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

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ClinicalTrials.gov Identifier: NCT02267135
Recruitment Status : Completed
First Posted : October 17, 2014
Results First Posted : February 28, 2018
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Scalp Psoriasis
Interventions Biological: Secukinumab 300 mg
Biological: Placebo
Enrollment 102
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Secukinumab Placebo
Hide Arm/Group Description 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 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 Title: Period 1 (Randomized Set)
Started 51 51
Completed 50 47
Not Completed 1 4
Reason Not Completed
Withdrawal by Subject             1             3
Lost to Follow-up             0             1
Period Title: Period 2 (Randomized Set)
Started 50 47
Completed 46 46
Not Completed 4 1
Reason Not Completed
Lost to Follow-up             1             1
Adverse Event             2             0
Withdrawal by Subject             1             0
Arm/Group Title Secukinumab Placebo Total
Hide Arm/Group Description 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 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 of all reporting groups
Overall Number of Baseline Participants 51 51 102
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Age (years)
Mean Number Analyzed 51 participants 51 participants 102 participants
42.7  (13.39) 41.1  (14.17) 41.9  (13.74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 51 participants 102 participants
Female
24
  47.1%
30
  58.8%
54
  52.9%
Male
27
  52.9%
21
  41.2%
48
  47.1%
1.Primary Outcome
Title Psoriasis Scalp Severity Index 90 (PSSI 90)
Hide Description

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"

Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Secukinumab Placebo
Hide Arm/Group Description:
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
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.
Overall Number of Participants Analyzed 51 51
Measure Type: Number
Unit of Measure: Percent of Participants
52.9 2.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Secukinumab, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments adjusted for body weight (< 90 kg, ≥ 90 kg)
Method of Estimation Estimation Parameter Difference between percentages
Estimated Value 51
Confidence Interval (2-Sided) 95%
37 to 65
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Secondary: Investigator's Global Assessment Model 2011 (IGA Mod 2011) Score of 0 or 1 (Scalp Only)
Hide Description 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
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Secukinumab Placebo
Hide Arm/Group Description:
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
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.
Overall Number of Participants Analyzed 51 51
Measure Type: Number
Unit of Measure: Percent of Participants
56.9 5.9
3.Secondary Outcome
Title Change From Baseline in PSSI Score
Hide Description Change from baseline in Psoriasis Scalp Severity Index (PSSI) score. PSSI score ranges from 0-72 with 72 being severe
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Secukinumab Placebo
Hide Arm/Group Description:
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
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.
Overall Number of Participants Analyzed 51 51
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-25.47  (17.052) -5.98  (12.868)
4.Secondary Outcome
Title Psoriasis Scalp Severity Index 75 (PSSI 75) Response
Hide Description PSSI 75 response (yes) at Week 12 (non-responder imputation); PSSI 75 response means at least a 75% improvement in scalp psoriasis
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Secukinumab Placebo
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 51 51
Measure Type: Number
Unit of Measure: Percent of Participants
62.7 5.9
5.Secondary Outcome
Title Psoriasis Scalp Severity Index 100 (PSSI 100) Response
Hide Description PSSI 100 response (yes) at Week 12 (non-responder imputation); PSSI 100 response means no sign of scalp psoriasis
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Secukinumab Placebo
Hide Arm/Group Description:
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
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.
Overall Number of Participants Analyzed 51 51
Measure Type: Number
Unit of Measure: Percent of Participants
35.3 0.0
6.Secondary Outcome
Title Time to 50% Reduction in PSSI Score up to Week 12
Hide Description

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

Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Secukinumab
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 51
Median (95% Confidence Interval)
Unit of Measure: weeks
3.29
(2.43 to 8.14)
7.Secondary Outcome
Title Psoriasis Area and Severity Index 75 (PASI 75)
Hide Description PASI 75 response (yes) at Week 12 (non-responder imputation); PASI 75 response means at least a 75% improvement in body psoriasis
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Secukinumab Placebo
Hide Arm/Group Description:
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
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.
Overall Number of Participants Analyzed 51 51
Measure Type: Number
Unit of Measure: Percent of participants
64.7 2.0
8.Secondary Outcome
Title Psoriasis Area and Severity Index 90 (PASI 90)
Hide Description PASI 90 response (yes) at Week 12 (non-responder imputation); PASI 90 response means at least a 90% improvement in body psoriasis
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Secukinumab Placebo
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 51 51
Measure Type: Number
Unit of Measure: Percent of Participants
47.1 0.0
9.Secondary Outcome
Title Psoriasis Area and Severity Index 100 (PASI 100)
Hide Description PASI 100 response (yes) at Week 12 (non-responder imputation); PASI 100 response means no sign of body psoriasis
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Secukinumab Placebo
Hide Arm/Group Description:
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
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.
Overall Number of Participants Analyzed 51 51
Measure Type: Number
Unit of Measure: Percent of Participants
23.5 0.0
10.Secondary Outcome
Title Investigator's Global Assessment Model 2011 (GA Mod 2011) Score of 0 or 1 (Entire Body Including Scalp)
Hide Description 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
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Secukinumab Placebo
Hide Arm/Group Description:
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
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.
Overall Number of Participants Analyzed 51 51
Measure Type: Number
Unit of Measure: Percent of Participants
52.9 3.9
11.Secondary Outcome
Title Change From Baseline in Subject Assessment of Pain
Hide Description

Change from baseline in the Subject Assessment of Pain

Scale of 0-10 with 10 being the most painful

Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Secukinumab Placebo
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 51 51
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-1.43  (3.233) 1.04  (2.615)
12.Secondary Outcome
Title Change From Baseline in Subject Assessment of Itching
Hide Description

Change from baseline in the Subject Assessment of Itching

Scale of 0-10 with 10 being the most itchy

Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Secukinumab Placebo
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 51 51
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-4.10  (3.008) -0.24  (2.840)
13.Secondary Outcome
Title Change From Baseline in Subject Assessment of Scaling (Scalp Only)
Hide Description

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

Scale of 0-10 with 10 being the most scaling

Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Secukinumab Placebo
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 51 51
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-5.24  (2.861) -0.65  (2.763)
Time Frame 24 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment Period 1 Secukinumab 300 mg Treatment Period 1 Placebo Treatment Period 2 Placebo/Secukinumab 300 mg Treatment Period 1 & 2: Any Secukinumab
Hide Arm/Group Description Treatment Period 1 Secukinumab 300 mg Treatment Period 1 Placebo Treatment Period 2 Placebo/Secukinumab 300 mg [Not Specified]
All-Cause Mortality
Treatment Period 1 Secukinumab 300 mg Treatment Period 1 Placebo Treatment Period 2 Placebo/Secukinumab 300 mg Treatment Period 1 & 2: Any Secukinumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment Period 1 Secukinumab 300 mg Treatment Period 1 Placebo Treatment Period 2 Placebo/Secukinumab 300 mg Treatment Period 1 & 2: Any Secukinumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/51 (0.00%)   1/51 (1.96%)   1/46 (2.17%)   1/96 (1.04%) 
Infections and infestations         
CELLULITIS  1  0/51 (0.00%)  1/51 (1.96%)  1/46 (2.17%)  1/96 (1.04%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment Period 1 Secukinumab 300 mg Treatment Period 1 Placebo Treatment Period 2 Placebo/Secukinumab 300 mg Treatment Period 1 & 2: Any Secukinumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/51 (15.69%)   5/51 (9.80%)   5/46 (10.87%)   5/96 (5.21%) 
Gastrointestinal disorders         
DIARRHOEA  1  2/51 (3.92%)  2/51 (3.92%)  3/46 (6.52%)  3/96 (3.13%) 
Infections and infestations         
NASOPHARYNGITIS  1  3/51 (5.88%)  1/51 (1.96%)  1/46 (2.17%)  1/96 (1.04%) 
Skin and subcutaneous tissue disorders         
DERMATITIS CONTACT  1  3/51 (5.88%)  2/51 (3.92%)  1/46 (2.17%)  1/96 (1.04%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: +1 (800) 778-8300
EMail: trialandresults.registries@novartis.com
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT02267135     History of Changes
Other Study ID Numbers: CAIN457AUS01
First Submitted: September 30, 2014
First Posted: October 17, 2014
Results First Submitted: December 7, 2016
Results First Posted: February 28, 2018
Last Update Posted: April 10, 2019