High Dose Risankizumab for Psoriasis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2024-07-10

Brief Summary

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This pilot study explores higher than standard doses of risankizumab for plaque psoriasis, to see effects on resident memory T cells and skin clearance.

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Detailed Description

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This is a pilot study that explores whether higher initial doses of risankizumab (300 mg and 600 mg, 2 times and 4 times the standard initial doses for plaque psoriasis) can more effectively target resident memory T cells, a type of immune cell within psoriatic lesions, and whether this results in higher levels of completely clear skin and for longer periods of time following withdrawal of drug. It is believed that resident memory T cells in psoriatic skin contribute to the persistence of psoriasis. It is believed that if the study drug can more effectively eliminate these cells, better clearance of psoriasis may be achieved (when compared to standard initial doses of study drug).

Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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risankizumab subcutaneous injection 600 mg (4x dosing) at Weeks 0, 4, and 16

Group Type EXPERIMENTAL

risankizumab

Intervention Type DRUG

Risankizumab (Skyrizi) is an anti-IL-23 antibody being investigated for the treatment of multiple inflammatory diseases, including psoriasis, Crohn's disease, ulcerative colitis, and psoriatic arthritis.

risankizumab subcutaneous injection 300 mg (2x dosing) at Weeks 0, 4, and 16

Group Type EXPERIMENTAL

risankizumab

Intervention Type DRUG

Risankizumab (Skyrizi) is an anti-IL-23 antibody being investigated for the treatment of multiple inflammatory diseases, including psoriasis, Crohn's disease, ulcerative colitis, and psoriatic arthritis.

Interventions

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risankizumab

Risankizumab (Skyrizi) is an anti-IL-23 antibody being investigated for the treatment of multiple inflammatory diseases, including psoriasis, Crohn's disease, ulcerative colitis, and psoriatic arthritis.

Intervention Type DRUG

Other Intervention Names

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Skyrizi

Eligibility Criteria

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Inclusion Criteria

* Subject has provided written consent
* Subject has the ability to comply with all study visits and procedures
* Subject is at least 18 years of age
* Subject has chronic stable plaque psoriasis for at least 6 months and with a severity of BSA greater than or equal to 10 and PASI greater than or equal to 12
* Female subjects of child-bearing potential must have a negative urine test at screening and baseline. Female subjects must be either postmenopausal, or permanently surgically sterile, or for women of child-bearing potential practicing at least one form of birth control

Exclusion Criteria

* Breastfeeding or pregnant women, or women who plan to become pregnant during study period
* Participation in any other clinical trial
* Active infection with HIV, hepatitis B virus, or hepatitis C virus
* Active infection with tuberculosis or untreated latent tuberculosis
* History of known active cancer, other than non-melanoma skin cancer or cervical carcinoma in situ, in the past 3 years
* History of drug or alcohol abuse in the past 6 months, as per investigator's assessment
* History of suicidal ideation or attempts in the past 6 months
* Presence of any concurrent illness, which in the opinion of the investigator, would place the patient at unnecessary safety risk during the trial or interfere with completion of the trial
* Treatment with topical medications for psoriasis in the past 2 weeks
* Treatment with oral medications for psoriasis in the past 4 weeks
* Phototherapy for psoriasis in the past 4 weeks
* Any prior treatment with Risankizumab
* Treatment with biologic medications for psoriasis (other than Risankizumab) in the past 4 months

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No