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Monoclonal Antibodies

Secukinumab for Giant Cell Arteritis and Polymyalgia Rheumatica

Phase 1
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 4 and week 8: pre-dose and end-of infusion (eoi); weeks 9, 10, 11, 12, 16 and 20: anytime
Awards & highlights

Summary

This trial will look at how the drug Secukinumab is processed in the body and whether it is safe for adult patients with giant cell arteritis or polymyalgia rheumatica after receiving

Who is the study for?
Adults over 50 with Giant Cell Arteritis (GCA) or Polymyalgia Rheumatica (PMR), experiencing symptoms like severe headaches, vision loss, jaw pain when eating, and morning stiffness. Participants must have signs of active GCA not due to past damage and no other joint issues. They should also test negative for certain arthritis markers and show evidence of vasculitis on medical imaging or a temporal artery biopsy.
What is being tested?
The trial is testing the safety and how well the body handles multiple doses of Secukinumab given through an IV in patients with GCA or PMR. It will track how the drug moves through and exits the body, as well as its tolerability after repeated infusions.
What are the potential side effects?
Possible side effects from Secukinumab may include reactions at the infusion site, increased risk of infections due to immune system suppression, allergic reactions, headache, runny nose or sore throat.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 4 and week 8: pre-dose and end-of infusion (eoi); weeks 9, 10, 11, 12, 16 and 20: anytime
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 4 and week 8: pre-dose and end-of infusion (eoi); weeks 9, 10, 11, 12, 16 and 20: anytime for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Secukinumab: Area under the concentration-time curve at steady state during a dosing interval (AUCtau,ss)
Secukinumab: Average concentration at steady state (Cavg,ss [=AUCtau,ss/tau])
Secukinumab: Maximum concentration at steady state (Cmax,ss)
+1 more
Secondary study objectives
Number of Participants with Treatment Emergent Adverse Events
Secukinumab: Clearance (CL)
Secukinumab: Volume of distribution at steady state (Vss)

Side effects data

From 2019 Phase 4 trial • 102 Patients • NCT03055494
19%
Nasopharyngitis
13%
Upper respiratory tract infection
7%
Cough
7%
Back pain
6%
Headache
4%
Muscle strain
4%
Urinary tract infection
4%
Anxiety
4%
Rhinorrhoea
4%
Sinus congestion
4%
Postoperative wound infection
4%
Conjunctivitis
4%
Pharyngitis streptococcal
4%
Gastroenteritis viral
4%
Diarrhoea
4%
Fatigue
4%
Aphthous ulcer
4%
Influenza
4%
Fall
2%
Insomnia
2%
Hypoglycaemia
2%
Tooth abscess
2%
Post procedural contusion
2%
Road traffic accident
2%
Ligament sprain
2%
Blood pressure increased
2%
Wound dehiscence
2%
Tinea pedis
2%
Tonsillitis
2%
Ligament rupture
2%
Oropharyngeal pain
2%
Productive cough
2%
Actinic keratosis
2%
Dermatitis
2%
Pruritus
2%
Dehydration
2%
Squamous cell carcinoma
2%
Irritability
2%
Sneezing
2%
Intertrigo
2%
Pruritus generalised
2%
Decreased appetite
2%
Nasal congestion
2%
Sinusitis
2%
Palpitations
2%
Glossodynia
2%
Cyst
2%
Cystitis
2%
Otitis externa candida
2%
Peripheral swelling
2%
Hordeolum
2%
Otitis media
2%
Ear pain
2%
Anaemia
2%
Cellulitis
2%
Suicidal ideation
2%
Lacrimation increased
2%
Muscle spasms
2%
Ear discomfort
2%
Pyrexia
2%
Abdominal distension
2%
Nausea
2%
Toothache
2%
Myalgia
2%
Influenza like illness
2%
Rash
2%
Seborrhoeic dermatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Secukinumab 300 mg
Placebo/Secukinumab 300 mg

Trial Design

2Treatment groups
Experimental Treatment
Group I: Secukinumab: Polymyalgia Rheumatica (PMR)Experimental Treatment1 Intervention
Group II: Secukinumab: Giant Cell Arteritis (GCA)Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Secukinumab
2015
Completed Phase 4
~22170

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,889 Previous Clinical Trials
4,201,944 Total Patients Enrolled
6 Trials studying Polymyalgia Rheumatica
1,223 Patients Enrolled for Polymyalgia Rheumatica
~34 spots leftby Jun 2025
Unbiased ResultsWe believe in providing patients with all the options.
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