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A Study to Evaluate Clear Skin Effect on Quality of Life in Patients With Plaque Psoriasis. (PROSE)

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ClinicalTrials.gov Identifier: NCT02752776
Recruitment Status : Completed
First Posted : April 27, 2016
Last Update Posted : December 10, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
Study of effects of secukinumab 300 mg s.c. on quality of life (QoL) in psoriasis patients with or without prior exposure to systemic therapy.

Condition or disease Intervention/treatment Phase
Moderate to Severe Plaque Psoriasis Drug: Secukinumab Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1661 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Prospective, Non-randomized, Multicenter Study to Evaluate Clear Skin Effect on Health Related Quality of Life Outcomes at 16 and 52 Weeks in Patients With Moderate to Severe Plaque Psoriasis Treated With Secukinumab 300 mg s.c. With or Without Previous Exposure to Systemic Therapy.
Actual Study Start Date : March 17, 2016
Actual Primary Completion Date : March 28, 2018
Actual Study Completion Date : March 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Secukinumab

Arm Intervention/treatment
Experimental: Secukinumab

All patients are scheduled to receive s.c. injections of secukinumab 300 mg at Week 0, 1, 2 and 3 during the first 4 weeks followed by monthly maintenance dosing of 300 mg secukinumab starting at Week 4 until Week 48. Consideration should be given to discontinuing treatment in patients who have shown no response up to 16 weeks of treatment (e.g. patients who did not achieve a PASI 50 response). If discontinued, patients will complete the end of study visit assessments. Some patients with an initially partial response (e.g.

patients who achieve a PASI 50 response but not a PASI 75 response) may subsequently improve with continued treatment beyond 16 weeks.

Drug: Secukinumab
Secukinumab will be used as commercially available PFS of 150 mg. Patients will receive PFS at the site and will be instructed to administer Secukinumab as needed (300 mg each application).




Primary Outcome Measures :
  1. Proportion of patients achieving a Dermatology life quality index 0/1 (DLQI 0/1) [ Time Frame: 16 weeks ]
    To assess the proportion of patients achieving a Dermatology life quality index 0/1 (DLQI 0/1) response at Week 16 in 3 pre-defined subpopulations and in the overall study population.


Secondary Outcome Measures :
  1. Proportion of patients achieving a Dermatology life quality index 0/1 (DLQI 0/1) [ Time Frame: 52 weeks ]
    To assess the proportion of patients achieving a Dermatology life quality index 0/1 (DLQI 0/1) response at Week 52 in 3 pre-defined subpopulations and in the overall study population.

  2. Changes in Patient Related Outcome (PRO) - EQ-5D©) - compared to Baseline [ Time Frame: 16 and 52 weeks ]
    To assess the effects of treatment with secukinumab 300 mg with respect to changes in EuroQOL 5-Dimension Health Questionnaire (EQ-5D©) response over time up to Week 16 and Week 52 compared to Baseline in 3 pre-defined subpopulations and in the overall study population.

  3. Proportion of patients achieving various scores of psoriasis area and severity index (PASI) [ Time Frame: 16 and 52 weeks ]
    To assess the proportion of patients achieving PASI 50, PASI 75, PASI 90, PASI 100 and investigator's global assessment (IGA) mod 2011 0/1 responses at Week 16 and Week 52 in 3 pre-defined subpopulations and in the overall study population.

  4. Proportion of patients achieving various Dermatology life quality index (DLQI) scores [ Time Frame: 16 and 52 weeks ]
    To assess the proportion of patients with DLQI scores 2-5, 6-10, 11-20, 21-30 at Week 16 and Week 52 compared to Baseline in 3 pre-defined subpopulations and in the overall study population.

  5. Overall safety and tolerability of treatment with secukinumab 300 mg in all three subpopulations [ Time Frame: 16 and 52 weeks ]
    Clinical safety and tolerability of treatment with secukinumab 300 mg in 3 pre-defined subpopulations and in the overall study population as assessed by vital signs, clinical laboratory variables and adverse events monitoring are measured as number of events.

  6. Changes in Patient Related Outcome (PRO) - HAQ©-DI - compared to Baseline [ Time Frame: 16 and 52 weeks ]
    To assess the effects of treatment with secukinumab 300 mg with respect to changes in Health assessment questionnaire disability index (HAQ©-DI) response over time up to Week 16 and Week 52 compared to Baseline in 3 pre-defined subpopulations and in the overall study population.

  7. Changes in Patient Related Outcome (PRO) - Numeric rating scale (NRS) - compared to Baseline [ Time Frame: 16 and 52 weeks ]
    To assess the effects of treatment with secukinumab 300 mg with respect to changes in Numeric rating scale: patient's assessment of pain, itching and scaling (NRS) response over time up to Week 16 and Week 52 compared to Baseline in 3 pre-defined subpopulations and in the overall study population.

  8. Changes in Patient Related Outcome (PRO) - TSQM - compared to Baseline [ Time Frame: 16 and 52 weeks ]
    To assess the effects of treatment with secukinumab 300 mg with respect to changes in Treatment satisfaction questionnaire for medication (TSQM) response over time up to Week 16 and Week 52 compared to Baseline in 3 pre-defined subpopulations and in the overall study population.

  9. Changes in Patient Related Outcome (PRO) - Patient benefit index (PBI) - compared to Baseline [ Time Frame: 16 and 52 weeks ]
    To assess the effects of treatment with secukinumab 300 mg with respect to changes in Patient benefit index (PBI) response over time up to Week 16 and Week 52 compared to Baseline in 3 pre-defined subpopulations and in the overall study population.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men or women aged at least 18 years at time of Screening.
  • Moderate to severe plaque-type psoriasis diagnosed for at least 3 months prior to Screening and candidate for systemic therapy.
  • Other protocol defined inclusion criteria may apply. Please refer to the protocol.

Exclusion Criteria:

  • Forms of psoriasis other than moderate to severe plaque-type psoriasis, e.g. drug-induced psoriasis at Screening.
  • Patients with previous treatment with any agent targeting interleukin (IL)-17 directly or IL-17 receptor A (e.g. secukinumab, ixekizumab, or brodalumab).
  • Pregnant or nursing (lactating) women
  • Women of child-bearing potential unless they use effective contraception
  • Other protocol-defined exclusion criteria may apply. Please refer to the protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02752776


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Sponsors and Collaborators
Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02752776     History of Changes
Other Study ID Numbers: CAIN457A3401
2015-003701-42 ( EudraCT Number )
First Posted: April 27, 2016    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

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


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Moderate to severe plaque psoriasis
immune-mediated systemic disease
scaly patches
papules
plaques
itching

Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs