Trial Outcomes & Findings for Efficacy and Safety of Subcutaneous Secukinumab in Adults With Moderate to Severe Scalp Psoriasis (NCT NCT02267135)

NCT ID: NCT02267135

Last Updated: 2021-01-05

Results Overview

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"

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 102 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2021-01-05

Participant Flow

Participant milestones

Measure	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	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.
Period 1 (Randomized Set) STARTED	51	51
Period 1 (Randomized Set) COMPLETED	50	47
Period 1 (Randomized Set) NOT COMPLETED	1	4
Period 2 (Randomized Set) STARTED	50	47
Period 2 (Randomized Set) COMPLETED	46	46
Period 2 (Randomized Set) NOT COMPLETED	4	1

Reasons for withdrawal

Measure	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	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.
Period 1 (Randomized Set) Withdrawal by Subject	1	3
Period 1 (Randomized Set) Lost to Follow-up	0	1
Period 2 (Randomized Set) Lost to Follow-up	1	1
Period 2 (Randomized Set) Adverse Event	2	0
Period 2 (Randomized Set) Withdrawal by Subject	1	0

Baseline Characteristics

Efficacy and Safety of Subcutaneous Secukinumab in Adults With Moderate to Severe Scalp Psoriasis

Baseline characteristics by cohort

Measure	Secukinumab n=51 Participants 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	Placebo n=51 Participants 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.	Total n=102 Participants Total of all reporting groups
Age, Customized Mean	42.7 Age (years) STANDARD_DEVIATION 13.39 • n=5 Participants	41.1 Age (years) STANDARD_DEVIATION 14.17 • n=7 Participants	41.9 Age (years) STANDARD_DEVIATION 13.74 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	30 Participants n=7 Participants	54 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	21 Participants n=7 Participants	48 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Full Analysis Set

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"

Outcome measures

Measure	Secukinumab n=51 Participants 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	Placebo n=51 Participants 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.
Psoriasis Scalp Severity Index 90 (PSSI 90)	52.9 Percent of Participants	2.0 Percent of Participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Full Analysis Set

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

Outcome measures

Measure	Secukinumab n=51 Participants 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	Placebo n=51 Participants 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.
Secondary: Investigator's Global Assessment Model 2011 (IGA Mod 2011) Score of 0 or 1 (Scalp Only)	56.9 Percent of Participants	5.9 Percent of Participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Full Analysis Set

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

Outcome measures

Measure	Secukinumab n=51 Participants 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	Placebo n=51 Participants 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.
Change From Baseline in PSSI Score	-25.47 Scores on a scale Standard Deviation 17.052	-5.98 Scores on a scale Standard Deviation 12.868

SECONDARY outcome

Timeframe: 12 weeks

Population: Full Analysis Set

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

Outcome measures

Measure	Secukinumab n=51 Participants 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	Placebo n=51 Participants 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.
Psoriasis Scalp Severity Index 75 (PSSI 75) Response	62.7 Percent of Participants	5.9 Percent of Participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Full Analysis Set

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

Outcome measures

Measure	Secukinumab n=51 Participants 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	Placebo n=51 Participants 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.
Psoriasis Scalp Severity Index 100 (PSSI 100) Response	35.3 Percent of Participants	0.0 Percent of Participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Full Analysis Set

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

Outcome measures

Measure	Secukinumab n=51 Participants 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	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.
Time to 50% Reduction in PSSI Score up to Week 12	3.29 weeks Interval 2.43 to 8.14	—

SECONDARY outcome

Timeframe: 12 weeks

Population: Full Analysis Set

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

Outcome measures

Measure	Secukinumab n=51 Participants 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	Placebo n=51 Participants 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.
Psoriasis Area and Severity Index 75 (PASI 75)	64.7 Percent of participants	2.0 Percent of participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Full Analysis Set

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

Outcome measures

Measure	Secukinumab n=51 Participants 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	Placebo n=51 Participants 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.
Psoriasis Area and Severity Index 90 (PASI 90)	47.1 Percent of Participants	0.0 Percent of Participants

SECONDARY outcome

Timeframe: 12 weeks

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

Outcome measures

Measure	Secukinumab n=51 Participants 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	Placebo n=51 Participants 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.
Psoriasis Area and Severity Index 100 (PASI 100)	23.5 Percent of Participants	0.0 Percent of Participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Full Analysis Set

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

Outcome measures

Measure	Secukinumab n=51 Participants 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	Placebo n=51 Participants 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.
Investigator's Global Assessment Model 2011 (GA Mod 2011) Score of 0 or 1 (Entire Body Including Scalp)	52.9 Percent of Participants	3.9 Percent of Participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Full Analysis Set

Change from baseline in the Subject Assessment of Pain

Scale of 0-10 with 10 being the most painful

Outcome measures

Measure	Secukinumab n=51 Participants 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	Placebo n=51 Participants 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.
Change From Baseline in Subject Assessment of Pain	-1.43 Scores on a scale Standard Deviation 3.233	1.04 Scores on a scale Standard Deviation 2.615

SECONDARY outcome

Timeframe: 12 weeks

Population: Full Analysis Set

Change from baseline in the Subject Assessment of Itching

Scale of 0-10 with 10 being the most itchy

Outcome measures

Measure	Secukinumab n=51 Participants 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	Placebo n=51 Participants 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.
Change From Baseline in Subject Assessment of Itching	-4.10 Scores on a scale Standard Deviation 3.008	-0.24 Scores on a scale Standard Deviation 2.840

SECONDARY outcome

Timeframe: 12 weeks

Population: Full Analysis Set

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

Scale of 0-10 with 10 being the most scaling

Outcome measures

Measure	Secukinumab n=51 Participants 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	Placebo n=51 Participants 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.
Change From Baseline in Subject Assessment of Scaling (Scalp Only)	-5.24 Scores on a scale Standard Deviation 2.861	-0.65 Scores on a scale Standard Deviation 2.763

Adverse Events

Treatment Period 1 Secukinumab 300 mg

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Treatment Period 1 Placebo

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Treatment Period 2 Placebo/Secukinumab 300 mg

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Treatment Period 1 & 2: Any Secukinumab

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment Period 1 Secukinumab 300 mg n=51 participants at risk Treatment Period 1 Secukinumab 300 mg	Treatment Period 1 Placebo n=51 participants at risk Treatment Period 1 Placebo	Treatment Period 2 Placebo/Secukinumab 300 mg n=46 participants at risk Treatment Period 2 Placebo/Secukinumab 300 mg	Treatment Period 1 & 2: Any Secukinumab n=96 participants at risk
Infections and infestations CELLULITIS	0.00% 0/51 • 24 weeks	2.0% 1/51 • 24 weeks	2.2% 1/46 • 24 weeks	1.0% 1/96 • 24 weeks

Other adverse events

Measure	Treatment Period 1 Secukinumab 300 mg n=51 participants at risk Treatment Period 1 Secukinumab 300 mg	Treatment Period 1 Placebo n=51 participants at risk Treatment Period 1 Placebo	Treatment Period 2 Placebo/Secukinumab 300 mg n=46 participants at risk Treatment Period 2 Placebo/Secukinumab 300 mg	Treatment Period 1 & 2: Any Secukinumab n=96 participants at risk
Infections and infestations NASOPHARYNGITIS	5.9% 3/51 • 24 weeks	2.0% 1/51 • 24 weeks	2.2% 1/46 • 24 weeks	1.0% 1/96 • 24 weeks
Skin and subcutaneous tissue disorders DERMATITIS CONTACT	5.9% 3/51 • 24 weeks	3.9% 2/51 • 24 weeks	2.2% 1/46 • 24 weeks	1.0% 1/96 • 24 weeks
Gastrointestinal disorders DIARRHOEA	3.9% 2/51 • 24 weeks	3.9% 2/51 • 24 weeks	6.5% 3/46 • 24 weeks	3.1% 3/96 • 24 weeks

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: +1 (800) 778-8300

Email: trialandresults.registries@novartis.com

Results disclosure agreements

• Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until publication of the pooled data (i.e., data from all sites) in the clinical trial.
• Publication restrictions are in place

Restriction type: OTHER