A Phase 3 interventional study of Secukinumab in Plaque Type Psorisis, sponsored by Novartis Pharmaceuticals. Completed at 45 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-23.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 3, Interventional, and Treatment
A study to evaluate the differences in the efficacy and safety of secukinumab between Cw6-negative and Cw6-positive patients with moderate to severe plaque-type psoriasis
Biological agents represent the most advanced type of treatment for psoriasis. Secukinumab is a human monoclonal anti IL-17A antibody that binds to human IL-17A and neutralizes its bioactivity by inhibiting IL17A produced by both Th17 cells and those of the innate immune system, thus providing complete anti IL17A blockage. Targeting IL-17A has the potential to reduce autoimmune inflammation while leaving other immune functions undisturbed. While targeting of Th1-promoting or Th17-promoting cytokines affects critical mediators such as IFN-γ, IL-22 and IL-21, selective targeting of IL-17A leaves these Th1/17 activities, as well as certain protective functions of innate cells intact. Furthermore, as a fully human monoclonal antibody, secukinumab should reduce immunogenic risks compared to current or emerging antibody therapies that are not fully human.
Many recent studies have shown that highly selective biologic drugs are not effective in every patient and that variations in the genome can be associated with different clinical responses or side effects to a given drug. The PSORS1 locus on chromosome 6p is generally understood to confer the most risk for psoriasis. A specific allele for this locus, HLA C*06, is present in about 60% of psoriatic patient cases. Data linking secukinumab efficacy to a particular genetic marker are lacking.
Recent research has revealed a marked difference in the proportion of PASI 90 achievers at 12 weeks between Cw6-positive and Cw6-negative patients (85.7% vs 56.5%) treated with ustekinumab (Talamonti M et al. 2013) and a greater efficacy of anti-TNFα drugs in CW6 negative patients (Galli et al. 2013).Unlike anti-IL-12/23 agents, secukinumab inhibits IL-17 produced by both Th17 cells after presentation by antigen presenting cells (in this case Cw6) and cells of the innate immune system whose activation does not require antigen presentation. Providing a drug that is equally effective on both Cw6-negative and Cw6-positive patients would be an important clinical accomplishment and would eliminate the need for costly HLA-Cw6 tests. The choice of a cohort study would therefore seem appropriate for this clinical context.
The purpose of this study was to explore the different efficacy and safety profile of secukinumab 300 mg in patients with moderate to severe chronic plaque-type psoriasis, stratified for the presence of HLA-C*06, whose determination was blinded for patients and investigators. The study was conducted both on anti-TNFα-naïve and anti-TNFα failure patients and also stratified for TNFα - 308 polymorphism, BMI, smoking and metabolic syndrome, among others.
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Moderate to severe psoriasis as defined at enrollment by:
Exclusion criteria
Stratified to Cw6 positive cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks
Biological: Secukinumab
Stratified to Cw6 negative cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks
Biological: Secukinumab
Secukinumab was supplied as 150 mg solution in pre-filled syringe for subcutaneous injection
Also known as: AIN457
Percentage (%) of Patients Who Reach Psoriasis Area Severity Index (PASI) 90 at 16 Weeks - LOCF Approach (ITT Set)
PASI (Langley et al 2015) combines the assessment of the severity of lesions and the area affected into a single score with a range of 0 (no disease) to 72 (maximal disease). The PASI was assessed at all visits in CORE and extension phases. PASI 90 response: patients achieving ≥ 90% improvement (reduction) in PASI score compared to baseline are defined as PASI 90 responders.
Time frame: Baseline up to 16 weeks
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set)
IGA mod 2011 scale measures severity of the psoriasis on a five-point scale ranging from 0 (no disease, 'clear') to 4 ('very severe'). PASI 50,75,90,100 represent: patients achieving ≥ 50% improvement (reduction) in PASI score compared to baseline, ≥ 75% improvement (reduction), ≥ 90% improvement (reduction) and PASI 100 response/remission: complete clearing of psoriasis (PASI=0).
Time frame: Baseline up to approximately 72 weeks
Percent Mean Changes From Baseline in IGA Mod 2011 Between Cohorts at Each Time Point (LOCF) (ITT)
IGA mod 2011 scale measures severity of the psoriasis on a five-point scale ranging from 0 (no disease, 'clear') to 4 ('very severe').
Time frame: Baseline up to approximately 72 weeks
Median Time to Reach PASI 90 and 75 (ITT)
Time in days to reach PASI scores of 90 and 75.
Time frame: Baseline up to approximately 72 weeks
Change From Baseline in the Dermatology Life Quality Index (DLQI) (LOCF) (FAS)
The DLQI total score was calculated by summing the score of each domain resulting in a maximum of 30 and a minimum of 0. The higher the score, the more Quality of Life was impaired. Meaning of DLQI Scores: 0-1 = no effect at all on patient's life, 2-5 = small effect on patient's life, 6-10 = moderate effect on patient's life, 11-20= very large effect on patient's life, 21-30 = extremely large effect on patient's life. It was pre-specified that results would be presented for all patients, not by cohort
Time frame: Baseline up to approximatly 72 weeks
Change From Baseline in Mean Scores of HAD-A and HAD-D (Anxiety and Depression) (LOCF) (FAS)
The Hospital Anxiety and Depression Scale (HADS) is a fourteen-item scale.. Seven of the items relate to anxiety and seven relate to depression. This outcome measure was specifically developed to avoid reliance on aspects of these conditions that are also common somatic symptoms of illness, for example fatigue and insomnia or hypersomnia. Calculations of scores: each of the 14 items was rated on a 4-point scale. All items except 7 and 10 were scored as Yes, definitely = 3, Yes, sometimes = 2, No, not much = 1, to No, not at all = 0. Items 7 and 10 were scored as Yes, definitely = 0 to No, not at all = 3 in the reverse order. The HADS consisted of two sub-scores: the HAD-A (anxiety) and HAD-D (depression); each sub-score ranged from 0 to 21 points; scores ≥11 = presence of anxious or depressive disorders; scores between 8-10 points = borderline abnormal, and scores of ≤7 = disorder was not present. It was pre-specified that results would be presented for all patients, not by cohort
Time frame: Baseline up approximately 72 weeks
Correlation Between the Hospital Anxiety and Depression Scale (HADS) and PASI (FAS)
PASI score, HADS questionnaire correlation using Spearman rank correlation coefficient. It was pre-specified that results would be presented for all patients, not by cohort
Time frame: Baseline up to approximately 72 weeks
Changes From Baseline in Body Mass Index (Safety Set)
Change in Body mass index from baseline for patients with a value at baseline and the respective post-baseline visit
Time frame: Baseline up to approximately 72 weeks
Changes From Baseline in Waist Circumference (Safety Set)
Change in waist circumference from baseline for patients with a value at baseline and the respective post-baseline visit
Time frame: Baseline up to approximately 72 weeks
Changes From Baseline in Weight (Safety Set)
Change in weight from baseline for patients with a value at baseline and the respective post-baseline visit
Time frame: Baseline up to approximately 72 weeks
| Milestone | Cw6-positive AIN457 300 mg | Cw6-negative AIN457 300 mg |
|---|---|---|
| Started | 185 | 246 |
| Full analysis set | 185 | 246 |
| Safety set | 185 | 246 |
| Itt set | 184 | 246 |
| Completed | 172 | 227 |
| Not completed | 13 | 19 |
| Withdrew: Adverse event | 7 | 9 |
| Withdrew: Death | 0 | 1 |
| Withdrew: Pregnancy | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Physician decision | 1 | 1 |
| Withdrew: Withdrawal by subject | 2 | 2 |
| Withdrew: Lack of efficacy | 1 | 6 |
| Milestone | Cw6-positive AIN457 300 mg | Cw6-negative AIN457 300 mg |
|---|---|---|
| Started | 162 | 219 |
| Completed | 151 | 207 |
| Not completed | 11 | 12 |
| Withdrew: Adverse event | 6 | 1 |
| Withdrew: Death | 0 | 1 |
| Withdrew: Protocol violation | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Physician decision | 0 | 2 |
| Withdrew: Withdrawal by subject | 0 | 5 |
| Withdrew: Lack of efficacy | 3 | 3 |
PASI (Langley et al 2015) combines the assessment of the severity of lesions and the area affected into a single score with a range of 0 (no disease) to 72 (maximal disease). The PASI was assessed at all visits in CORE and extension phases. PASI 90 response: patients achieving ≥ 90% improvement (reduction) in PASI score compared to baseline are defined as PASI 90 responders.
| percentage of participants | Cw6-positive AIN457 300 mg | Cw6-negative AIN457 300 mg |
|---|---|---|
| Percentage (%) of Patients Who Reach Psoriasis Area Severity Index (PASI) 90 at 16 Weeks - LOCF Approach (ITT Set) | 80.4 (74.0 to 85.9) | 81.7 (76.3 to 86.3) |
IGA mod 2011 scale measures severity of the psoriasis on a five-point scale ranging from 0 (no disease, 'clear') to 4 ('very severe'). PASI 50,75,90,100 represent: patients achieving ≥ 50% improvement (reduction) in PASI score compared to baseline, ≥ 75% improvement (reduction), ≥ 90% improvement (reduction) and PASI 100 response/remission: complete clearing of psoriasis (PASI=0).
| percentage of participants | Cw6-positive AIN457 300 mg | Cw6-negative AIN457 300 mg | Difference in % (Cw6-pos vs Cw6-neg) |
|---|---|---|---|
| W1 IGA 0/1 | 2.2 (0.62 to 5.65) | 2.1 (0.68 to 4.79) | 0.16 (-2.86 to 3.75) |
| W1 PASI 50 | 13.4 (8.78 to 19.29) | 12.1 (8.24 to 16.89) | 1.32 (-5.02 to 8.09) |
| W1 PASI 75 | 2.2 (0.61 to 5.62) | 0.4 (0.01 to 2.30) | 1.82 (-0.52 to 5.20) |
| W2 IGA 0/1 | 8.7 (5.05 to 13.74) | 6.9 (4.08 to 10.83) | 1.79 (-3.29 to 7.36) |
| W2 PASI 50 | 44.0 (36.73 to 51.51) | 44.5 (38.16 to 50.95) | -0.47 (-9.84 to 8.98) |
| W2 PASI 75 | 15.8 (10.82 to 21.84) | 10.2 (6.71 to 14.69) | 5.56 (-0.80 to 12.32) |
| W2 PASI 90 | 3.3 (1.21 to 6.96) | 2.4 (0.90 to 5.25) | 0.81 (-2.49 to 4.71) |
| W2 PASI 100 | 0.5 (0.01 to 2.99) | 0.4 (0.01 to 2.25) | 0.14 (-1.78 to 2.63) |
| W3 IGA 0/1 | 24.5 (18.43 to 31.32) | 21.1 (16.21 to 26.78) | 3.32 (-4.58 to 11.46) |
| W3 PASI 50 | 76.1 (69.26 to 82.06) | 71.8 (65.76 to 77.38) | 4.25 (-4.23 to 12.40) |
| W3 PASI 75 | 38.6 (31.52 to 46.03) | 34.3 (28.36 to 40.60) | 4.30 (-4.81 to 13.46) |
| W3 PASI 90 | 13.0 (8.54 to 18.78) | 11.4 (7.73 to 16.09) | 1.61 (-4.55 to 8.19) |
| W3 PASI 100 | 2.7 (0.89 to 6.23) | 2.4 (0.90 to 5.25) | 0.27 (-2.92 to 4.00) |
| W4 IGA 0/1 | 42.4 (35.15 to 49.88) | 39.8 (33.67 to 46.25) | 2.55 (-6.75 to 11.89) |
| W4 PASI 50 | 87.5 (81.84 to 91.91) | 87.4 (82.59 to 91.27) | 0.10 (-6.51 to 6.31) |
| W4 PASI 75 | 61.4 (53.97 to 68.48) | 57.3 (50.88 to 63.58) | 4.10 (-5.29 to 13.28) |
| W4 PASI 90 | 27.7 (21.39 to 34.78) | 22.0 (16.94 to 27.65) | 5.77 (-2.40 to 14.10) |
| W4 PASI 100 | 10.3 (6.33 to 15.66) | 9.8 (6.35 to 14.17) | 0.57 (-5.09 to 6.66) |
| W8 IGA 0/1 | 72.3 (65.22 to 78.61) | 73.2 (67.17 to 78.60) | -0.89 (-9.48 to 7.47) |
| W8 PASI 50 | 95.7 (91.61 to 98.10) | 95.1 (91.63 to 97.45) | 0.53 (-3.97 to 4.59) |
| W8 PASI 75 | 84.8 (78.76 to 89.64) | 85.0 (79.87 to 89.18) | -0.18 (-7.26 to 6.53) |
| W8 PASI 90 | 61.4 (53.97 to 68.48) | 60.6 (54.16 to 66.72) | 0.84 (-8.46 to 10.01) |
| W8 PASI 100 | 34.8 (27.93 to 42.14) | 34.6 (28.63 to 40.86) | 0.23 (-8.72 to 9.34) |
| WK12 IGA 0/1 | 81.0 (74.55 to 86.38) | 81.7 (76.30 to 86.33) | -0.73 (-8.36 to 6.57) |
| WK12 PASI 50 | 97.3 (93.77 to 99.11) | 97.2 (94.23 to 98.85) | 0.13 (-3.65 to 3.43) |
| WK12 PASI 75 | 92.9 (88.22 to 96.18) | 90.7 (86.30 to 93.98) | 2.28 (-3.27 to 7.46) |
| WK12 PASI 90 | 72.8 (65.79 to 79.11) | 73.6 (67.60 to 78.98) | -0.75 (-9.30 to 7.56) |
| WK12 PASI 100 | 49.5 (42.02 to 56.91) | 43.9 (37.60 to 50.35) | 5.55 (-3.93 to 14.94) |
| WK16 IGA 0/1 | 85.3 (79.37 to 90.10) | 86.2 (81.23 to 90.23) | -0.85 (-7.79 to 5.70) |
| WK16 PASI 50 | 97.8 (94.53 to 99.40) | 98.8 (96.48 to 99.75) | -0.95 (-4.33 to 1.70) |
| WK16 PASI 75 | 94.0 (89.56 to 96.98) | 93.1 (89.17 to 95.92) | 0.93 (-4.16 to 5.60) |
| WK16 PASI 90 | 80.4 (73.96 to 85.90) | 81.7 (76.30 to 86.33) | -1.27 (-8.94 to 6.08) |
| WK16 PASI 100 | 59.2 (51.77 to 66.41) | 53.3 (46.81 to 59.62) | 5.99 (-3.49 to 15.24) |
| WK20 IGA0/1 | 87.0 (81.22 to 91.46) | 87.4 (82.59 to 91.27) | -0.44 (-7.11 to 5.83) |
| WK20 PASI 50 | 97.8 (94.53 to 99.40) | 97.6 (94.77 to 99.10) | 0.27 (-3.27 to 3.34) |
| WK20 PASI 75 | 94.6 (90.23 to 97.36) | 92.7 (88.68 to 95.61) | 1.88 (-3.14 to 6.53) |
| WK20 PASI 90 | 81.0 (74.55 to 86.38) | 81.7 (76.30 to 86.33) | -0.73 (-8.36 to 6.57) |
| WK20 PASI 100 | 59.8 (52.32 to 66.93) | 57.3 (50.88 to 63.58) | 2.47 (-6.93 to 11.71) |
| WK24 IGA 0/1 | 89.7 (84.34 to 93.67) | 85.4 (80.32 to 89.54) | 4.31 (-2.21 to 10.45) |
| WK24 PASI 50 | 97.3 (93.77 to 99.11) | 97.2 (94.23 to 98.85) | 0.13 (-3.65 to 3.43) |
| WK24 PASI 75 | 94.6 (90.23 to 97.36) | 93.1 (89.17 to 95.92) | 1.48 (-3.51 to 6.07) |
| WK24 PASI 90 | 84.2 (78.16 to 89.18) | 83.3 (78.08 to 87.77) | 0.91 (-6.35 to 7.79) |
| WK24 PASI 100 | 62.0 (54.52 to 69.00) | 61.4 (54.99 to 67.50) | 0.57 (-8.71 to 9.71) |
| WK36 IGA 0/1 | 91.9 (86.59 to 95.63) | 90.9 (86.25 to 94.33) | 1.06 (-5.06 to 6.68) |
| WK36 PASI 50 | 98.8 (95.58 to 99.85) | 99.1 (96.74 to 99.89) | -0.33 (-3.57 to 2.19) |
| WK36 PASI 75 | 94.4 (89.65 to 97.41) | 95.0 (91.19 to 97.47) | -0.57 (-5.75 to 4.00) |
| WK36 PASI 90 | 88.8 (82.91 to 93.24) | 84.0 (78.48 to 88.61) | 4.80 (-2.39 to 11.54) |
| WK36 PASI 100 | 65.8 (57.96 to 73.12) | 64.4 (57.65 to 70.72) | 1.45 (-8.27 to 10.95) |
| WK48 IGA 0/1 | 87.8 (80.42 to 93.18) | 86.8 (80.52 to 91.63) | 1.03 (-7.43 to 8.82) |
| WK48 PASI 50 | 98.3 (93.86 to 99.79) | 98.1 (94.59 to 99.61) | 0.15 (-4.41 to 3.88) |
| WK48 PASI 75 | 93.9 (87.86 to 97.52) | 91.2 (85.67 to 95.10) | 2.72 (-4.18 to 8.98) |
| WK48 PASI 90 | 84.3 (76.40 to 90.45) | 80.5 (73.48 to 86.35) | 3.84 (-5.59 to 12.64) |
| WK48 PASI 100 | 68.7 (59.38 to 77.02) | 61.6 (53.60 to 69.23) | 7.06 (-4.44 to 18.02) |
| WK60 IGA 0/1 | 87.5 (78.21 to 93.84) | 83.9 (76.00 to 90.02) | 3.60 (-6.97 to 13.09) |
| WK60 PASI 50 | 96.3 (89.43 to 99.22) | 95.0 (89.35 to 98.13) | 1.29 (-5.94 to 7.34) |
| WK60 PASI 75 | 90.0 (81.24 to 95.58) | 89.9 (83.05 to 94.68) | 0.08 (-9.42 to 8.37) |
| WK60 PASI 90 | 82.5 (72.38 to 90.09) | 74.8 (66.01 to 82.30) | 7.71 (-4.27 to 18.58) |
| WK60 PASI 100 | 65.0 (53.52 to 75.33) | 56.3 (46.91 to 65.37) | 8.70 (-5.19 to 21.80) |
| WK72 IGA 0/1 | 85.4 (70.83 to 94.43) | 80.0 (67.67 to 89.22) | 5.37 (-10.7 to 19.47) |
| WK72 PASI 50 | 92.7 (80.08 to 98.46) | 93.4 (84.05 to 98.18) | -0.76 (-13.5 to 9.55) |
| WK72 PASI 75 | 85.4 (70.83 to 94.43) | 88.5 (77.78 to 95.26) | -3.16 (-18.1 to 9.79) |
| WK72 PASI 90 | 75.6 (59.70 to 87.64) | 73.8 (60.93 to 84.20) | 1.84 (-15.8 to 17.98) |
| WK72 PASI 100 | 58.5 (42.11 to 73.68) | 50.8 (37.70 to 63.86) | 7.72 (-11.7 to 26.08) |
IGA mod 2011 scale measures severity of the psoriasis on a five-point scale ranging from 0 (no disease, 'clear') to 4 ('very severe').
| percent change | Cw6-positive AIN457 300 mg | Cw6-negative AIN457 300 mg |
|---|---|---|
| W1 | -8.5 ± 16.08 | -7.3 ± 17.04 |
| W2 | -22.4 ± 22.73 | -21.6 ± 22.72 |
| W3 | -38.0 ± 25.45 | -36.5 ± 27.20 |
| W4 | -49.6 ± 29.36 | -49.5 ± 29.24 |
| W8 | -71.2 ± 28.60 | -71.2 ± 28.91 |
| W12 | -78.7 ± 27.31 | -79.0 ± 25.37 |
| W16 | -84.1 ± 24.52 | -83.3 ± 22.97 |
| W20 | -85.3 ± 24.26 | -84.5 ± 23.80 |
| W24 | -86.2 ± 25.17 | -84.1 ± 26.34 |
| W36 | -88.6 ± 22.34 | -87.6 ± 23.82 |
| W48 | -86.2 ± 25.75 | -84.9 ± 26.06 |
| W60 | -83.3 ± 28.44 | -81.0 ± 26.97 |
| W72 | -79.1 ± 32.92 | -75.8 ± 29.58 |
Time in days to reach PASI scores of 90 and 75.
| days | Cw6-positive AIN457 300 mg | Cw6-negative AIN457 300 mg |
|---|---|---|
| PASI 90 | 57 (30 to 89) | 58 (55 to 92) |
| PASI 75 | 29 (22 to 57) | 29 (22 to 57) |
The DLQI total score was calculated by summing the score of each domain resulting in a maximum of 30 and a minimum of 0. The higher the score, the more Quality of Life was impaired. Meaning of DLQI Scores: 0-1 = no effect at all on patient's life, 2-5 = small effect on patient's life, 6-10 = moderate effect on patient's life, 11-20= very large effect on patient's life, 21-30 = extremely large effect on patient's life. It was pre-specified that results would be presented for all patients, not by cohort
| numbers in a score | All Patients |
|---|---|
| Week 16 | -8.5 ± 6.79 |
| Week 24 | -8.8 ± 7.05 |
| Week 48 | -8.9 ± 7.13 |
| Week 72 | -8.3 ± 6.70 |
The Hospital Anxiety and Depression Scale (HADS) is a fourteen-item scale.. Seven of the items relate to anxiety and seven relate to depression. This outcome measure was specifically developed to avoid reliance on aspects of these conditions that are also common somatic symptoms of illness, for example fatigue and insomnia or hypersomnia. Calculations of scores: each of the 14 items was rated on a 4-point scale. All items except 7 and 10 were scored as Yes, definitely = 3, Yes, sometimes = 2, No, not much = 1, to No, not at all = 0. Items 7 and 10 were scored as Yes, definitely = 0 to No, not at all = 3 in the reverse order. The HADS consisted of two sub-scores: the HAD-A (anxiety) and HAD-D (depression); each sub-score ranged from 0 to 21 points; scores ≥11 = presence of anxious or depressive disorders; scores between 8-10 points = borderline abnormal, and scores of ≤7 = disorder was not present. It was pre-specified that results would be presented for all patients, not by cohort
| numbers on a scale | All Patients |
|---|---|
| W16 Anxiety | -1.7 ± 3.37 |
| W24 Anxiety | -2.0 ± 3.38 |
| W48 Anxiety | -2.5 ± 3.67 |
| W72 Anxiety | -2.3 ± 3.44 |
| W16 Depression | -1.3 ± 3.19 |
| W24 Depression | -1.4 ± 3.22 |
| W48 Depression | -1.5 ± 3.31 |
| W72 Depression | -1.7 ± 3.19 |
PASI score, HADS questionnaire correlation using Spearman rank correlation coefficient. It was pre-specified that results would be presented for all patients, not by cohort
| numbers on scores | All Patients |
|---|---|
| Baseline | 0.02 |
| Week 16 | 0.19 |
| Week 24 | 0.18 |
| Week 48 | 0.21 |
| Week 72 | 0.32 |
Change in Body mass index from baseline for patients with a value at baseline and the respective post-baseline visit
| kg/m2 | Cw6-positive AIN457 300 mg | Cw6-negative AIN457 300 mg |
|---|---|---|
| Week 16 | -0.064 ± 0.7748 | -0.047 ± 0.9905 |
| Week 24 | 0.086 ± 1.0213 | -0.071 ± 1.2260 |
| Week 48 | 0.302 ± 1.3474 | -0.052 ± 1.4991 |
| Week 72 | 0.533 ± 1.8101 | -0.015 ± 1.8982 |
Change in waist circumference from baseline for patients with a value at baseline and the respective post-baseline visit
| cm | Cw6-positive AIN457 300 mg | Cw6-negative AIN457 300 mg |
|---|---|---|
| Week 16 | -0.86 ± 3.147 | -0.40 ± 3.006 |
| Week 24 | -0.81 ± 3.689 | -0.73 ± 4.119 |
| Week 48 | -0.76 ± 4.596 | -0.72 ± 5.547 |
| Week 72 | -1.81 ± 4.583 | -0.47 ± 4.501 |
Change in weight from baseline for patients with a value at baseline and the respective post-baseline visit
| kg | Cw6-positive AIN457 300 mg | Cw6-negative AIN457 300 mg |
|---|---|---|
| Week 16 | -0.20 ± 2.242 | -0.13 ± 2.809 |
| Week 24 | 0.24 ± 3.008 | -0.21 ± 3.572 |
| Week 48 | 0.87 ± 3.909 | -0.15 ± 4.329 |
| Week 72 | 1.40 ± 4.678 | -0.05 ± 5.538 |
Collected over Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 72 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cw6-Negative AIN457 300 mg | 2/246 (0.8%) | 21/246 (8.5%) | 14/246 (5.7%) |
| Cw6-Positive AIN457 300 mg | 0/185 (0%) | 10/185 (5.4%) | 20/185 (10.8%) |
| Event | Cw6-Negative AIN457 300 mg | Cw6-Positive AIN457 300 mg |
|---|---|---|
| HyperbilirubinaemiaHepatobiliary disorders | 3/246 | 0/185 |
| Alanine aminotransferase increasedInvestigations | 2/246 | 0/185 |
| Aspartate aminotransferase increasedInvestigations | 2/246 | 1/185 |
| Blood bilirubin increasedInvestigations | 2/246 | 1/185 |
| Abdominal pain upperGastrointestinal disorders | 0/246 | 1/185 |
| GastroenteritisInfections and infestations | 0/246 | 1/185 |
| Perirectal abscessInfections and infestations | 0/246 | 1/185 |
| Urinary tract infectionInfections and infestations | 0/246 | 1/185 |
| Vulvovaginal candidiasisInfections and infestations | 0/246 | 1/185 |
| HypertriglyceridaemiaMetabolism and nutrition disorders | 0/246 | 1/185 |
| Event | Cw6-Negative AIN457 300 mg | Cw6-Positive AIN457 300 mg |
|---|---|---|
| PruritusSkin and subcutaneous tissue disorders | 4/246 | 12/185 |
| HypertensionVascular disorders | 10/246 | 11/185 |
| Age, Continuous(years) | Cw6-positive AIN457 300 mg | Cw6-negative AIN457 300 mg | Total |
|---|---|---|---|
| Mean | 42.71 ± 13.148 | 47.18 ± 12.919 | 45.26 ± 13.189 |
| Sex: Female, Male(Participants) | Cw6-positive AIN457 300 mg | Cw6-negative AIN457 300 mg | Total |
|---|---|---|---|
| Female | 60 | 62 | 122 |
| Male | 125 | 184 | 309 |
| Race/Ethnicity, Customized(Participants) | Cw6-positive AIN457 300 mg | Cw6-negative AIN457 300 mg | Total |
|---|---|---|---|
| Caucasian | 184 | 241 | 425 |
| Asian | 0 | 1 | 1 |
| Native American | 0 | 1 | 1 |
| Unknown | 0 | 2 | 2 |
| Other | 1 | 1 | 2 |
| Time since first diagnosis of psoriasis(years) | Cw6-positive AIN457 300 mg | Cw6-negative AIN457 300 mg | Total |
|---|---|---|---|
| Mean | 19.63 ± 12.489 | 17.46 ± 11.343 | 18.39 ± 11.883 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided
Ran from Apr 2015 to primary completion in Jun 2017, 25 months.
Results were first posted in Apr 2019, 1 year 10 months after primary completion.
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This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Secukinumab