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Basaksehir Cam and Sakura City Hospital
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting

12. IPD Sharing Statement

Links:
URL
https://app.patientwing.com/campaign/indigo-igg4rd-ctgov
Description
For more information or to see if you may qualify, click here.

Learn more about this trial

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

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