Efficacy and Safety of Subcutaneous Secukinumab in Adults... | NCT02267135

NCT02267135

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Secukinumab	Experimental	Eligible patients will receive secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive	Biological: Secukinumab 300 mg
Placebo	Placebo Comparator	Eligible patients will receive placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, the patient will be assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the subject is a responder, the subject will continue on placebo dosing weekly at Weeks 12, 13, 14, 15 and 16 and then after four weeks at Week 20. Subjects who are not responders will be switched to treatment with secukinumab 300 mg and will dose once weekly at Weeks 12, 13, 14, 15 and 16 and then after four weeks at Week 20.	Biological: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Secukinumab 300 mg	Biological	Secukinumab 300 mg will be provided in 1 mL prefilled syringes of 150 mg. Each dose of 300 mg secukinumab will consist of two secukinumab 150 mg injections once weekly for 5 weeks (Baseline, Weeks 1, 2, 3 and 4), followed by dosing every four weeks starting at Week 8 through Week 20 inclusive. In order to maintain the blinding, patients will receive additional placebo injections at Weeks 13, 14 and 15. The patients (or caregivers) will self-inject each dose at the study site under the supervision of site personnel when injections occur of days of study visits. The injections not occurring during a study visit will be done by the patients (or caregivers) at home.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Psoriasis Scalp Severity Index 90 (PSSI 90)	PSSI 90 response (yes) at Week 12; PSSI 90 response means at least a 90% improvement in scalp psoriasis Percentage of participants with Psoriasis Scalp Severity Index 90 (PSSI 90) response of "yes"	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Secondary: Investigator's Global Assessment Model 2011 (IGA Mod 2011) Score of 0 or 1 (Scalp Only)	IGA mod 2011 score of 0 or 1 (scalp only) response at Week 12 (non-responder imputation); IGA mod 2011 score of 0 means no sign of scalp psoriasis, and IGA score of 1 means almost no scalp psoriasis	12 weeks

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Sacramento	California	95819	United States
Novartis Investigative Site

References Module

Label	URL
A Plain Language Trial Summary is available on novartisclinicaltrials.com	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Secukinumab	Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive
FG001	Placebo

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Eligible participants received placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, participants were assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the participant was a responder, the participant continued on placebo through Week 20. Participants who were not responders were switched to treatment with secukinumab 300 mg.

FG00051 subjects
FG00151 subjects

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Secukinumab	Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive
BG001	Placebo	Eligible participants received placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, participants were assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the participant was a responder, the participant continued on placebo through Week 20. Participants who were not responders were switched to treatment with secukinumab 300 mg.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Mean

Standard Deviation

Age (years)

Title

Denominators

Categories

Title	Measurements
	OG00052.9 OG0012.0

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Cochran-Mantel-Haenszel	adjusted for body weight (< 90 kg, ≥ 90 kg)	<0.001		Difference between percentages	51			2-Sided	95	37	65					Superiority or Other (legacy)

Secondary

Secondary: Investigator's Global Assessment Model 2011 (IGA Mod 2011) Score of 0 or 1 (Scalp Only)

IGA mod 2011 score of 0 or 1 (scalp only) response at Week 12 (non-responder imputation); IGA mod 2011 score of 0 means no sign of scalp psoriasis, and IGA score of 1 means almost no scalp psoriasis

Full Analysis Set

Posted

Number

Percent of Participants

12 weeks

ID	Title	Description
OG000	Secukinumab	Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive
OG001	Placebo	Eligible participants received placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, participants were assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the participant was a responder, the participant continued on placebo through Week 20. Participants who were not responders were switched to treatment with secukinumab 300 mg.

Units	Counts
Participants

Secondary

Change From Baseline in PSSI Score

Change from baseline in Psoriasis Scalp Severity Index (PSSI) score. PSSI score ranges from 0-72 with 72 being severe

Full Analysis Set

Posted

Mean

Standard Deviation

Scores on a scale

12 weeks

ID	Title	Description
OG000	Secukinumab	Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive
OG001	Placebo	Eligible participants received placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, participants were assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the participant was a responder, the participant continued on placebo through Week 20. Participants who were not responders were switched to treatment with secukinumab 300 mg.

Units	Counts
Participants

Secondary

Psoriasis Scalp Severity Index 75 (PSSI 75) Response

PSSI 75 response (yes) at Week 12 (non-responder imputation); PSSI 75 response means at least a 75% improvement in scalp psoriasis

Full Analysis Set

Posted

Number

Percent of Participants

12 weeks

ID	Title	Description
OG000	Secukinumab	Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive
OG001	Placebo	Eligible participants received placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, participants were assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the participant was a responder, the participant continued on placebo through Week 20. Participants who were not responders were switched to treatment with secukinumab 300 mg

Units	Counts
Participants

Secondary

Psoriasis Scalp Severity Index 100 (PSSI 100) Response

PSSI 100 response (yes) at Week 12 (non-responder imputation); PSSI 100 response means no sign of scalp psoriasis

Full Analysis Set

Posted

Number

Percent of Participants

12 weeks

ID	Title	Description
OG000	Secukinumab	Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive
OG001	Placebo	Eligible participants received placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, participants were assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the participant was a responder, the participant continued on placebo through Week 20. Participants who were not responders were switched to treatment with secukinumab 300 mg.

Units	Counts
Participants

Secondary

Time to 50% Reduction in PSSI Score up to Week 12

Time to 50% reduction in PSSI score up to week 12 was estimated for drug arm

The median time to reduction was not estimable for placebo because a 50% reduction in PSSI score was not achieved by enough participants receiving placebo

Full Analysis Set

Posted

Median

95% Confidence Interval

weeks

12 weeks

ID	Title	Description
OG000	Secukinumab	Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive

Units	Counts
Participants	OG000

Secondary

Psoriasis Area and Severity Index 75 (PASI 75)

PASI 75 response (yes) at Week 12 (non-responder imputation); PASI 75 response means at least a 75% improvement in body psoriasis

Full Analysis Set

Posted

Number

Percent of participants

12 weeks

ID	Title	Description
OG000	Secukinumab	Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive
OG001	Placebo	Eligible participants received placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, participants were assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the participant was a responder, the participant continued on placebo through Week 20. Participants who were not responders were switched to treatment with secukinumab 300 mg.

Units	Counts
Participants

Secondary

Psoriasis Area and Severity Index 90 (PASI 90)

PASI 90 response (yes) at Week 12 (non-responder imputation); PASI 90 response means at least a 90% improvement in body psoriasis

Full Analysis Set

Posted

Number

Percent of Participants

12 weeks

ID	Title	Description
OG000	Secukinumab	Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive
OG001	Placebo	Eligible participants received placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, participants were assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the participant was a responder, the participant continued on placebo through Week 20. Participants who were not responders were switched to treatment with secukinumab 300 mg

Units	Counts
Participants

Secondary

Psoriasis Area and Severity Index 100 (PASI 100)

PASI 100 response (yes) at Week 12 (non-responder imputation); PASI 100 response means no sign of body psoriasis

Posted

Number

Percent of Participants

12 weeks

ID	Title	Description
OG000	Secukinumab	Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive
OG001	Placebo	Eligible participants received placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, participants were assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the participant was a responder, the participant continued on placebo through Week 20. Participants who were not responders were switched to treatment with secukinumab 300 mg.

Units	Counts
Participants	OG000

Secondary

Investigator's Global Assessment Model 2011 (GA Mod 2011) Score of 0 or 1 (Entire Body Including Scalp)

IGA mod 2011 score of 0 or 1 (entire body including scalp); IGA mod 2011 score of 0 means no sign of psoriasis, and IGA mod 2011 score of 1 means almost no psoriasis

Full Analysis Set

Posted

Number

Percent of Participants

12 weeks

ID	Title	Description
OG000	Secukinumab	Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive
OG001	Placebo	Eligible participants received placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, participants were assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the participant was a responder, the participant continued on placebo through Week 20. Participants who were not responders were switched to treatment with secukinumab 300 mg.

Units	Counts
Participants

Secondary

Change From Baseline in Subject Assessment of Pain

Change from baseline in the Subject Assessment of Pain

Scale of 0-10 with 10 being the most painful

Full Analysis Set

Posted

Mean

Standard Deviation

Scores on a scale

12 weeks

ID	Title	Description
OG000	Secukinumab	Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive
OG001	Placebo	Eligible participants received placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, participants were assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the participant was a responder, the participant continued on placebo through Week 20. Participants who were not responders were switched to treatment with secukinumab 300 mg

Units	Counts
Participants

Secondary

Change From Baseline in Subject Assessment of Itching

Change from baseline in the Subject Assessment of Itching

Scale of 0-10 with 10 being the most itchy

Full Analysis Set

Posted

Mean

Standard Deviation

Scores on a scale

12 weeks

ID	Title	Description
OG000	Secukinumab	Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive
OG001	Placebo	Eligible participants received placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, participants were assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the participant was a responder, the participant continued on placebo through Week 20. Participants who were not responders were switched to treatment with secukinumab 300 mg

Units	Counts
Participants

Secondary

Change From Baseline in Subject Assessment of Scaling (Scalp Only)

Change from baseline in the Subject Assessment of Scaling (scalp only)

Scale of 0-10 with 10 being the most scaling

Full Analysis Set

Posted

Mean

Standard Deviation

Scores on a scale

12 weeks

ID	Title	Description
OG000	Secukinumab	Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive
OG001	Placebo	Eligible participants received placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, participants were assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the participant was a responder, the participant continued on placebo through Week 20. Participants who were not responders were switched to treatment with secukinumab 300 mg

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Treatment Period 1 Secukinumab 300 mg	Treatment Period 1 Secukinumab 300 mg	0	51	8	51
EG001	Treatment Period 1 Placebo	Treatment Period 1 Placebo	1	51	5	51
EG002	Treatment Period 2 Placebo/Secukinumab 300 mg	Treatment Period 2 Placebo/Secukinumab 300 mg	1	46	5	46
EG003	Treatment Period 1 & 2: Any Secukinumab		1	96	5	96

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
CELLULITIS	Infections and infestations	MedDRA (18.1)	Systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk EG0021 affected46 at risk EG0031 affected96 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
DIARRHOEA	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected51 at risk EG0012 affected51 at risk EG0023 affected46 at risk EG0033 affected96 at risk
NASOPHARYNGITIS	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0003 affected51 at risk EG0011 affected51 at risk EG0021 affected46 at risk EG003
DERMATITIS CONTACT	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected51 at risk EG0012 affected51 at risk EG0021 affected46 at risk EG003

ID	Term
D011565	Psoriasis

ID	Term
C555450	secukinumab

ID	Term
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases