Exploring the Effects of IL-23 Inhibition by Risankizumab on Psoriasis Autoimmunity

NCT04722640 | Unknown Phase 4

• 1 other identifier: 2763
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief Summary

Approximately 80 patients affected by moderate to severe psoriasis will be screened for the presence of LL37( and ADAMTSL5 autoreactive T-cells in their blood at Day 0. Patients whose lymphocytes reacted with proliferation to LL37 or ADAMTSL5 will receive SKYRIZI (Risakizumab) at Day 1, week 4, 16, 28, 40. LL37 and ADAMTSL5-specific T-cell responses will be evaluated at Day 0, week 16, week 28 and week 52. Each patient will be followed for 52 weeks.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Proportion of activated autoantigen-specific T-cells

  Proportion of activated autoantigen-specific T-cells as measured by LL37 and ADAMTSL5 antigens by antigenic-specific proliferation assay at 28 weeks with respect to baseline.

  12 Months

Study Arms (1)

RISAKIZUMAB

EXPERIMENTAL

SKYRIZI

Drug: SKYRIZI

Interventions

SKYRIZI DRUG

SKYRIZI

RISAKIZUMAB

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has provided informed consent
• Subject is \> 18 and \< 75 years of age at time of screening
• Subject has had stable moderate to severe plaque psoriasis for at least 6 months (e.g., no morphology changes or significant flares of disease activity in the opinion of the Investigator)
• Subject has involved body surface area (BSA) \> 10% and PASI \> 12 at baseline
• Subject candidates to SKYRIZI therapy according to local label
• Subject is able to complete study procedures, including self-assessments and self injections
• Subjects who responded with T-lymphocytes proliferation to the psoriasis autoantigen LL37 or ADAMTSL5.
• Subject is male or a woman not of child-bearing potential, including:
• infertile patients due to surgical sterilization, congenital anomalies
• OR postmenopausal, defined as: a woman of at least 50 years of age with an intact uterus, not on hormone therapy, who has either:
• Cessation of menses for at least 1 year
• OR At least 6 months of spontaneous amenorrhea with a follicle stimulating hormone level of \>40 mIU/mL
• OR A woman of 55 years or older not on hormone therapy who has had at least 6 months of spontaneous amenorrhea
• OR A woman at least 55 years of age with a diagnosis of menopause prior to starting hormone replacement therapy
• Subject is a woman of child-bearing potential and:

You may not qualify if:

• Skin disease related:
• Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of investigational product on psoriasis
• Other medical conditions:
• Subject has a planned surgical intervention during the duration of the study
• Subject has a known history of human immunodeficiency virus
• Hepatitis B surface antigen or Hepatitis C antibody positivity at screening
• Patient is hepatitis B core antibody positive (HBcAb+) but HbsAg and HBsAb negative
• Subject has uncontrolled, clinically significant systemic disease such as diabetes mellitus, cardiovascular disease, renal failure, liver disease, or hypertension
• Subject has any active malignancy, including evidence of cutaneous basal orsquamous cell carcinoma or melanoma
• Subject has history of malignancy within 5 years except treated and considered cured cutaneous squamous or basal cell carcinoma, in situ cervical cancer, or in situ breast ductal carcinoma
• Subject has any concurrent medical condition that, in the opinion of the Investigator, could cause this study to be detrimental to the subject
• Has active TB or other serious infection
• Has received, or is expected to receive, any live virus or bacterial vaccination within 4 weeks before the first administration of study intervention
• Laboratory abnormalities:
• Laboratory abnormalities at screening, including any of the following:

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

MeSH Terms

Conditions

Psoriasis

Interventions

risankizumab

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Antonio Costanzo, MD

CONTACT

0039-02-82244050; antonio.costanzo@hunimed.eu

Study Design

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

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: January 25, 2021
• Study Start: January 25, 2021
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: January 29, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share