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

• Sponsor: Zenas BioPharma (USA), LLC (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05662241
• Collaborator: (none)
• Enrollment: 200
• Locations: 4
• Arms: 2
• Anticipated Duration (Months): 51
• Patients Per Site: 50
• Patients Per Site Per Month: 1

Study Details

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)

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).

Study Design

• Study Type: Interventional
• Anticipated 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: Sep 30, 2022
• Anticipated Primary Completion Date: Oct 31, 2025
• Anticipated Study Completion Date: Dec 31, 2026

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Allergy & Asthma Clinical Research- Dedicated Research Facility	Walnut Creek	California	United States	94598
2	GI PROS Research - Dedicated Research Facility	Naples	Florida	United States	34102
3	Rush University Medical Center	Chicago	Illinois	United States	60612
4	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Zenas BioPharma (USA), LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Zenas BioPharma (USA), LLC
• ClinicalTrials.gov Identifier: NCT05662241
• Other Study ID Numbers: ZB012-03-001
• First Posted: Dec 22, 2022
• Last Update Posted: Jan 30, 2023
• Last Verified: Jan 1, 2023

• 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: Immunoglobulin G4-Related Disease

Study Results

No Results Posted as of Jan 30, 2023