Sponsor Novartis. Generic Drug Name Secukinumab. Therapeutic Area of Trial Psoriasis. Approved Indication investigational

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1 Clinical Trial Results Database Page 2 Sponsor Novartis Generic Drug Name Secukinumab Therapeutic Area of Trial Psoriasis Approved Indication investigational

2 Clinical Trial Results Database Page 3 Study Number CA2220 Title A randomized, double-blind, placebo controlled, multicenter dose ranging study of subcutaneously administered secukinumab (), assessing Psoriasis Area and Severity Index (PASI) response in patients with moderate to severe chronic plaque-type psoriasis Phase of Development II Study Start/End Dates 01-Mar-2010 / 14-Feb-2011 Study Design/Methodology This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in patients with moderate to severe chronic plaque-type psoriasis. The study consisted of 3 periods: screening, treatment and follow up. The screening period of up to 4 weeks was used to assess eligibility of the patients and taper patients off disallowed medications. Eligible patients were randomized in a ratio of 1:1:1:1:1 to either placebo or one of 4 different regimens of secukinumab (monthly dosing of 25 mg, 75 mg or 150 mg, or a single dose of 25 mg). Randomization was stratified according to body weight (< 90 kg or 90 kg).

3 Clinical Trial Results Database Page 4 Centres A total of 19 centers in 6 countries: Canada (3 centers), Estonia (3), Iceland (1), Japan (4), Latvia (3) and United States (5). Publication NA

4 Clinical Trial Results Database Page 5 Objectives Primary objective(s) To assess the efficacy of three different doses of s.c. administered monthly (25 mg, 75 mg and 150 mg) or as a single administration (25 mg) in patients with moderate to severe chronic plaque-type psoriasis with respect to PASI 75 achievement 12 weeks after start of treatment, compared to placebo Secondary objective(s) To evaluate treatment success as assessed by the Investigator s Global Assessment (static IGA) 12 weeks after start of treatment To evaluate the efficacy of the three different doses administered monthly as well as the single dosing at 12 weeks after start of treatment To assess the time to relapse To measure the effect of on PASI over time To investigate the safety and tolerability Test Product (s), Dose(s), and Mode(s) of Administration Secukinumab mg: secukinumab 150 mg s.c. administered at weeks 1, 5, and 9 Secukinumab 3 75 mg: secukinumab 75 mg s.c. administered at weeks 1, 5, and 9 Secukinumab 3 25 mg: secukinumab 25 mg s.c. administered at weeks 1, 5, and 9 Secukinumab 1 25 mg: secukinumab 25 mg s.c. administered at week 1, and placebo s.c. administered at weeks 5 and 9

5 Clinical Trial Results Database Page 6 Reference Product(s), Dose(s), and Mode(s) of Administration Placebo: placebo s.c. administered at weeks 1, 5, and 9 Criteria for Evaluation Primary variables Improvement of Psoriasis Area and Severity Index (PASI) score Secondary variables Investigator s global assessment (IGA) Safety and tolerability Hematology, blood chemistry and urinalysis Vital signs ECG Immunogenicity Pharmacology Pharmacokinetic samplings Other NA Statistical Methods The randomized set included all 125 patients randomized to treatment. The full analysis set (FAS), identical to the randomized set, also consisted of all randomized patients. For both sets, patients were analyzed according to the treatment and body weight stratum (i.e. 90 or < 90 kg) assigned at randomization. The safety set included all patients who took at least one dose of study drug and had at least one post-baseline safety assessment. All efficacy analyses were based on the FAS. The safety analyses were based on the safety set. Patient disposition, protocol deviations, demographic and baseline data, relevant medical histories and continuing medical conditions and exposure to study drug were summarized by treatment group and listed. Concomitant medications and significant non-drug therapies were coded by the ATC classification, summarized by treatment and listed. MedDRA version 13.1 was used for coding of medical history/co-existing disease and AEs/SAEs. The primary efficacy variable was PASI 75 response, i.e., the 75% improvement (reduction) in PASI score compared to baseline (i.e. treatment response). The primary endpoint, achievement of PASI 75 at Week 13, was analyzed by means of the stratified Cochran-Mantel-Haenszel (CMH) with region and body weight (< 90 kg, 90 kg) as strata. Results were presented with odds ratio,

6 Clinical Trial Results Database Page 7 95% confidence interval (CI), and two-sided p-values for all contrasts versus placebo. If a patient s total PASI score was missing at any visit after baseline, the missing score was imputed by the last observation carried forward, LOCF, method. Missing post-baseline data of the IGA score (overall psoriatic disease as well as involvement of hands and feet) were imputed in the same way as the PASI score. Supportive analysis of the primary efficacy variable consisted of logistic regression of PASI 75 response at Week 13. The model accounted for treatment group, region, body weight stratum and baseline PASI. The key secondary efficacy endpoint was IGA treatment response at Week 13 (for overall psoriatic disease) which was analyzed by descriptive statistics, stratified CMH test and logistic regression, as described for the primary endpoint. Other secondary efficacy endpoints were analyzed by descriptive statistics and logistic regression, where appropriate. Plots and corresponding tables of Kaplan-Meier estimates for probability of time to relapse were provided by active treatment group. Shift tables for the shift from baseline to the best assessment (i.e. lowest IGA) during treatment period were provided. Subgroup analyses of the primary efficacy and secondary endpoints were performed for body weight (< 90 kg, 90 kg), region (Japan, other than Japan), psoriatic arthritis at screening, previous systemic psoriasis therapy, previous biologic psoriasis therapy and previous psoriasis UV therapy. All AEs, SAEs and deaths were summarized overall and by treatment group. Potential risks were defined based on AEs (infections; malignancies; hypersensitivity, infusion and local site reations; lack of efficacy/worsening of underlying disease; antibody development and immunogenicity; and risk during pregnancy). Relative risks were calculated (as ratio of percentages) with 95% CIs for each potential risk. In addition, the potential risk 'Infections' was summarized separately. Time to infection as analyzed using stratified log-rank tests (stratified by body weight group). Each active treatment group was compared to placebo. Plots and corresponding tables of Kaplan Meier estimates of time to infection were provided by treatment group. Subgroup analyses were performed for region. Laboratory data were summarized by treatment group and listed. Shift tables using normal ranges from the central laboratory and box-plots for selected laboratory parameters were provided. Vital signs were summarized with standard descriptive statistics for absolute values and changes from baseline by treatment group and visit. Patients with clinically notable abnormalities in laboratory values or vital signs were summarized. Summary statistics were provided for anti- antibodies as well as for the binary assessment of immunogenicity (yes/no), by treatment group and visit. Study Population: Inclusion/Exclusion Criteria and Demographics Main Inclusion Criteria: Chronic plaque-type psoriasis diagnosed for at least 6 months at time of randomization At randomization, moderate to severe psoriasis as defined by: o PASI score of 12 or greater and, o IGA score of 3 or greater and, o Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater At screening and randomization, chronic plaque-type psoriasis considered inadequately controlled by topical treatment Main Exclusion Criteria: Forms of psoriasis other than chronic plaque-type

7 Clinical Trial Results Database Page 8 Drug-induced psoriasis (e.g., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) at randomization Previous exposure to Ongoing use of prohibited psoriasis treatments / medications and other prohibited medication at randomization. Washout periods detailed in the protocol have to be adhered to Known immunosuppression (e.g., AIDS) at screening and / or randomization History or evidence of active tuberculosis at screening Active systemic infections (other than common cold) History or symptoms of malignancy of any organ system, treated or untreated, within the past 5 years. Any severe, progressive or uncontrolled medical condition at randomization that in the judgment of the investigator prevents the patient from participating in the study Any clinically significant abnormal laboratory tests at randomization, that in the judgment of the investigator prevents the patient from participating in the study Inability or unwillingness to undergo repeated venipuntures History or evidence of drug or alcohol abuse Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply

8 Clinical Trial Results Database Page 9 Number of Subjects 1x25 mg 3x150 mg Placebo Total Planned N Randomized 29 (100.0) 26 (100.0) 21 (100.0) 27 (100.0) 22 (100.0) 125 (100.0) Randomized and treated 29 (100.0) 26 (100.0) 21 (100.0) 27 (100.0) 22 (100.0) 125 (100.0) Completed 14 (48.3) 16 (61.5) 17 (81.0) 20 (74.1) 11 (50.0) 78 (62.4) Discontinued 15 (51.7) 10 (38.5) 4 (19.0) 7 (25.9) 11 (50.0) 47 (37.6) Primary reason for premature discontinuation Unsatisfactory therapeutic effect 4 (13.8) 6 (23.1) 2 (9.5) 0 6 (27.3) 18 (14.4) Subject withdrew consent 8 (27.6) 2 (7.7) 1 (4.8) 2 (7.4) 3 (13.6) 16 (12.8) Administrative problems 1 (3.4) 1 (3.8) 0 2 (7.4) 1 (4.5) 5 (4.0) Lost to follow-up 1 (3.4) 0 1 (4.8) 2 (7.4) 0 4 (3.2) Adverse Event(s) 1 (3.4) 1 (3.8) 0 1 (3.7) 0 3 (2.4) Death (4.5) 1 (0.8) Demographic and Background Characteristics 1x25 mg N=29 N=26 N=21 3x150 mg N=27 Placebo N=22 Total N=125 Mean Age (years) Male 20 (69.0) 22 (84.6) 14 (66.7) 21 (77.8) 14 (63.6) 91 (72.8) Female 9 (31.0) 4 (15.4) 7 (33.3) 6 (22.2) 8 (36.4) 34 (27.2) Race - Caucasian 24 (82.8) 20 (76.9) 15 (71.4) 20 (74.1) 17 (77.3) 96 (76.8) Asian 4 (13.8) 6 (23.1) 5 (23.8) 7 (25.9) 5 (22.7) 27 (21.6) Other 1 (3.4) 0 1 (4.8) (1.6) Mean weight (kg) Mean PASI score Primary Objective Result(s) PASI 75 achievement at Week 13: number (%) of responders and treatment comparisons vs. placebo (Full analysis set, LOCF) Treatment Group Number (%) of PASI 75 responders at Week 13 p-value (CMH test) 1x25 mg (N=29) 1 (3.4) vs. placebo (N=26) 5 (19.2) vs. placebo (N=21) 12 (57.1) vs. placebo x150 mg (N=27) 22 (81.5) vs. placebo <0.001

9 Clinical Trial Results Database Page 10 Placebo (N=22) 2 (9.1)

10 Clinical Trial Results Database Page 11 Secondary Objective Result(s) Investigator s Global Assessment (IGA) by visit and treatment (Full analysis set, LOCF) Visit Statistic 1x25 mg N=29 N=26 N=21 3x150 mg N=27 Placebo N=22 Week 2 n evaluable Response, (3.7) 0 Week 3 n evaluable Response, (3.7) 0 Week 5 n evaluable Response, 0 1 (3.8) 1 (4.8) 2 (7.4) 0 Week 9 n evaluable Response, 0 2 (7.7) 6 (28.6) 10 (37.0) 2 (9.1) Week 13 n evaluable Response, 0 3 (11.5) 7 (33.3) 13 (48.1) 2 (9.1) Week 17 n evaluable Response, 1 (3.4) 5 (19.2) 6 (28.6) 14 (51.9) 2 (9.1) Week 21 n evaluable Response, 0 5 (19.2) 8 (38.1) 11 (40.7) 3 (13.6) Week 25 n evaluable Response, 0 4 (15.4) 7 (33.3) 10 (37.0) 4 (18.2) Week 29 n evaluable Response, 0 3 (11.5) 4 (19.0) 11 (40.7) 3 (13.6) Week 33 n evaluable Response, 0 4 (15.4) 4 (19.0) 8 (29.6) 0 Week 37 n evaluable Response, 0 4 (15.4) 2 (9.5) 7 (25.9) 0 Treatment response was defined as an IGA score of 0 (clear) or 1 (almost clear) and improvement of at least 2 points on the IGA scale compared to baseline. Number (%) of patients achieving PASI 50, PASI 75, or PASI 90 by visit and treatment (Full analysis set, LOCF) Visit Criterion 1x25 mg N=29 N=26 N=21 3x150 mg N=27 Placebo N=22 Week 2 n evaluable PASI 50 1 (3.4) 2 (7.7) 1 (4.8) 3 (11.1) 0 PASI PASI Week 3 n evaluable PASI 50 1 (3.4) 2 (7.7) 5 (23.8) 5 (18.5) 1 (4.5) PASI PASI Week 5 n evaluable PASI 50 3 (10.3) 4 (15.4) 6 (28.6) 13 (48.1) 1 (4.5)

11 Clinical Trial Results Database Page 12 PASI (7.7) 1 (4.8) 4 (14.8) 1 (4.5) PASI (3.7) 0 Week 9 n evaluable PASI 50 3 (10.3) 10 (38.5) 11 (52.4) 23 (85.2) 3 (13.6) PASI 75 1 (3.4) 3 (11.5) 7 (33.3) 18 (66.7) 2 (9.1) PASI (3.8) 2 (9.5) 4 (14.8) 0 Week 13 n evaluable PASI 50 5 (17.2) 15 (57.7) 17 (81.0) 23 (85.2) 4 (18.2) PASI 75 1 (3.4) 5 (19.2) 12 (57.1) 22 (81.5) 2 (9.1) PASI (7.7) 4 (19.0) 14 (51.9) 1 (4.5) Week 17 n evaluable PASI 50 6 (20.7) 14 (53.8) 16 (76.2) 23 (85.2) 6 (27.3) PASI 75 2 (6.9) 7 (26.9) 9 (42.9) 22 (81.5) 3 (13.6) PASI (15.4) 2 (9.5) 12 (44.4) 0 Week 21 n evaluable PASI 50 4 (13.8) 13 (50.0) 12 (57.1) 23 (85.2) 7 (31.8) PASI (23.1) 8 (38.1) 21 (77.8) 3 (13.6) PASI (15.4) 2 (9.5) 10 (37.0) 1 (4.5) Week 25 n evaluable PASI 50 4 (13.8) 13 (50.0) 12 (57.1) 23 (85.2) 7 (31.8) PASI (19.2) 7 (33.3) 19 (70.4) 2 (9.1) PASI (11.5) 4 (19.0) 8 (29.6) 1 (4.5) Week 29 n evaluable PASI 50 5 (17.2) 12 (46.2) 11 (52.4) 23 (85.2) 6 (27.3) PASI (15.4) 5 (23.8) 16 (59.3) 3 (13.6) PASI (7.7) 3 (14.3) 6 (22.2) 2 (9.1) Week 33 n evaluable PASI 50 3 (10.3) 9 (34.6) 10 (47.6) 21 (77.8) 5 (22.7) PASI 75 1 (3.4) 5 (19.2) 5 (23.8) 15 (55.6) 1 (4.5) PASI (9.5) 5 (18.5) 1 (4.5) Week 37 n evaluable PASI 50 5 (17.2) 8 (30.8) 10 (47.6) 17 (63.0) 5 (22.7) PASI 75 1 (3.4) 5 (19.2) 4 (19.0) 7 (25.9) 1 (4.5) PASI (3.8) 2 (9.5) 3 (11.1) 1 (4.5) Time to relapse, by treatment (LOCF) 1x25 mg N=29 N=26 N=21 Subjects in Analysis Subjects with the event Event rate (%) Median Time to relapse (days) NE NE NE

12 Clinical Trial Results Database Page 13 Safety Results Adverse events by primary system organ class (Safety set) Primary system organ class 1x25 mg N=29 N=26 N=21 3x150 mg N=27 Placebo N=22 Total N=125 Patients with any AE(s) 22 (75.9) 19 (73.1) 16 (76.2) 24 (88.9) 16 (72.7) 97 (77.6) Blood and lymphatic system disorders 0 1 (3.8) 0 1 (3.7) 0 2 (1.6) Cardiac disorders 1 (3.4) 1 (3.8) 1 (4.8) 0 3 (13.6) 6 (4.8) Congenital, familial and genetic 0 1 (3.8) (0.8) disorders Ear and labyrinth disorders 2 (6.9) 1 (3.8) (2.4) Endocrine disorders (4.5) 1 (0.8) Eye disorders 0 1 (3.8) 0 1 (3.7) 0 2 (1.6) Gastrointestinal disorders 2 (6.9) 5 (19.2) 3 (14.3) 3 (11.1) 1 (4.5) 14 (11.2) General disorders and administration 0 1 (3.8) 0 6 (22.2) 2 (9.1) 9 (7.2) site conditions Hepatobiliary disorders (3.7) 0 1 (0.8) Immune system disorders 0 2 (7.7) 0 1 (3.7) 1 (4.5) 4 (3.2) Infections and infestations 9 (31.0) 12 (46.2) 10 (47.6) 12 (44.4) 8 (36.4) 51 (40.8) Injury, poisoning and procedural 1 (3.4) 1 (3.8) 0 5 (18.5) 2 (9.1) 9 (7.2) complications Investigations 1 (3.4) 1 (3.8) 2 (9.5) 1 (3.7) 1 (4.5) 6 (4.8) Metabolism and nutrition disorders 1 (3.4) 1 (3.8) (4.5) 3 (2.4) Musculoskeletal and connective 4 (13.8) 4 (15.4) 4 (19.0) 3 (11.1) 2 (9.1) 17 (13.6) tissue disorders Neoplasms benign, malignant and (3.7) 0 1 (0.8) unspecified (incl cysts and polyps) Nervous system disorders 1 (3.4) 4 (15.4) 2 (9.5) 2 (7.4) 0 9 (7.2) Pregnancy, puerperium and perinatal (4.5) 1 (0.8) conditions Psychiatric disorders 0 2 (7.7) (1.6) Renal and urinary disorders 0 1 (3.8) (0.8) Respiratory, thoracic and mediastinal 2 (6.9) 4 (15.4) 1 (4.8) 1 (3.7) 1 (4.5) 9 (7.2) disorders Skin and subcutaneous tissue disorders 9 (31.0) 5 (19.2) 5 (23.8) 5 (18.5) 7 (31.8) 31 (24.8) Social circumstances (3.7) 0 1 (0.8) Vascular disorders 1 (3.4) 2 (7.7) 0 2 (7.4) 0 5 (4.0) Primary system organ classes are sorted alphabetically

13 Clinical Trial Results Database Page 14 Most frequent adverse events (at least 5% in any treatment group) by preferred term and treatment group (Safety set) Preferred term 1x25 mg N=29 N=26 N=21 3x150 mg N=27 Placebo N=22 Total N=125 Patients with any AE(s) 22 (75.9) 19 (73.1) 16 (76.2) 24 (88.9) 16 (72.7) 97 (77.6) Psoriasis* 8 (27.6) 4 (15.4) 4 (19.0) 3 (11.1) 2 (9.1) 21 (16.8) Nasopharyngitis 1 (3.4) 4 (15.4) 4 (19.0) 4 (14.8) 2 (9.1) 15 (12.0) Upper respiratory tract infection 3 (10.3) 2 (7.7) 1 (4.8) 2 (7.4) 0 8 (6.4) Headache 1 (3.4) 2 (7.7) 1 (4.8) 1 (3.7) 0 5 (4.0) Pruritus 1 (3.4) (3.7) 3 (13.6) 5 (4.0) Respiratory tract infection viral 1 (3.4) 1 (3.8) 1 (4.8) 0 2 (9.1) 5 (4.0) Back pain 0 1 (3.8) 2 (9.5) 1 (3.7) 0 4 (3.2) Fatigue (11.1) 1 (4.5) 4 (3.2) Hypertension 1 (3.4) 1 (3.8) 0 2 (7.4) 0 4 (3.2) Muscle strain 1 (3.4) (7.4) 0 3 (2.4) Myalgia 2 (6.9) (4.5) 3 (2.4) Edema peripheral (7.4) 1 (4.5) 3 (2.4) Pharyngitis 0 1 (3.8) 0 2 (7.4) 0 3 (2.4) Preferred terms are presented in descending order of frequency in the total column. Deaths, other serious adverse events and adverse events leading to discontinuation of study drug by treatment group (Safety set) 1x25 mg N=29 N=26 N=21 3x150 mg N=27 Placebo N=22 Total N=125 Patients with any AE(s) 22 (75.9) 19 (73.1) 16 (76.2) 24 (88.9) 16 (72.7) 97 (77.6) Death(s) (4.5) 1 (0.8) SAE(s) 0 2 (7.7) 1 (4.8) 0 2 (9.1) 5 (4.0) Discontinued due to AE(s) 0 1 (3.8) 0 1 (3.7) 0 2 (1.6) Other Relevant Findings NA

14 Clinical Trial Results Database Page 15 Date of Clinical Trial Report 02 February 2012 Date Inclusion on Novartis Clinical Trial Results Database 24 February 2012 Date of Latest Update

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