Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucoco… (NCT04930094) | Clinical Trial Compass
CompletedPhase 3
Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Giant Cell Arteritis (GCA)
United States354 participantsStarted 2021-10-06
Plain-language summary
This is a phase III study of efficacy and safety of secukinumab versus placebo, in combination with glucocorticoid taper regimen, in patients with giant cell arteritis (GCA)
Who can participate
Age range50 Years – 100 Years
SexALL
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Inclusion criteria
✓. 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:
✓. Active disease as defined by meeting both of the following within 6 weeks of BSL (see Section 8.1 for details)
✓. Patients to meet definition of new-onset GCA or relapsing GCA:
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Proportion of participants with sustained remission
. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during study treatment or longer if required by locally approved prescribing information (e.g., in European Union (EU) 20 weeks after treatment discontinuation). Also, contraception should be used in accordance with locally approved prescribing information of concomitant medications administered (e.g., Rescue Treatment). Effective contraception methods include:
✕. Previous exposure to secukinumab or other biologic drug directly targeting IL-17 or IL-17 receptor.
✕. 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
✕. 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 the patient did not respond to or experienced a relapse during treatment any time before BSL.
✕. Any treatment received for GCA in which 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.