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High Dose Risankizumab for Psoriasis (KNOCKOUT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05283135
Recruitment Status : Active, not recruiting
First Posted : March 16, 2022
Last Update Posted : March 15, 2024
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Oregon Medical Research Center

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Psoriasis Drug: risankizumab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Decreasing Resident Memory T Cells While Increasing Clinical Durability: Higher Induction Doses of Risankizumab for Moderate-to-severe Plaque Psoriasis
Actual Study Start Date : March 1, 2022
Actual Primary Completion Date : December 1, 2022
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arms and Interventions
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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 Name: 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 Name: Skyrizi


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05283135


Locations
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United States, Oregon
Oregon Medical Research Center
Portland, Oregon, United States, 97201
Sponsors and Collaborators
Oregon Medical Research Center
AbbVie
Investigators
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Principal Investigator: Benjamin D Ehst, MD, PhD Oregon Medical Research Center
More Information
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Publications:

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Responsible Party: Oregon Medical Research Center
ClinicalTrials.gov Identifier: NCT05283135    
Other Study ID Numbers: B20-433
First Posted: March 16, 2022    Key Record Dates
Last Update Posted: March 15, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Oregon Medical Research Center:
Psoriasis
Risankizumab
Plaque
Skyrizi
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases