Immunologic Response to Secukinumab in Plaque Psoriasis

NCT02592018 | Completed Phase 4 Results

• 1 other identifier: CAIN457AUS04T
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm, open-label study, which will examine the effect of secukinumab on the immunologic and genetic environment within psoriatic lesions.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (3)

• 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 (9)

• Change in Number of Differentially Expressed Genes in CD4+ Effectors Compared to Baseline Across All Participants

  Baseline to Week 2

• Change in Number of Differentially Expressed Genes in CD4+ Effectors Compared to Baseline

  Baseline to Week 4

• Change in Number of Differentially Expressed Genes in CD4+ Effectors Compared to Baseline

  Baseline to Week 12

• Change in Number of Differentially Expressed Genes in CD4+ T Regs Compared to Baseline

  Baseline to Week 2

• Change in Number of Differentially Expressed Genes in CD4+ T Regs Compared to Baseline

  Baseline to Week 4

Study Arms (1)

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

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.

Also known as: Cosentyx

Secukinumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

UCSF Psoriasis and Skin Treatment Center

San Francisco, California, 94118, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. Wilson Liao
• Organization: UCSF Department of Dermatology

wilson.liao@ucsf.edu

415-476-4701

Study Officials

• Wilson Liao, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2015
• First Posted: October 30, 2015
• Study Start: October 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: September 16, 2020
• Results First Posted: August 27, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)