High Dose Risankizumab for Psoriasis (KNOCKOUT)

March 12, 2024 updated by: Oregon Medical Research Center

Decreasing Resident Memory T Cells While Increasing Clinical Durability: Higher Induction Doses of Risankizumab for Moderate-to-severe Plaque Psoriasis

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97201
        • Oregon Medical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: risankizumab subcutaneous injection 600 mg (4x dosing) at Weeks 0, 4, and 16
Drug: 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.
Other Names:
  • Skyrizi
Experimental: risankizumab subcutaneous injection 300 mg (2x dosing) at Weeks 0, 4, and 16
Drug: 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.
Other Names:
  • Skyrizi

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Endpoint: The number and effector function of epidermal CD8+CD103+ Trm cells at Week 52 (compared to baseline) in psoriasis patients treated with 4X standard induction doses of risankizumab or 2X standard induction doses of risankizumab
Time Frame: Enrollment to Week 52

The number and effector function of epidermal CD8+CD103+ Trm cells at Week 52 (compared to baseline numbers) in psoriasis patients treated with 4X standard induction doses of risankizumab (600 mg at Weeks 0, 4, and 16) or 2X standard induction doses of risankizumab (300 mg at Weeks 0, 4, and 16).

Please note, these are laboratory parameters that do not have units of measurement and will be reported together.
Enrollment to Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Endpoint 1: The percentage of patients with Psoriasis Area and Severity Index (PASI) 100 at Weeks 28, 40, and 52 in patients receiving 4X standard induction doses of risankizumab vs. those receiving 2X standard induction doses of risankizumab.
Time Frame: Enrollment to Week 52
The percentage of patients with Psoriasis Area and Severity Index (PASI) 100 (complete clearance) at Weeks 28, 40, and 52 in patients receiving 4X standard induction doses of risankizumab vs. those receiving 2X standard induction doses of risankizumab.
Enrollment to Week 52
Secondary Endpoint 2: Safety events over 52 weeks in patients receiving 4X standard induction doses of risankizumab vs. those receiving 2X standard induction doses of risankizumab
Time Frame: Enrollment to Week 52
Safety events over 52 weeks in patients receiving 4X standard induction doses of risankizumab vs. those receiving 2X standard induction doses of risankizumab.
Enrollment to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Medical Research Center

Collaborators

AbbVie

Investigators

  • Principal Investigator: Benjamin D Ehst, MD, PhD, Oregon Medical Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Actual)

December 1, 2022

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

February 3, 2022

First Submitted That Met QC Criteria

March 8, 2022

First Posted (Actual)

March 16, 2022

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B20-433

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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