All > Giant Cell Arteritis

Guselkumab for Giant Cell Arteritis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Hosp. Univ. 12 De Octubre, Madrid, SpainGiant Cell ArteritisGuselkumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Giant Cell Arteritis

Treatment Effectiveness

Effectiveness Progress

1 of 3

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JNJ-78934804
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Study Objectives

1 Primary · 18 Secondary · Reporting Duration: From Week 28 up to Week 52

At Week 28
Percentage of Participants Achieving Glucocorticoid (GC)-Free Remission
Week 52
Electron Spin Resonance Spectroscopy
Percentage of Participants Achieving GC-Free Remission and Normalization of C-Reactive Protein (CRP)
Percentage of Participants Achieving GC-Free Remission and Normalization of Erythrocyte Sedimentation Rate (ESR)
Week 52
Change From Baseline in CRP Level
Change From Baseline in ESR
Week 52
Percentage of Participants Achieving GC-Free Remission
Week 52
Cumulative GC dose
Number of GCA Disease Flares or Discontinuation of Study Intervention due to AE of Worsening of GCA
Time to First GCA Disease Flare or Discontinuation of Study Intervention due to AE of Worsening of GCA
Up to Week 52
Number of GCA Disease Flares
Serum Concentrations of Guselkumab
Time to First GCA Disease Flare
Up to Week 60
Number of Participants with Antibodies to Guselkumab
Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters
Number of Participants with Clinically Significant Abnormalities in Vital Signs
Number of Participants with TEAEs by System Organ Class With a Frequency Threshold of 5 percent (%) or More
Therapeutic procedure
Number of Participants with Treatment Emergent Serious Adverse Event (SAEs)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

2
JNJ-78934804
2
JNJ-78934804
2
PRV-3279

Side Effects for

Ixekizumab
9%Injection site reaction
8%Upper respiratory tract infection
7%Nasopharyngitis
This histogram enumerates side effects from a completed 2020 Phase 4 trial (NCT03573323) in the Ixekizumab ARM group. Side effects include: Injection site reaction with 9%, Upper respiratory tract infection with 8%, Nasopharyngitis with 7%.

Trial Design

2 Treatment Groups

Guselkumab
1 of 2
Placebo
1 of 2

Experimental Treatment

51 Total Participants · 2 Treatment Groups

Primary Treatment: Guselkumab · Has Placebo Group · Phase 2

Guselkumab
Drug
Experimental Group · 1 Intervention: Guselkumab · Intervention Types: Drug
Placebo
Drug
Experimental Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Guselkumab
FDA approved
Placebo
1995
Completed Phase 3
~2640

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from week 28 up to week 52

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
933 Previous Clinical Trials
6,368,680 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
716 Previous Clinical Trials
3,950,821 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have recently developed or experienced a return of giant cell arteritis (GCA).
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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