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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05662241
Recruitment Status : Recruiting
First Posted : December 22, 2022
Last Update Posted : March 20, 2023
Sponsor:
Information provided by (Responsible Party):
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)

Condition or disease Intervention/treatment Phase
IgG4 Related Disease Drug: Obexelimab Other: Placebo Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : September 30, 2022
Estimated Primary Completion Date : October 31, 2025
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ZB012
Obexelimab administered as an SC injection.
Drug: Obexelimab
Obexelimab is a monoclonal antibody that simultaneously binds CD19 and FcγRIIb, resulting in down regulation of B cell activity.

Placebo Comparator: Placebo
Placebo administered as an SC injection.
Other: Placebo
Placebo




Primary Outcome Measures :
  1. Primary outcome measure [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05662241


Contacts
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Contact: Patient and Medical Information 833-269-4696 Clinicaltrialsinfo@zenasbio.com
Contact: Zenas Patient Center 213-459-2979 zenas@patientwing.com

Locations
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United States, California
Stanford Medicine Recruiting
Stanford, California, United States, 94305
Allergy & Asthma Clinical Research- Dedicated Research Facility Recruiting
Walnut Creek, California, United States, 94598
United States, Florida
GI PROS Research - Dedicated Research Facility Recruiting
Naples, Florida, United States, 34102
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Zenas BioPharma (USA), LLC
Additional Information:
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Responsible Party: Zenas BioPharma (USA), LLC
ClinicalTrials.gov Identifier: NCT05662241    
Other Study ID Numbers: ZB012-03-001
First Posted: December 22, 2022    Key Record Dates
Last Update Posted: March 20, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zenas BioPharma (USA), LLC:
IgG4
IgG4-RD
Additional relevant MeSH terms:
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Immunoglobulin G4-Related Disease
Autoimmune Diseases
Immune System Diseases