Palmoplantar Pustular Psoriasis Efficacy and Safety With Secukinumab

NCT02008890 | Completed Phase 3 Results

• 2 other identifiers: CAIN457A33012013-003086-34
• Study Type: interventional
• Target: 237
• Locations: 10 countries
• Sites: 68

Brief Summary

A one year study assessing the efficacy and safety of secukinumab compared with placebo in adult patients with moderate to severe palmoplantar pustular psoriasis - amended with an optional extension treatment period of up to a total of 148 weeks

Conditions

Palmoplantar Pustular Psoriasis

Keywords

palmoplantar, pustular, psoriasis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With ppPASI 75 Response at Week 16 (Period 1)

  The primary endpoint was assessed by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieved a 75% reduction in ppPASI score from Baseline to Week 16 was measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.

  Baseline to Week 16

Secondary Outcomes (7)

• ppPASI: Absolute Change From Baseline to Week 16

  Baseline to Week 16

• Percentage of Participants With ppPASI 75 Response Over Time (Period 1)

  Baseline to Week 16

• Percentage of Participants With ppPASI 75 Response Over Time (Period 2)

  Week 16 to Week 52

• Percentage of Participants With ppPASI 75 Response Over Time (Extension Period)

  Week 52 to Week 148

• Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety)

  Baseline to Week 16 (Period 1)

Study Arms (3)

Secukinumab 300mg

EXPERIMENTAL

Secukinumab 300mg once weekly at Weeks 1, 2 and 3, thereafter at 4-weekly intervals starting Week 4 until Week 48. In order to maintain the blinding beyond the primary endpoint, placebo was administered at Weeks 17, 18 and 19. For extension period: Secukinumab 300mg at 4-weekly intervals starting Week 52 up to Week 148.

Biological: Secukinumab 300mg; Biological: Placebo

Secukinumab 150mg

EXPERIMENTAL

Secukinumab 150mg once weekly at Weeks 1, 2 and 3, thereafter at 4-weekly intervals starting Week 4 until Week 48. In order to maintain the blinding beyond the primary endpoint, placebo was administered at Weeks 17, 18 and 19. For extension period: Secukinumab 150mg at 4-weekly intervals starting Week 52 up to Week 148.

Biological: Secukinumab 150mg; Biological: Placebo

Placebo

PLACEBO COMPARATOR

Placebo once weekly at Weeks 1, 2 and 3, thereafter at 4-weekly intervals starting Week 4 until Week 12. Patients who achieved ppPASI 75 at Week 16 remained on placebo treatment Until week 48 and were not eligible to enter the extension. Patients who did not achieve ppPASI 75 at Week 16 were re-randomized to receive Secukinumab 150mg or Secukinumab 300mg from Week 16 onwards up to Week 148.

Biological: Secukinumab 300mg; Biological: Secukinumab 150mg; Biological: Placebo

Interventions

Secukinumab 300mg BIOLOGICAL

Secukinumab was used as 150 mg pre-filled syringes (PFS) in a double-blinded fashion. Secukinumab 300 mg s.c. (two PFS injections of the 150 mg dose) self-administered

Placebo; Secukinumab 300mg

Secukinumab 150mg BIOLOGICAL

secukinumab 150 mg s.c. (one PFS injection of the 150 mg dose + one PFS injection of placebo) self-administered

Placebo; Secukinumab 150mg

Placebo BIOLOGICAL

secukinumab placebo s.c. (two PFS injections of placebo) self-administered

Placebo; Secukinumab 150mg; Secukinumab 300mg

Eligibility Criteria

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

You may qualify if:

• Palmoplantar pustular psoriasis for at least 6 months before Randomization
• Moderate to severe palmoplantar pustular psoriasis as defined at Baseline by:
• ppPASI score of ≥ 12 and
• DLQI ≥ 10
• Candidate for systemic therapy, defined as having palmoplantar pustular psoriasis inadequately controlled by:
• Topical treatment, and/or
• Phototherapy, and/or
• Previous systemic therapy

You may not qualify if:

• Forms of psoriasis other than chronic plaque psoriasis and pustular palmoplantar psoriasis (e.g., erythrodermic, guttate, or generalized pustular psoriasis)
• Drug-induced psoriasis (e.g., new onset or current exacerbation from beta-blockers, calcium channel inhibitors, or lithium) or history of proven contact dermatitis
• Patients not willing to limit UV light exposure (e.g. sunbathing and/or the use of tanning devices) during the course of the study
• Ongoing use of prohibited psoriasis treatments (e.g., topical or systemic corticosteroids, UV therapy). Washout periods detailed in the protocol have to be adhered to
• Previous exposure to any biologic drug directly targeting IL-17 or IL-17 Receptor (e.g., secukinumab, ixekizumab, or brodalumab)
• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment and for 16 weeks after stopping treatment
• Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab therapy
• Use of any other investigational drugs within 4 weeks of study drug initiation or within a period of 5 half-lives of the investigational treatment, whichever is longer

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (68)

Novartis Investigative Site

Feldkirch, A-6807, Austria

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Novartis Investigative Site

Graz, 8036, Austria

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Novartis Investigative Site

Linz, A-4020, Austria

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Novartis Investigative Site

Vienna, 1090, Austria

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Novartis Investigative Site

Vienna, A-1090, Austria

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Novartis Investigative Site

Brussels, 1200, Belgium

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Novartis Investigative Site

Ghent, 9000, Belgium

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Novartis Investigative Site

Leuven, 3000, Belgium

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Novartis Investigative Site

Liège, 4000, Belgium

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Novartis Investigative Site

Limoges, Haute Vienne, 87000, France

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Novartis Investigative Site

Bordeaux, 33075, France

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Novartis Investigative Site

Clermont-Ferrand, 63003, France

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Novartis Investigative Site

Martigues, 13500, France

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Novartis Investigative Site

Nice, 06202, France

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Novartis Investigative Site

Paris, 75010, France

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Novartis Investigative Site

Paris, 75014, France

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Novartis Investigative Site

Poitiers, 86021, France

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Novartis Investigative Site

Rouen, 76031, France

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Novartis Investigative Site

Toulouse, 31400, France

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Novartis Investigative Site

Berlin, 10827, Germany

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Novartis Investigative Site

Bochum, 44803, Germany

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Novartis Investigative Site

Dresden, 01307, Germany

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Novartis Investigative Site

Düsseldorf, D 40225, Germany

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Novartis Investigative Site

Freiburg im Breisgau, 79104, Germany

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Novartis Investigative Site

Gera, 07548, Germany

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Novartis Investigative Site

Göttingen, 37075, Germany

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Novartis Investigative Site

Greifswald, 17475, Germany

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Novartis Investigative Site

Hamburg, 20354, Germany

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Novartis Investigative Site

Hamburg, 22391, Germany

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Novartis Investigative Site

Hanau, 63450, Germany

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Novartis Investigative Site

Kiel, 24105, Germany

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Novartis Investigative Site

Lübeck, 23538, Germany

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Novartis Investigative Site

Mahlow, 15831, Germany

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Novartis Investigative Site

Münster, 48149, Germany

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Novartis Investigative Site

Plauen, 08529, Germany

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Novartis Investigative Site

Recklinghausen, 45657, Germany

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Novartis Investigative Site

Schwerin, 19055, Germany

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Novartis Investigative Site

Bologna, BO, 40138, Italy

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Novartis Investigative Site

Brescia, BS, 25123, Italy

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Novartis Investigative Site

Bydgoszcz, 85-094, Poland

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Novartis Investigative Site

Gdansk, 80-803, Poland

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Novartis Investigative Site

Olsztyn, 10-045, Poland

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Novartis Investigative Site

Zabrze, 41-800, Poland

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Novartis Investigative Site

Moscow, 107076, Russia

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Novartis Investigative Site

Rostov on Don Region, 346880, Russia

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Novartis Investigative Site

Ryazan, 390046, Russia

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Novartis Investigative Site

Saratov, 410012, Russia

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Novartis Investigative Site

San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain

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Novartis Investigative Site

Valencia, Valencia, 46014, Spain

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Novartis Investigative Site

A Coruña, 15001, Spain

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Novartis Investigative Site

Barcelona, 08041, Spain

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Novartis Investigative Site

Madrid, 28006, Spain

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Novartis Investigative Site

Madrid, 28031, Spain

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Novartis Investigative Site

Gothenburg, Västra Götaland County, SE-413 45, Sweden

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Novartis Investigative Site

Jönköping, 551 85, Sweden

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Novartis Investigative Site

Malmo, SE-205 02, Sweden

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Novartis Investigative Site

Stockholm, 171 76, Sweden

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Novartis Investigative Site

Uppsala, 751 85, Sweden

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Novartis Investigative Site

Leytonstone, London, E11 1NR, United Kingdom

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Novartis Investigative Site

Salford, Manchester, M6 8HD, United Kingdom

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Novartis Investigative Site

Dundee, Perthshire, DD1 9SY, United Kingdom

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Novartis Investigative Site

Dudley, West Midlands, DY1 2HQ, United Kingdom

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Novartis Investigative Site

Glasgow, G11 6NT, United Kingdom

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Novartis Investigative Site

Liverpool, L14 3PE, United Kingdom

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Novartis Investigative Site

Newport, NP20 4SZ, United Kingdom

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Novartis Investigative Site

Portsmouth, PO6 6AD, United Kingdom

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Novartis Investigative Site

Wolverhampton, WV10 0QP, United Kingdom

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Novartis Investigative Site

York, YO31 8HE, United Kingdom

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MeSH Terms

Conditions

Psoriasis

Interventions

secukinumab

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2013
• First Posted: December 11, 2013
• Study Start: December 26, 2013
• Primary Completion: November 24, 2014
• Study Completion: May 31, 2017
• Last Updated: January 4, 2019
• Results First Posted: January 4, 2019

Record last verified: 2019-01

Locations

RU (4); DE (18); PL (4); IT (2); AU (5); FR (10); BE (4); ES (6); SE (5); GB (10)