Immunologic Response to Secukinumab in Plaque Psoriasis

NCT ID: NCT02592018

Last Updated: 2020-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2018-12-31

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.

Detailed Description

Quantitative analysis of the immunologic changes in immune cell populations will be performed after secukinumab treatment in 15 patients at weeks 2, 4, and 12 compared to baseline week 0. The immunologic profiles in psoriasis patients will also be compared to healthy control skin surgical discard specimens (n=10). The number of differentially expressed genes in each cell population will be quantified by RNA-seq at weeks 2, 4, 12 after secukinumab compared to baseline.

Conditions

Psoriasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Secukinumab

All subjects will receive Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48.

Group Type: EXPERIMENTAL

Secukinumab

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Cosentyx

Eligibility Criteria

Inclusion Criteria

1. Ability to provide written informed consent and comply with the protocol.

2. At least 18 years of age.

3. Diagnosis of predominately plaque psoriasis for at least 6 months prior to enrollment.

4. Subject is considered a candidate for phototherapy or systemic therapy

5. PASI ≥ 12

6. PGA ≥ 3

7. 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.

8. Subject is unlikely to conceive (male, post-menopausal, or using adequate oral contraceptive therapy or IUD).

9. Physical exam within clinically acceptable limits.

Exclusion Criteria

1. Subject is unable to provide written informed consent or comply with the protocol.

2. Subject is younger than 18 years of age.

3. Subject has predominately non-plaque form of psoriasis.

4. Subject with mild psoriasis (PASI<12 and PGA<3) or is not a candidate for phototherapy or systemic treatments.

5. Subject has drug-induced psoriasis.

6. Subject with current, or a history of, severe psoriatic arthritis well controlled on current therapy.

7. Subjects with a serum creatinine level exceeding 176.8 μmol/L (2.0 mg/dl).

8. Screening total white blood cell (WBC count) < 2,500/μl, platelets < 100,000/μl, neutrophils < 1,500/μl, or hemoglobin <8.5 g/dl.

9. 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.

10. History of an ongoing, chronic or recurrent infectious disease including past medical history record of HIV, hepatitis B or hepatitis C.

11. 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.

12. History of known or suspected intolerance to any of the ingredients of the investigational study product.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wilson Liao, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

UCSF Psoriasis and Skin Treatment Center

San Francisco, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CAIN457AUS04T

Identifier Type: -

Identifier Source: org_study_id