A Randomized, Controlled, Multicenter, Open-label Study With Blinded Assessment of the Efficacy of Subcutaneous Secukinumab Compared to Fumaderm® in Adults With Moderate to Severe Plaque Psoriasis.
Overview
- Phase
- Phase 3
- Intervention
- Secukinumab
- Conditions
- Psoriasis
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 202
- Locations
- 1
- Primary Endpoint
- Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75 Response at Week 24
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Men or women must be at least 18 years of age at the time of screening
- •Chronic plaque-type psoriasis diagnosed for at least 6 months before randomization Patients with moderate to severe plaque psoriasis who are candidates for systemic therapy as defined at randomization by:
- •PASI score of \>10
- •Affected body surface area (BSA) \> 10%
- •DLQI \>10
- •Inadequate response, intolerance or contraindication to topical psoriasis treatment as documented in the patient's medical history or reported by the patient or determined by the investigator at screening.
- •Exclusion Criteria (abbreviated):
- •Previous systemic treatment of plaque psoriasis or known contraindication for systemic therapy at baseline
- •Ongoing use of other prohibited psoriasis and non-psoriasis treatment.
- •Clinically important active infections or infestations, chronic, recurrent or latent infections or infestations
Exclusion Criteria
- Not provided
Arms & Interventions
Secukinumab
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.
Intervention: Secukinumab
Fumaric acid (initial and maintenance therapy)
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.
Intervention: Fumaric acid
Outcomes
Primary Outcomes
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75 Response at Week 24
Time Frame: Baseline, 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.
Secondary Outcomes
- Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75 Response at Week 1, 2, 3, 4, 6, 8, 12, 16 and 20(Baseline, Week 1, 2, 3, 4, 6, 8, 12, 16 and 20)
- Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24(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(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(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(Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 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(Baseline, Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24)
- 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(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(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(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(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(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(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(Baseline, 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(Week 4, 16 and 24)