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Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Intravenous Secukinumab in Patients With GCA or PMR | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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)

NCT06130540•Novartis Pharmaceuticals

View on ClinicalTrials.gov

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).

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.

Eligibility

Age

50 - 100 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or non-pregnant, non-lactating female participants at least 50 years of age
•2. 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
•3. 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)
•* Elevated ESR \>= 30 mm/hr or CRP \>= 10 mg/L attributed to active GCA or active GCA on TAB or on imaging study
•1. Male or non-pregnant, non-lactating female participants at least 50 years of age
•2. 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)
+5 more criteria

Exclusion Criteria

•1. 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
•2. History of hypersensitivity or contraindication to any of the study treatments or its excipients or to drugs of similar chemical classes
•3. 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
•4. 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.
•5. 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)
+28 more criteria

Locations (19)

Rheumatology Associates of South Florida

Boca Raton, Florida, United States

FL Medical Clinic Orlando Health

Zephyrhills, Florida, United States

Willow Rheumatology Wellness

Willowbrook, Illinois, United States

Altoona Center for Clin Res

Duncansville, Pennsylvania, United States

West Tennessee Research Institute

Jackson, Tennessee, United States

Accurate Clinical Research Inc

San Antonio, Texas, United States

Overlake Internal Med Associates

Bellevue, Washington, United States

Rheumatology Pulmonary Clinic

Beckley, West Virginia, United States

Novartis Investigative Site

Uherské Hradiště, Uherske Hradiste, Czechia

Novartis Investigative Site

Brno-Bohunice, Czechia

Key Dates

Start Date

March 27, 2024

Primary Completion Date

March 12, 2025

Completion Date

April 2, 2025

Last Updated

January 26, 2026

Enrollment

ACTUAL participants

Conditions

Giant Cell ArteritisPolymyalgia Rheumatica

Interventions

Secukinumab

DRUG

Rheumatology Patient Registry and Biorepository

NCT04402086

Rheumatic DiseasesAdult Onset Still Disease+18 more

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RECRUITINGPHASE2

Dapagliflozin and Endothelin Receptor Antagonism in Large Vessel Vasculitis (DERAIL-LVV)

NCT06887062

Large Vessel VasculitisGiant Cell Arteritis (GCA)+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 26, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Rheumatology Patient Registry and Biorepository

Dapagliflozin and Endothelin Receptor Antagonism in Large Vessel Vasculitis (DERAIL-LVV)

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