Evaluating the benefits of using secukinumab rather than standard treatments as the first systemic treatment in moderate to severe psoriasis

Evaluation of the eFfect of early Initiation of secukinumab in systemic treatment-naïve patients with moderate to severe plaque psoriasis Requiring Systemic Treatment (FIRST) - F1RST - Evaluation of early initiation of secukinumab

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003592-21-GB

Enrollment

148

Registered

2016-10-17

Start date

2016-11-22

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate to severe plaque psoriasis MedDRA version: 19.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858

Interventions

Trade Name: COSENTYX Product Name: Secukinumab Product Code: AIN457 Pharmaceutical Form: Solution for injection in pre-filled syringe IN

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Men or women aged >18 years at time of Screening. 2.Chronic plaque-type psoriasis diagnosed for at least 4months prior to Screening. 3.Moderate to severe plaque-type psoriasis and candidate for systemic therapy as defined by: a.PASI score =10 and DLQI >10 at Baseline, and b. Psoriasis that is inadequately controlled by topical treatment (including topical corticosteroids) and/or phototherapy/PUVA 4.Patients must be able to understand and communicate with the Investigator and comply with the requirements of the study (including administration of s.c. injections) and must provide written, signed and dated informed consent before any study related activity is performed. Where relevant, a legal representative will also sign the informed study consent according to local laws and regulations. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 140 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8

Exclusion criteria

Exclusion criteria: 1. Any forms of psoriasis other than moderate to severe plaque-type psoriasis, e.g. ,pustular, erythrodermic, guttate and drug-induced psoriasis (i.e., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) at Screening. 2.Previous treatment with any systemic therapy for psoriasis, including methotrexate, ciclosporin, acitretin and biologic therapies. 3.Ongoing use of prohibited psoriasis treatments (e.g., topical or systemic corticosteroids, UVB/PUVA); washout periods detailed in the protocol must be adhered to. 4.Ongoing use of non-psoriasis prohibited treatments (e.g., immunosuppressants); washout periods detailed in the protocol must be adhered to. 5.Allergy to rubber or latex or a history of hypersensitivity to any of the study drugs, any of their excipients or to drugs of similar chemical classes. 6.Pregnant or nursing (lactating) women. 7.Women of child-bearing potential (WOCBP). 8.History of an ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection

Design outcomes

Primary

Measure	Time frame
Secondary Objective: To assess the cumulative effects of treatment with secukinumab 300 mg over 32 weeks, as measured by the AUC for DLQI percent change from baseline, compared with a standard treatment pathway in systemic treatment-naïve patients with moderate to severe plaque psoriasis.;Timepoint(s) of evaluation of this end point: Over 32 week period - analysis timepoints will be based on scheduled visit windows, not real time measurements.;Main Objective: The primary objective is to demonstrate, in systemic treatment-naïve patients with moderate to severe plaque psoriasis, that the cumulative effect of treatment with secukinumab 300 mg over 32 weeks, as measured by the area under the curve (AUC) for PASI percent change from baseline, is superior to that seen with a standard treatment pathway.;Primary end point(s): The primary variable for this study is the area under the curve (AUC) for the percentage change from baseline for PASIscore over the 32 week treatment period. The AUC will be calculated using the trapezoidal rule. Where Ti (i = 0, 1, 2, 3, 4, 5…,14) denote the time points Week 0,1, 2, 3, 4, 8,… 32 respectively and Pi denotes the percentage change from baseline of PASI score at each time point,Ti.	—

Measure

Time frame

Secondary Objective: To assess the cumulative effects of treatment with secukinumab 300 mg over 32 weeks, as measured by the AUC for DLQI percent change from baseline, compared with a standard treatment pathway in systemic treatment-naïve patients with moderate to severe plaque psoriasis.;Timepoint(s) of evaluation of this end point: Over 32 week period - analysis timepoints will be based on scheduled visit windows, not real time measurements.;Main Objective: The primary objective is to demonstrate, in systemic treatment-naïve patients with moderate to severe plaque psoriasis, that the cumulative effect of treatment with secukinumab 300 mg over 32 weeks, as measured by the area under the curve (AUC) for PASI percent change from baseline, is superior to that seen with a standard treatment pathway.;Primary end point(s): The primary variable for this study is the area under the curve (AUC) for the percentage change from baseline for PASIscore over the 32 week treatment period. The AUC will be calculated using the trapezoidal rule. Where Ti (i = 0, 1, 2, 3, 4, 5…,14) denote the time points Week 0,1, 2, 3, 4, 8,… 32 respectively and Pi denotes the percentage change from baseline of PASI score at each time point,Ti.

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Secondary

Measure	Time frame
Secondary end point(s): PASI 75, PASI 90 and PASI 100, PASI=3 and IGA mod 2011 0/1 PASI based variables will be analysed using logistic regression with treatment pathway and baseline PASI score as explanatory variables. The IGA variable will be analysed using logistic regression with treatment pathway and randomised strata as explanatory variables. Percentages and 95% CIs will be presented per treatment pathway. Odds ratios will be computed for comparisons of Pathway A versus Pathway B utilising the logistic regression model fitted and presented together with 95% CIs and p-values. Non-responder imputation will be used whereby missing values with respect to PASI or IGA response variables will be imputed with non-response regardless of the reason for the missing data (e.g., premature study discontinuation, missed visit, administrative issues) with the following exceptions considered as responders: • Any patient who withdraws from the study prior to the last scheduled visit but was a responder for at least their last two attended and consecutively scheduled visits will be imputed as a responder for all remaining visits post-withdrawal. •Any patient who was a responder at both visit x-1 and visit x+1 but has missing data at visit x, will be imputed as a responder for visit x. Response will not be imputed in cases of missing baseline PASI scores or in the absence of all post-baseline PASI scores. The analysis will be performed using the FAS. A simple descriptive approach will be considered for potential supplementary presentations of PASI data. For each treatment pathway, the percentage of responders (per PASI 75, PASI 90 and PASI 100 criteria) will be calculated per visit with a single resulting AUC calculated across visits. An average AUC may then be calculated by dividing the resulting AUC by the study time-frame (i.e., AUC/32). Ratios of these AUC	—

Measure

Time frame

Secondary end point(s): PASI 75, PASI 90 and PASI 100, PASI=3 and IGA mod 2011 0/1 PASI based variables will be analysed using logistic regression with treatment pathway and baseline PASI score as explanatory variables. The IGA variable will be analysed using logistic regression with treatment pathway and randomised strata as explanatory variables. Percentages and 95% CIs will be presented per treatment pathway. Odds ratios will be computed for comparisons of Pathway A versus Pathway B utilising the logistic regression model fitted and presented together with 95% CIs and p-values. Non-responder imputation will be used whereby missing values with respect to PASI or IGA response variables will be imputed with non-response regardless of the reason for the missing data (e.g., premature study discontinuation, missed visit, administrative issues) with the following exceptions considered as responders: • Any patient who withdraws from the study prior to the last scheduled visit but was a responder for at least their last two attended and consecutively scheduled visits will be imputed as a responder for all remaining visits post-withdrawal. •Any patient who was a responder at both visit x-1 and visit x+1 but has missing data at visit x, will be imputed as a responder for visit x. Response will not be imputed in cases of missing baseline PASI scores or in the absence of all post-baseline PASI scores. The analysis will be performed using the FAS. A simple descriptive approach will be considered for potential supplementary presentations of PASI data. For each treatment pathway, the percentage of responders (per PASI 75, PASI 90 and PASI 100 criteria) will be calculated per visit with a single resulting AUC calculated across visits. An average AUC may then be calculated by dividing the resulting AUC by the study time-frame (i.e., AUC/32). Ratios of these AUC

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Countries

United Kingdom

Contacts

Public ContactFiona Brisbane

Novartis Pharmaceuticals UK Limited

fiona.brisbane@novartis.com+4407876870485

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026