Trial Outcomes & Findings for Study to Evaluate Psoriasis Severity and Its Psychosocial Impact Using the Simplified Psoriasis Index (SPI), as Well as Long-term Safety, Tolerability and Efficacy of Secukinumab Administered Subcutaneously in Patients With Moderate to Severe Psoriasis (NCT NCT02595970)

Results Overview

The primary efficacy outcome of this study evaluates the benefit of secukinumab on the severity of psoriasis based on the SPI. This index comprises 3 components: severity (SPIs), psychosocial (SPIp) and intervention (SPIi) and were evaluated by both health care professional (professional, proSPI) and the patient (self-administered: saSPI). Only the severity components were evaluated for the primary objective: proSPI (s) and saSPI (s). Changes at Week 16 compared to Baseline in patients suffering from moderate to severe plaque psoriasis were analyzed for the purpose of this study.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

120 participants

Primary outcome timeframe

Week 0 (baseline) to 16 weeks

Results posted on

2019-04-17

Participant Flow

Study centers: This study involved 17 active centers who enrolled (or recruited) patients in France First patient enrolled: 20-May-2015 Last patient completed: 09-Feb-2017

No significant events in the study (for example, wash out, run-in) that occur after participant enrollment, but prior to assignment of participants to the treatment arm

Participant milestones

Participant milestones
Measure	Single Arm Secukinumab Weekly injections of 300mg of secukinumab during the first month (induction period), followed by monthly injections thereafter to week 48. During this extension period, patients continued to receive monthly injections until End of Extension visit.
Overall Study STARTED	120
Overall Study COMPLETED	100
Overall Study NOT COMPLETED	20

Reasons for withdrawal

Reasons for withdrawal
Measure	Single Arm Secukinumab Weekly injections of 300mg of secukinumab during the first month (induction period), followed by monthly injections thereafter to week 48. During this extension period, patients continued to receive monthly injections until End of Extension visit.
Overall Study Withdrawal by Subject	2
Overall Study Physician Decision	2
Overall Study Protocol Violation	4
Overall Study Adverse Event	5
Overall Study Lack of Efficacy	7

Baseline Characteristics

Study to Evaluate Psoriasis Severity and Its Psychosocial Impact Using the Simplified Psoriasis Index (SPI), as Well as Long-term Safety, Tolerability and Efficacy of Secukinumab Administered Subcutaneously in Patients With Moderate to Severe Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm Secukinumab n=120 Participants Weekly injections of 300mg of secukinumab during the first month (induction period), followed by monthly injections thereafter to week 48. During this extension period, patients continued to receive monthly injections until End of Extension visit.
Age, Continuous	45.9 years STANDARD_DEVIATION 14.17 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants
Sex: Female, Male Male	83 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	116 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
proSPI (s)	24.9 scores on a scale STANDARD_DEVIATION 10.71 • n=5 Participants
saSPI (s)	23.5 score on a scale for each domain of SPI STANDARD_DEVIATION 10.37 • n=5 Participants

PRIMARY outcome

Timeframe: Week 0 (baseline) to 16 weeks

Population: The primary analysis was performed on the FAS. To assess for robustness of the results, the primary analysis was repeated for the FAS (on observed data).

The primary efficacy outcome of this study evaluates the benefit of secukinumab on the severity of psoriasis based on the SPI. This index comprises 3 components: severity (SPIs), psychosocial (SPIp) and intervention (SPIi) and were evaluated by both health care professional (professional, proSPI) and the patient (self-administered: saSPI). Only the severity components were evaluated for the primary objective: proSPI (s) and saSPI (s). Changes at Week 16 compared to Baseline in patients suffering from moderate to severe plaque psoriasis were analyzed for the purpose of this study.

Outcome measures

Outcome measures
Measure	Single Arm Secukinumab n=119 Participants Weekly injections of 300mg of secukinumab during the first month (induction period), followed by monthly injections thereafter to week 48. During this extension period, patients continued to receive monthly injections until End of Extension visit.
proSPI (s) at Week 16 Compared to Baseline W0	24.89 scores on a scale Standard Deviation 10.747
proSPI (s) at Week 16 Compared to Baseline W16	2.34 scores on a scale Standard Deviation 6.144

PRIMARY outcome

Timeframe: Week 0 (baseline) to 16 weeks

Population: Full Analysis Set (FAS): The FAS comprised all patients from the IS who were administered at least one dose of investigational drug with at least one Baseline and one post-baseline SPI evaluation.

The primary efficacy objective of the study was to evaluate the benefit of secukinumab on the severity of psoriasis based on the SPI. This index comprises 3 components: severity (SPIs), psychosocial (SPIp) and intervention (SPIi) and were evaluated by both health care professional (professional, proSPI) and the patient (self-administered: saSPI). Only the severity components were evaluated for the primary objective: proSPI (s) and saSPI (s). Changes at Week 16 compared to Baseline in patients suffering from moderate to severe plaque psoriasis were analyzed. proSPI (s) score range is 0 to 50. Higher score means worse condition