What side effects are associated with this type of intervention?

Common treatments for Giant Cell Arteritis (GCA) include glucocorticoids and monoclonal antibodies targeting interleukins, such as guselkumab. Glucocorticoids can cause serious side effects like severe infections, impaired glucose tolerance, weight gain, and hospitalization, particularly at high doses. Monoclonal antibodies like guselkumab, which target IL-23, generally have a good safety profile but can lead to infections, injection site reactions, and fatigue. These treatments are effective in reducing inflammation but require careful management of their associated risks.

What prior FDA approvals exist?

The FDA has approved several treatments for Giant Cell Arteritis (GCA), including tocilizumab, a monoclonal antibody that targets the interleukin-6 (IL-6) receptor. Tocilizumab was the first biologic approved specifically for GCA and has shown efficacy in reducing disease activity and steroid dependence. While guselkumab, which targets interleukin-23 (IL-23), is being studied for GCA, there are no current FDA approvals for IL-23 inhibitors specifically for this condition. Other treatments for GCA primarily involve glucocorticoids and immunosuppressive agents.

What other types of research exist?

Promising alternatives to Guselkumab for Giant Cell Arteritis patients include Tocilizumab (an IL-6 receptor antagonist) and Ustekinumab (targets IL-12 and IL-23). Both have shown efficacy in treating inflammatory and autoimmune conditions similar to GCA.

← Back to Search

Monoclonal Antibodies

Guselkumab for Giant Cell Arteritis (THEIA Trial)

Phase 2

Waitlist Available

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

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

Must have

New onset or relapsing GCA

Diagnosis of Giant cell arteritis (GCA) according to the revised American College of Rheumatology criteria

Must not have

History of, or ongoing, chronic or recurrent infectious disease

Comorbidities requiring 3 or more courses of systemic GCs within 12 months of first study intervention, inability to withdraw GC therapy through protocol-defined taper regimen due to suspected or established adrenal insufficiency, or currently on systemic chronic GC therapy for reasons other than GCA and be GC dependent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from week 28 up to week 52

Summary

This trial is testing guselkumab, a medication that blocks a protein causing inflammation, in adults with new or returning giant cell arteritis. The goal is to see if it helps reduce symptoms. Guselkumab has been approved for treatment of multiple immunologic diseases including psoriasis and palmoplantar pustulosis.

Who is the study for?

This trial is for adults with new-onset or relapsing Giant Cell Arteritis (GCA), confirmed by specific criteria and imaging tests. Participants should have active GCA within the past 6 weeks and be on a stable dose of glucocorticoids. Those with other rheumatic diseases, recent major ischemic events, chronic infections, or who have used certain immunosuppressants can't join.

What is being tested?

The study is testing the effectiveness of Guselkumab versus a placebo in combination with a 26-week tapering schedule of glucocorticoids to treat GCA. The goal is to see if Guselkumab can help manage symptoms better than a non-active treatment.

What are the potential side effects?

Potential side effects of Guselkumab may include allergic reactions, injection site reactions, headaches, upper respiratory infections, and fatigue. As it affects the immune system, there might also be an increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with new or returning Giant Cell Arteritis.

Select...

I have been diagnosed with Giant cell arteritis.

Select...

I have been diagnosed with active GCA in the last 6 weeks.

Select...

My giant cell arteritis was confirmed through a specific imaging test.

Select...

My GCA is stable, and I'm taking 20-60 mg of glucocorticoids daily.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a history of or currently have a chronic infection.

Select...

I've needed 3 or more steroid treatments this year and can't stop due to adrenal issues, or I'm on long-term steroids not for GCA but am dependent on them.

Select...

I have tried or failed treatment with specific advanced drugs before this study.

Select...

I have been on steroids for over 4 years or can't stop them due to adrenal issues.

Select...

I do not have any rheumatic diseases that could affect my GCA assessment.

Select...

I haven't had a major blood clot or stroke in the last 3 months.

Select...

I have severe complications from giant cell arteritis that are not under control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from week 28 up to week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from week 28 up to week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and from week 28 up to week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants Achieving Glucocorticoid (GC)-Free Remission

Secondary study objectives

Cumulative GC dose

Number of GCA Disease Flares or Discontinuation of Study Intervention due to AE of Worsening of GCA

Number of Participants with Antibodies to Guselkumab

+11 more

Side effects data

From 2020 Phase 4 trial • 1027 Patients • NCT03573323

Nasopharyngitis

Upper respiratory tract infection

100%

80%

60%

40%

20%

Study treatment Arm

Ixekizumab Post-Treatment Follow Up

Ixekizumab

Guselkumab

Guselkumab Post-Treatment Follow Up

Trial Design

2Treatment groups

Experimental Treatment

Group I: PlaceboExperimental Treatment1 Intervention

Participants will receive matching placebo SC every 4 weeks from Week 0 through Week 48. This will be in combination with a protocol-specified 26-week GC taper. Participants of the LTE period will continue to receive SC injections every 4 weeks starting at Week 52 (LTE Week 0) through Week 100 (LTE Week 48) or until the participants have a GCA flare, or the participants discontinues treatment due to unblinding after the Week 60 DBL for the Main study, or until a decision is made not to continue clinical development in this GCA population, whichever occurs first.

Group II: GuselkumabExperimental Treatment1 Intervention

Participants will receive guselkumab subcutaneously (SC) every 4 weeks from Week 0 through Wweek 48. This will be in combination with a protocol specified 26-week GC taper. Participants of the long-term extension (LTE) period will continue to receive subcutaneous (SC) injections every 4 weeks starting at Week 52 (LTE Week 0) through Week 100 (LTE Week 48) or until the participants have a Giant cell arteritis (GCA) flare, or the participants discontinues treatment due to unblinding after the Week 60 DBL for the Main study, or until a decision is made not to continue clinical development in this GCA population, whichever occurs first.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Guselkumab

2015

Completed Phase 4

~6080

Placebo

1995

Completed Phase 3

~2670

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Giant Cell Arteritis (GCA) include glucocorticoids and monoclonal antibodies targeting specific cytokines like interleukin-23 (IL-23). Glucocorticoids work by broadly suppressing the immune system to reduce inflammation, which is effective but can lead to significant side effects with long-term use. Monoclonal antibodies such as guselkumab specifically target IL-23, a cytokine involved in the inflammatory process of GCA. By inhibiting IL-23, guselkumab can reduce inflammation more precisely, potentially offering better efficacy and a lower risk of side effects compared to traditional glucocorticoid therapy. This targeted approach is crucial for GCA patients as it provides a more tailored and potentially safer treatment option.

Anti-interleukin-23 agents for the treatment of ulcerative colitis.