Secukinumab 300 mg for Giant Cell Arteritis

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Giant Cell ArteritisSecukinumab 300 mg - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug to see if it's effective and safe for people with a disease that causes inflammation in the arteries.

Eligible Conditions
  • Giant Cell Arteritis

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 10 Secondary · Reporting Duration: 52 weeks

12 weeks
Number of participants with clinical failure
52 Weeks
Gas Chromatography
52 weeks
Change in EQ-5D score
Change in FACIT-Fatigue Score
Change in GlucocorticoidToxicity Index (GTI)
Change in SF-36 score (PCS)
Cumulative GC dose
Number of participants with sustained remission
Proportion of participants with sustained remission
Safety and tolerability of secukinumab
Time to clinical failure

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Secukinumab 300 mg
20%Nasopharyngitis
13%Upper respiratory tract infection
11%Arthralgia
7%Bronchitis
7%Diarrhoea
2%Rib fracture
2%Upper limb fracture
2%Aortic stenosis
2%Dizziness
2%Muscular weakness
2%Abdominal pain
2%Cough
This histogram enumerates side effects from a completed 2018 Phase 4 trial (NCT02690701) in the Secukinumab 300 mg ARM group. Side effects include: Nasopharyngitis with 20%, Upper respiratory tract infection with 13%, Arthralgia with 11%, Bronchitis with 7%, Diarrhoea with 7%.

Trial Design

3 Treatment Groups

Secukinumab 150 mg
1 of 3
Secukinumab 300 mg
1 of 3
Placebo
1 of 3

Experimental Treatment

Non-Treatment Group

349 Total Participants · 3 Treatment Groups

Primary Treatment: Secukinumab 300 mg · Has Placebo Group · Phase 3

Secukinumab 150 mg
Biological
Experimental Group · 1 Intervention: Secukinumab 150 mg · Intervention Types: Biological
Secukinumab 300 mg
Biological
Experimental Group · 1 Intervention: Secukinumab 300 mg · Intervention Types: Biological
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Secukinumab 150 mg
2016
Completed Phase 4
~260
Secukinumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 52 weeks

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,717 Previous Clinical Trials
3,524,506 Total Patients Enrolled
3 Trials studying Giant Cell Arteritis
214 Patients Enrolled for Giant Cell Arteritis

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Patient must be able to understand and comply with the requirements of the study.
You have symptoms of polymyalgia rheumatica (PMR) and/or symptoms of limb ischemia (claudication).
You have signs or symptoms attributed to active GCA and not related to prior damage.
You have a diagnosis of GCA within 6 weeks of a BSL visit.