A Phase 2 interventional study of Secukinumab 300 mg, s.c. and Prednisolone in Giant Cell Arteritis, sponsored by Novartis Pharmaceuticals. Completed at 11 sites in Germany. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2023-08-21.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 2, Interventional, and Treatment
This study was designed to evaluate the efficacy and safety of secukinumab compared to placebo to maintain disease remission up to 28 weeks including corticosteroid tapering, as well as up to 1 year (52 weeks) in patients with newly diagnosed or relapsing giant cell arteritis (GCA) who were naïve to biological therapy.
This randomized, parallel-group, double-blind, placebo-controlled, multicenter, Phase II study was designed to evaluate the efficacy of secukinumab compared to placebo in combination with a 26-week prednisolone taper regimen in terms of sustained remission in patients with newly diagnosed or relapsing Giant Cell Arteritis (GCA) who were naïve to biological therapy. The study consisted of a Screening Period of up to 6 weeks (maximum duration), a 52-week Treatment Period and an 8-week Safety Follow-up Period
Patients who did not achieve remission by Week 12, experienced a flare after remission or could not adhere to the prednisolone taper regimen entered "escape". Upon entering "escape", patients received prednisolone at a dose determined by the physician's clinical judgment and continued to receive secukinumab or placebo in a blinded manner.
Safety evaluation was included in all visits including two safety follow-up visits performed 8 and 12 weeks after the last study drug administration.
173 studies on the registry are indexed under Giant Cell Arteritis; 49 are open to participants now.
This study's enrollment of 52 is below the median of 60 across 82 interventional studies indexed under Giant Cell Arteritis.
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Diagnosis of GCA classified according to the following criteria:
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.
Participants received secukinumab at a dose of 300 milligrams (mg) as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to week 48 along with a 26-week prednisolone tapering regimen.
Drug: Secukinumab 300 mg, s.c. · Drug: Prednisolone
Participants received placebo as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to week 48 along with a 26-week prednisolone tapering regimen.
Drug: Prednisolone · Drug: Placebo
Secukinumab 300 mg was administered by subcutaneous (s.c.) injections using 1 mL pre-filled syringes (PFSs) throughout the study.
Also known as: AIN457
Prednisolone was provided as tablets (1 mg, 5 mg, 10 mg, 20 mg tablets) for daily administration as tapered regimen from a dose of 25 mg to 60 mg at Baseline to 1 mg at Week 26 (last dose)
Placebo 300 mg was administered by subcutaneous (s.c.) injections using 1 mL pre-filled syringes (PFSs) throughout the study.
Percentage of Participants in Sustained Remission Until Week 28
Remission was defined as the absence of flare. Sustained remission was defined as the absence of flare until Week 28 and in adherence to the protocol prednisolone taper regimen. Flare was determined by the investigator and was defined as the recurrence after remission of signs or symptoms of Giant Cell Arteritis (GCA) and/or erythrocyte sedimentation rate (ESR) greater than or equal to (\>/=) 30 millimeters per hour (mm/hr) and/or C-reactive Protein (CRP) (\>/=10.0 mg/L) attributable to GCA. Patients were classified as non-responders if they did not achieve remission within 12 weeks of Baseline (remission referred to the absence of flare), were in the "escape arm" (this referred to patients entering escape between Baseline and Week 28), prematurely discontinued study treatment prior to Week 28 (absence of flare was checked prior to study treatment administration), did not have information to evaluate sustained remission response until Week 28.
Time frame: Until week 28
Percentage of Participants in Remission at Week 12
Remission was defined as the absence of flare. Sustained remission was defined as the absence of flare until Week 28 and in adherence to the protocol prednisolone taper Regimen. Flare was determined by the investigator and was defined as the recurrence after remission of signs or symptoms of GCA and/or erythrocyte sedimentation rate (ESR) greater than or equal to (\>/=) 30 millimeters per hour (mm/hr) and/or CRP (\>/=10.0 mg/L) attributable to GCA. Patients were classified as non-responders if they did not achieve remission within 12 weeks of Baseline (remission referred to the absence of flare), were in the "escape arm" (this referred to patients entering escape between Baseline and Week 28), prematurely discontinued study treatment prior to Week 28 (absence of flare was checked prior to study treatment administration), did not have information to evaluate sustained remission response until Week 28.
Time frame: Week 12
Time to First GCA Flare After Clinical Remission
Flare was determined by the investigator and was defined as the recurrence after remission of signs or symptoms of GCA and/or erythrocyte sedimentation rate (ESR) greater than or equal to (\>/=) 30 millimeters per hour (mm/hr) and/or CRP (\>/=10.0 mg/L) attributable to GCA. Time to first flare after remission referred to time from first day of study treatment until first post-Baseline flare. For time to first GCA flare after remission (up to and including Week 52), patients who prematurely discontinued study treatment prior to Week 52 were censored at the time of premature discontinuation and patients who completed treatment and did not have a flare were censored at their last visit in the treatment phase. Time to first GCA flare after remission was calculated using Kaplan-Meier plot of time.
Time frame: Up to Week 52 (included)
Total Cumulative Prednisolone Dose Over 28 Weeks and 52 Weeks
Total cumulative co-administered prednisolone treatment was summarized over time by treatment arm. Patients received a daily dose of prednisolone, which was decreased (i.e. tapered down) from Baseline to Week 26. No additional prednisolone or equivalent was permitted.
Time frame: from Baseline to week 28, from baseline to week 52 weeks
Percentage of Participants With GCA Who Had Sustained Remission Until Week 52
Remission was defined as the absence of flare. Sustained remission was defined as patients without flare until Week 52 and in adherence to the protocol prednisolone taper regimen plus prednisolone-free phase from Week 27 onwards. Flare was determined by the investigator and was defined as the recurrence after remission of signs or symptoms of GCA and/or erythrocyte sedimentation rate (ESR) greater than or equal to (\>/=) 30 millimeters per hour (mm/hr) and/or CRP (\>/=10.0 mg/L) attributable to GCA. Patients were classified as non-responders if they did not achieve remission within 12 weeks of Baseline (remission referred to the absence of flare), were in the "escape arm" (this referred to patients entering escape between Baseline and Week 28), prematurely discontinued study treatment prior to Week 28 (absence of flare was checked prior to study treatment administration), did not have information to evaluate sustained remission response until Week 28.
Time frame: Until Week 52
Number of Participants on Prednisolone Dose ≤ 5mg/Day
Number of participants on co-administered prednisolone treatment ≤ 5mg/day who responded at Week 19, Week 26 and Week 52. Remission was defined as the absence of flare. Sustained remission was defined as the absence of flare until Week 28 and in adherence to the protocol prednisolone taper Regimen. There were 2 taper regimens: for patients on 40 to 60 mg/day prednisolone at Baseline and for patients on 25 to 40 mg/day prednisolone at Baseline depending on patients' prednisolone levels at Baseline. Prednisolone was tapered from a dose of 25 mg to 60 mg at Baseline to 1 mg at Week 26 \[last dose\].
Time frame: Week 19, Week 28, Week 52
Physicians Global Assessment (PhGA) of Disease Activity: Change From Baseline Score Via Visual Analogue Scale (VAS)
Clinician Reported Outcome: Physicians global assessment (PhGA) using a visual analogue scale (VAS) scale. VAS is a range of scores from 0-100, with lower change from baseline scores indicating a more favorable outcome and higher change from baseline scores indicating a greater disease activity.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 & 52
Patients Global Assessment (PGA) of Disease Activity: Change From Baseline Via Visual Analogue Scale (VAS)
Patient Reported Outcome: Patients global assessment (PGA) score using a VAS scale. VAS is a range of scores from 0-100, with lower change from baseline scores indicating a more favorable outcome and higher change from baseline scores indicating a greater disease activity.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 & 52
Change From Baseline in FACIT-Fatigue Scale
Patient Reported Outcome: Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue is a 13-item questionnaire with a full scale of 0 -52 that assesses self-reported fatigue and its impact upon daily activities and function. The higher the score the better functioning (less fatigue).
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 & 52
Change From Baseline in Short-Form (SF)-36 Questionnaire
Patient Reported Outcome: The SF-36 is a standardized questionnaire used to measure health-related quality of life among healthy patients and patients with acute and chronic conditions. It consists of 8 subscales that can be scored individually: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. The higher the score (change from baseline) the more favorable the outcome. The values were reported by change from baseline in SF-36 domain scores.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 & 52
Change From Baseline in EQ-5D-5L (EuroQol 5D) Questionnaire
EQ-5D-5L, a self-administered questionnaire assessing health status in adults, is divided into 2 sections. The 1st section addresses 5 dimensions (mobility, self-care, usual activity, pain/discomfort, \& anxiety/depression). Items are rated either "no problem", "slight problems", "moderate problems", "severe problems", or "extreme problems/unable." A composite health index is defined by combining the levels for each dimension. The 2nd section measures self-rated (global) health status via vertically oriented VAS where 100 represents the "best possible health state" \& 0 represents the "worst possible health state." The EQ-5D-5L contains 6 items assessing health status via a single index value or health utility score and allows "weighting" by the patient of health states \& generation of patient utilities. Published weights are available allowing for creation of a single summary health utility score. Scores range from 0 to 1, with lower scores representing a higher level of dysfunction.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 & 52
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
ESR is a laboratory test that provides a non-specific measure of inflammation. This was assessed in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.
Time frame: Baseline, Week 28, Week 52
Change From Baseline in C-Reactive Protein (CRP) Level
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. This was assessed in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time frame: Baseline, Week 28, Week 52
Participants took part in 11 investigative sites in 1 country.
| Milestone | Secukinumab | Placebo |
|---|---|---|
| Started | 27 | 25 |
| Completed | 22 | 17 |
| Not completed | 5 | 8 |
| Withdrew: Subject decision | 2 | 3 |
| Withdrew: Physician decision | 2 | 4 |
| Withdrew: Death | 0 | 1 |
| Withdrew: Lost to follow-up | 1 | 0 |
Remission was defined as the absence of flare. Sustained remission was defined as the absence of flare until Week 28 and in adherence to the protocol prednisolone taper regimen. Flare was determined by the investigator and was defined as the recurrence after remission of signs or symptoms of Giant Cell Arteritis (GCA) and/or erythrocyte sedimentation rate (ESR) greater than or equal to (\>/=) 30 millimeters per hour (mm/hr) and/or C-reactive Protein (CRP) (\>/=10.0 mg/L) attributable to GCA. Patients were classified as non-responders if they did not achieve remission within 12 weeks of Baseline (remission referred to the absence of flare), were in the "escape arm" (this referred to patients entering escape between Baseline and Week 28), prematurely discontinued study treatment prior to Week 28 (absence of flare was checked prior to study treatment administration), did not have information to evaluate sustained remission response until Week 28.
| Participants | Secukinumab | Placebo |
|---|---|---|
| Percentage of Participants in Sustained Remission Until Week 28 | 19 | 6 |
Remission was defined as the absence of flare. Sustained remission was defined as the absence of flare until Week 28 and in adherence to the protocol prednisolone taper Regimen. Flare was determined by the investigator and was defined as the recurrence after remission of signs or symptoms of GCA and/or erythrocyte sedimentation rate (ESR) greater than or equal to (\>/=) 30 millimeters per hour (mm/hr) and/or CRP (\>/=10.0 mg/L) attributable to GCA. Patients were classified as non-responders if they did not achieve remission within 12 weeks of Baseline (remission referred to the absence of flare), were in the "escape arm" (this referred to patients entering escape between Baseline and Week 28), prematurely discontinued study treatment prior to Week 28 (absence of flare was checked prior to study treatment administration), did not have information to evaluate sustained remission response until Week 28.
| Participants | Secukinumab | Placebo |
|---|---|---|
| Percentage of Participants in Remission at Week 12 | 22 | 12 |
Flare was determined by the investigator and was defined as the recurrence after remission of signs or symptoms of GCA and/or erythrocyte sedimentation rate (ESR) greater than or equal to (\>/=) 30 millimeters per hour (mm/hr) and/or CRP (\>/=10.0 mg/L) attributable to GCA. Time to first flare after remission referred to time from first day of study treatment until first post-Baseline flare. For time to first GCA flare after remission (up to and including Week 52), patients who prematurely discontinued study treatment prior to Week 52 were censored at the time of premature discontinuation and patients who completed treatment and did not have a flare were censored at their last visit in the treatment phase. Time to first GCA flare after remission was calculated using Kaplan-Meier plot of time.
| days | Secukinumab | Placebo |
|---|---|---|
| Time to First GCA Flare After Clinical Remission | NA (NA to NA) | 197.0 (101.0 to 280.0) |
Total cumulative co-administered prednisolone treatment was summarized over time by treatment arm. Patients received a daily dose of prednisolone, which was decreased (i.e. tapered down) from Baseline to Week 26. No additional prednisolone or equivalent was permitted.
| milligrams | Secukinumab | Placebo |
|---|---|---|
| Baseline to Week 28 | 2689.70 ± 935.860 | 2693.74 ± 1241.907 |
| Baseline to Week 52 | 2841.26 ± 1116.192 | 3375.58 ± 1720.978 |
Remission was defined as the absence of flare. Sustained remission was defined as patients without flare until Week 52 and in adherence to the protocol prednisolone taper regimen plus prednisolone-free phase from Week 27 onwards. Flare was determined by the investigator and was defined as the recurrence after remission of signs or symptoms of GCA and/or erythrocyte sedimentation rate (ESR) greater than or equal to (\>/=) 30 millimeters per hour (mm/hr) and/or CRP (\>/=10.0 mg/L) attributable to GCA. Patients were classified as non-responders if they did not achieve remission within 12 weeks of Baseline (remission referred to the absence of flare), were in the "escape arm" (this referred to patients entering escape between Baseline and Week 28), prematurely discontinued study treatment prior to Week 28 (absence of flare was checked prior to study treatment administration), did not have information to evaluate sustained remission response until Week 28.
| Participants | Secukinumab | Placebo |
|---|---|---|
| Percentage of Participants With GCA Who Had Sustained Remission Until Week 52 | 16 | 2 |
Number of participants on co-administered prednisolone treatment ≤ 5mg/day who responded at Week 19, Week 26 and Week 52. Remission was defined as the absence of flare. Sustained remission was defined as the absence of flare until Week 28 and in adherence to the protocol prednisolone taper Regimen. There were 2 taper regimens: for patients on 40 to 60 mg/day prednisolone at Baseline and for patients on 25 to 40 mg/day prednisolone at Baseline depending on patients' prednisolone levels at Baseline. Prednisolone was tapered from a dose of 25 mg to 60 mg at Baseline to 1 mg at Week 26 \[last dose\].
| Participants | Secukinumab | Placebo |
|---|---|---|
| Week 19 (n = 25, 20) | 22 | 10 |
| Week 28 (n = 23, 20) | 19 | 9 |
| Week 52 (n = 21, 17) | 19 | 13 |
Clinician Reported Outcome: Physicians global assessment (PhGA) using a visual analogue scale (VAS) scale. VAS is a range of scores from 0-100, with lower change from baseline scores indicating a more favorable outcome and higher change from baseline scores indicating a greater disease activity.
| scores on a scale | Secukinumab | Placebo |
|---|---|---|
| Week 4 (n = 27, 23) | -4.8 ± 14.43 | -3.2 ± 18.45 |
| Week 8 (n = 26, 21) | -5.8 ± 12.77 | 2.1 ± 18.94 |
| Week 12 (n = 25, 20) | -3.4 ± 21.93 | -3.1 ± 10.81 |
| Week 16 (n = 25, 20) | -4.1 ± 15.62 | 0.7 ± 13.97 |
| Week 20 (n = 24, 20) | -6.9 ± 14.78 | -1.5 ± 14.32 |
| Week 24 (n = 23, 20) | -4.3 ± 15.92 | 2.2 ± 17.22 |
| Week 28 (23, 19) | -5.4 ± 15.61 | 3.9 ± 21.47 |
| Week 36 (21, 19) | -8.7 ± 18.45 | 0.7 ± 17.45 |
| Week 44 (n = 21, 16) | -5.5 ± 16.87 | 1.1 ± 15.20 |
| Week 52 (n = 21, 16) | -9.5 ± 16.72 | 4.0 ± 21.24 |
Patient Reported Outcome: Patients global assessment (PGA) score using a VAS scale. VAS is a range of scores from 0-100, with lower change from baseline scores indicating a more favorable outcome and higher change from baseline scores indicating a greater disease activity.
| scores on a scale | Secukinumab | Placebo |
|---|---|---|
| Week 4 (n = 27, 23) | -15.8 ± 28.17 | -0.5 ± 23.58 |
| Week 8 (n = 26, 21) | -15.8 ± 27.61 | -10.8 ± 27.64 |
| Week 12 (n = 25, 20) | -8.0 ± 29.43 | -11.9 ± 31.46 |
| Week 16 (n = 25, 20) | -18.6 ± 19.39 | -8.8 ± 31.43 |
| Week 20 (n = 24, 20) | -19.18 ± 30.68 | -6.9 ± 31.94 |
| Week 24 (n = 23, 20) | -14.9 ± 28.84 | -7.0 ± 30.61 |
| Week 28 (n = 23, 19) | -14.4 ± 25.46 | -8.0 ± 31.31 |
| Week 36 (n = 21, 19) | -20.9 ± 22.31 | -8.6 ± 29.90 |
| Week 44 (n = 21, 16) | -21.7 ± 27.35 | -9.4 ± 30.58 |
| Week 52 (n = 21, 16) | -19.2 ± 27.35 | -15.9 ± 24.04 |
Patient Reported Outcome: Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue is a 13-item questionnaire with a full scale of 0 -52 that assesses self-reported fatigue and its impact upon daily activities and function. The higher the score the better functioning (less fatigue).
| scores on a scale | Secukinumab | Placebo |
|---|---|---|
| Week 4 (n = 27, 23) | 2.11 ± 9.613 | -0.96 ± 7.358 |
| Week 8 (n = 26, 21) | 2.19 ± 10.190 | 0.81 ± 7.498 |
| Week 12 (n = 25, 20) | 0.96 ± 11.175 | -0.25 ± 10.047 |
| Week 16 (n = 25, 20) | 2.12 ± 8.876 | -0.36 ± 8.884 |
| Week 20 (n =24, 20) | 3.42 ± 8.617 | 0.05 ± 10.318 |
| Week 24 (n = 23, 20) | 2.91 ± 10.409 | -3.10 ± 11.281 |
| Week 28 (n = 23, 19) | 3.61 ± 11.044 | 0.42 ± 9.203 |
| Week 36 (n = 21, 19) | 3.90 ± 7.245 | 1.84 ± 8.719 |
| Week 44 (n = 21, 16) | 2.67 ± 5.986 | 0.31 ± 10.928 |
| Week 52 (n = 21, 16) | 3.19 ± 7.033 | 0.19 ± 8.848 |
Patient Reported Outcome: The SF-36 is a standardized questionnaire used to measure health-related quality of life among healthy patients and patients with acute and chronic conditions. It consists of 8 subscales that can be scored individually: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. The higher the score (change from baseline) the more favorable the outcome. The values were reported by change from baseline in SF-36 domain scores.
| scores on a scale | Secukinumab | Placebo |
|---|---|---|
| Week 4: Physical Functioning (PF) (n = 27, 23) | 0.14 ± 7.562 | -1.25 ± 4.417 |
| Week 8: PF (n = 26 ,21) | -0.44 ± 8.849 | 0.18 ± 4.987 |
| Week 12: PF (n = 25, 20) | 0.38 ± 6.322 | -0.38 ± 8.750 |
| Week 16: PF (n = 25, 20) | -0.00 ± 8.646 | -0.86 ± 6.814 |
| Week 20: PF (n = 24, 20) | 0.80 ± 8.098 | -0.10 ± 6.495 |
| Week 24: PF (n = 22, 20) | 0.52 ± 5.702 | -2.11 ± 8.667 |
| Week 28: PF (n = 23, 19) | 1.25 ± 5.276 | -0.40 ± 6.460 |
| Week 36: PF (n = 21, 19) | 1.37 ± 5.778 | -1.31 ± 6.631 |
| Week 44: PF (n = 21, 16) | 1.00 ± 6.674 | -0.36 ± 8.065 |
| Week 52: PF (n = 21, 16) | 2.46 ± 4.770 | 0.12 ± 5.696 |
| Week 4: Role-Physical (R-P) (n =27, 23) | 3.49 ± 7.886 | 0.49 ± 10.616 |
| Week 8: R-P (n =26, 21) | 3.80 ± 9.628 | -0.75 ± 10.515 |
| Week 12: R-P (n = 25, 20) | 3.32 ± 9.3301 | 1.01 ± 9.539 |
| Week 16: R-P (n = 25, 20) | 4.58 ± 8.947 | -1.12 ± 8.847 |
| Week 20: R-P (n = 24, 20) | 4.40 ± 9.538 | -0.45 ± 8.163 |
| Week 24: R-P (n = 22, 20) | 3.37 ± 7.458 | -0.00 ± 10.094 |
| Week 28: R-P (n = 23, 19) | 5.96 ± 10.034 | 1.77 ± 8.553 |
| Week 36: R-P (n = 21, 19) | 5.99 ± 6.444 | 0.24 ± 10.121 |
| Week 44: R-P (n = 21, 16) | 5.13 ± 6.515 | 0.70 ± 11.262 |
| Week 52: R-P (n = 21, 16) | 6.20 ± 6.659 | 1.40 ± 9.126 |
| Week 4: Bodily Pain (BP) (n = 27, 23) | 8.03 ± 13.272 | 7.68 ± 11.235 |
| Week 8: BP (n = 26, 21 | 5.80 ± 14.475 | 9.68 ± 10.485 |
| Week 12: BP (n = 25, 20) | 6.92 ± 13.426 | 6.84 ± 11.674 |
| Week 16: BP (n = 25, 20) | 7.69 ± 14.841 | 4.50 ± 13.560 |
| Week 20: BP (n = 24, 20) | 6.10 ± 14.072 | 8.63 ± 12.457 |
| Week 24: BP (n = 22, 20) | 5.97 ± 12.689 | 3.93 ± 11.952 |
| Week 28: BP (n = 23, 19) | 6.47 ± 12.643 | 6.32 ± 13.149 |
| Week 36: BP (n = 21, 19) | 7.20 ± 13.724 | 7.81 ± 10.794 |
| Week 44: BP (n = 21, 16) | 8.01 ± 15.378 | 9.00 ± 7.910 |
| Week 52: BP (n = 21, 16) | 5.49 ± 12.328 | 8.39 ± 11.866 |
| Week 4: General Health (GH) ( n = 27, 23) | 3.49 ± 9.207 | 0.23 ± 6.761 |
| Week 8: GH (n = 26, 21) | 2.74 ± 8.119 | 0.18 ± 6.758 |
| Week 12: GH (n = 25, 20 | 2.22 ± 7.383 | 0.62 ± 8.158 |
| Week 16: GH (n = 25, 20) | 2.28 ± 8.235 | -0.74 ± 7.858 |
| Week 20: GH (n = 24, 20) | 4.50 ± 6.774 | -0.38 ± 7.933 |
| Week 24: GH (n = 22, 20) | 2.85 ± 7.149 | -0.19 ± 9.031 |
| Week 28: GH (n = 23, 19) | 3.53 ± 7.285 | 1.18 ± 7.837 |
| Week 36:GH (n = 21, 19) | 3.42 ± 6.680 | -0.47 ± 7.833 |
| Week 44: GH (n = 21, 16) | 1.02 ± 8.127 | -0.30 ± 9.597 |
| Week 52: GH (n = 21, 16) | 3.03 ± 6.733 | 0.15 ± 10.277 |
| Week 4: Vitality (n = 27, 23) | 4.07 ± 8.607 | -1.42 ± 7.699 |
| Week 8: Vitality (n = 26, 21) | 2.17 ± 7.952 | 0.71 ± 8.185 |
| Week 12: Vitality (n = 25, 20) | 3.57 ± 7.477 | -0.30 ± 9.241 |
| Week 16: Vitality (n = 25, 20) | 4.28 ± 7.431 | -0.45 ± 7.847 |
| Week 20: Vitality (n = 24, 20) | 4.70 ± 8.445 | 0.45 ± 9.652 |
| Week 24: Vitality (n = 22, 20) | 3.78 ± 7.112 | -1.93 ± 11.697 |
| Week 28: Vitality (n = 23, 19) | 6.20 ± 7.489 | 0.16 ± 6.679 |
| Week 36: Vitality (n = 21, 19) | 7.07 ± 7.060 | 1.41 ± 5.635 |
| Week 44: Vitality (n = 21, 16) | 6.08 ± 8.375 | -0.93 ± 12.497 |
| Week 52: Vitality (n = 21, 16) | 7.21 ± 8.690 | 0.37 ± 11.474 |
| Week 4: Social Functioning (SF) (n = 27, 23) | 3.71 ± 7.939 | 1.74 ± 7.499 |
| Week 8: SF (n = 26, 21) | 4.82 ± 8.327 | 2.63 ± 9.979 |
| Week 12: SF (n = 25, 20) | 4.01 ± 9.154 | 1.76 ± 7.325 |
| Week 16: SF (n = 25, 20) | 5.21 ± 11.069 | 0.75 ± 7.325 |
| Week 20: SF (n = 24, 20) | 4.81 ± 10.080 | 3.51 ± 8.150 |
| Week 24: SF (n = 22, 20) | 4.56 ± 8.602 | 0.00 ± 10.912 |
| Week 28: SF (n = 23, 19) | 3.49 ± 8.476 | 3.17 ± 9.631 |
| Week 36: SF (n = 21, 19) | 7.16 ± 10.703 | 5.01 ± 7.285 |
| Week 44: SF (n = 21, 16) | 6.45 ± 8.988 | 0.63 ± 11.561 |
| Week 52: SF (n = 21, 16) | 7.16 ± 8.621 | 2.82 ± 9.681 |
| Week 4: Role-Emotional (RE) (n = 27, 23) | -0.77 ± 12.454 | 3.48 ± 12.985 |
| Week 8: RE (n = 26, 21) | 3.08 ± 11.457 | 1.99 ± 13.239 |
| Week 12: RE (n = 25, 20) | -0.42 ± 12.076 | 0.52 ± 13.188 |
| Week 16: RE (n = 25, 20) | 3.76 ± 10.586 | -0.00 ± 11.465 |
| Week 20: RE (n = 24, 20) | 3.48 ± 11.058 | 0.35 ± 11.569 |
| Week 24: RE (n = 22, 20) | 2.85 ± 11.753 | -1.22 ± 16.025 |
| Week 28: RE (n = 23, 19) | 3.63 ± 11.853 | 1.10 ± 11.725 |
| Week 36: RE (n = 21, 19) | 5.47 ± 10.066 | 0.73 ± 16.518 |
| Week 44: RE (n = 21, 16) | 4.15 ± 12.293 | 3.26 ± 16.354 |
| Week 52: RE (n = 21, 16) | 6.14 ± 11.385 | 0.43 ± 19.234 |
| Week 4: Mental Health (MH) (n = 27, 23) | 3.0 ± 8.514 | 0.57 ± 8.420 |
| Week 8: MH (n = 26, 21) | 2.82 ± 10.643 | 1.49 ± 6.950 |
| Week 12: MH (n = 25, 20) | 3.14 ± 10.786 | 4.45 ± 7.690 |
| Week 16: MH (n = 25, 20) | 4.29 ± 8.337 | 5.36 ± 6.379 |
| Week 20: MH (n = 24, 20) | 3.49 ± 10.926 | 6.41 ± 7.984 |
| Week 24: MH (n = 22, 20) | 2.62 ± 8.730 | 2.61 ± 13.149 |
| Week 28: MH (n = 23, 19) | 2.84 ± 9.816 | 6.06 ± 7.350 |
| Week 36: MH (n = 21, 19) | 5.98 ± 8.111 | 5.64 ± 8.988 |
| Week 44: MH (n = 21, 16) | 4.11 ± 8.969 | 1.14 ± 11.891 |
| Week 52: MH (n = 21, 16) | 5.73 ± 7.473 | 4.25 ± 11.257 |
EQ-5D-5L, a self-administered questionnaire assessing health status in adults, is divided into 2 sections. The 1st section addresses 5 dimensions (mobility, self-care, usual activity, pain/discomfort, \& anxiety/depression). Items are rated either "no problem", "slight problems", "moderate problems", "severe problems", or "extreme problems/unable." A composite health index is defined by combining the levels for each dimension. The 2nd section measures self-rated (global) health status via vertically oriented VAS where 100 represents the "best possible health state" \& 0 represents the "worst possible health state." The EQ-5D-5L contains 6 items assessing health status via a single index value or health utility score and allows "weighting" by the patient of health states \& generation of patient utilities. Published weights are available allowing for creation of a single summary health utility score. Scores range from 0 to 1, with lower scores representing a higher level of dysfunction.
| scores on a scale | Secukinumab | Placebo |
|---|---|---|
| EQ-5D-5L VAS: Week 4 (n = 27, 23) | 11.26 ± 16.819 | 1.87 ± 21.467 |
| EQ-5D-5L VAS: Week 8 (n = 26, 21) | 5.58 ± 16.650 | 5.52 ± 29.646 |
| EQ-5D-5L VAS: Week 12 (n = 25, 20) | 4.64 ± 19.598 | 3.30 ± 22.850 |
| EQ-5D-5L VAS: Week 16 (n = 25, 20) | 7.000 ± 19.530 | 4.40 ± 27.354 |
| EQ-5D-5L VAS: Week 20 (n = 24, 20) | 7.88 ± 19.077 | 6.30 ± 25.041 |
| EQ-5D-5L VAS: Week 24 (n = 23, 20) | 5.39 ± 17.598 | -1.00 ± 29.902 |
| EQ-5D-5L VAS: Week 28 (n = 23, 19) | 4.43 ± 17.840 | 10.37 ± 21.670 |
| WEQ-5D-5L VAS: Week 36 (n = 21, 19) | 6.90 ± 17.972 | 5.32 ± 28.825 |
| EQ-5D-5L VAS: Week 44 (n = 21, 16) | 6.38 ± 19.505 | 12.69 ± 21.941 |
| EQ-5D-5L VAS: Week 52 (n = 21, 16) | 11.62 ± 16.877 | 10.81 ± 24.109 |
| EQ-5D-5L utility index: Week 4 (n = 27, 23) | 0.0166 ± 0.19559 | -0.0702 ± 0.21239 |
| EQ-5D-5L utility index: Week 8 (n = 26, 21) | -0.0034 ± 0.19972 | 0.0087 ± 0.9869 |
| EQ-5D-5L utility index: Week 12 (n = 25, 20) | 0.0016 ± 0.16236 | -0.0122 ± 0.15686 |
| EQ-5D-5L utility index: Week 16 (n = 25, 20) | 0.0186 ± 0.14639 | -0.0196 ± 0.19789 |
| EQ-5D-5L utility index: Week 20 (n = 24, 20) | 0.0210 ± 0.13308 | 0.0221 ± 0.16759 |
| EQ-5D-5L utility index: Week 24 (n = 23, 20) | 0.0402 ± 0.12427 | -0.0444 ± 0.20875 |
| EQ-5D-5L utility index: Week 28 (n = 23, 19) | -0.0002 ± 0.06695 | 0.0240 ± 0.13458 |
| EQ-5D-5L utility index: Week 36 (n = 21, 19) | 0.0063 ± 0.06432 | -0.0155 ± 0.13186 |
| EQ-5D-5L utility index: Week 44 (n = 21, 16) | -0.0119 ± 0.08525 | 0.0090 ± 0.13033 |
| EQ-5D-5L utility index: Week 52 (n = 21, 16) | -0.0076 ± 0.11997 | 0.0205 ± 0.09403 |
ESR is a laboratory test that provides a non-specific measure of inflammation. This was assessed in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.
| mm/hr | Secukinumab | Placebo |
|---|---|---|
| Week 28 (n = 23, 18) | 4.043 ± 16.1934 | 14.667 ± 23.9141 |
| Week 52 (n = 21, 16) | -3.286 ± 10.6167 | 10.000 ± 14.8728 |
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. This was assessed in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
| mg/L | Secukinumab | Placebo |
|---|---|---|
| Week 28 (n = 23, 19) | 4.426 ± 9.6836 | 5.216 ± 8.9820 |
| Week 52 (n = 21, 16) | -1.433 ± 8.7909 | 4.650 ± 14.3691 |
Collected over Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Secukinumab | 1/27 (3.7%) | 6/27 (22.2%) | 25/27 (92.6%) |
| Placebo | 1/25 (4%) | 11/25 (44%) | 23/25 (92%) |
| All Participants | 2/52 (3.8%) | 17/52 (32.7%) | 48/52 (92.3%) |
| Event | Secukinumab | Placebo | All Participants |
|---|---|---|---|
| Atrial fibrillationCardiac disorders | 0/27 | 1/25 | 1/52 |
| Atrial tachycardiaCardiac disorders | 0/27 | 1/25 | 1/52 |
| Cardiac failureCardiac disorders | 1/27 | 1/25 | 2/52 |
| Gastrointestinal painGastrointestinal disorders | 0/27 | 1/25 | 1/52 |
| MelaenaGastrointestinal disorders | 0/27 | 1/25 | 1/52 |
| General physical health deteriorationGeneral disorders | 0/27 | 1/25 | 1/52 |
| Urinary tract infectionInfections and infestations | 0/27 | 1/25 | 1/52 |
| FallInjury, poisoning and procedural complications | 1/27 | 1/25 | 2/52 |
| Femur fractureInjury, poisoning and procedural complications | 0/27 | 1/25 | 1/52 |
| Fibula fractureInjury, poisoning and procedural complications | 0/27 | 1/25 | 1/52 |
| Event | Secukinumab | Placebo | All Participants |
|---|---|---|---|
| HypertensionVascular disorders | 6/27 | 8/25 | 14/52 |
| NasopharyngitisInfections and infestations | 5/27 | 5/25 | 10/52 |
| Back painMusculoskeletal and connective tissue disorders | 0/27 | 5/25 | 5/52 |
| Oedema peripheralGeneral disorders | 2/27 | 4/25 | 6/52 |
| Oral candidiasisInfections and infestations | 4/27 | 1/25 | 5/52 |
| Urinary tract infectionInfections and infestations | 4/27 | 2/25 | 6/52 |
| Muscle spasmsMusculoskeletal and connective tissue disorders | 4/27 | 1/25 | 5/52 |
| HeadacheNervous system disorders | 4/27 | 3/25 | 7/52 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 3/27 | 3/25 | 6/52 |
| HaematomaVascular disorders | 1/27 | 3/25 | 4/52 |
The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo).
| Age, Continuous(years) | Secukinumab | Placebo | Total |
|---|---|---|---|
| Mean | 76.4 ± 5.31 | 69.6 ± 8.02 | 73.1 ± 7.52 |
| Sex: Female, Male(Participants) | Secukinumab | Placebo | Total |
|---|---|---|---|
| Female | 17 | 18 | 35 |
| Male | 10 | 7 | 17 |
| Race/Ethnicity, Customized(Participants) | Secukinumab | Placebo | Total |
|---|---|---|---|
| White | 27 | 25 | 52 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Data sharing details ↗ · www.clinicalstudydatarequest.com
Ran from Jan 2019 to primary completion in Jun 2021, 28 months.
Results were first posted in Apr 2023, 1 year 10 months after primary completion.
Of 16 phase 2 interventional studies under Giant Cell Arteritis, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 49. This study's 28 months is below that.
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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Secukinumab