Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Secukinumab Compared to Fumaderm® in Adults With Moderate to Severe Psoriasis. (PRIME)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02474082
Recruitment Status : Completed
First Posted : June 17, 2015
Results First Posted : October 27, 2017
Last Update Posted : October 27, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Psoriasis
Interventions Biological: Secukinumab
Drug: Fumaric acid
Enrollment 202
Recruitment Details  
Pre-assignment Details A total of 202 (secukinumab: 105 and fumaric acid derivatives: 97) participants were randomized in the study out of which 200 (secukinumab: 105 and fumaric acid derivatives: 95) received treatment. 2 participants were discontinued from the study due to non-compliance with study treatment (1) and withdrawal of informed consent (1).
Arm/Group Title Secukinumab Fumaric Acid (Initial and Maintenance Therapy)
Hide Arm/Group Description Participants were self-administered subcutaneously (s.c.) with a dose of 300 milligrams (mg) of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 centimeters (cm) around the navel). Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
Period Title: Overall Study
Started 105 97
Full Analysis Set (FAS) 105 95
Completed 99 43
Not Completed 6 54
Reason Not Completed
Adverse Event             2             32
Withdrawal of informed consent             1             11
Lost to Follow-up             2             2
Dose tapering not achieved             0             4
Participant/guardian decision             1             2
Non-compliance with study treatment             0             2
Protocol deviation             0             1
Arm/Group Title Secukinumab Fumaric Acid (Initial and Maintenance Therapy) Total
Hide Arm/Group Description Participants were self-administered s.c. with a dose of 300 mg of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 cm around the navel). Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier. Total of all reporting groups
Overall Number of Baseline Participants 105 97 202
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants 97 participants 202 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
98
  93.3%
90
  92.8%
188
  93.1%
>=65 years
7
   6.7%
7
   7.2%
14
   6.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 105 participants 97 participants 202 participants
43.2  (14.2) 42.4  (13.2) 42.8  (13.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants 97 participants 202 participants
Female
40
  38.1%
37
  38.1%
77
  38.1%
Male
65
  61.9%
60
  61.9%
125
  61.9%
1.Primary Outcome
Title Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75 Response at Week 24
Hide Description PASI score is an average degree of severity of signs in head [H], trunk [T], upper limbs [U] and lower limbs [L], assessed separately for erythema [E], thickening (plaque elevation, induration) [I], and scaling (desquamation) [D]. Area [A] covered by lesions on each body region was estimated as a percentage (%) of total area of that particular body region and was assigned a score of 0=0%; 1=1-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100%. The head and neck, upper limbs, trunk and lower limbs correspond to approximately 10%, 20%, 30% and 40% of the body surface area, respectively. PASI score was calculated as: PASI = 0.1(EH+IH+DH) AH + 0.2(EU+IU+DU) AU + 0.3(ET+IT+DT) AT + 0.4(EL+IL+DL) AL. PASI scores can range from 0 (no signs) to a maximum of 72.0. PASI 75 responders were participants who achieved >=75% improvement (reduction) in PASI score compared to baseline.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in Full analysis set (FAS) population, defined as all randomized participants who received at least one dose of study drug.
Arm/Group Title Secukinumab Fumaric Acid (Initial and Maintenance Therapy)
Hide Arm/Group Description:
Participants were self-administered s.c. with a dose of 300 mg of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 cm around the navel).
Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
Overall Number of Participants Analyzed 105 95
Measure Type: Number
Unit of Measure: Percentage of participants
89.52 33.68
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Secukinumab, Fumaric Acid (Initial and Maintenance Therapy)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 16.61
Confidence Interval (2-Sided) 95%
7.79 to 35.40
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 50 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Hide Description PASI score is an average degree of severity of signs in head [H], trunk [T], upper limbs [U] and lower limbs [L], assessed separately for erythema [E], thickening (plaque elevation, induration) [I], and scaling (desquamation) [D]. Area [A] covered by lesions on each body region was estimated as a percentage (%) of total area of that particular body region and was assigned a score of 0=0%; 1=1-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100%. The head and neck, upper limbs, trunk and lower limbs correspond to approximately 10%, 20%, 30% and 40% of the body surface area, respectively. PASI score was calculated as: PASI = 0.1(EH+IH+DH) AH + 0.2(EU+IU+DU) AU + 0.3(ET+IT+DT) AT + 0.4(EL+IL+DL) AL. PASI scores can range from 0 (no signs) to a maximum of 72.0. PASI 50 responders were participants who achieved >=50% improvement (reduction) in PASI score compared to baseline.
Time Frame Baseline, Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in FAS population. Here 'number analyzed' signifies participants evaluable for PASI 50 at week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.
Arm/Group Title Secukinumab Fumaric Acid (Initial and Maintenance Therapy)
Hide Arm/Group Description:
Participants were self-administered s.c. with a dose of 300 mg of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 cm around the navel).
Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
Overall Number of Participants Analyzed 105 95
Measure Type: Number
Unit of Measure: Percentage of participants
Week 1 Number Analyzed 105 participants 91 participants
9.5 1.1
Week 2 Number Analyzed 105 participants 95 participants
37.1 6.3
Week 3 Number Analyzed 105 participants 95 participants
63.8 10.5
Week 4 Number Analyzed 105 participants 95 participants
81.9 14.7
Week 6 Number Analyzed 105 participants 95 participants
93.3 28.4
Week 8) Number Analyzed 105 participants 95 participants
96.2 41.1
Week 12 Number Analyzed 105 participants 95 participants
97.1 56.8
Week 16 Number Analyzed 105 participants 95 participants
98.1 60.0
Week 20 Number Analyzed 105 participants 95 participants
98.1 61.1
Week 24 Number Analyzed 105 participants 95 participants
98.1 61.1
3.Secondary Outcome
Title Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75 Response at Week 1, 2, 3, 4, 6, 8, 12, 16 and 20
Hide Description PASI score is an average degree of severity of signs in head [H], trunk [T], upper limbs [U] and lower limbs [L], assessed separately for erythema [E], thickening (plaque elevation, induration) [I], and scaling (desquamation) [D]. Area [A] covered by lesions on each body region was estimated as a percentage (%) of total area of that particular body region and was assigned a score of 0=0%; 1=1-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100%. The head and neck, upper limbs, trunk and lower limbs correspond to approximately 10%, 20%, 30% and 40% of the body surface area, respectively. PASI score was calculated as: PASI = 0.1(EH+IH+DH) AH + 0.2(EU+IU+DU) AU + 0.3(ET+IT+DT) AT + 0.4(EL+IL+DL) AL. PASI scores can range from 0 (no signs) to a maximum of 72.0. PASI 75 responders were participants who achieved >=75% improvement (reduction) in PASI score compared to baseline.
Time Frame Baseline, Week 1, 2, 3, 4, 6, 8, 12, 16 and 20
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in FAS population. Here 'number analyzed' signifies participants evaluable for PASI 75 at week 1, 2, 3, 4, 6, 8, 12, 16 and 20.
Arm/Group Title Secukinumab Fumaric Acid (Initial and Maintenance Therapy)
Hide Arm/Group Description:
Participants were self-administered s.c. with a dose of 300 mg of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 cm around the navel).
Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
Overall Number of Participants Analyzed 105 95
Measure Type: Number
Unit of Measure: Percentage of participants
Week 1 Number Analyzed 105 participants 91 participants
0 0
Week 2 Number Analyzed 105 participants 95 participants
5.7 0
Week 3 Number Analyzed 105 participants 95 participants
24.8 0
Week 4 Number Analyzed 105 participants 95 participants
47.6 1.1
Week 6 Number Analyzed 105 participants 95 participants
69.5 2.1
Week 8 Number Analyzed 105 participants 95 participants
80.0 8.4
Week 12 Number Analyzed 105 participants 95 participants
87.6 21.1
Week 16 Number Analyzed 105 participants 95 participants
88.6 27.4
Week 20 Number Analyzed 105 participants 95 participants
88.6 36.8
4.Secondary Outcome
Title Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Hide Description PASI score is an average degree of severity of signs in head [H], trunk [T], upper limbs [U] and lower limbs [L], assessed separately for erythema [E], thickening (plaque elevation, induration) [I], and scaling (desquamation) [D]. Area [A] covered by lesions on each body region was estimated as a percentage (%) of total area of that particular body region and was assigned a score of 0=0%; 1=1-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100%. The head and neck, upper limbs, trunk and lower limbs correspond to approximately 10%, 20%, 30% and 40% of the body surface area, respectively. PASI score was calculated as: PASI = 0.1(EH+IH+DH) AH + 0.2(EU+IU+DU) AU + 0.3(ET+IT+DT) AT + 0.4(EL+IL+DL) AL. PASI scores can range from 0 (no signs) to a maximum of 72.0. PASI 90 responders were participants who achieved >=90% improvement (reduction) in PASI score compared to baseline.
Time Frame Baseline, Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in FAS population. Here 'number analyzed' signifies participants evaluable for PASI 90 at week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.
Arm/Group Title Secukinumab Fumaric Acid (Initial and Maintenance Therapy)
Hide Arm/Group Description:
Participants were self-administered s.c. with a dose of 300 mg of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 cm around the navel).
Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
Overall Number of Participants Analyzed 105 95
Measure Type: Number
Unit of Measure: Percentage of participants
Week 1 Number Analyzed 105 participants 91 participants
0 0
Week 2 Number Analyzed 105 participants 95 participants
1.9 0
Week 3 Number Analyzed 105 participants 95 participants
2.9 0
Week 4 Number Analyzed 105 participants 95 participants
17.1 0
Week 6 Number Analyzed 105 participants 95 participants
32.4 0
Week 8 Number Analyzed 105 participants 95 participants
46.7 1.1
Week 12 Number Analyzed 105 participants 95 participants
63.8 2.1
Week 16 Number Analyzed 105 participants 95 participants
68.6 8.4
Week 20 Number Analyzed 105 participants 95 participants
75.2 14.7
Week 24 Number Analyzed 105 participants 95 participants
75.2 18.9
5.Secondary Outcome
Title Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 100 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Hide Description PASI score is an average degree of severity of signs in head [H], trunk [T], upper limbs [U] and lower limbs [L], assessed separately for erythema [E], thickening (plaque elevation, induration) [I], and scaling (desquamation) [D]. Area [A] covered by lesions on each body region was estimated as a percentage (%) of total area of that particular body region and was assigned a score of 0=0%; 1=1-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100%. The head and neck, upper limbs, trunk and lower limbs correspond to approximately 10%, 20%, 30% and 40% of the body surface area, respectively. PASI score was calculated as: PASI = 0.1(EH+IH+DH) AH + 0.2(EU+IU+DU) AU + 0.3(ET+IT+DT) AT + 0.4(EL+IL+DL) AL. PASI scores can range from 0 (no signs) to a maximum of 72.0. PASI 100 responders were participants who achieved complete clearance of psoriasis (PASI=0).
Time Frame Baseline, Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in FAS population. Here 'number analyzed' signifies participants evaluable for PASI 100 at week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.
Arm/Group Title Secukinumab Fumaric Acid (Initial and Maintenance Therapy)
Hide Arm/Group Description:
Participants were self-administered s.c. with a dose of 300 mg of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 cm around the navel).
Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
Overall Number of Participants Analyzed 105 95
Measure Type: Number
Unit of Measure: Percentage of participants
Week 1 Number Analyzed 105 participants 91 participants
0 0
Week 2 Number Analyzed 105 participants 95 participants
0 0
Week 3 Number Analyzed 105 participants 95 participants
0 0
Week 4 Number Analyzed 105 participants 95 participants
3.8 0
Week 6 Number Analyzed 105 participants 95 participants
7.6 0
Week 8 Number Analyzed 105 participants 95 participants
15.2 0
Week 12 Number Analyzed 105 participants 95 participants
28.6 0
Week 16 Number Analyzed 105 participants 95 participants
37.1 0
Week 20 Number Analyzed 105 participants 95 participants
41.0 0
Week 24 Number Analyzed 105 participants 95 participants
43.8 3.2
6.Secondary Outcome
Title Body Surface Area (BSA) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Time Frame Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in FAS population. Here 'number analyzed' signifies participants evaluable for BSA at week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.
Arm/Group Title Secukinumab Fumaric Acid (Initial and Maintenance Therapy)
Hide Arm/Group Description:
Participants were self-administered s.c. with a dose of 300 mg of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 cm around the navel).
Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
Overall Number of Participants Analyzed 105 95
Mean (Standard Deviation)
Unit of Measure: Percentage of area
Week 1 Number Analyzed 105 participants 94 participants
23.8  (12.82) 23.2  (14.11)
Week 2 Number Analyzed 105 participants 91 participants
20.1  (12.25) 22.5  (14.37)
Week 3 Number Analyzed 105 participants 89 participants
17.0  (11.95) 22.1  (14.33)
Week 4 Number Analyzed 103 participants 84 participants
13.0  (11.93) 21.6  (14.12)
Week 6 Number Analyzed 98 participants 82 participants
9.8  (11.12) 19.7  (13.52)
Week 8 Number Analyzed 102 participants 75 participants
7.6  (10.19) 17.8  (12.65)
Week 12 Number Analyzed 103 participants 67 participants
5.2  (9.12) 13.7  (11.60)
Week 16 Number Analyzed 99 participants 59 participants
3.7  (6.72) 11.4  (11.52)
Week 20 Number Analyzed 99 participants 50 participants
2.6  (5.77) 9.2  (11.87)
Week 24 Number Analyzed 99 participants 48 participants
2.9  (6.43) 7.9  (9.92)
7.Secondary Outcome
Title Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 50 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Hide Description NAPSI was used to assess psoriatic nail involvement in participants with nail psoriasis. NAPSI score was calculated as total of nail matrix and nail bed score, ranging from 0-8 per nail. Total NAPSI score ranges from 0 to 80 for all fingernails. Each nail was divided with imaginary horizontal and longitudinal lines into quadrants. Each nail was given a score of 0 - 4 for nail matrix and nail bed psoriasis 0–4 (0: for none, 1: for 1 quadrant, 2: for 2 quadrants, 3: for 3 quadrants, 4: for all 4 quadrants), based on presence of any feature of nail psoriasis in that quadrant. Nail matrix psoriasis feature includes: pitting, leukonychia red spots in lunula, crumbling. Nail bed psoriasis feature includes: onycholysis, splinter hemorrhages, subungual hyperkeratosis, “oil drop” (salmon patch dyschroma). NPASI 50 responders were participants who achieved >=50% improvement (reduction) in NPASI score compared to baseline.
Time Frame Baseline, Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on FAS population. Here ‘number analyzed’ signifies participants evaluable for NAPSI 50 at week 1, 2, 3, 4, 5, 6, 7,12,16, 20 and 24.
Arm/Group Title Secukinumab Fumaric Acid (Initial and Maintenance Therapy)
Hide Arm/Group Description:
Participants were self-administered s.c. with a dose of 300 mg of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 cm around the navel).
Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
Overall Number of Participants Analyzed 105 95
Measure Type: Number
Unit of Measure: Percentage of participants
Week 1 Number Analyzed 56 participants 49 participants
1.8 4.1
Week 2 Number Analyzed 56 participants 49 participants
3.6 8.2
Week 3 Number Analyzed 56 participants 49 participants
5.4 10.2
Week 4 Number Analyzed 56 participants 49 participants
7.1 12.2
Week 6 Number Analyzed 56 participants 49 participants
19.6 10.2
Week 8 Number Analyzed 56 participants 49 participants
23.2 8.2
Week 12 Number Analyzed 56 participants 49 participants
41.1 12.2
Week 16 Number Analyzed 56 participants 49 participants
51.8 10.2
Week 20 Number Analyzed 56 participants 49 participants
62.5 18.4
Week 24 Number Analyzed 56 participants 49 participants
67.9 18.4
8.Secondary Outcome
Title Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 75 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Hide Description NAPSI was used to assess psoriatic nail involvement in participants with nail psoriasis. NAPSI score was calculated as total of nail matrix and nail bed score, ranging from 0-8 per nail. Total NAPSI score ranges from 0 to 80 for all fingernails. Each nail was divided with imaginary horizontal and longitudinal lines into quadrants. Each nail was given a score of 0 - 4 for nail matrix and nail bed psoriasis 0–4 (0: for none, 1: for 1 quadrant, 2: for 2 quadrants, 3: for 3 quadrants, 4: for all 4 quadrants), based on presence of any feature of nail psoriasis in that quadrant. Nail matrix psoriasis feature includes: pitting, leukonychia red spots in lunula, crumbling. Nail bed psoriasis feature includes: onycholysis, splinter hemorrhages, subungual hyperkeratosis, “oil drop” (salmon patch dyschroma). NPASI 75 responders were participants who achieved >=75% improvement (reduction) in NPASI score compared to baseline.
Time Frame Baseline, Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on FAS population. Here 'number analyzed' signifies participants evaluable for NAPSI 75 at week 1, 2, 3, 4, 5, 6, 8,12,16, 20 and 24.
Arm/Group Title Secukinumab Fumaric Acid (Initial and Maintenance Therapy)
Hide Arm/Group Description:
Participants were self-administered s.c. with a dose of 300 mg of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 cm around the navel).
Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
Overall Number of Participants Analyzed 105 95
Measure Type: Number
Unit of Measure: Percentage of participants
Week 1 Number Analyzed 56 participants 49 participants
1.8 0
Week 2 Number Analyzed 56 participants 49 participants
1.8 2.0
Week 3 Number Analyzed 56 participants 49 participants
5.4 2.0
Week 4 Number Analyzed 56 participants 49 participants
7.1 2.0
Week 6 Number Analyzed 56 participants 49 participants
8.9 2.0
Week 8 Number Analyzed 56 participants 49 participants
17.9 2.0
Week 12 Number Analyzed 56 participants 49 participants
28.6 2.0
Week 16 Number Analyzed 56 participants 49 participants
30.4 2.0
Week 20 Number Analyzed 56 participants 49 participants
44.6 6.1
Week 24 Number Analyzed 56 participants 49 participants
53.6 4.1
9.Secondary Outcome
Title Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 90 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Hide Description NAPSI was used to assess psoriatic nail involvement in participants with nail psoriasis. NAPSI score was calculated as total of nail matrix and nail bed score, ranging from 0-8 per nail. Total NAPSI score ranges from 0 to 80 for all fingernails. Each nail was divided with imaginary horizontal and longitudinal lines into quadrants. Each nail was given a score of 0 - 4 for nail matrix and nail bed psoriasis 0–4 (0: for none, 1: for 1 quadrant, 2: for 2 quadrants, 3: for 3 quadrants, 4: for all 4 quadrants), based on presence of any feature of nail psoriasis in that quadrant. Nail matrix psoriasis feature includes: pitting, leukonychia red spots in lunula, crumbling. Nail bed psoriasis feature includes: onycholysis, splinter hemorrhages, subungual hyperkeratosis, “oil drop” (salmon patch dyschroma). NPASI 90 responders were participants who achieved >=90% improvement (reduction) in NPASI score compared to baseline.
Time Frame Baseline, Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on FAS population. Here 'number analyzed' signifies the participants evaluable for NAPSI 90 response at week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.
Arm/Group Title Secukinumab Fumaric Acid (Initial and Maintenance Therapy)
Hide Arm/Group Description:
Participants were self-administered s.c. with a dose of 300 mg of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 cm around the navel).
Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
Overall Number of Participants Analyzed 105 95
Measure Type: Number
Unit of Measure: Percentage of participants
Week 1 Number Analyzed 56 participants 49 participants
1.8 0
Week 2 Number Analyzed 56 participants 49 participants
1.8 0
Week 3 Number Analyzed 56 participants 49 participants
0 0
Week 4 Number Analyzed 56 participants 49 participants
3.6 0
Week 6 Number Analyzed 56 participants 49 participants
3.6 0
Week 8 Number Analyzed 56 participants 49 participants
7.1 2.0
Week 12 Number Analyzed 56 participants 49 participants
14.3 2.0
Week 16 Number Analyzed 56 participants 49 participants
21.4 2.0
Week 20 Number Analyzed 56 participants 49 participants
26.8 4.1
Week 24 Number Analyzed 56 participants 49 participants
35.7 4.1
10.Secondary Outcome
Title Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 100 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Hide Description NAPSI was used to assess psoriatic nail involvement in participants with nail psoriasis. NAPSI score was calculated as total of nail matrix and nail bed score, ranging from 0-8 per nail. Total NAPSI score ranges from 0 to 80 for all fingernails. Each nail was divided with imaginary horizontal and longitudinal lines into quadrants. Each nail was given a score of 0 - 4 for nail matrix and nail bed psoriasis 0–4 (0: for none, 1: for 1 quadrant, 2: for 2 quadrants, 3: for 3 quadrants, 4: for all 4 quadrants), based on presence of any feature of nail psoriasis in that quadrant. Nail matrix psoriasis feature includes: pitting, leukonychia red spots in lunula, crumbling. Nail bed psoriasis feature includes: onycholysis, splinter hemorrhages, subungual hyperkeratosis, “oil drop” (salmon patch dyschroma). NPASI 100 responders were participants who PASI 100 responders were participants who achieved complete clearance of psoriasis.
Time Frame Baseline, Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on FAS population. Here 'number analyzed' signifies the participants evaluable for NAPSI 100 response at week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.
Arm/Group Title Secukinumab Fumaric Acid (Initial and Maintenance Therapy)
Hide Arm/Group Description:
Participants were self-administered s.c. with a dose of 300 mg of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 cm around the navel).
Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
Overall Number of Participants Analyzed 105 95
Measure Type: Number
Unit of Measure: Percentage of participants
Week 1 Number Analyzed 56 participants 49 participants
1.8 0
Week 2 Number Analyzed 56 participants 49 participants
0 0
Week 3 Number Analyzed 56 participants 49 participants
0 0
Week 4 Number Analyzed 56 participants 49 participants
3.6 0
Week 6 Number Analyzed 56 participants 49 participants
3.6 0
Week 8 Number Analyzed 56 participants 49 participants
5.4 2.0
Week 12 Number Analyzed 56 participants 49 participants
10.7 2.0
Week 16 Number Analyzed 56 participants 49 participants
19.6 2.0
Week 20 Number Analyzed 56 participants 49 participants
19.6 2.0
Week 24 Number Analyzed 56 participants 49 participants
23.2 2.0
11.Secondary Outcome
Title Number of Participants With Investigator’s Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Hide Description IGA mod 2011 is a global static severity rating scale referring exclusively to the participant’s disease state at the time of the assessments and don’t attempt comparison with participant’s any previous disease states at baseline or visit. IGA mod 2011 has a scale of 0-4 with the lower scores correlating to better performance. Scores used were: 0/Clear: no signs of psoriasis, Post-inflammatory hyperpigmentation may be present; 1/almost clear: Normal to pink coloration of lesions/no thickening/no to minimal focal scaling; 2/Mild: Pink to light red coloration/just detectable to mild thickening/predominantly fine scaling; 3/Moderate: Dull bright red, clearly distinguishable erythema/clearly distinguishable to moderate thickening/moderate scaling; 4/Severe: Bright to deep dark red coloration/severe thickening with hard edges/severe or coarse scaling covering almost all or all lesions.
Time Frame Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in FAS population. Here 'number analyzed' signifies the participants evaluable for IGA mod 2011 at week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.
Arm/Group Title Secukinumab Fumaric Acid (Initial and Maintenance Therapy)
Hide Arm/Group Description:
Participants were self-administered s.c. with a dose of 300 mg of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 cm around the navel).
Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
Overall Number of Participants Analyzed 105 95
Measure Type: Count of Participants
Unit of Measure: Participants
Week 1: Clear Number Analyzed 105 participants 94 participants
0
   0.0%
0
   0.0%
Week 1: Almost Clear Number Analyzed 105 participants 94 participants
0
   0.0%
0
   0.0%
Week 1: Mild Number Analyzed 105 participants 94 participants
18
  17.1%
8
   8.5%
Week 1: Moderate Number Analyzed 105 participants 94 participants
65
  61.9%
58
  61.7%
Week 1: Severe Number Analyzed 105 participants 94 participants
22
  21.0%
28
  29.8%
Week 2: Clear Number Analyzed 105 participants 91 participants
0
   0.0%
0
   0.0%
Week 2: Almost Clear Number Analyzed 105 participants 91 participants
6
   5.7%
0
   0.0%
Week 2: Mild Number Analyzed 105 participants 91 participants
38
  36.2%
15
  16.5%
Week 2: Moderate Number Analyzed 105 participants 91 participants
49
  46.7%
56
  61.5%
Week 2: Severe Number Analyzed 105 participants 91 participants
12
  11.4%
20
  22.0%
Week 3: Clear Number Analyzed 105 participants 89 participants
0
   0.0%
0
   0.0%
Week 3: Almost Clear Number Analyzed 105 participants 89 participants
14
  13.3%
1
   1.1%
Week 3: Mild Number Analyzed 105 participants 89 participants
51
  48.6%
18
  20.2%
Week 3: Moderate Number Analyzed 105 participants 89 participants
35
  33.3%
51
  57.3%
Week 3: Severe Number Analyzed 105 participants 89 participants
5
   4.8%
19
  21.3%
Week 4: Clear Number Analyzed 103 participants 84 participants
4
   3.9%
0
   0.0%
Week 4: Almost Clear Number Analyzed 103 participants 84 participants
31
  30.1%
1
   1.2%
Week 4: Mild Number Analyzed 103 participants 84 participants
46
  44.7%
21
  25.0%
Week 4: Moderate Number Analyzed 103 participants 84 participants
19
  18.4%
46
  54.8%
Week 4: Severe Number Analyzed 103 participants 84 participants
3
   2.9%
16
  19.0%
Week 6: Clear Number Analyzed 98 participants 82 participants
9
   9.2%
0
   0.0%
Week 6: Almost Clear Number Analyzed 98 participants 82 participants
42
  42.9%
2
   2.4%
Week 6: Mild Number Analyzed 98 participants 82 participants
39
  39.8%
26
  31.7%
Week 6: Moderate Number Analyzed 98 participants 82 participants
7
   7.1%
44
  53.7%
Week 6: Severe Number Analyzed 98 participants 82 participants
1
   1.0%
10
  12.2%
Week 8: Clear Number Analyzed 102 participants 75 participants
17
  16.7%
0
   0.0%
Week 8: Almost Clear Number Analyzed 102 participants 75 participants
52
  51.0%
4
   5.3%
Week 8: Mild Number Analyzed 102 participants 95 participants
29
  28.4%
32
  33.7%
Week 8: Moderate Number Analyzed 102 participants 75 participants
2
   2.0%
34
  45.3%
Week 8: Severe Number Analyzed 102 participants 75 participants
2
   2.0%
5
   6.7%
Week 12: Clear Number Analyzed 103 participants 67 participants
31
  30.1%
0
   0.0%
Week 12: Almost Clear Number Analyzed 103 participants 67 participants
49
  47.6%
11
  16.4%
Week 12: Mild Number Analyzed 103 participants 67 participants
19
  18.4%
35
  52.2%
Week 12: Moderate Number Analyzed 103 participants 67 participants
4
   3.9%
19
  28.4%
Week 12: Severe Number Analyzed 103 participants 67 participants
0
   0.0%
2
   3.0%
Week 16: Clear Number Analyzed 99 participants 59 participants
38
  38.4%
0
   0.0%
Week 16: Almost Clear Number Analyzed 99 participants 59 participants
42
  42.4%
12
  20.3%
Week 16: Mild Number Analyzed 99 participants 59 participants
15
  15.2%
35
  59.3%
Week 16: Moderate Number Analyzed 99 participants 59 participants
4
   4.0%
11
  18.6%
Week 16: Severe Number Analyzed 99 participants 59 participants
0
   0.0%
1
   1.7%
Week 20: Clear Number Analyzed 99 participants 50 participants
43
  43.4%
0
   0.0%
Week 20: Almost Clear Number Analyzed 99 participants 50 participants
36
  36.4%
17
  34.0%
Week 20: Mild Number Analyzed 99 participants 50 participants
18
  18.2%
24
  48.0%
Week 20: Moderate Number Analyzed 99 participants 50 participants
2
   2.0%
8
  16.0%
Week 20: Severe Number Analyzed 99 participants 50 participants
0
   0.0%
1
   2.0%
Week 24: Clear Number Analyzed 99 participants 48 participants
45
  45.5%
4
   8.3%
Week 24: Almost Clear Number Analyzed 99 participants 48 participants
36
  36.4%
21
  43.8%
Week 24: Mild Number Analyzed 99 participants 48 participants
13
  13.1%
15
  31.3%
Week 24: Moderate Number Analyzed 99 participants 48 participants
5
   5.1%
7
  14.6%
Week 24: Severe Number Analyzed 99 participants 48 participants
0
   0.0%
1
   2.1%
12.Secondary Outcome
Title Percentage of Participants With IGA Mod. 2011 0/1-response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Hide Description The IGA mod 2011 scale has been developed based on a previous version of the scale used in secukinumab phase II studies in collaboration with health authorities, in particular the FDA. The explanations/descriptions of the points on the scale have been improved to ensure appropriate differentiation between the points. The IGA mod 2011 used in this study is static, i.e. it refers exclusively to the subject’s disease state at the time of the assessments, and does not attempt a comparison with any of the subject’s previous disease states, whether at baseline or at a previous visit.IGA mod 2011 has a scale of 0-4 with the lower scores correlating to better performance. A score of 0= clear skin, 1= almost clear skin, 2=mild, 3=moderate,4=severe. IGA 0/1 responders: who achieved score of 0/1 and improved by at least 2 points on the IGA scale compared to baseline.
Time Frame Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on FAS population.
Arm/Group Title Secukinumab Fumaric Acid (Initial and Maintenance Therapy)
Hide Arm/Group Description:
Participants were self-administered s.c. with a dose of 300 mg of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 cm around the navel).
Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
Overall Number of Participants Analyzed 105 95
Measure Type: Number
Unit of Measure: Percentage of participants
Week 1 0 0
Week 2 5.7 0
Week 3 13.3 1.1
Week 4 34.3 1.1
Week 6 50.5 2.1
Week 8 66.7 4.2
Week 12 77.1 12.6
Week 16 80.0 14.7
Week 20 79.0 20.0
Week 24 81.0 28.4
13.Secondary Outcome
Title Dermatology Life Quality Index (DLQI) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Hide Description DLQI is a 10-item general dermatology disability index designed to assess health-related quality of life in adult subjects with skin diseases such as eczema, psoriasis, acne, and viral. The measure was self-administered and included domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. Each item had four response categories ranging from 0 (not at all) to 3 (very much). “Not relevant” was also a valid response and was scored as 0. The DLQI total score was a sum of the 10 questions. Scores ranged from 0 to 30, with higher scores indicating greater impairment in health related quality of life.
Time Frame Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on FAS population. Here 'number analyzed' signifies the participants evaluable for DLQI at week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.
Arm/Group Title Secukinumab Fumaric Acid (Initial and Maintenance Therapy)
Hide Arm/Group Description:
Participants were self-administered s.c. with a dose of 300 mg of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 cm around the navel).
Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
Overall Number of Participants Analyzed 105 95
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Week 1 Number Analyzed 105 participants 94 participants
13.9  (5.86) 16.3  (6.44)
Week 2 Number Analyzed 105 participants 91 participants
10.5  (6.22) 15.3  (6.99)
Week 3 Number Analyzed 105 participants 89 participants
8.4  (5.96) 14.6  (7.01)
Week 4 Number Analyzed 102 participants 84 participants
6.6  (5.13) 13.8  (7.23)
Week 6 Number Analyzed 98 participants 82 participants
5.3  (5.79) 12.4  (7.24)
Week 8 Number Analyzed 102 participants 77 participants
4.2  (4.75) 11.0  (7.16)
Week 12 Number Analyzed 103 participants 67 participants
3.1  (4.41) 8.8  (7.10)
Week 16 Number Analyzed 99 participants 59 participants
2.7  (3.95) 6.8  (6.05)
Week 20 Number Analyzed 98 participants 50 participants
2.5  (3.84) 5.9  (5.67)
Week 24 Number Analyzed 99 participants 48 participants
2.0  (3.58) 5.4  (5.56)
14.Secondary Outcome
Title Percentage of Participants With DLQI 0/1 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Hide Description DLQI is a 10-item general dermatology disability index designed to assess health-related quality of life in adult subjects with skin diseases such as eczema, psoriasis, acne, and viral. The measure was self-administered and included domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. Each item had four response categories ranging from 0 (not at all) to 3 (very much). “Not relevant” was also a valid response and was scored as 0. The DLQI total score was a sum of the 10 questions. Scores ranged from 0 to 30, with higher scores indicating greater impairment in health related quality of life. DLQI 0/1 response was the achievement of a DLQI score of 0 or 1.
Time Frame Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on FAS population.
Arm/Group Title Secukinumab Fumaric Acid (Initial and Maintenance Therapy)
Hide Arm/Group Description:
Participants were self-administered s.c. with a dose of 300 mg of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 cm around the navel).
Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
Overall Number of Participants Analyzed 105 95
Measure Type: Number
Unit of Measure: Percentage of participants
Week 1 0 0
Week 2 3.8 1.1
Week 3 7.6 0
Week 4 19.0 2.1
Week 6 30.5 4.2
Week 8 40.0 6.3
Week 12 57.1 10.5
Week 16 59.0 14.7
Week 20 64.8 15.8
Week 24 71.4 25.3
15.Secondary Outcome
Title Percentage of Participants With Short Form 36 (SF-36) Response at Week 4, 16 and 24
Hide Description

SF-36 is a generic indicator of health status for use in population surveys and evaluative studies of health policy. The SF-36 included 36 items in a Likert-type or forced-choice format measured on eight dimensions. The scores for each domain range from 0 to 100, with high scores indicating a better status. SF-36 responder is defined as subject reaching at least an improvement of minimum important difference (MID). The SF-36 measure dimensions and their MID includes:

  • Physical Functioning:4.3
  • Role-Physical: 3.4
  • Bodily Pain: 6.2
  • General Health: 7.2
  • Vitality: 6.2
  • Social Functioning: 6.9
  • Role-Emotional: 4.5
  • Mental Health: 6.2

Two component scores and their MID which were derived from the above mentioned 8 domains includes-:

  • Physical component summary: 3.4
  • Mental component summary: 4.6
Time Frame Week 4, 16 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on FAS population. Here 'number analyzed' signifies the participants evaluable for SF-36 response at week 4, 16 and 24
Arm/Group Title Secukinumab Fumaric Acid (Initial and Maintenance Therapy)
Hide Arm/Group Description:
Participants were self-administered s.c. with a dose of 300 mg of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 cm around the navel).
Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
Overall Number of Participants Analyzed 105 95
Measure Type: Number
Unit of Measure: Percentage of participants
Physical Component Summary Week 4 Number Analyzed 97 participants 88 participants
38.1 26.1
Mental component summary Week 4 Number Analyzed 97 participants 88 participants
41.2 36.4
Physical functioning scale Week 4 Number Analyzed 102 participants 92 participants
24.5 19.6
Role physical scale Week 4 Number Analyzed 104 participants 93 participants
44.2 23.7
Bodily pain scale Week 4 Number Analyzed 105 participants 95 participants
53.3 31.6
General health scale Week 4 Number Analyzed 102 participants 95 participants
32.4 21.1
Vitality scale Week 4 Number Analyzed 104 participants 93 participants
31.7 20.4
Social functioning scale Week 4 Number Analyzed 102 participants 94 participants
39.2 27.7
Role emotional scale Week 4 Number Analyzed 104 participants 95 participants
41.3 34.7
Mental health scale Week 4 Number Analyzed 105 participants 95 participants
33.3 32.6
Physical Component Summary Week 16 Number Analyzed 97 participants 88 participants
52.6 39.8
Mental component summary Week 16 Number Analyzed 97 participants 88 participants
63.9 46.6
Physical functioning scale Week 16 Number Analyzed 102 participants 92 participants
36.3 31.5
Role physical scale Week 16 Number Analyzed 104 participants 93 participants
52.9 36.6
Bodily pain scale Week 16 Number Analyzed 105 participants 95 participants
63.8 45.3
General health scale Week 16 Number Analyzed 102 participants 95 participants
38.2 22.1
Vitality scale Week 16 Number Analyzed 104 participants 93 participants
45.2 23.7
Social functioning scale Week 16 Number Analyzed 102 participants 94 participants
57.8 41.5
Role emotional scale Week 16 Number Analyzed 104 participants 95 participants
56.7 43.2
Mental health scale Week 16 Number Analyzed 105 participants 95 participants
54.3 42.1
Physical Component Summary Week 24 Number Analyzed 97 participants 88 participants
57.7 43.2
Mental component summary Week 24 Number Analyzed 97 participants 88 participants
63.9 50.0
Physical functioning scale Week 24 Number Analyzed 102 participants 92 participants
38.2 31.5
Role physical scale Week 24 Number Analyzed 104 participants 93 participants
52.9 37.6
Bodily pain scale Week 24 Number Analyzed 105 participants 95 participants
64.8 49.5
General health scale Week 24 Number Analyzed 102 participants 95 participants
41.2 21.1
Vitality scale Week 24 Number Analyzed 104 participants 93 participants
48.1 29.0
Social functioning scale Week 24 Number Analyzed 102 participants 94 participants
63.7 45.7
Role emotional scale Week 24 Number Analyzed 104 participants 95 participants
54.8 41.1
Mental health scale Week 24 Number Analyzed 105 participants 95 participants
53.3 38.9
Time Frame Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit (up to 29 weeks).
Adverse Event Reporting Description The safety analysis set consisted of all patients who took at least one dose of study treatment during the treatment period.
 
Arm/Group Title Secukinumab Fumaric Acid (Initial and Maintenance Therapy)
Hide Arm/Group Description Participants were self-administered subcutaneously (s.c.) with a dose of 300 milligrams (mg) of secukinumab at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. Secukinumab was injected in non-affected areas of the skin at front of thighs or lower abdomen (but not the area 5 centimeters (cm) around the navel). Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dose-titrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
All-Cause Mortality
Secukinumab Fumaric Acid (Initial and Maintenance Therapy)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Secukinumab Fumaric Acid (Initial and Maintenance Therapy)
Affected / at Risk (%) Affected / at Risk (%)
Total   4/105 (3.81%)   4/95 (4.21%) 
Gastrointestinal disorders     
ANAL HAEMORRHAGE  1  0/105 (0.00%)  1/95 (1.05%) 
DIARRHOEA  1  0/105 (0.00%)  1/95 (1.05%) 
General disorders     
ASTHENIA  1  1/105 (0.95%)  0/95 (0.00%) 
Infections and infestations     
PILONIDAL CYST  1  0/105 (0.00%)  1/95 (1.05%) 
Injury, poisoning and procedural complications     
CLAVICLE FRACTURE  1  1/105 (0.95%)  0/95 (0.00%) 
Metabolism and nutrition disorders     
DEHYDRATION  1  1/105 (0.95%)  0/95 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
METASTASES TO CENTRAL NERVOUS SYSTEM  1  1/105 (0.95%)  0/95 (0.00%) 
SMALL CELL LUNG CANCER  1  1/105 (0.95%)  0/95 (0.00%) 
Nervous system disorders     
BRAIN OEDEMA  1  1/105 (0.95%)  0/95 (0.00%) 
Skin and subcutaneous tissue disorders     
PSORIASIS  1  0/105 (0.00%)  2/95 (2.11%) 
Vascular disorders     
THROMBOSIS  1  1/105 (0.95%)  0/95 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (19.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Secukinumab Fumaric Acid (Initial and Maintenance Therapy)
Affected / at Risk (%) Affected / at Risk (%)
Total   75/105 (71.43%)   85/95 (89.47%) 
Blood and lymphatic system disorders     
EOSINOPHILIA  1  1/105 (0.95%)  17/95 (17.89%) 
LEUKOCYTOSIS  1  2/105 (1.90%)  5/95 (5.26%) 
LEUKOPENIA  1  1/105 (0.95%)  5/95 (5.26%) 
LYMPHOPENIA  1  2/105 (1.90%)  23/95 (24.21%) 
Gastrointestinal disorders     
ABDOMINAL DISTENSION  1  1/105 (0.95%)  6/95 (6.32%) 
ABDOMINAL PAIN  1  2/105 (1.90%)  11/95 (11.58%) 
ABDOMINAL PAIN UPPER  1  3/105 (2.86%)  37/95 (38.95%) 
DIARRHOEA  1  7/105 (6.67%)  48/95 (50.53%) 
FLATULENCE  1  0/105 (0.00%)  5/95 (5.26%) 
NAUSEA  1  3/105 (2.86%)  20/95 (21.05%) 
VOMITING  1  2/105 (1.90%)  7/95 (7.37%) 
General disorders     
FATIGUE  1  4/105 (3.81%)  6/95 (6.32%) 
Infections and infestations     
NASOPHARYNGITIS  1  54/105 (51.43%)  40/95 (42.11%) 
URINARY TRACT INFECTION  1  6/105 (5.71%)  3/95 (3.16%) 
Investigations     
BLOOD CREATININE INCREASED  1  1/105 (0.95%)  6/95 (6.32%) 
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  6/105 (5.71%)  4/95 (4.21%) 
Nervous system disorders     
HEADACHE  1  15/105 (14.29%)  15/95 (15.79%) 
Renal and urinary disorders     
HAEMATURIA  1  6/105 (5.71%)  3/95 (3.16%) 
Skin and subcutaneous tissue disorders     
PRURITUS  1  7/105 (6.67%)  8/95 (8.42%) 
Vascular disorders     
FLUSHING  1  1/105 (0.95%)  34/95 (35.79%) 
HOT FLUSH  1  1/105 (0.95%)  7/95 (7.37%) 
HYPERTENSION  1  6/105 (5.71%)  1/95 (1.05%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (19.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single­site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862 ­778­ 8300
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT02474082     History of Changes
Other Study ID Numbers: CAIN457ADE06
First Submitted: April 16, 2015
First Posted: June 17, 2015
Results First Submitted: June 11, 2017
Results First Posted: October 27, 2017
Last Update Posted: October 27, 2017