Trial Outcomes & Findings for Immunologic Response to Secukinumab in Plaque Psoriasis (NCT NCT02592018)

NCT ID: NCT02592018

Last Updated: 2020-09-16

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 15 participants
• Primary outcome timeframe: Baseline to Week 2
• Results posted on: 2020-09-16

Participant Flow

Participant milestones

Measure	Secukinumab All subjects will receive Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48. Secukinumab: Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48. Skin biopsy procedures will be performed at weeks 0, 2, 4, and 12.
Overall Study STARTED	15
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Secukinumab All subjects will receive Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48. Secukinumab: Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48. Skin biopsy procedures will be performed at weeks 0, 2, 4, and 12.
Overall Study Adverse Event	1
Overall Study Lost to Follow-up	1

Baseline Characteristics

Immunologic Response to Secukinumab in Plaque Psoriasis

Baseline characteristics by cohort

Measure	Secukinumab n=15 Participants All subjects will receive Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48. Secukinumab: Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48. Skin biopsy procedures will be performed at weeks 0, 2, 4, and 12.
Age, Continuous	37 years n=93 Participants
Sex: Female, Male Female	6 Participants n=93 Participants
Sex: Female, Male Male	9 Participants n=93 Participants
Race/Ethnicity, Customized Asian/Pacific Islander	4 Participants n=93 Participants
Race/Ethnicity, Customized Black/African American	2 Participants n=93 Participants
Race/Ethnicity, Customized Caucasian	5 Participants n=93 Participants
Race/Ethnicity, Customized Hispanic	4 Participants n=93 Participants
Family history of psoriasis	5 Participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline to Week 2

Outcome measures

Measure	Secukinumab n=15 Participants All subjects will receive Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48. Secukinumab: Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48. Skin biopsy procedures will be performed at weeks 0, 2, 4, and 12.
Change in Percentage of CD4+ T Effector Cells Expressing IL17 Compared to Baseline	-1.42 percent change from week 0 Standard Deviation 4.36

PRIMARY outcome

Timeframe: Baseline to Week 4

Outcome measures

Measure	Secukinumab n=15 Participants All subjects will receive Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48. Secukinumab: Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48. Skin biopsy procedures will be performed at weeks 0, 2, 4, and 12.
Change in Percentage of CD4+ T Effector Cells Expressing IL17 Compared to Baseline	0.23 percent change from week 0 Standard Deviation 8.76

PRIMARY outcome

Timeframe: Baseline to Week 12

Outcome measures

Measure	Secukinumab n=15 Participants All subjects will receive Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48. Secukinumab: Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48. Skin biopsy procedures will be performed at weeks 0, 2, 4, and 12.
Change in Percentage of CD4+ T Effector Cells Expressing IL17 Compared to Baseline	-0.17 percent change from week 0 Standard Deviation 8.73

SECONDARY outcome

Timeframe: Baseline to Week 2

by RNA-seq

Outcome measures

Measure	Secukinumab n=15 Participants All subjects will receive Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48. Secukinumab: Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48. Skin biopsy procedures will be performed at weeks 0, 2, 4, and 12.
Change in Number of Differentially Expressed Genes in CD4+ Effectors Compared to Baseline Across All Participants	67 genes

SECONDARY outcome

Timeframe: Baseline to Week 4

by RNA-seq

Outcome measures

Measure	Secukinumab n=15 Participants All subjects will receive Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48. Secukinumab: Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48. Skin biopsy procedures will be performed at weeks 0, 2, 4, and 12.
Change in Number of Differentially Expressed Genes in CD4+ Effectors Compared to Baseline	308 number of genes

SECONDARY outcome

Timeframe: Baseline to Week 12

by RNA-seq

Outcome measures

Measure	Secukinumab n=15 Participants All subjects will receive Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48. Secukinumab: Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48. Skin biopsy procedures will be performed at weeks 0, 2, 4, and 12.
Change in Number of Differentially Expressed Genes in CD4+ Effectors Compared to Baseline	1618 number of genes

SECONDARY outcome

Timeframe: Baseline to Week 2

by RNA-seq

Outcome measures

Measure	Secukinumab n=15 Participants All subjects will receive Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48. Secukinumab: Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48. Skin biopsy procedures will be performed at weeks 0, 2, 4, and 12.
Change in Number of Differentially Expressed Genes in CD4+ T Regs Compared to Baseline	453 number of genes

SECONDARY outcome

Timeframe: Baseline to Week 4

by RNA-seq

Outcome measures

Measure	Secukinumab n=15 Participants All subjects will receive Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48. Secukinumab: Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48. Skin biopsy procedures will be performed at weeks 0, 2, 4, and 12.
Change in Number of Differentially Expressed Genes in CD4+ T Regs Compared to Baseline	240 number of genes

SECONDARY outcome

Timeframe: Baseline to Week 12

by RNA-seq

Outcome measures

Measure	Secukinumab n=15 Participants All subjects will receive Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48. Secukinumab: Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48. Skin biopsy procedures will be performed at weeks 0, 2, 4, and 12.
Change in Number of Differentially Expressed Genes in CD4+ T Regs Compared to Baseline	127 number of genes

SECONDARY outcome

Timeframe: Baseline to Week 2

by RNA-seq

Outcome measures

Measure	Secukinumab n=15 Participants All subjects will receive Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48. Secukinumab: Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48. Skin biopsy procedures will be performed at weeks 0, 2, 4, and 12.
Change in Number of Differentially Expressed Genes in CD8+ T Effectors Compared to Baseline	20 number of genes

SECONDARY outcome

Timeframe: Baseline to Week 4

by RNA-seq

Outcome measures

Measure	Secukinumab n=15 Participants All subjects will receive Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48. Secukinumab: Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48. Skin biopsy procedures will be performed at weeks 0, 2, 4, and 12.
Change in Number of Differentially Expressed Genes in CD8+ T Effectors Compared to Baseline	102 number of genes

SECONDARY outcome

Timeframe: Baseline to Week 12

by RNA-seq

Outcome measures

Measure	Secukinumab n=15 Participants All subjects will receive Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48. Secukinumab: Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48. Skin biopsy procedures will be performed at weeks 0, 2, 4, and 12.
Change in Number of Differentially Expressed Genes in CD8+ T Effectors Compared to Baseline	104 number of genes

Adverse Events

Secukinumab

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Measure	Secukinumab n=15 participants at risk All subjects will receive Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48. Secukinumab: Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48. Skin biopsy procedures will be performed at weeks 0, 2, 4, and 12.
Nervous system disorders Bell's palsy	6.7% 1/15 • 52 weeks

Other adverse events

Measure	Secukinumab n=15 participants at risk All subjects will receive Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48. Secukinumab: Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48. Skin biopsy procedures will be performed at weeks 0, 2, 4, and 12.
Respiratory, thoracic and mediastinal disorders Sore throat	13.3% 2/15 • 52 weeks
Respiratory, thoracic and mediastinal disorders Cough	20.0% 3/15 • 52 weeks
Gastrointestinal disorders Diarrhea	13.3% 2/15 • 52 weeks
Infections and infestations Upper respiratory infection	60.0% 9/15 • 52 weeks

Additional Information

Dr. Wilson Liao

UCSF Department of Dermatology

Phone: 415-476-4701

Email: wilson.liao@ucsf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place