Ended Therapeutic confirmatory (Phase III) Giant cell arteritis (GCA)

Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Giant Cell Arteritis (GCA)

EU CTIS ID: 2024-510744-31-00

What this study is testing

The primary objective is to demonstrate that the efficacy of secukinumab 300 mg s.c. in combination with a 26-week glucocorticoid (GC) taper regimen is superior to placebo in combination with a 52-week GC taper regimen in participants with GCA based on sustained remission at Week 52.

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Signed informed consent must be obtained prior to participation in the study.
  • Patient must be able to understand and communicate with the investigator and comply with the requirements of the study.
  • Male or non-pregnant, non-lactating female patients at least 50 years of age.
  • Diagnosis of GCA based on meeting all of the following criteria: Age at onset of disease ≥ 50 years. 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 polymyalgia rheumatica (PMR) (defined as shoulder and/or hip girdle pain associated with inflammatory morning stiffness) and/or symptoms of limb ischemia (claudication). 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 disease as defined by meeting both of the following within 6 weeks of BSL (see Section 8.1 for details) Presence of signs or symptoms attributed to active GCA and not related to prior damage (e.g., visual loss that occurred prior to 6 weeks before BSL without new findings occurring within 6 weeks of BSL) Elevated ESR ≥ 30 mm/hr or CRP ≥ 10 mg/L attributed to active GCA or active GCA on TAB or on imaging study.
  • Patients to meet definition of new-onset GCA or relapsing GCA: Definition of new-onset GCA*: GCA that is diagnosed within 6 weeks of BSL visit Definition relapsing GCA*: GCA diagnosed > 6 weeks before BSL visit and Following institution of an appropriate treatment course for GCA, participant has experienced recurrence of active symptoms or signs of disease after resolution. * The 6-week timeframe is to be calculated from the date of suspected GCA diagnosis. Suspected diagnosis is defined as date when GC therapy was initiated.

You likely can't join if

  • Previous exposure to secukinumab or other biologic drug directly targeting IL-17 or IL-17 receptor.
  • Confirmed diagnosis of any primary form of systemic vasculitis, other than GCA.
  • History of hypersensitivity or contraindication to any of the study treatments or its excipients or to drugs in similar chemical classes
  • Active ongoing diseases which in the opinion of the investigator immunocompromises the patient and/or places the patient at unacceptable risk for treatment with immunomodulatory therapy.
  • History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection as defined by a positive QuantiFERON TB- Gold Plus test. Patients with a positive test may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the patient has no evidence of active tuberculosis. 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 procedure. If presence of latent tuberculosis is established then treatment according to local country guidelines must be initiated prior to randomization.
  • Patients treated with i.v. immunoglobulins or plasmapheresis within 8 weeks prior to BSL.
See the full eligibility criteria
Who can join
  • Signed informed consent must be obtained prior to participation in the study.
  • Patient must be able to understand and communicate with the investigator and comply with the requirements of the study.
  • Male or non-pregnant, non-lactating female patients at least 50 years of age.
  • Diagnosis of GCA based on meeting all of the following criteria: Age at onset of disease ≥ 50 years. 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 polymyalgia rheumatica (PMR) (defined as shoulder and/or hip girdle pain associated with inflammatory morning stiffness) and/or symptoms of limb ischemia (claudication). 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 disease as defined by meeting both of the following within 6 weeks of BSL (see Section 8.1 for details) Presence of signs or symptoms attributed to active GCA and not related to prior damage (e.g., visual loss that occurred prior to 6 weeks before BSL without new findings occurring within 6 weeks of BSL) Elevated ESR ≥ 30 mm/hr or CRP ≥ 10 mg/L attributed to active GCA or active GCA on TAB or on imaging study.
  • Patients to meet definition of new-onset GCA or relapsing GCA: Definition of new-onset GCA*: GCA that is diagnosed within 6 weeks of BSL visit Definition relapsing GCA*: GCA diagnosed > 6 weeks before BSL visit and Following institution of an appropriate treatment course for GCA, participant has experienced recurrence of active symptoms or signs of disease after resolution. * The 6-week timeframe is to be calculated from the date of suspected GCA diagnosis. Suspected diagnosis is defined as date when GC therapy was initiated.
  • Patients’ current GCA episode should be treatable with a dose of prednisone (or equivalent) designed to adequately achieve disease control in accordance with international guidelines. If this is not possible due to concerns regarding GC toxicity, the patient should not be enrolled. It must be medically appropriate for the patient to receive prednisone (or equivalent) 20 mg-60 mg daily (or equivalent) at BSL.
  • Patients taking MTX (≤ 25 mg/week) are allowed to continue their medication provided they have taken it for at least 2 months and are on a stable dose for at least 4 weeks prior to randomization and if they are on stable folic acid treatment before randomization.
What rules you out
  • Previous exposure to secukinumab or other biologic drug directly targeting IL-17 or IL-17 receptor.
  • Confirmed diagnosis of any primary form of systemic vasculitis, other than GCA.
  • History of hypersensitivity or contraindication to any of the study treatments or its excipients or to drugs in similar chemical classes
  • Active ongoing diseases which in the opinion of the investigator immunocompromises the patient and/or places the patient at unacceptable risk for treatment with immunomodulatory therapy.
  • History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection as defined by a positive QuantiFERON TB- Gold Plus test. Patients with a positive test may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the patient has no evidence of active tuberculosis. 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 procedure. If presence of latent tuberculosis is established then treatment according to local country guidelines must be initiated prior to randomization.
  • Patients treated with i.v. immunoglobulins or plasmapheresis within 8 weeks prior to BSL.
  • Patients treated (i.e., systemic therapy) with cyclophosphamide or hydroxychloroquine within 6 months prior to BSL or tacrolimus, everolimus, cyclosporine A, azathioprine, sulfasalazine, mycophenolate mofetil within 4 weeks prior to BSL
  • 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); BSL or longer if required by local regulations
  • Patients treated with leflunomide within 8 weeks of BSL unless a cholestyramine washout has been performed in which case the patient must be treated within 4 weeks of BSL. Patients treated with an alkylating agent within 5 years prior to BSL, unless specified in other exclusion criteria.
  • Major ischemic event (e.g., myocardial infarction, stroke, etc.) or transient ischemic attack (TIA) (except ischemia-related vision loss), related or unrelated to GCA, within 12 weeks of screening.
  • BSL Patients requiring chronic (i.e., not occasional “prn”) high potency opioid analgesics for pain management.
  • Any other systemic biologics (e.g., denosumab, TNFα inhibitors) within 4 weeks or within 5 half-lives of the drug (whichever is longer) prior to BSL, or anticipated use of a biologic prior to EOS.
  • Patients requiring or anticipated to require systemic chronic glucocorticoid therapy or pulses of glucocorticoids for reasons other than GCA (e.g., COPD, asthma, planned surgery) at screening or randomization.
  • Live vaccinations (e.g., monkey pox vaccine, oral polio vaccine, varicella/zoster vaccines) within 6 weeks prior to BSL, or planned or anticipated potential need for live vaccination during study participation until 12 weeks after last study treatment administration.
  • Active infections during the last 2 weeks prior to randomization.
  • Patients treated with any cell-depleting therapies.
  • Previous participation in a clinical trial where the outcome of treatment with the GCA drug is unknown. This does not include trials where the treatment for GCA was GCs, MTX, leflunomide or azathioprine
  • Active inflammatory bowel disease or other ongoing inflammatory diseases other than GCA that might confound the evaluation of the benefit of secukinumab therapy, including uveitis at screening or randomization.
  • Patients who have been treated with inhibitors directly targeting IL-1, or IL-1 receptor, IL-12 and IL-23, or abatacept within 4 weeks or within 5 half-lives of the drug (whichever is longer) prior to BSL.
  • Treatment with tocilizumab, other IL-6/IL6-R inhibitor or JAK inhibitor within 12 weeks or within 5 half-lives of the drug (whichever is longer) prior to BSL, or if patient did not respond to or experienced a relapse during treatment any time before BSL.
  • Any treatment received for GCA where patient did not respond to treatment or experienced a relapse while on that treatment any time before BSL. This also includes patients who were treated in a clinical trial for GCA. Patients who failed on treatment with GCs, MTX, leflunomide and/or azathioprine may be included.

The study team makes the final eligibility decision.

Where it's taking place

  • Brazil
  • United Kingdom
  • Chile
  • Guatemala
  • Switzerland
  • Canada
  • Australia
  • Israel
  • Turkey
  • Argentina
  • New Zealand
  • United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Brazil; United Kingdom; Chile; Guatemala; Switzerland; Canada and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.