A Phase 3 interventional study of Secukinumab and Fumaric acid in Psoriasis, sponsored by Novartis Pharmaceuticals. Completed at 32 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-27.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 3, Interventional, and Treatment
This is a randomized, controlled, multicenter, open-label study with blinded assessment of the efficacy of subcutaneous secukinumab compared to Fumaderm®, in 200 adults with moderate to severe plaque type psoriasis who are candidates for systemic therapy. The study consists of 2 periods: a screening period of at least one week and up to four weeks, and a treatment period of 24 weeks. During the screening period eligibility of the patients is confirmed. Eligible patients are randomized 1:1 to treatment arm A or B at week 0. Patients in treatment arm A receive secukinumab administered at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20 and are followed up for assessments of the study endpoints until week 24. Patients in treatment arm B receive daily doses of Fumaderm® p.o.. Safety and efficacy measurements of secukinumab and Fumaderm® will be performed throughout the study and up to week 24.
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Exclusion Criteria (abbreviated):
Patients in treatment arm A will receive a dose of 300 mg secukinumab administered as 2 subcutaneous injections of 150 mg in a SensoReady pen (i.e. 2 x 150 mg) at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20.
Biological: Secukinumab
Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dosetitrated 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.
Drug: Fumaric acid
Secukinumab 150 mg, 1 ml liquid formulation in a pre-filled pen for s.c. injection
Also known as: AIN457
Fumaric acid initial therapy (tablet contains 30 mg dimethylfumarate, 67 mg ethylhydrogenfumarate calcium salt, 5 mg ethylhydrogenfumarate magnesium salt, 3 mg ethylhydrogenfumarate zinc salt) and Fumaric acid maintenance therapy (tablet contains 120 mg dimethylfumarate, 87 mg ethylhydrogenfumarate calcium salt, 5 mg ethylhydrogenfumarate magnesium salt, 3 mg ethylhydrogenfumarate zinc salt)
Also known as: Fumarate, Fumaric acid, Fumaric acid esters
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75 Response at Week 24
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
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
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
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75 Response at Week 1, 2, 3, 4, 6, 8, 12, 16 and 20
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
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
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
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
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
Body Surface Area (BSA) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
The Body surface area (BSA) affected by plaque-type psoriasis was the total of percentages of areas affected, including head, trunk, upper limbs and lower limbs. Each reported percentage was multiplied by its respective body region corresponding factor (head = 0.1, trunk = 0.3, upper limbs = 0.2, lower limbs = 0.4). The resulting four percentages were added to estimate the total BSA affected by plaque-type psoriasis.
Time frame: Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 50 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
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
Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 75 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
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
Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 90 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
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
Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 100 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
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
Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
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
Percentage of Participants With IGA Mod. 2011 0/1-response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
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
Dermatology Life Quality Index (DLQI) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
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
Percentage of Participants With DLQI 0/1 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
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
Percentage of Participants With Short Form 36 (SF-36) Response at Week 4, 16 and 24
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
| Milestone | Secukinumab | Fumaric Acid (Initial and Maintenance Therapy) |
|---|---|---|
| Started | 105 | 97 |
| Full analysis set (fas) | 105 | 95 |
| Completed | 99 | 43 |
| Not completed | 6 | 54 |
| Withdrew: Adverse event | 2 | 32 |
| Withdrew: Withdrawal of informed consent | 1 | 11 |
| Withdrew: Lost to follow-up | 2 | 2 |
| Withdrew: Dose tapering not achieved | 0 | 4 |
| Withdrew: Participant/guardian decision | 1 | 2 |
| Withdrew: Non-compliance with study treatment | 0 | 2 |
| Withdrew: Protocol deviation | 0 | 1 |
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.
| Percentage of participants | Secukinumab | Fumaric Acid (Initial and Maintenance Therapy) |
|---|---|---|
| Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75 Response at Week 24 | 89.52 | 33.68 |
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.
| Percentage of participants | Secukinumab | Fumaric Acid (Initial and Maintenance Therapy) |
|---|---|---|
| Week 1 | 9.5 | 1.1 |
| Week 2 | 37.1 | 6.3 |
| Week 3 | 63.8 | 10.5 |
| Week 4 | 81.9 | 14.7 |
| Week 6 | 93.3 | 28.4 |
| Week 8) | 96.2 | 41.1 |
| Week 12 | 97.1 | 56.8 |
| Week 16 | 98.1 | 60.0 |
| Week 20 | 98.1 | 61.1 |
| Week 24 | 98.1 | 61.1 |
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.
| Percentage of participants | Secukinumab | Fumaric Acid (Initial and Maintenance Therapy) |
|---|---|---|
| Week 1 | 0 | 0 |
| Week 2 | 5.7 | 0 |
| Week 3 | 24.8 | 0 |
| Week 4 | 47.6 | 1.1 |
| Week 6 | 69.5 | 2.1 |
| Week 8 | 80.0 | 8.4 |
| Week 12 | 87.6 | 21.1 |
| Week 16 | 88.6 | 27.4 |
| Week 20 | 88.6 | 36.8 |
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.
| Percentage of participants | Secukinumab | Fumaric Acid (Initial and Maintenance Therapy) |
|---|---|---|
| Week 1 | 0 | 0 |
| Week 2 | 1.9 | 0 |
| Week 3 | 2.9 | 0 |
| Week 4 | 17.1 | 0 |
| Week 6 | 32.4 | 0 |
| Week 8 | 46.7 | 1.1 |
| Week 12 | 63.8 | 2.1 |
| Week 16 | 68.6 | 8.4 |
| Week 20 | 75.2 | 14.7 |
| Week 24 | 75.2 | 18.9 |
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).
| Percentage of participants | Secukinumab | Fumaric Acid (Initial and Maintenance Therapy) |
|---|---|---|
| Week 1 | 0 | 0 |
| Week 2 | 0 | 0 |
| Week 3 | 0 | 0 |
| Week 4 | 3.8 | 0 |
| Week 6 | 7.6 | 0 |
| Week 8 | 15.2 | 0 |
| Week 12 | 28.6 | 0 |
| Week 16 | 37.1 | 0 |
| Week 20 | 41.0 | 0 |
| Week 24 | 43.8 | 3.2 |
The Body surface area (BSA) affected by plaque-type psoriasis was the total of percentages of areas affected, including head, trunk, upper limbs and lower limbs. Each reported percentage was multiplied by its respective body region corresponding factor (head = 0.1, trunk = 0.3, upper limbs = 0.2, lower limbs = 0.4). The resulting four percentages were added to estimate the total BSA affected by plaque-type psoriasis.
| Percentage of area | Secukinumab | Fumaric Acid (Initial and Maintenance Therapy) |
|---|---|---|
| Week 1 | 23.8 ± 12.82 | 23.2 ± 14.11 |
| Week 2 | 20.1 ± 12.25 | 22.5 ± 14.37 |
| Week 3 | 17.0 ± 11.95 | 22.1 ± 14.33 |
| Week 4 | 13.0 ± 11.93 | 21.6 ± 14.12 |
| Week 6 | 9.8 ± 11.12 | 19.7 ± 13.52 |
| Week 8 | 7.6 ± 10.19 | 17.8 ± 12.65 |
| Week 12 | 5.2 ± 9.12 | 13.7 ± 11.60 |
| Week 16 | 3.7 ± 6.72 | 11.4 ± 11.52 |
| Week 20 | 2.6 ± 5.77 | 9.2 ± 11.87 |
| Week 24 | 2.9 ± 6.43 | 7.9 ± 9.92 |
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.
| Percentage of participants | Secukinumab | Fumaric Acid (Initial and Maintenance Therapy) |
|---|---|---|
| Week 1 | 1.8 | 4.1 |
| Week 2 | 3.6 | 8.2 |
| Week 3 | 5.4 | 10.2 |
| Week 4 | 7.1 | 12.2 |
| Week 6 | 19.6 | 10.2 |
| Week 8 | 23.2 | 8.2 |
| Week 12 | 41.1 | 12.2 |
| Week 16 | 51.8 | 10.2 |
| Week 20 | 62.5 | 18.4 |
| Week 24 | 67.9 | 18.4 |
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.
| Percentage of participants | Secukinumab | Fumaric Acid (Initial and Maintenance Therapy) |
|---|---|---|
| Week 1 | 1.8 | 0 |
| Week 2 | 1.8 | 2.0 |
| Week 3 | 5.4 | 2.0 |
| Week 4 | 7.1 | 2.0 |
| Week 6 | 8.9 | 2.0 |
| Week 8 | 17.9 | 2.0 |
| Week 12 | 28.6 | 2.0 |
| Week 16 | 30.4 | 2.0 |
| Week 20 | 44.6 | 6.1 |
| Week 24 | 53.6 | 4.1 |
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.
| Percentage of participants | Secukinumab | Fumaric Acid (Initial and Maintenance Therapy) |
|---|---|---|
| Week 1 | 1.8 | 0 |
| Week 2 | 1.8 | 0 |
| Week 3 | 0 | 0 |
| Week 4 | 3.6 | 0 |
| Week 6 | 3.6 | 0 |
| Week 8 | 7.1 | 2.0 |
| Week 12 | 14.3 | 2.0 |
| Week 16 | 21.4 | 2.0 |
| Week 20 | 26.8 | 4.1 |
| Week 24 | 35.7 | 4.1 |
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.
| Percentage of participants | Secukinumab | Fumaric Acid (Initial and Maintenance Therapy) |
|---|---|---|
| Week 1 | 1.8 | 0 |
| Week 2 | 0 | 0 |
| Week 3 | 0 | 0 |
| Week 4 | 3.6 | 0 |
| Week 6 | 3.6 | 0 |
| Week 8 | 5.4 | 2.0 |
| Week 12 | 10.7 | 2.0 |
| Week 16 | 19.6 | 2.0 |
| Week 20 | 19.6 | 2.0 |
| Week 24 | 23.2 | 2.0 |
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.
| Participants | Secukinumab | Fumaric Acid (Initial and Maintenance Therapy) |
|---|---|---|
| Week 1: Clear | 0 | 0 |
| Week 1: Almost Clear | 0 | 0 |
| Week 1: Mild | 18 | 8 |
| Week 1: Moderate | 65 | 58 |
| Week 1: Severe | 22 | 28 |
| Week 2: Clear | 0 | 0 |
| Week 2: Almost Clear | 6 | 0 |
| Week 2: Mild | 38 | 15 |
| Week 2: Moderate | 49 | 56 |
| Week 2: Severe | 12 | 20 |
| Week 3: Clear | 0 | 0 |
| Week 3: Almost Clear | 14 | 1 |
| Week 3: Mild | 51 | 18 |
| Week 3: Moderate | 35 | 51 |
| Week 3: Severe | 5 | 19 |
| Week 4: Clear | 4 | 0 |
| Week 4: Almost Clear | 31 | 1 |
| Week 4: Mild | 46 | 21 |
| Week 4: Moderate | 19 | 46 |
| Week 4: Severe | 3 | 16 |
| Week 6: Clear | 9 | 0 |
| Week 6: Almost Clear | 42 | 2 |
| Week 6: Mild | 39 | 26 |
| Week 6: Moderate | 7 | 44 |
| Week 6: Severe | 1 | 10 |
| Week 8: Clear | 17 | 0 |
| Week 8: Almost Clear | 52 | 4 |
| Week 8: Mild | 29 | 32 |
| Week 8: Moderate | 2 | 34 |
| Week 8: Severe | 2 | 5 |
| Week 12: Clear | 31 | 0 |
| Week 12: Almost Clear | 49 | 11 |
| Week 12: Mild | 19 | 35 |
| Week 12: Moderate | 4 | 19 |
| Week 12: Severe | 0 | 2 |
| Week 16: Clear | 38 | 0 |
| Week 16: Almost Clear | 42 | 12 |
| Week 16: Mild | 15 | 35 |
| Week 16: Moderate | 4 | 11 |
| Week 16: Severe | 0 | 1 |
| Week 20: Clear | 43 | 0 |
| Week 20: Almost Clear | 36 | 17 |
| Week 20: Mild | 18 | 24 |
| Week 20: Moderate | 2 | 8 |
| Week 20: Severe | 0 | 1 |
| Week 24: Clear | 45 | 4 |
| Week 24: Almost Clear | 36 | 21 |
| Week 24: Mild | 13 | 15 |
| Week 24: Moderate | 5 | 7 |
| Week 24: Severe | 0 | 1 |
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.
| Percentage of participants | Secukinumab | Fumaric Acid (Initial and Maintenance Therapy) |
|---|---|---|
| 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 |
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.
| Score on a scale | Secukinumab | Fumaric Acid (Initial and Maintenance Therapy) |
|---|---|---|
| Week 1 | 13.9 ± 5.86 | 16.3 ± 6.44 |
| Week 2 | 10.5 ± 6.22 | 15.3 ± 6.99 |
| Week 3 | 8.4 ± 5.96 | 14.6 ± 7.01 |
| Week 4 | 6.6 ± 5.13 | 13.8 ± 7.23 |
| Week 6 | 5.3 ± 5.79 | 12.4 ± 7.24 |
| Week 8 | 4.2 ± 4.75 | 11.0 ± 7.16 |
| Week 12 | 3.1 ± 4.41 | 8.8 ± 7.10 |
| Week 16 | 2.7 ± 3.95 | 6.8 ± 6.05 |
| Week 20 | 2.5 ± 3.84 | 5.9 ± 5.67 |
| Week 24 | 2.0 ± 3.58 | 5.4 ± 5.56 |
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.
| Percentage of participants | Secukinumab | Fumaric Acid (Initial and Maintenance Therapy) |
|---|---|---|
| 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 |
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
| Percentage of participants | Secukinumab | Fumaric Acid (Initial and Maintenance Therapy) |
|---|---|---|
| Physical Component Summary Week 4 | 38.1 | 26.1 |
| Mental component summary Week 4 | 41.2 | 36.4 |
| Physical functioning scale Week 4 | 24.5 | 19.6 |
| Role physical scale Week 4 | 44.2 | 23.7 |
| Bodily pain scale Week 4 | 53.3 | 31.6 |
| General health scale Week 4 | 32.4 | 21.1 |
| Vitality scale Week 4 | 31.7 | 20.4 |
| Social functioning scale Week 4 | 39.2 | 27.7 |
| Role emotional scale Week 4 | 41.3 | 34.7 |
| Mental health scale Week 4 | 33.3 | 32.6 |
| Physical Component Summary Week 16 | 52.6 | 39.8 |
| Mental component summary Week 16 | 63.9 | 46.6 |
| Physical functioning scale Week 16 | 36.3 | 31.5 |
| Role physical scale Week 16 | 52.9 | 36.6 |
| Bodily pain scale Week 16 | 63.8 | 45.3 |
| General health scale Week 16 | 38.2 | 22.1 |
| Vitality scale Week 16 | 45.2 | 23.7 |
| Social functioning scale Week 16 | 57.8 | 41.5 |
| Role emotional scale Week 16 | 56.7 | 43.2 |
| Mental health scale Week 16 | 54.3 | 42.1 |
| Physical Component Summary Week 24 | 57.7 | 43.2 |
| Mental component summary Week 24 | 63.9 | 50.0 |
| Physical functioning scale Week 24 | 38.2 | 31.5 |
| Role physical scale Week 24 | 52.9 | 37.6 |
| Bodily pain scale Week 24 | 64.8 | 49.5 |
| General health scale Week 24 | 41.2 | 21.1 |
| Vitality scale Week 24 | 48.1 | 29.0 |
| Social functioning scale Week 24 | 63.7 | 45.7 |
| Role emotional scale Week 24 | 54.8 | 41.1 |
| Mental health scale Week 24 | 53.3 | 38.9 |
Collected over 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).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Secukinumab | — | 4/105 (3.8%) | 75/105 (71.4%) |
| Fumaric Acid (Initial and Maintenance Therapy) | — | 4/95 (4.2%) | 85/95 (89.5%) |
| Event | Secukinumab | Fumaric Acid (Initial and Maintenance Therapy) |
|---|---|---|
| PSORIASISSkin and subcutaneous tissue disorders | 0/105 | 2/95 |
| ANAL HAEMORRHAGEGastrointestinal disorders | 0/105 | 1/95 |
| DIARRHOEAGastrointestinal disorders | 0/105 | 1/95 |
| PILONIDAL CYSTInfections and infestations | 0/105 | 1/95 |
| ASTHENIAGeneral disorders | 1/105 | 0/95 |
| CLAVICLE FRACTUREInjury, poisoning and procedural complications | 1/105 | 0/95 |
| DEHYDRATIONMetabolism and nutrition disorders | 1/105 | 0/95 |
| METASTASES TO CENTRAL NERVOUS SYSTEMNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/105 | 0/95 |
| SMALL CELL LUNG CANCERNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/105 | 0/95 |
| BRAIN OEDEMANervous system disorders | 1/105 | 0/95 |
| Event | Secukinumab | Fumaric Acid (Initial and Maintenance Therapy) |
|---|---|---|
| NASOPHARYNGITISInfections and infestations | 54/105 | 40/95 |
| DIARRHOEAGastrointestinal disorders | 7/105 | 48/95 |
| ABDOMINAL PAIN UPPERGastrointestinal disorders | 3/105 | 37/95 |
| FLUSHINGVascular disorders | 1/105 | 34/95 |
| LYMPHOPENIABlood and lymphatic system disorders | 2/105 | 23/95 |
| NAUSEAGastrointestinal disorders | 3/105 | 20/95 |
| EOSINOPHILIABlood and lymphatic system disorders | 1/105 | 17/95 |
| HEADACHENervous system disorders | 15/105 | 15/95 |
| ABDOMINAL PAINGastrointestinal disorders | 2/105 | 11/95 |
| PRURITUSSkin and subcutaneous tissue disorders | 7/105 | 8/95 |
| Age, Categorical(Participants) | Secukinumab | Fumaric Acid (Initial and Maintenance Therapy) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 98 | 90 | 188 |
| >=65 years | 7 | 7 | 14 |
| Age, Continuous(years) | Secukinumab | Fumaric Acid (Initial and Maintenance Therapy) | Total |
|---|---|---|---|
| Mean | 43.2 ± 14.2 | 42.4 ± 13.2 | 42.8 ± 13.7 |
| Sex: Female, Male(Participants) | Secukinumab | Fumaric Acid (Initial and Maintenance Therapy) | Total |
|---|---|---|---|
| Female | 40 | 37 | 77 |
| Male | 65 | 60 | 125 |
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