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Monoclonal Antibodies

Guselkumab for Giant Cell Arteritis (THEIA Trial)

Q: Is this trial a pioneering endeavor in its therapeutic field?

<p>Since 2018, Janssen Research &#x26; Development, LLC. has been studying Guselkumab with the first trial involving 1406 participants. After receiving Phase 2 and 3 drug approval due to positive results from this initial research there are now 19 ongoing studies for Guselkumab located in 57 different countries across 282 cities worldwide.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from week 28 up to week 52

Awards & highlights

THEIA Trial Summary

This trial will test whether the drug guselkumab is effective in treating giant cell arteritis, in combination with a tapering regimen of glucocorticoids.

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.Check my eligibility

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.See study design

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.

THEIA Trial 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.

THEIA Trial 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

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

Primary outcome measures

Percentage of Participants Achieving Glucocorticoid (GC)-Free Remission

Secondary outcome measures

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

Injection site reaction

Upper respiratory tract infection

Nasopharyngitis

100%

80%

60%

40%

20%

Study treatment Arm

Ixekizumab

Guselkumab

Ixekizumab Post-Treatment Follow Up

Guselkumab Post-Treatment Follow Up

THEIA 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

~5990

Placebo

1995

Completed Phase 3

~2670

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

975 Previous Clinical Trials

6,384,255 Total Patients Enrolled

Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC

745 Previous Clinical Trials

3,959,852 Total Patients Enrolled

Media Library

Guselkumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04633447 — Phase 2

Giant Cell Arteritis Research Study Groups: Guselkumab, Placebo

Giant Cell Arteritis Clinical Trial 2023: Guselkumab Highlights & Side Effects. Trial Name: NCT04633447 — Phase 2

Guselkumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04633447 — Phase 2

Frequently Asked Questions

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

To what extent have prior experiments featured Guselkumab?

"At the moment, 19 clinical trials are in progress to evaluate Guselkumab's efficacy with 7 of them at a Phase 3 level. While Milan, Kansas is known for its many studies on this medication, over two thousand six hundred and eighty-six sites worldwide have opened research on it."

Answered by AI

Is the study being conducted across multiple centers in North America?

"This trial is including patients from Hopital du Sacre-Coeur de Montreal, Mount Sinai Hospital, Massachusetts General Hospital and 4 other clinical sites."

Answered by AI

Are there any slots left for enrollment in this research investigation?

"Affirmative. According to clinicaltrials.gov, this medical trial is currently recruiting for 51 participants from 4 separate sites. The study was initated on December 10th 2020 and has been amended as recently as November 3rd 2022."

Answered by AI

Has Guselkumab obtained governmental authorization for public use?

"Guselkumab's safety is evaluated with a rating of 2, as it has yet to yield conclusive evidence on its efficacy despite demonstrating some success in regards to patient protection."

Answered by AI

What is the current size of the participant pool for this investigation?

"A minimum of 51 qualified subjects are essential for the successful completion of this trial. Janssen Research & Development, LLC is responsible for its management and will be running it out of multiple locations such as Hopital du Sacre-Coeur de Montreal in Quebec and Mount Sinai Hospital in Toronto, Ontario."

Answered by AI

Is this trial a pioneering endeavor in its therapeutic field?

"Since 2018, Janssen Research & Development, LLC. has been studying Guselkumab with the first trial involving 1406 participants. After receiving Phase 2 and 3 drug approval due to positive results from this initial research there are now 19 ongoing studies for Guselkumab located in 57 different countries across 282 cities worldwide."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell Arteritis

2020. "A Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell Arteritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04633447.

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