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Giant Cell ArteritisPhase 1NCT06130540

Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Intravenous Secukinumab in Patients With GCA or PMR

A Phase 1 study testing Secukinumab in people with Giant Cell Arteritis and Polymyalgia Rheumatica, run by Novartis Pharmaceuticals at 19 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will examine how intravenous (i.v.) Secukinumab will be processed in the body (pharmacokinetics [PK]) and whether it will be safe and tolerable after multiple doses of i.v. Secukinumab infusion in adult patients with giant cell arteritis (GCA) or polymyalgia rheumatica (PMR). Read more about this study

Who is it for?
Ages 50 to 100 years
Conditions the study is for
Giant Cell Arteritis, Polymyalgia Rheumatica
What is being tested?
Secukinumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
19 sitesin 6 countries
Study dates
27 Mar 2024to 2 Apr 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or non-pregnant, non-lactating female participants at least 50 years of age
  • Diagnosis of GCA based on meeting all of the following criteria:
  • Unequivocal cranial symptoms of GCA (e.g., new-onset localized headache, scalp or temporal artery tenderness, permanent or temporary ischemia-related vision loss, or otherwise unexplained mouth or jaw pain upon mastication), and/or unequivocal symptoms of PMR (defined as shoulder and/or hip girdle pain associated with inflammatory morning stiffness) and/or symptoms of limb ischemia (claudication)
  • Temporal artery biopsy (TAB) revealing features of GCA and/or cross-sectional imaging study such as ultrasound (e.g., cranial or axillary), MRI/MRA, CTA, or PET-CT with evidence of vasculitis
  • Active GCA disease within 6 months prior to Baseline as defined by meeting both of the following:
  • Presence of signs or symptoms attributed to active GCA and not related to prior damage (e.g., vision loss that occurred without new findings)
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  • Elevated ESR >= 30 mm/hr or CRP >= 10 mg/L attributed to active GCA or active GCA on TAB or on imaging study
  • Male or non-pregnant, non-lactating female participants at least 50 years of age
  • Diagnosis of PMR according to the provisional ACR/EULAR classification criteria: Participants >= 50 years of age with a history of bilateral shoulder pain accompanied by elevated CRP concentration (>= 10 mg/L) and/or elevated ESR (>= 30 mm/hr) who scored at least 4 points from the following optional classification criteria:
  • Morning stiffness >45 min (2 points)
  • Hip pain or restricted range of motion (1 point)
  • Absence of rheumatoid factor and/or anti-citrullinated protein antibodies (2 points)
  • Absence of other joint involvement (1 point)
  • Active PMR disease within 6 months prior to Baseline as defined by signs and symptoms attributable to PMR meeting the following:
  • Bilateral shoulder girdle and/or bilateral hip girdle pain associated with inflammatory stiffness with or without additional symptoms indicative of a PMR relapse (such as constitutional symptoms) that are in the opinion of the Investigator not due to other diseases that may mimic PMR such as osteoarthritis in shoulders or hips, polyarticular calcium pyrophosphate deposition disease, rotator cuff disease, adhesive capsulitis (frozen shoulder) or fibromyalgia

Who cannot join

  • Pregnant or nursing (lactating) women where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test
  • History of hypersensitivity or contraindication to any of the study treatments or its excipients or to drugs of similar chemical classes
  • Use of other investigational drugs within 5 half-lives of enrollment or within 30 days (e.g., small molecules) or until the expected pharmacodynamic effect has returned to BSL (e.g., biologics), whichever is longer; or longer if required by local regulations
  • History of clinically significant liver disease or liver injury as indicated by clinically significantly abnormal liver function tests (LFTs), such as SGOT (AST), SGPT (ALT) and serum bilirubin. The Investigator should be guided by the following criteria:
  • AST (Aspartate Aminotransferase) and ALT (Alanine Aminotransferase) may not exceed 3 x the upper limit of normal (ULN)
  • Total bilirubin concentration may not exceed 1.5 x ULN Any one of these parameters, if elevated above ULN, should be re-checked once more as soon as possible, and in all cases, at least prior to enrollment, to rule-out laboratory error.
Show all 39Show fewer
  • Active infections or history of ongoing, chronic or recurrent infectious disease including but not limited to below:
  • Active infections during the last 2 weeks prior to BSL
  • Known infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV) at screening or BSL, except for HCV successfully treated and cured, according to local/global guidelines
  • Evidence of tuberculosis (TB) infection as defined by a positive QuantiFERON TB-Gold Plus test. Participants with a positive test may participate in the study if further work-up (according to local practice/guidelines) establishes conclusively that the participant has no evidence of active TB. If the test result is indeterminate, the Investigator may repeat the test once or may proceed directly to perform the work-up for TB as per local procedures. If presence of latent TB is established, then treatment must be initiated prior to BSL (both treatment and timing prior to BSL according to local country guidelines)
  • Active inflammatory bowel disease or active uveitis
  • Active ongoing diseases which in the opinion of the Investigator immuno-compromises the participant and/or places the participant at unacceptable risk for treatment with immunomodulatory therapy
  • Current severe progressive or uncontrolled disease, which in the judgment of the Investigator renders the participant unsuitable for the trial, including but not limited to below:
  • Major ischemic event (e.g., myocardial infarction, stroke, etc.) or transient ischemic attack (TIA) within 12 weeks of screening
  • Significant medical conditions or diseases, including but not limited to the following: uncontrolled hypertension, congestive heart failure (New York Heart Association (NYHA) status of class III or IV) and uncontrolled diabetes mellitus
  • Any other current severe progressive or uncontrolled diseases per the Investigator's discretion
  • Confirmed diagnosis of any primary form of systemic vasculitis, other than GCA
  • Pregnant or nursing (lactating) women where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test
  • History of hypersensitivity or contraindication to any of the study treatments or its excipients or to drugs of similar chemical classes
  • Use of other investigational drugs within 5 half-lives of enrollment or within 30 days (e.g., small molecules) or until the expected pharmacodynamic effect has returned to BSL (e.g., biologics), whichever is longer; or longer if required by local regulations
  • History of clinically significant liver disease or liver injury as indicated by clinically significantly abnormal liver function tests (LFTs), such as SGOT (AST), SGPT (ALT) and serum bilirubin. The Investigator should be guided by the following criteria:
  • AST (Aspartate Aminotransferase) and ALT (Alanine Aminotransferase) may not exceed 3 x the upper limit of normal (ULN)
  • Total bilirubin concentration may not exceed 1.5 x ULN Any one of these parameters, if elevated above ULN, should be re-checked once more as soon as possible, and in all cases, at least prior to enrollment, to rule-out laboratory error.
  • Active infections or history of ongoing, chronic or recurrent infectious disease including but not limited to below:
  • Active infections during the last 2 weeks prior to BSL
  • Known infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV) at screening or BSL, except for HCV successfully treated and cured, according to local/global guidelines
  • Evidence of TB infection as defined by a positive QuantiFERON TB-Gold Plus test. Participants with a positive test may participate in the study if further work-up (according to local practice/guidelines) establishes conclusively that the participant has no evidence of active TB. If the test result is indeterminate, the Investigator may repeat the test once or may proceed directly to perform the work-up for TB as per local procedures. If presence of latent TB is established, then treatment must be initiated prior to BSL (both treatment and timing prior to BSL according to local country guidelines)
  • Active inflammatory bowel disease or active uveitis
  • Active ongoing diseases which in the opinion of the Investigator immuno-compromises the participant and/or places the participant at unacceptable risk for treatment with immunomodulatory therapy
  • Current severe progressive or uncontrolled disease, which in the judgment of the Investigator renders the participant unsuitable for the trial, including but not limited to below:
  • Major ischemic event (e.g., myocardial infarction, stroke, etc.) or transient ischemic attack (TIA) within 12 weeks of screening
  • Significant medical conditions or diseases, including but not limited to the following: uncontrolled hypertension, congestive heart failure (New York Heart Association (NYHA) status of class III or IV) and uncontrolled diabetes mellitus
  • Any other current severe progressive or uncontrolled diseases per the Investigator's discretion
  • Evidence of GCA as indicated by typical (cranial) symptoms (e.g., persistent or recurrent localized headache, temporal artery or scalp tenderness, jaw claudication, blurry or loss of vision, symptoms of stroke), extremity claudication, imaging and/or temporal artery biopsy result
  • Note: Imaging and/or temporal artery biopsy are not standard of care for PMR management and diagnosis and are therefore not mandated as part of the screening; Patients with PMR symptoms only who have a temporal artery biopsy in line with GCA and/or radiologic signs of vasculitis may be eligible for the GCA cohort
  • Concurrent rheumatoid arthritis or other inflammatory arthritis or other connective tissue diseases, such as but not limited to systemic lupus erythematosus, systemic sclerosis, vasculitis, myositis, mixed connective tissue disease, and ankylosing spondylitis
  • Concurrent diagnosis or history of neuropathic muscular diseases including fibromyalgia
  • Inadequately treated hypothyroidism (e.g., persistence of symptoms, lack of normalization of serum TSH despite regular hormonal replacement treatment)
  • Additional protocol-defined inclusion / exclusion criteria may apply.

Trial locations and contacts

19 sites in 6 countries.

19 sites in 6 countries

United States8 sites

  • Rheumatology Pulmonary Clinic

    Beckley, West Virginia, 25801

  • Overlake Internal Med Associates

    Bellevue, Washington, 98004

  • Rheumatology Associates of South Florida

    Boca Raton, Florida, 33486

  • Altoona Center for Clin Res

    Duncansville, Pennsylvania, 16635

  • West Tennessee Research Institute

    Jackson, Tennessee, 38305

  • Accurate Clinical Research Inc

    San Antonio, Texas, 78229

  • Willow Rheumatology Wellness

    Willowbrook, Illinois, 60527

  • FL Medical Clinic Orlando Health

    Zephyrhills, Florida, 33542

Other trials in United States

Spain3 sites

  • Novartis Investigative Site

    Madrid, 28009

  • Novartis Investigative Site

    Madrid, 28046

  • Novartis Investigative Site

    Santiago de Compostela, Galicia, 15706

Other trials in Spain

Switzerland3 sites

  • Novartis Investigative Site

    Basel, 4031

  • Novartis Investigative Site

    Bern, 3010

  • Novartis Investigative Site

    Sankt Gallen, 9007

Other trials in Switzerland

Czechia2 sites

  • Novartis Investigative Site

    Brno-Bohunice, 625 00

  • Novartis Investigative Site

    Uherské Hradiště, Uherske Hradiste, 686 01

Other trials in Czechia

Italy2 sites

  • Novartis Investigative Site

    Florence, FI, 50134

  • Novartis Investigative Site

    Reggio Emilia, RE, 42123

Other trials in Italy

Portugal1 site

  • Novartis Investigative Site

    Lisbon, 1649 035

Other trials in Portugal

About this study

Official title: An Open-label, Multicenter Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Intravenous Secukinumab Infusion in Adults With Giant Cell Arteritis (GCA) or Polymyalgia Rheumatica (PMR)

This study will examine how intravenous (i.v.) Secukinumab will be processed in the body (pharmacokinetics [PK]) and whether it will be safe and tolerable after multiple doses of i.v. Secukinumab infusion in adult patients with giant cell arteritis (GCA) or polymyalgia rheumatica (PMR).

Read the detailed description

This is a 12-week, open-label, multicenter, basket design study followed by an 8-week follow-up period in two cohorts of participants, one cohort with GCA and one cohort with PMR.

This study will consist of 3 phases: screening, treatment and follow-up.

Participants will enter a screening period: up to 6 weeks to assess eligibility [or up to 8 weeks in the event of a major healthcare disruption or a need to complete screening requirements (e.g., required washouts, TB testing, and work up and treatment as needed per local guidelines. Participants will enter a treatment period of 12 weeks: 2 cohorts (GCA and PMR cohorts) receiving total of 3 i.v. doses of Secukinumab (Week 0, Week 4 and Week 8). After treatment participants will enter a follow-up period: 8 weeks treatment-free follow-up (12 weeks after last dose of study treatment).

The total duration of the trial for a participant (from screening to follow up) is approximately 26 weeks (maximum of approximately 28 weeks) including safety follow-up.

Being tested
Secukinumab
Keywords
Giant cell arteritis (GCA), Polymyalgia rheumatica (PMR), Secukinumab, pharmacokinetics, intravenous
Medical subject headings
Giant Cell Arteritis, Polymyalgia Rheumatica

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SecukinumabDrug

    Also called AIN457

    Intravenous (i.v.) doses of Secukinumab at Week 0, Week 4 and Week 8

Study groups in NCT06130540
Study groupRoleWhat they receive
Secukinumab: Giant Cell Arteritis (GCA)ExperimentalNot described
Receives: Drug: Secukinumab
Secukinumab: Polymyalgia Rheumatica (PMR)ExperimentalNot described
Receives: Drug: Secukinumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Secukinumab: Maximum concentration at steady state (Cmax,ss)

    Venous whole blood samples will be collected and analyzed for all PK evaluable participants. Maximum concentration at steady state (Cmax,ss) will be listed and summarized using descriptive statistics.

    Measured: Baseline, Week 4 and Week 8: Pre-dose and End-of Infusion (EOI); Weeks 9, 10, 11, 12, 16 and 20: Anytime

  2. Secukinumab: Minimum concentration at steady state (Cmin,ss)

    Venous whole blood samples will be collected and analyzed for all PK evaluable participants. Minimum concentration at steady state (Cmin,ss) will be listed and summarized using descriptive statistics.

    Measured: Baseline, Week 4 and Week 8: Pre-dose and End-of Infusion (EOI); Weeks 9, 10, 11, 12, 16 and 20: Anytime

  3. Secukinumab: Area under the concentration-time curve at steady state during a dosing interval (AUCtau,ss)

    Venous whole blood samples will be collected and analyzed for all PK evaluable participants. Area under the concentration-time curve at steady state during a dosing interval (AUCtau,ss) will be listed and summarized using descriptive statistics.

    Measured: Baseline, Week 4 and Week 8: Pre-dose and End-of Infusion (EOI); Weeks 9, 10, 11, 12, 16 and 20: Anytime

  4. Secukinumab: Average concentration at steady state (Cavg,ss [=AUCtau,ss/tau])

    Venous whole blood samples will be collected and analyzed for all PK evaluable participants. Average concentration at steady state (Cavg,ss [=AUCtau,ss/tau]) will be listed and summarized using descriptive statistics.

    Measured: Baseline, Week 4 and Week 8: Pre-dose and End-of Infusion (EOI); Weeks 9, 10, 11, 12, 16 and 20: Anytime

Secondary outcomes (3)

  1. Number of Participants with Treatment Emergent Adverse Events

    The distribution of adverse events will be done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs) and Serious Adverse Event (TESAEs), through the monitoring of relevant clinical and laboratory safety parameters.

    Measured: Up to 12 weeks after last dose administration.

  2. Secukinumab: Clearance (CL)

    Venous whole blood samples will be collected and analyzed for all PK evaluable participants. Clearance (CL) will be listed and summarized using descriptive statistics.

    Measured: Baseline, Week 4 and Week 8: Pre-dose and End-of Infusion (EOI); Weeks 9, 10, 11, 12, 16 and 20: Anytime

  3. Secukinumab: Volume of distribution at steady state (Vss)

    Venous whole blood samples will be collected and analyzed for all PK evaluable participants. Volume of distribution at steady state (Vss) will be listed and summarized using descriptive statistics.

    Measured: Baseline, Week 4 and Week 8: Pre-dose and End-of Infusion (EOI); Weeks 9, 10, 11, 12, 16 and 20: Anytime

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2023
  2. Study start27 Mar 2024
  3. Primary completion12 Mar 2025
  4. Study completion2 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
30 patients per cohort (Giant Cell Arteritis (GCA) and Polymyalgia Rheumatica (PRM) are planned to be enrolled
Masking
None (open label)
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06130540
Sponsor's protocol ID
CAIN457E22101
Other IDs
2023-507667-19-00, 2023
Status last verified
Mar 2026
First submitted
8 Nov 2023
Last updated
1 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Secukinumab in people with Giant Cell Arteritis and Polymyalgia Rheumatica, run by Novartis Pharmaceuticals at 19 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States, Spain, Switzerland, Czechia, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Secukinumab: Maximum concentration at steady state (Cmax,ss) (time frame: Baseline, Week 4 and Week 8: Pre-dose and End-of Infusion (EOI); Weeks 9, 10, 11, 12, 16 and 20: Anytime). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06130540.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.

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