Secukinumab in Tumor Necrosis Factor (TNF) - Inadequate Response (IR) Psoriasis Participants.

NCT01961609 | Completed Phase 3 Results

• 1 other identifier: CAIN457AGB01
• Study Type: interventional
• Target: 235
• Locations: 2 countries
• Sites: 54

Brief Summary

This study was designed to prove and quantify the hypothesis that secukinumab is effective, safe and well tolerated in the treatment of moderate to severe chronic plaque-type psoriasis in patients who are inadequate responders to anti-TNFα therapy in a United Kingdom (UK) and Republic of Ireland) specific population.

Conditions

Psoriasis

Keywords

Chronic plaque psoriasis

Outcome Measures

Primary Outcomes (1)

• Percentage of Secukinumab 300 mg Participants Achieving PASI 75 at 16 Weeks

  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). PASI 75 is defined as participants achieving ≥ 75% improvement from baseline.

  16 weeks

Secondary Outcomes (16)

• Percentage of Secukinumab 150 mg Participants Achieving PASI 75 at 16 Weeks

  16 Weeks

• Percentage of Participants Achieving PASI 75 According to 3 Key Participant Subgroups (Primary Inadequate Response (IR), Secondary IR and IR After More Than One Anti-TNFalpha Therapies) at 16 Weeks

  16 Weeks

• Percentage of Participants Achieiving PASI 75 - Initiation Period

  2 ,4, 8, 12 and 16 Weeks

• Percentage of Participants Achieiving PASI 75 - Maintenance 1 Period

  16, 24 and 48 Weeks

• Percentage of Participants Achieiving PASI 75 - Maintenance 2 Period

  48 and 72 Weeks

Study Arms (2)

Secukinumab (AIN457) 300 mg

EXPERIMENTAL

Participants self-administered 300 mg secukinumab loading dose subcutaneously at Day 0 (initiation of study drug) and at weeks 1, 2, 3 \& 4, and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 32 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team.

Biological: Secukinumab (AIN457)

Secukinumab (AIN457) 150 mg

EXPERIMENTAL

Participants self-administered secukinumab 150 mg loading dose subcutaneously at Day 0 (initiation of study drug), weeks 1, 2, 3 \& 4 and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 32 weeks at the 150mg dose. Participants not achieving the NICE criteria at the Primary Endpoint were up titrated to 300mg. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks at the 150mg dose. Participants not achieving the NICE criteria at 48 weeks on the 150mg dose were up titrated to 300mg.

Biological: Secukinumab (AIN457)

Interventions

Secukinumab (AIN457) BIOLOGICAL

Secukinumab was supplied in 150mg pre-filled syringes.

Secukinumab (AIN457) 150 mg; Secukinumab (AIN457) 300 mg

Eligibility Criteria

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

You may qualify if:

• Written informed consent must be obtained before any assessment is performed
• Aged at least 18 years at screening
• Chronic plaque-type psoriasis diagnosed for at least 6 months prior to screening
• Moderate to severe disease severity:
• PASI ≥10 and
• DLQI \>10
• Failed to respond to systemic therapies including cyclosporine and/or methotrexate and/or PUVA (or is intolerant and/or has a contraindication to these)
• Previously treated with at least one anti-TNFα for moderate or severe psoriasis but is a primary or secondary non-responder
• Able to communicate well with the investigator, to understand and comply with the requirements of the study.

You may not qualify if:

• Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis)
• Drug-induced psoriasis (i.e., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium)
• Ongoing use of prohibited psoriasis treatments (e.g., topical or systemic corticosteroids (CS), UV therapy). Washout periods detailed in the protocol must be adhered to.
• Ongoing use of other non-psoriasis prohibited treatments. Washout periods detailed in the protocol have to be adhered to. All other prior non-psoriasis concomitant treatments must be on a stable dose for at least four weeks before initiation of study drug.
• Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or the IL-17 receptor
• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (\> 5 mIU/mL)
• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant unless they use 2 (two) effective forms of contraception during the study and for 16 weeks after stopping treatment.
• Men with a female partner of child bearing potential defined as all women physiologically capable of becoming pregnant unless they use 1 (one) effective form of contraception during the study and for 16 weeks after stopping treatment.
• Active systemic infections during the last two weeks (exception: common cold) prior to initiation of study drug and any infections that reoccur on a regular basis; investigator discretion should be used regarding patients who have travelled or recently resided in areas of endemic mycoses, such as histoplasmosis, coccidioidomycosis or blastomycosis and for patients with underlying conditions that may predispose them to infection, such as advanced or poorly controlled diabetes
• History of an ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis infection as defined by a positive QuantiFERON TB-Gold test (QFT) at screening. Patients with a positive QFT test may participate in the study if further work up establishes conclusively that the patient has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then treatment must have been initiated and maintained according to UK guidelines.
• Known infection with HIV, hepatitis B or hepatitis C at screening or at initiation of study drug.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (54)

Novartis Investigative Site

Cork, T12 X23H, Ireland

Location

Novartis Investigative Site

Dublin, 24, Ireland

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Novartis Investigative Site

Dublin, Ireland

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Novartis Investigative Site

Plymouth, Devon, PL6 8DH, United Kingdom

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Novartis Investigative Site

London, England, E11 1NR, United Kingdom

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Novartis Investigative Site

Harlow, Essex, CM20 1QX, United Kingdom

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Novartis Investigative Site

London, GBR, SW10 9NH, United Kingdom

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Novartis Investigative Site

Canterbury, Kent, CT1 3NG, United Kingdom

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Novartis Investigative Site

Dafen, Llanelli, SA14 8QF, United Kingdom

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Novartis Investigative Site

Salford, Manchester, M6 8HD, United Kingdom

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Novartis Investigative Site

Cliftonville, Northampton, NN1 5BD, United Kingdom

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Novartis Investigative Site

Nottingham, Nottinghamshire, NG17 4JL, United Kingdom

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Aberdeen, Scotland, AB25 2ZN, United Kingdom

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Novartis Investigative Site

Yeovil, Somerset, BA21 4AT, United Kingdom

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Cardiff, South Glamorgan, CF4 4XW, United Kingdom

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Staffordshire, Staffordshire, WS11 5XY, United Kingdom

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Ipswich, Suffolk, IP4 5PD, United Kingdom

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Frimley, Surrey, GU16 7UJ, United Kingdom

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Novartis Investigative Site

Surrey, Surrey, RH1 5RH, United Kingdom

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Rhyl, Wales, LL18 5UJ, United Kingdom

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Coventry, Warwickshire, CV2 2DX, United Kingdom

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Dudley, West Midlands, DY1 2HQ, United Kingdom

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Novartis Investigative Site

Bradford, West Yorkshire, BD5 0NA, United Kingdom

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Novartis Investigative Site

Leeds, West Yorkshire, LS7 4SA, United Kingdom

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Novartis Investigative Site

Airdrie, ML6 0JS, United Kingdom

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Novartis Investigative Site

Bath, BA1 3NG, United Kingdom

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Novartis Investigative Site

Belfast, BT9 7AB, United Kingdom

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Novartis Investigative Site

Birmingham, B15 2TT, United Kingdom

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Novartis Investigative Site

Birmingham, B18 7QH, United Kingdom

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Novartis Investigative Site

Chester, CH2 1UL, United Kingdom

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Durham, DH1 5TW, United Kingdom

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Fife, KY12 OSU, United Kingdom

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Glasgow, G3 8SJ, United Kingdom

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Hull, HU3 2JZ, United Kingdom

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Lancaster, LA1 4RP, United Kingdom

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Leicester, LE7 5WW, United Kingdom

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Liverpool, L14 3PE, United Kingdom

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Novartis Investigative Site

London, N19 5NF, United Kingdom

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Novartis Investigative Site

London, NW3 2QG, United Kingdom

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Novartis Investigative Site

London, SE1 9RT, United Kingdom

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Novartis Investigative Site

Middlesbrough, TS4 3BW, United Kingdom

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Novartis Investigative Site

Middlesex, TW7 6AF, United Kingdom

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Newcastle upon Tyne, NE1 4LP, United Kingdom

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Norwich, NR4 7UY, United Kingdom

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Nottingham, NG7 2UH, United Kingdom

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Oxford, OX3 7LJ, United Kingdom

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Novartis Investigative Site

Poole, BH15 2JB, United Kingdom

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Novartis Investigative Site

Portsmouth, PO6 6AD, United Kingdom

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Novartis Investigative Site

Scaroborough, YO12 6QL, United Kingdom

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Novartis Investigative Site

Scunthorpe, DN15 7GB, United Kingdom

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Novartis Investigative Site

Stoke-on-Trent, ST4 6QG, United Kingdom

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Novartis Investigative Site

Surrey, SM5 1AA, United Kingdom

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Novartis Investigative Site

Wrexham, LL13 7TD, 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

862-778-1873

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: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2013
• First Posted: October 11, 2013
• Study Start: October 9, 2013
• Primary Completion: July 12, 2016
• Study Completion: July 12, 2016
• Last Updated: March 18, 2019
• Results First Posted: March 18, 2019

Record last verified: 2018-12

Locations

IE (3); GB (51)