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Monoclonal Antibodies

Obexelimab for IgG4-Related Disease (INDIGO Trial)

Phase 3

Recruiting

Research Sponsored by Zenas BioPharma (USA), LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up randomization to week 52

Awards & highlights

INDIGO Trial Summary

This trial will test a new drug to see if it can help prevent flare-ups of a rare autoimmune disease called IgG4-Related Disease.

Who is the study for?

Adults diagnosed with IgG4-Related Disease showing active symptoms needing treatment can join this trial. They must meet specific criteria for the disease's classification. Excluded are those with only one affected organ system, high-dose steroid use in the last month, recent other treatments or live vaccines, and certain infections or use of B cell targeting drugs within six months.Check my eligibility

What is being tested?

The trial is testing Obexelimab against a placebo to see if it prevents flare-ups of IgG4-Related Disease when added to standard therapy. Participants will be randomly assigned to receive either Obexelimab or a placebo alongside their usual treatment.See study design

What are the potential side effects?

While not specified here, potential side effects may include reactions at the injection site, increased risk of infections due to immune system suppression, and possible allergic reactions among others typically associated with immunomodulatory therapies.

INDIGO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ randomization to week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~randomization to week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization to week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

measure

INDIGO Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ZB012Experimental Treatment1 Intervention

Obexelimab administered as an SC injection.

Group II: PlaceboPlacebo Group1 Intervention

Placebo administered as an SC injection.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Zenas BioPharma (USA), LLCLead Sponsor

5 Previous Clinical Trials

287 Total Patients Enrolled

Media Library

Obexelimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05662241 — Phase 3

Related Disease Research Study Groups: ZB012, Placebo

Related Disease Clinical Trial 2023: Obexelimab Highlights & Side Effects. Trial Name: NCT05662241 — Phase 3

Obexelimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05662241 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has ZB012 been authorized by the FDA?

"The safety of ZB012 is highly rated, with a numerical score of 3. This can be attributed to the Phase 3 trial status, which has revealed efficacy and established its general safety through multiple rounds of data collection."

Answered by AI

Are there any current openings for participation in this clinical experiment?

"Verified, the information posted on clinicaltrials.gov states that this medical experiment is currently searching for volunteers. The trial's first posting was made on September 30th 2022 and has since been updated as recently as December 14th 2022. 200 participants are needed between 1 site of enrolment."

Answered by AI

What is the total number of participants involved in this clinical research?

"Affirmative. Evidence accessible on clinicaltrials.gov suggests that recruitment for this medical trial is still underway, with the study being originally posted in September of 2022 and updated most recently in December of that same year. 200 patients need to be enrolled from one single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "A Phase 3 Study of Obexelimab in Patients With IgG4-Related Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05662241.