Palmoplantar Pustular Psoriasis Clinical Trial
Official title:
A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study of Subcutaneous Secukinumab to Demonstrate Efficacy as Assessed by Palmoplantar Pustulosis Psoriasis Area and Severity Index (ppPASI) at 16 Weeks of Treatment, Compared to Placebo, and to Assess Long-term Safety, Tolerability, and Efficacy in Subjects With Moderate to Severe Chronic Palmoplantar Pustular Psoriasis - Amended With an Optional Extension Treatment Period of up to a Total of 148 Weeks
| Verified date | January 2019 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
A one year study assessing the efficacy and safety of secukinumab compared with placebo in adult patients with moderate to severe palmoplantar pustular psoriasis - amended with an optional extension treatment period of up to a total of 148 weeks
| Status | Completed |
| Enrollment | 237 |
| Est. completion date | May 31, 2017 |
| Est. primary completion date | November 24, 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Palmoplantar pustular psoriasis for at least 6 months before Randomization - Moderate to severe palmoplantar pustular psoriasis as defined at Baseline by: - ppPASI score of = 12 and - DLQI = 10 - Candidate for systemic therapy, defined as having palmoplantar pustular psoriasis inadequately controlled by: - Topical treatment, and/or - Phototherapy, and/or - Previous systemic therapy Exclusion Criteria: - Forms of psoriasis other than chronic plaque psoriasis and pustular palmoplantar psoriasis (e.g., erythrodermic, guttate, or generalized pustular psoriasis) - Drug-induced psoriasis (e.g., new onset or current exacerbation from beta-blockers, calcium channel inhibitors, or lithium) or history of proven contact dermatitis - Patients not willing to limit UV light exposure (e.g. sunbathing and/or the use of tanning devices) during the course of the study - Ongoing use of prohibited psoriasis treatments (e.g., topical or systemic corticosteroids, UV therapy). Washout periods detailed in the protocol have to be adhered to - Previous exposure to any biologic drug directly targeting IL-17 or IL-17 Receptor (e.g., secukinumab, ixekizumab, or brodalumab) - Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment and for 16 weeks after stopping treatment - Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab therapy - Use of any other investigational drugs within 4 weeks of study drug initiation or within a period of 5 half-lives of the investigational treatment, whichever is longer Other protocol-defined inclusion/exclusion criteria may apply. |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Novartis Investigative Site | Feldkirch | |
| Austria | Novartis Investigative Site | Graz | |
| Austria | Novartis Investigative Site | Linz | |
| Austria | Novartis Investigative Site | Wien | |
| Austria | Novartis Investigative Site | Wien | |
| Belgium | Novartis Investigative Site | Bruxelles | |
| Belgium | Novartis Investigative Site | Gent | |
| Belgium | Novartis Investigative Site | Leuven | |
| Belgium | Novartis Investigative Site | Liege | |
| France | Novartis Investigative Site | Bordeaux Cedex | |
| France | Novartis Investigative Site | Clermont Ferrand cedex 1 | |
| France | Novartis Investigative Site | Limoges cedex | Haute Vienne |
| France | Novartis Investigative Site | Martigues | |
| France | Novartis Investigative Site | Nice Cedex 3 | |
| France | Novartis Investigative Site | Paris | |
| France | Novartis Investigative Site | Paris | |
| France | Novartis Investigative Site | Poitiers | |
| France | Novartis Investigative Site | Rouen | |
| France | Novartis Investigative Site | Toulouse Cedex | |
| Germany | Novartis Investigative Site | Berlin | |
| Germany | Novartis Investigative Site | Bochum | |
| Germany | Novartis Investigative Site | Dresden | |
| Germany | Novartis Investigative Site | Duesseldorf | |
| Germany | Novartis Investigative Site | Freiburg | |
| Germany | Novartis Investigative Site | Gera | |
| Germany | Novartis Investigative Site | Gottingen | |
| Germany | Novartis Investigative Site | Greifswald | |
| Germany | Novartis Investigative Site | Hamburg | |
| Germany | Novartis Investigative Site | Hamburg | |
| Germany | Novartis Investigative Site | Hanau | |
| Germany | Novartis Investigative Site | Kiel | |
| Germany | Novartis Investigative Site | Lubeck | |
| Germany | Novartis Investigative Site | Mahlow | |
| Germany | Novartis Investigative Site | Muenster | |
| Germany | Novartis Investigative Site | Plauen | |
| Germany | Novartis Investigative Site | Recklinghausen | |
| Germany | Novartis Investigative Site | Schwerin | |
| Italy | Novartis Investigative Site | Bologna | BO |
| Italy | Novartis Investigative Site | Brescia | BS |
| Poland | Novartis Investigative Site | Bydgoszcz | |
| Poland | Novartis Investigative Site | Gdansk | |
| Poland | Novartis Investigative Site | Olsztyn | |
| Poland | Novartis Investigative Site | Zabrze | |
| Russian Federation | Novartis Investigative Site | Moscow | |
| Russian Federation | Novartis Investigative Site | Rostov on Don region | |
| Russian Federation | Novartis Investigative Site | Ryazan | |
| Russian Federation | Novartis Investigative Site | Saratov | |
| Spain | Novartis Investigative Site | A Coruna | |
| Spain | Novartis Investigative Site | Barcelona | |
| Spain | Novartis Investigative Site | La Laguna | Santa Cruz De Tenerife |
| Spain | Novartis Investigative Site | Madrid | |
| Spain | Novartis Investigative Site | Madrid | |
| Spain | Novartis Investigative Site | Valencia | Comunidad Valenciana |
| Sweden | Novartis Investigative Site | Göteborg | Vastra Gotalands Lan |
| Sweden | Novartis Investigative Site | Joenkoeping | |
| Sweden | Novartis Investigative Site | Malmo | |
| Sweden | Novartis Investigative Site | Stockholm | |
| Sweden | Novartis Investigative Site | Uppsala | |
| United Kingdom | Novartis Investigative Site | Dudley | West Midlands |
| United Kingdom | Novartis Investigative Site | Dundee | Perthshire |
| United Kingdom | Novartis Investigative Site | Glasgow | |
| United Kingdom | Novartis Investigative Site | Leytonstone | London |
| United Kingdom | Novartis Investigative Site | Liverpool | |
| United Kingdom | Novartis Investigative Site | Newport | |
| United Kingdom | Novartis Investigative Site | Portsmouth | |
| United Kingdom | Novartis Investigative Site | Salford | Manchester |
| United Kingdom | Novartis Investigative Site | Wolverhampton | |
| United Kingdom | Novartis Investigative Site | York |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
Austria, Belgium, France, Germany, Italy, Poland, Russian Federation, Spain, Sweden, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants With ppPASI 75 Response at Week 16 (Period 1) | The primary endpoint was assessed by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieved a 75% reduction in ppPASI score from Baseline to Week 16 was measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72. | Baseline to Week 16 | |
| Secondary | ppPASI: Absolute Change From Baseline to Week 16 | A secondary endpoint was assessed by the palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI). The mean change of ppPASI score from Baseline to Week 16 was measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72. | Baseline to Week 16 | |
| Secondary | Percentage of Participants With ppPASI 75 Response Over Time (Period 1) | A secondary endpoint was assessed as response rate of patients to treatment measured by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieve a 75% reduction in ppPASI score from Baseline to each post-baseline visit is measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72. | Baseline to Week 16 | |
| Secondary | Percentage of Participants With ppPASI 75 Response Over Time (Period 2) | A secondary endpoint was assessed as response rate of patients to treatment measured by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieve a 75% reduction in ppPASI score from Baseline to each post-baseline visit is measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72. | Week 16 to Week 52 | |
| Secondary | Percentage of Participants With ppPASI 75 Response Over Time (Extension Period) | A secondary endpoint was assessed as response rate of patients to treatment measured by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieved a 75% reduction in ppPASI score from Baseline to each post-baseline visit was measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72. | Week 52 to Week 148 | |
| Secondary | Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety) | Most frequent (at least 5% in any of the AIN457 groups) Adverse Events | Baseline to Week 16 (Period 1) | |
| Secondary | Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety) | Most frequent (at least 5% in any of the AIN457 groups) Adverse Events | Week 16 to Week 52 (Period 2) | |
| Secondary | Percentage of Participants With Most Frequent Adverse Events - Extension Period (Patient's Safety) | Most frequent (at least 5% in any of the AIN457 groups) Adverse Events | Week 52 to Week 148 (extension period) |