Secukinumab Dosage Optimisation in Partial Responders With Moderate to Severe Plaque-type Psoriasis

NCT02474069 | Completed Phase 3 Results

• 2 other identifiers: CAIN457ADE042014-001974-32
• Study Type: interventional
• Target: 772
• Locations: 1 country
• Sites: 89

Brief Summary

This study is designed to support the optimal use of secukinumab by providing data to refine guidance on dosing flexibility in patients with psoriasis. The purpose of the study is to explore the effects of dosage interval shorteng to achieve PASI 90 at week 32 for patients who had less than almost clear skin at week 16.

Conditions

Moderate to Severe Plaque-type Psoriasis

Keywords

skin condition; skin disease; itching condition; psoriasis vulgaris; relapsing psoriasis; remitting psoriasis; immune-mediated systemic disease; skin lesions, red skin lesions; scaly patches; papules, plaques; itching; auto-immune; plaque-type psoriasis; plaque

Outcome Measures

Primary Outcomes (2)

• Number of Participants With PASI 90 Response at Week 32

  Number of participants with at least 90% improvement from baseline. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).

  at 32 weeks

• Number of Participants With PASI 90 Response at Week 32 for PPS

  Number of participants with at least 90% improvement from baseline. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).

  at week 32

Secondary Outcomes (10)

• Selection Phase: Number of Participants Achieving (Psoriasis Area and Severity Index Score)PASI 50, 75, 90, 100

  at weeks 1, 2, 3, 4, 8, 12 and 16

• Comparative Dose Phase: Number of Participants Achieving Psoriasis Area and Severity Index Score (PASI) 90 and 100

  at weeks 18, 22, 30, 32

• Selection Phase:Summary of PASI Total Score

  at weeks 1,2,3,4,8, 12, 16

• Comparative Dose Phase: Summary of PASI Total Score

  Weeks 18, 22, 26, 30 and 32

• Number of Patients Achieving Dermatology Life Quality Index (DLQI) Scores of 0 or 1 by Visits in the CDP

  Weeks 4, 16, 18, 22, 26, 30, 32

Study Arms (2)

Secukinumab Interval Shortening

ACTIVE COMPARATOR

Drug: Secukinumab

Secukinumab 4-weekly

ACTIVE COMPARATOR

Drug: Secukinumab

Interventions

Secukinumab DRUG

Secukinumab 4-weekly; Secukinumab Interval Shortening

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be able to understand and communicate with the investigator and must give a written, signed and dated informed consent before any study related activity is performed and who are willing and capable to comply with all study procedures.
• Men or women at least 18 years of age at time of screening.
• Chronic plaque type psoriasis diagnosed for at least 6 months prior to baseline
• Moderate to severe plaque type psoriasis at baseline derived from the European consensus (Mrowietz et al., 2011): BSA (Body Surface Area) \>10% and PASI\>10 and DLQI\>10.
• Candidates for biologic therapy who failed to respond to, or who had a contraindication to or were intolerant to previous conventional systemic therapies.
• According to local guidelines, to exclude chest infection before initiation of a biologic immunomodulating therapy, it is necessary to have obtained an image of the chest (X-ray, computerized tomography or magnetic resonance imaging) within 12 weeks prior to screening and have this evaluated by a qualified physician.

You may not qualify if:

• Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttata psoriasis).
• Drug-induced psoriasis (i.e., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium).
• Ongoing use of prohibited psoriasis and non-psoriasis treatments. Washout periods have to be adhered to.
• Subjects not willing to limit UV light exposure (e.g., sunbathing and/or the use of tanning devices) during the course of the study.
• Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
• Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL-17A or the IL-17A receptor (e.g. brodalumab, ixekizumab).
• History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures.
• Study personnel or first degree relatives of investigator(s) must not be included in the study.
• \*definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels \>40 mIU/m or 6 weeks post- surgical bilateral oophorectomy with or without hysterectomy
• \*\*examples of particularly reliable methods with Pearl Index (PI) \<1, according to guidelines of Deutsche Gesellschaft für Gynakologie und Geburtshilfe:
• hormonal oral contraception (Combination of estrogen and gestagen, PI=0.1-0.9) hormonal vaginal ring (combination of estrogen and gestagen, PI=0.65 uncorr.; 0.4 corr.)
• hormonal transdermal patch (combination of estrogen and gestagen, PI= 0.72 uncorr.; 0.9 corr.)
• Estrogen-free ovulation inhibitors containing desogestrel (PI=0.14)
• Implanted hormones containing etonogestrel (PI=0-0.08)
• Injectable 3-month depot progestins (PI=0.3-1.4; 0.88 corr.)

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (89)

Novartis Investigative Site

Bad Bentheim, 48455, Germany

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Novartis Investigative Site

Berlin, 10247, Germany

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Novartis Investigative Site

Berlin, 10405, Germany

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Novartis Investigative Site

Berlin, 10437, Germany

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Novartis Investigative Site

Berlin, 10783, Germany

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Novartis Investigative Site

Berlin, 12437, Germany

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Novartis Investigative Site

Berlin, 13055, Germany

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Novartis Investigative Site

Berlin, 13086, Germany

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Novartis Investigative Site

Berlin, 13088, Germany

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Novartis Investigative Site

Berlin, 13125, Germany

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Novartis Investigative Site

Berlin, 13187, Germany

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Novartis Investigative Site

Berlin, 13353, Germany

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Novartis Investigative Site

Berlin, 13507, Germany

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Novartis Investigative Site

Berlin, 14052, Germany

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Novartis Investigative Site

Bielefeld, 33647, Germany

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Novartis Investigative Site

Blaubeuren Abbey, 89143, Germany

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Novartis Investigative Site

Blaustein, 89134, Germany

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Novartis Investigative Site

Bochum, 44803, Germany

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Novartis Investigative Site

Bonn, 53111, Germany

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Novartis Investigative Site

Borna, 04552, Germany

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Novartis Investigative Site

Cologne, 50674, Germany

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Novartis Investigative Site

Darmstadt, 64283, Germany

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Novartis Investigative Site

Dresden, 01097, Germany

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Novartis Investigative Site

Dresden, 01307, Germany

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Novartis Investigative Site

Duisburg, 47166, Germany

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Novartis Investigative Site

Dülmen, 48249, Germany

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Novartis Investigative Site

Düren, 52349, Germany

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Novartis Investigative Site

Erlangen, 91054, Germany

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Novartis Investigative Site

Essen, 45147, Germany

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Novartis Investigative Site

Frankfurt, 60590, Germany

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Novartis Investigative Site

Freiburg im Breisgau, 79098, Germany

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Novartis Investigative Site

Freiburg im Breisgau, 79100, Germany

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Novartis Investigative Site

Freising, 85354, Germany

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Novartis Investigative Site

Friedrichshafen, 88045, Germany

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Novartis Investigative Site

Garching, 85748, Germany

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Novartis Investigative Site

Germering, 82110, Germany

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Novartis Investigative Site

Giessen, 35390, Germany

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Novartis Investigative Site

Glückstadt, 25348, Germany

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Novartis Investigative Site

Goslar, 38640, 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

Halle, 06108, Germany

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Novartis Investigative Site

Halle, 06120, Germany

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Novartis Investigative Site

Hamburg, 20246, 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

Hanover, 30159, Germany

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Novartis Investigative Site

Heidelberg, 69120, Germany

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Novartis Investigative Site

Hildesheim, 31134, Germany

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Novartis Investigative Site

Ibbenbuehren, 49477, Germany

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Novartis Investigative Site

Ibbenbueren, 49477, Germany

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Novartis Investigative Site

Itzehoe, 25524, Germany

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Novartis Investigative Site

Jena, 07740, Germany

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Novartis Investigative Site

Kassel, 34125, Germany

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Novartis Investigative Site

Kiel, 24103, Germany

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Novartis Investigative Site

Kiel, 24105, Germany

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Novartis Investigative Site

Langenau, 89129, Germany

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Novartis Investigative Site

Leipzig, 04103, Germany

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Novartis Investigative Site

Lingen, 49809, Germany

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Novartis Investigative Site

Löhne, 32584, Germany

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Novartis Investigative Site

Lüdenscheid, D 58511, Germany

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Novartis Investigative Site

Mainz, 55131, Germany

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Novartis Investigative Site

München, 80335, Germany

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Novartis Investigative Site

München, 80469, Germany

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Novartis Investigative Site

München, 81675, Germany

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Novartis Investigative Site

Münster, 48143, Germany

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Novartis Investigative Site

Münster, 48149, Germany

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Novartis Investigative Site

Oberhausen, 46147, Germany

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Novartis Investigative Site

Osnabrück, 49078, Germany

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Novartis Investigative Site

Pommelsbrunn, 91224, Germany

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Novartis Investigative Site

Potsdam, 14467, Germany

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Novartis Investigative Site

Quedlinburg, 06484, Germany

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Novartis Investigative Site

Remscheid, 42897, Germany

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Novartis Investigative Site

Rheinbach, 53359, Germany

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Novartis Investigative Site

Schweinfurt, 97421, Germany

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Novartis Investigative Site

Soest, 59494, Germany

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Novartis Investigative Site

Stade, 21682, Germany

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Novartis Investigative Site

Straubing, 94315, Germany

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Novartis Investigative Site

Stuttgart, 70176, Germany

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Novartis Investigative Site

Stuttgart-Weilimdorf, 70499, Germany

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Novartis Investigative Site

Tübingen, 72076, Germany

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Novartis Investigative Site

Ulm, 89081, Germany

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Novartis Investigative Site

Weißenfels, 06667, Germany

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Novartis Investigative Site

Wiesbaden, 65199, Germany

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Novartis Investigative Site

Wolfenbüttel, 38300, Germany

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Novartis Investigative Site

Wuppertal, 42105, Germany

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Novartis Investigative Site

Wuppertal, 42117, Germany

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Novartis Investigative Site

Wuppertal, 42349, Germany

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Novartis Investigative Site

Würzburg, 97080, Germany

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MeSH Terms

Conditions

Skin Diseases; Plaque, Amyloid; Pruritus

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Clinical Disclosure Office
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

(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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This was a multicenter, double-blind, randomized study in 772 patients with moderate to severe chronic plaque-type psoriasis. Patients were enrolled at 89 study sites in Germany. The study was divided into 3 phases: screening, selection phase (SP), and comparative dosing phase (CDP). In the screening phase, inclusion and exclusion criteria were confirmed. Eligible patients rolled over into a selection phase (SP) where all patients received 300 mg s.c. open-label secukinumab at baseline, Weeks 1, 2, 3, 4, 8, and 12. At Week 16, PASI response was assessed as a basis for further treatment: 300 mg s.c. secukinumab treatment every 4 weeks vesus 300 mg s.c. secukinumab treatment every 2 weeks. Patients who achieved at least clear or almost clear skin (≥ PASI 90) at Week 16 discontinued the study

Study Record Dates

• First Submitted: February 26, 2015
• First Posted: June 17, 2015
• Study Start: February 8, 2015
• Primary Completion: September 15, 2016
• Study Completion: September 15, 2016
• Last Updated: July 5, 2019
• Results First Posted: July 5, 2019

Record last verified: 2019-04

Locations

DE (89)