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

NCT02474082 | Completed Phase 3 Results

• 1 other identifier: CAIN457ADE06
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 32

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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Week 24

Secondary Outcomes (14)

• 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) 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

• 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

Study Arms (2)

Secukinumab

EXPERIMENTAL

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

Fumaric acid (initial and maintenance therapy)

ACTIVE COMPARATOR

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

Interventions

Secukinumab BIOLOGICAL

Secukinumab 150 mg, 1 ml liquid formulation in a pre-filled pen for s.c. injection

Also known as: AIN457

Secukinumab

Fumaric acid DRUG

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

Fumaric acid (initial and maintenance therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (32)

Novartis Investigative Site

Bad Bentheim, 48455, Germany

Location

Novartis Investigative Site

Berlin, 10117, Germany

Location

Novartis Investigative Site

Berlin, 10247, Germany

Location

Novartis Investigative Site

Berlin, 10789, Germany

Location

Novartis Investigative Site

Berlin, 13187, Germany

Location

Novartis Investigative Site

Berlin, 13578, Germany

Location

Novartis Investigative Site

Bielefeld, 33647, Germany

Location

Novartis Investigative Site

Bochum, 44791, Germany

Location

Novartis Investigative Site

Bochum, 44803, Germany

Location

Novartis Investigative Site

Bonn, 53105, Germany

Location

Novartis Investigative Site

Darmstadt, 64283, Germany

Location

Novartis Investigative Site

Erlangen, 91054, Germany

Location

Novartis Investigative Site

Essen, 45147, Germany

Location

Novartis Investigative Site

Frankfurt, 60590, Germany

Location

Novartis Investigative Site

Gera, 07548, Germany

Location

Novartis Investigative Site

Halle, 06108, Germany

Location

Novartis Investigative Site

Hamburg, 20246, Germany

Location

Novartis Investigative Site

Hamburg, 20354, Germany

Location

Novartis Investigative Site

Hamburg, 22391, Germany

Location

Novartis Investigative Site

Hanover, 30625, Germany

Location

Novartis Investigative Site

Heidelberg, 69120, Germany

Location

Novartis Investigative Site

Kiel, 24105, Germany

Location

Novartis Investigative Site

Ludwigshafen, 67063, Germany

Location

Novartis Investigative Site

Lübeck, 23538, Germany

Location

Novartis Investigative Site

Mannheim, 68167, Germany

Location

Novartis Investigative Site

München, 81675, Germany

Location

Novartis Investigative Site

Münster, 48149, Germany

Location

Novartis Investigative Site

Osnabrück, 49074, Germany

Location

Novartis Investigative Site

Quedlinburg, 06484, Germany

Location

Novartis Investigative Site

Schwerin, 19055, Germany

Location

Novartis Investigative Site

Selters, 56242, Germany

Location

Novartis Investigative Site

Stade, 21682, Germany

Location

MeSH Terms

Conditions

Psoriasis

Interventions

secukinumab; fumaric acid; Fumarates

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862 -778- 8300

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2015
• First Posted: June 17, 2015
• Study Start: April 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: October 27, 2017
• Results First Posted: October 27, 2017

Record last verified: 2017-06

Locations

DE (32)