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Monoclonal Antibodies

High Dose Risankizumab for Psoriasis (KNOCKOUT Trial)

Phase 2

Waitlist Available

Led By Andrew Blauvelt, MD, MBA

Research Sponsored by Oregon Medical Research Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up enrollment to week 52

Awards & highlights

KNOCKOUT Trial Summary

This trial is testing whether higher doses of risankizumab can more effectively target and eliminate resident memory T cells in psoriatic skin, leading to better clearance of the disease.

Who is the study for?

This trial is for adults with chronic stable plaque psoriasis, having a body surface area (BSA) involvement of at least 10% and a Psoriasis Area Severity Index (PASI) score of 12 or more. Participants must be able to follow the study plan and women should use birth control if they can have children. People who've had certain treatments recently, those with other serious illnesses, drug or alcohol abuse history, suicidal behavior in the past six months, active infections like HIV or tuberculosis, pregnant or breastfeeding women cannot join.Check my eligibility

What is being tested?

The study tests whether higher initial doses of risankizumab (300 mg and 600 mg) are more effective than standard doses at clearing skin by targeting immune cells called resident memory T cells in psoriatic lesions. The goal is to see if this leads to completely clear skin that lasts longer after stopping treatment.See study design

What are the potential side effects?

Risankizumab may cause side effects such as infections due to lowered immunity, allergic reactions where the medicine is injected into the skin, headaches, fatigue and digestive issues. It's important for participants to report any unusual symptoms they experience during the trial.

KNOCKOUT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I have had stable plaque psoriasis for over 6 months, covering more than 10% of my body.

KNOCKOUT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ enrollment to week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~enrollment to week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment to week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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.

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

Side effects data

From 2020 Phase 3 trial • 18 Patients • NCT03022045

25%

Urticaria

25%

Osteoarthritis

25%

Rash

25%

Intervertebral disc protrusion

25%

Hepatic function abnormal

25%

Alanine aminotransferase increased

25%

Aspartate aminotransferase increased

25%

Erythema

25%

Viral upper respiratory tract infection

25%

Gamma-glutamyltransferase increased

100%

80%

60%

40%

20%

Study treatment Arm

GPP Risankizumab 75 mg

GPP Risankizumab 150 mg

EP Risankizumab 75 mg

EP Risankizumab 150 mg

KNOCKOUT Trial Design

2Treatment groups

Experimental Treatment

Group I: risankizumab subcutaneous injection 600 mg (4x dosing) at Weeks 0, 4, and 16Experimental Treatment1 Intervention

Group II: risankizumab subcutaneous injection 300 mg (2x dosing) at Weeks 0, 4, and 16Experimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Isopropyl alcohol

FDA approved

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

AbbVieIndustry Sponsor

954 Previous Clinical Trials

501,024 Total Patients Enrolled

62 Trials studying Psoriasis

125,592 Patients Enrolled for Psoriasis

Oregon Medical Research CenterLead Sponsor

Andrew Blauvelt, MD, MBAPrincipal InvestigatorOregon Medical Research Center

1 Previous Clinical Trials

172 Total Patients Enrolled

Media Library

Risankizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05283135 — Phase 2

Risankizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05283135 — Phase 2

Psoriasis Research Study Groups: risankizumab subcutaneous injection 300 mg (2x dosing) at Weeks 0, 4, and 16, risankizumab subcutaneous injection 600 mg (4x dosing) at Weeks 0, 4, and 16

Psoriasis Clinical Trial 2023: Risankizumab Highlights & Side Effects. Trial Name: NCT05283135 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any recorded negative side effects of risankizumab?

"Because risankizumab is still in Phase 2 clinical trials, there is currently only data supporting its safety and no efficacy data. Our team scored it as a 2."

Answered by AI

Are there any unfilled openings for this particular clinical trial?

"Unfortunately, this particular trial is not enrolling patients at the moment. The study was first posted on March 1st, 2022 but has not been updated since August 15th of the same year. However, there are 179 other trials that are currently looking for participants."

Answered by AI

Recent research and studies

JAMA DermatologyJournal

Efficacy and Safety of Continuous Risankizumab Therapy Vs Treatment Withdrawal in Patients with Moderate to Severe Plaque Psoriasis

Blauvelt, Andrew, Craig L. Leonardi, Melinda Gooderham, Kim A. Papp, Sandra Philipp, Jashin J. Wu, Atsuyuki Igarashi, et al.. 2020. “Efficacy and Safety of Continuous Risankizumab Therapy Vs Treatment Withdrawal in Patients with Moderate to Severe Plaque Psoriasis”. JAMA Dermatology. American Medical Association (AMA). doi:10.1001/jamadermatol.2020.0723.

The LancetJournal

Risankizumab Compared with Adalimumab in Patients with Moderate-to-severe Plaque Psoriasis (immvent): A Randomised, Double-blind, Active-comparator-controlled Phase 3 Trial

Reich, Kristian, Melinda Gooderham, Diamant Thaçi, Jeffrey J Crowley, Caitriona Ryan, James G Krueger, Tsen-Fang Tsai, et al.. 2019. “Risankizumab Compared with Adalimumab in Patients with Moderate-to-severe Plaque Psoriasis (immvent): A Randomised, Double-blind, Active-comparator-controlled Phase 3 Trial”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(19)30952-3.

The LancetJournal

Efficacy and Safety of Risankizumab in Moderate-to-severe Plaque Psoriasis (ultimma-1 and Ultimma-2): Results from Two Double-blind, Randomised, Placebo-controlled and Ustekinumab-controlled Phase 3 Trials

Gordon, Kenneth B, Bruce Strober, Mark Lebwohl, Matthias Augustin, Andrew Blauvelt, Yves Poulin, Kim A Papp, et al.. 2018. “Efficacy and Safety of Risankizumab in Moderate-to-severe Plaque Psoriasis (ultimma-1 and Ultimma-2): Results from Two Double-blind, Randomised, Placebo-controlled and Ustekinumab-controlled Phase 3 Trials”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(18)31713-6.

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