Immunologic Response to Secukinumab in Plaque Psoriasis | NCT02592018

NCT02592018

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Novartis Pharmaceuticals	INDUSTRY

Oversight Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Secukinumab	Experimental	All subjects will receive Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48.	Drug: Secukinumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Secukinumab	Drug	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.	Secukinumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Percentage of CD4+ T Effector Cells Expressing IL17 Compared to Baseline		Baseline to Week 2
Change in Percentage of CD4+ T Effector Cells Expressing IL17 Compared to Baseline		Baseline to Week 4
Change in Percentage of CD4+ T Effector Cells Expressing IL17 Compared to Baseline		Baseline to Week 12

Secondary Outcomes

Measure	Description	Time Frame
Change in Number of Differentially Expressed Genes in CD4+ Effectors Compared to Baseline Across All Participants	by RNA-seq	Baseline to Week 2
Change in Number of Differentially Expressed Genes in CD4+ Effectors Compared to Baseline

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ability to provide written informed consent and comply with the protocol.
At least 18 years of age.
Diagnosis of predominately plaque psoriasis for at least 6 months prior to enrollment.
Subject is considered a candidate for phototherapy or systemic therapy
PASI ≥ 12
PGA ≥ 3
Subject has a negative Quantiferon Gold, or if positive undergoes CXR. If CXR negative, subject initiated prophylactic therapy with isoniazid for a course of 9 months with one month of therapy completed prior to first dose of secukinumab.
Subject is unlikely to conceive (male, post-menopausal, or using adequate oral contraceptive therapy or IUD).
Physical exam within clinically acceptable limits.

Exclusion Criteria:

Subject is unable to provide written informed consent or comply with the protocol.
Subject is younger than 18 years of age.
Subject has predominately non-plaque form of psoriasis.
Subject with mild psoriasis (PASI<12 and PGA<3) or is not a candidate for phototherapy or systemic treatments.
Subject has drug-induced psoriasis.
Subject with current, or a history of, severe psoriatic arthritis well controlled on current therapy.
Subjects with a serum creatinine level exceeding 176.8 μmol/L (2.0 mg/dl).
Screening total white blood cell (WBC count) < 2,500/μl, platelets < 100,000/μl, neutrophils < 1,500/μl, or hemoglobin <8.5 g/dl.
Evidence of active tuberculosis infection as defined by a positive QuantiFERON TB-Gold test (QFT) with a positive chest X-ray at screening, or untreated latent tuberculosis defined by positive QFT with a negative chest X-ray without prophylactic therapy with isoniazid for a course of 9 months with one month of therapy completed prior to first dose of secukinumab.
History of an ongoing, chronic or recurrent infectious disease including past medical history record of HIV, hepatitis B or hepatitis C.
Subjects possess other diagnoses that, in the investigator's opinion, preclude him/her from safely participating in this study or interfere with the evaluation of the subject's psoriasis.
History of known or suspected intolerance to any of the ingredients of the investigational study product.

Name	Affiliation	Role
Wilson Liao, MD	University of California, San Francisco	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
UCSF Psoriasis and Skin Treatment Center		San Francisco	California	94118	United States

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Median

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change in Percentage of CD4+ T Effector Cells Expressing IL17 Compared to Baseline

Posted

Mean

Standard Deviation

percent change from week 0

Baseline to Week 2

ID	Title	Description
OG000	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.

Units	Counts
Participants

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.

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