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PsoriasisPURENCT02786186

A Registry of Patients With Moderate to Severe Plaque Psoriasis

An observational study of Psoriasis, run by Novartis Pharmaceuticals at 13 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main purpose of the current study will be to provide real - world evidence regarding the safety and effectiveness of secukinumab in the management of patients with moderate to severe chronic plaque psoriasis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriasis
What is being tested?
Secikinumab
How many people
2,376 participants
Where
13 sitesCanada
Study dates
23 Dec 2015to 22 Jan 2026
How long will I take part?
60 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patient with moderate to severe plaque psoriasis

Who may be able to join

  • - Patients able to give written informed consent
  • - Patients at least 18 years of age at time of informed consent signature
  • - Confirmed diagnosis of chronic moderate to severe chronic plaque-type psoriasis diagnosed by a specialist and presence of moderate to severe psoriasis symptoms according to physician's clinical judgment at the time of recruitment.
  • - Patients initiating a treatment for psoriasis as per regional policy. This will include secukinumab, other biologics, systemic treatments, and phototherapy. Decision to treat with any of the above-mentioned treatments must have been reached prior to and independently of recruitment in the study.
  • - Treatments prescribed in accordance to the product monograph and regional regulatory and reimbursement policies
  • - Patients able to understand and communicate with the investigator and comply with the requirements of the study.

Who cannot join

  • - Unwillingness or inability to comply with the study requirements
  • - Participation in a clinical trial of an investigational drug, concurrently or within the last 30 days.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Canada13 sites

  • Novartis Investigative Site

    Brandon, Manitoba, R7A 0L5

  • Novartis Investigative Site

    Edmonton, Alberta, T6G 1C3

  • Novartis Investigative Site

    Fredericton, New Brunswick, E3B 1G9

  • Novartis Investigative Site

    Hamilton, Ontario, L8N 3Z5

  • Novartis Investigative Site

    London, Ontario, N6A 3H7

  • Novartis Investigative Site

    Nanaimo, British Columbia, V9T 1W1

  • Novartis Investigative Site

    Nepean, Ontario, K2G 6E2

  • Novartis Investigative Site

    St. John's, Newfoundland and Labrador, A1A 4Y3

  • Novartis Investigative Site

    St. John's, Newfoundland and Labrador, A1C 2H5

  • Novartis Investigative Site

    Surrey, British Columbia, V3R 6A7

  • Novartis Investigative Site

    Vancouver, British Columbia, V5Z 1M9

  • Novartis Investigative Site

    Winnepeg, Manitoba, R3M1Z9

  • Novartis Investigative Site

    Winnipeg, Manitoba, R3C 0N2

Other trials in Canada

About this study

Official title: A Registry of Patients With Moderate to Severe Chronic Plaque Psoriasis in Canada and Latin AmErica (LACan)

The main purpose of the current study will be to provide real - world evidence regarding the safety and effectiveness of secukinumab in the management of patients with moderate to severe chronic plaque psoriasis.

Read the detailed description

PURE is a multi-national, prospective, observational cohort study of patients with moderate to severe chronic plaque psoriasis aimed at assessing the real-world safety and effectiveness of secukinumab and other indicated therapies. The study will enroll patients for whom, prior to and independent of study enrollment, the treating physician has decided to treat with secukinumab, or one of the other indicated therapies regimens approved for the management of moderate to severe chronic plaque psoriasis.

Two study cohorts will be defined by patients treated with secukinumab (Cohort 1), and patients treated with other indicated therapies (systemic, phototherapy, or biologic therapy; Cohort 2). Each investigator will recruit approximately the same number of patients in each treatment arm. 2,500 patients (1,250 patients in each cohort) will be followed over a period of 5 years from the Baseline assessment (Visit 1).

Conditions
Psoriasis
Being tested
Secikinumab
Keywords
Psoriasis, Plaque Psoriasis, Chronic Plaque Psoriasis, Cosentyx, Secukinumab, Moderate to severe plaque psoriasis, PURE registry, Registry
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SecikinumabDrug

    Also called AIN457

Study groups in NCT02786186
Study groupRoleWhat they receive
SecikinumabPatients treated with secukinumab
Receives: Drug: Secikinumab
Approved standard of carePatients treated with other indicated therapies (systemic, phototherapy, or biologic therapy)
Receives: Drug: Secikinumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Incidence of all adverse events in the study cohorts as measured by:

    1. The proportion of patients that experience at least one event; and
    2. The number of events per participant

    Measured: Change from Baseline through month 60

Secondary outcomes (8)

  1. Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response

    PASI: 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)

    Measured: Change from Baseline through month 60

  2. Mean change for Work Productivity and Activity Impairment (WPAI) score

    Measured: Change from Baseline through month 60

  3. Mean change for Hospital Anxiety and Depression Scale (HADS) score

    Measured: Change from Baseline through month 60

  4. Mean change for Psoriasis Symptom Diary (PSD) score

    Measured: Change from Baseline through month 60

  5. Mean change for Treatment Satisfaction Scale (TSS) score

    Measured: Change from Baseline through month 60

  6. Mean change for Dermatology Life Quality Index (DLQI) score

    Measured: Change from Baseline through month 60

  7. Mean change for Psoriasis Epidemiology Screening Tool (PEST) score

    Measured: Change from Baseline through month 60

  8. Mean change for direct and indirect cost associated to Psoriasis

    Measured: Change from Baseline through month 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2016 (estimated)
  2. Study start23 Dec 2015
  3. Primary completion22 Jan 2026
  4. Study completion22 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,376 participants (actual)
Target duration
60 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT02786186
Sponsor's protocol ID
CAIN457ACA02
Acronym
PURE
Status last verified
Feb 2026
First submitted
6 May 2016
Last updated
19 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Publications

  • Beecker J, Albrecht L, Dei-Cas I, Gooderham M, Lynde C, Papp KA, Keown P, Vieira A, Farag MS, Maguin M, Zappitelli T, Helliwell PS. Longitudinal Performance of the Psoriasis Epidemiology Screening Tool (PEST) in Canada and Latin America: Results from the Prospective, Observational, 5-Year PURE Registry. Dermatol Ther (Heidelb). 2026 Aug;16(8):4097-4115. doi: 10.1007/s13555-026-01826-7. Epub 2026 Jul 21.

    PubMed 42479398

  • Papp KA, Gooderham M, Dei-Cas I, LopezTello A, Garcia-Rodriguez JC, Taveras CY, Rousselin AH, Lavieri A, Maiolino M, Quintero DGV, Rihakova L, Salibe M, Pertuz W. Effectiveness and Safety of Secukinumab in Latin American Patients with Moderate to Severe Plaque Psoriasis: PURE Registry 12-Month Data. Dermatol Ther (Heidelb). 2023 Jan;13(1):269-283. doi: 10.1007/s13555-022-00849-0. Epub 2022 Dec 10.

    PubMed 36496547

  • Papp KA, Gooderham M, Beecker J, Lynde CW, Delorme I, Dei-Cas I, Albrecht L, Rampakakis E, Sampalis JS, Vieira A, Hussein S, Chambenoit O, Rihakova L. Rationale, objectives and design of PURE, a prospective registry of patients with moderate to severe chronic plaque psoriasis in Canada and Latin America. BMC Dermatol. 2019 Jun 21;19(1):9. doi: 10.1186/s12895-019-0087-3.

    PubMed 31226985

Questions about this trial

What is this clinical trial studying?

An observational study of Psoriasis, run by Novartis Pharmaceuticals at 13 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: Change from Baseline through month 60). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02786186, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.

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