Clinical trial: A Placebo-controlled Phase 2 Trial to Investigate the Safety and Efficacy of Secukinumab in Giant Cell Arteritis (NCT03765788)

Eligibility criteria:
Inclusion Criteria:

        Diagnosis of GCA classified according to the following criteria:

          -  Age at onset of disease ≥ 50 years.

          -  History of ESR ≥ 30 mm/hr or CRP ≥ 10 mg/L.

          -  Unequivocal cranial symptoms of GCA (new-onset localized headache, scalp or temporal
             artery tenderness, ischemia-related vision loss, or otherwise unexplained mouth or jaw
             pain upon mastication) AND/OR symptoms of polymyalgia rheumatica (PMR) defined as
             shoulder and/or hip girdle pain associated with inflammatory morning stiffness

          -  Temporal artery biopsy revealing features of GCA AND/OR

          -  evidence of large-vessel vasculitis by angiography or cross-sectional imaging study
             such as magnetic resonance angiography (MRA), computed tomography angiography (CTA),
             positron emission tomography-computed tomography (PET CT), or ultrasound

        Patients with new onset GCA or relapsing GCA (Definition new onset: diagnosis of GCA within
        6 weeks of Baseline Visit; Definition relapsing GCA: diagnosis of GCA (in accordance with
        inclusion criterion no. 4) > 6 weeks before Baseline Visit and in the meantime achieved
        remission (absence of signs and symptoms attributable to GCA and normalization of ESR (< 30
        mm/hr) and CRP (<10.0mg/L) included) including previous treatment with ≥ 25 mg/day
        prednisolone equivalent for ≥ 2 weeks.)

        Active disease as defined by the presence of signs and symptoms of GCA (cranial or PMR) and
        elevated ESR ≥ 30 mm/hr, or CRP ≥ 10 mg/L, attributed to active GCA within 6 weeks of
        Baseline.

        Prednisolone dose of 25-60 mg/day at Baseline.

        Exclusion Criteria:

        Previous exposure to secukinumab or other biologic drug directly targeting
        Interleukin(IL)-17 or IL-17 receptor.

        Patients treated with any cell-depleting therapies including but not limited to anti-CD20
        or investigational agents (e.g. anti-CD3, anti-CD4, anti-CD5 or anti-CD19).

        Patients who have previously been treated with any biologic agent including but not limited
        to tocilizumab, sirukumab, abatacept, or tumor necrosis factor alpha (TNFα) inhibitors
        (infliximab, adalimumab, etanercept, certolizumab, golimumab).

        Patients who have previously been treated with tofacitinib or baricitinib.

        Patients treated with i.v. immunoglobulins or plasmapheresis within 8 weeks prior to
        Baseline.

        Patients treated with cyclophosphamide, tacrolimus or everolimus within 6 months prior to
        Baseline.

        Patients treated with hydroxychloroquine, cyclosporine A, azathioprine, sulfasalazine or
        mycophenolate mofetil within 4 weeks of Baseline.

        Patients treated with leflunomide within 8 weeks of Baseline unless a cholestyramine
        washout has been performed in which case the patient must be treated within 4 weeks of
        Baseline.

        Patients treated with an alkylating agent except for cyclophosphamide as mentioned above.

        Patients requiring systemic chronic glucocorticoid therapy for any other reason than GCA.

        Chronic systemic glucocorticoid therapy over the last 4 years or longer; or inability, in
        the opinion of the investigator, to withdraw glucocorticoid therapy through
        protocol-defined taper regimen due to suspected or established adrenal insufficiency.

        Patients requiring chronic (i.e. not occasional "prn") high potency opioid analgesics for
        pain management.

        Active ongoing inflammatory diseases or underlying metabolic, hematologic, renal, hepatic,
        pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal conditions, which
        in the opinion of the investigator immunosuppressed the patient and/or places the patient
        at unacceptable risk for participation in an immunomodulatory therapy.

        History of renal trauma, glomerulonephritis, or patients with one kidney only, or a serum
        creatinine level exceeding 1.8 mg/dL (159.12 μmol/L).

        Screening total white blood cell (WBC) count < 3000/μL, or platelets < 100 000/μL or
        neutrophils < 1500/μL or hemoglobin < 8.3 g/dL (83 g/L).

        Major ischemic event, unrelated to GCA, within 12 weeks of screening.

        Known infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C at
        screening or randomization.

        Life vaccinations within 6 weeks prior to Baseline or planned vaccination during study
        participation until 12 weeks after last study treatment administration.

        Other protocol-defined inclusion/exclusion criteria may apply.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.


Patient description (medical language): A 61-year-old man comes to the emergency department complaining of an acute vision disturbance. He had an episode of vision disturbance in the right eye that occurred suddenly and resolved spontaneously in 15 minutes. He also has right jaw pain while chewing.  He also complains of fatigue and hip muscle aches over the last several months.  The patient has a history of mild hyperlipidemia that has been controlled by diet and lifestyle modifications.  On examination, his blood pressure is 130/70 mm Hg and pulse is 66/min.  Neurological examination is unremarkable.  Visual examination is also normal. ESR is 103 mm/h. Temporal artery biopsy shows multinuclear giant cells and internal elastic membrane fragmentation.

Patient description (patient's own words): I’m a 61-year-old man and I came to the ER because I had a sudden episode where I couldn’t see out of my right eye. It only lasted about 15 minutes and went away on its own but it really scared me. I’ve also been having pain in my right jaw when I chew. For the past few months I’ve felt really tired and noticed my hips ache a lot. I have a history of mild cholesterol issues but I’ve been managing that with my diet and lifestyle. When the doctors checked me my blood pressure and pulse were normal and my vision and neurological exams didn’t show anything wrong. However they ran some tests and said my ESR levels were very high and a biopsy of my temporal artery showed some inflammation and damage.

Does the patient match the trial criteria? Entailment