Clinical trial NCT02474082: Study of Secukinumab Compared to Fumaderm® in Adults With Moderate to Severe Psoriasis.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2015-06-17
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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
* Patients with severe liver diseases
* Patients with severe gastrointestinal diseases including but not limited to ventricular and duodenal ulcers
* Patients with severe kidney diseases or serum creatinine above 1 x ULN
* Patients with known hematological disease or lab abnormalities
* Pregnancy, breast feeding, or unwillingness/inability to use appropriate measures of contraception (if necessary)

Primary outcomes:
measure: Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75 Response at Week 24
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: 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
timeFrame: Baseline, Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
measure: Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75 Response at Week 1, 2, 3, 4, 6, 8, 12, 16 and 20
timeFrame: Baseline, Week 1, 2, 3, 4, 6, 8, 12, 16 and 20
measure: 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
timeFrame: Baseline, Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
measure: 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
timeFrame: Baseline, Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
measure: Body Surface Area (BSA) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
timeFrame: Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
measure: Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 50 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
timeFrame: Baseline, Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
measure: Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 75 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
timeFrame: Baseline, Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
measure: Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 90 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
timeFrame: Baseline, Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
measure: Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 100 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
timeFrame: Baseline, Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
measure: Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
timeFrame: Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
measure: Percentage of Participants With IGA Mod. 2011 0/1-response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
timeFrame: Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
measure: Dermatology Life Quality Index (DLQI) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
timeFrame: Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
measure: Percentage of Participants With DLQI 0/1 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
timeFrame: Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24
measure: Percentage of Participants With Short Form 36 (SF-36) Response at Week 4, 16 and 24
timeFrame: Week 4, 16 and 24
Other outcomes:
Locations:
city: Bad Bentheim
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Bielefeld
country: Germany
facility: Novartis Investigative Site
city: Bochum
country: Germany
facility: Novartis Investigative Site
city: Bochum
country: Germany
facility: Novartis Investigative Site
city: Bonn
country: Germany
facility: Novartis Investigative Site
city: Darmstadt
country: Germany
facility: Novartis Investigative Site
city: Erlangen
country: Germany
facility: Novartis Investigative Site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Gera
country: Germany
facility: Novartis Investigative Site
city: Halle
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Heidelberg
country: Germany
facility: Novartis Investigative Site
city: Kiel
country: Germany
facility: Novartis Investigative Site
city: Lubeck
country: Germany
facility: Novartis Investigative Site
city: Ludwigshafen
country: Germany
facility: Novartis Investigative Site
city: Mannheim
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Muenster
country: Germany
facility: Novartis Investigative Site
city: Osnabruck
country: Germany
facility: Novartis Investigative Site
city: Quedlinburg
country: Germany
facility: Novartis Investigative Site
city: Schwerin
country: Germany
facility: Novartis Investigative Site
city: Selters
country: Germany
facility: Novartis Investigative Site
city: Stade
country: Germany
facility: Novartis Investigative Site
Study officials:
References: