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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 belowSelect...
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
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 moreSide effects data
From 2020 Phase 4 trial • 1027 Patients • NCT035733231%
Nasopharyngitis
1%
Upper respiratory tract infection
100%
80%
60%
40%
20%
0%
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
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.
Anti-interleukin-23 agents for the treatment of ulcerative colitis.
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Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
992 Previous Clinical Trials
6,386,840 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
758 Previous Clinical Trials
3,962,640 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of or currently have a chronic infection.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.I have tried or failed treatment with specific advanced drugs before this study.I haven't taken certain immune-weakening medicines recently.I have a severe health condition that could worsen by joining this study.I have been diagnosed with new or returning Giant Cell Arteritis.I have been on steroids for over 4 years or can't stop them due to adrenal issues.I have been diagnosed with Giant cell arteritis.I do not have any rheumatic diseases that could affect my GCA assessment.I haven't had a major blood clot or stroke in the last 3 months.I have been diagnosed with active GCA in the last 6 weeks.I have severe complications from giant cell arteritis that are not under control.My giant cell arteritis was confirmed through a specific imaging test.My GCA is stable, and I'm taking 20-60 mg of glucocorticoids daily.
Research Study Groups:
This trial has the following groups:- Group 1: Guselkumab
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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