PsoriasisPhase 2KNOCKOUTNCT05283135

High Dose Risankizumab for Psoriasis

A Phase 2 study testing risankizumab in people with Psoriasis, run by Oregon Medical Research Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Psoriasis
What is being tested?: risankizumab
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 1 Mar 2022to 10 Jul 2024
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 13Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Oregon Medical Research Center
Portland, Oregon, 97201

Other trials in United States

About this study

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

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

Read the detailed description

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: Psoriasis
Being tested: risankizumab
Keywords: Psoriasis, Risankizumab, Plaque, Skyrizi
Medical subject headings: Psoriasis, Plaque, Amyloid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

risankizumabDrug
Also called Skyrizi
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.

Study groups in NCT05283135
Study group	Role	What they receive
risankizumab subcutaneous injection 600 mg (4x dosing) at Weeks 0, 4, and 16	Experimental	Not described Receives: Drug: risankizumab
risankizumab subcutaneous injection 300 mg (2x dosing) at Weeks 0, 4, and 16	Experimental	Not described Receives: Drug: risankizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

CD8+ Trm1 Cells in Lesional Skin at Baseline and Week 52
The number of lesional CD8+ Trm1 cells at baseline and Week 52 was calculated by longitudinal single-cell RNA-sequencing of full-thickness skin biopsy samples. Uniform Manifold Approximation Projection (UMAP) was used for T cell subtype visualization and CD8+ Trm1 cells were identified as IFNγ+/CD8+/CD69+ T cells.
Measured: 52 weeks
CD8+ Trm17 Cells in Lesional Skin at Baseline and Week 52
The number of lesional CD8+ Trm17 cells at baseline and Week 52 was calculated by longitudinal single-cell RNA-sequencing of full-thickness skin biopsy samples. Uniform Manifold Approximation Projection (UMAP) was used for T cell subtype visualization and CD8+ Trm17 cells were identified as IFNγ+/CD8+/CD69+ T cells.
Measured: 52 weeks

Secondary outcomes (2)

PASI 100 Results in Patients Receiving 4X Standard Induction Doses of Risankizumab vs. Those Receiving 2X Standard Induction Doses of Risankizumab.
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.
Measured: Enrollment to Week 52
Safety Events
Safety events over 52 weeks in patients receiving 4X standard induction doses of risankizumab vs. those receiving 2X standard induction doses of risankizumab.
Measured: Enrollment to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 202210 Jul 2024

First posted16 Mar 2022
Study start1 Mar 2022
Primary completion7 Aug 2023
Study completion10 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for PsoriasisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05283135
Sponsor's protocol ID: B20-433
Acronym: KNOCKOUT
Status last verified: Oct 2025
First submitted: 3 Feb 2022
Last updated: 24 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Gordon KB, Strober B, Lebwohl M, Augustin M, Blauvelt A, Poulin Y, Papp KA, Sofen H, Puig L, Foley P, Ohtsuki M, Flack M, Geng Z, Gu Y, Valdes JM, Thompson EHZ, Bachelez H. 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. Lancet. 2018 Aug 25;392(10148):650-661. doi: 10.1016/S0140-6736(18)31713-6. Epub 2018 Aug 7.
PubMed 30097359
Reich K, Gooderham M, Thaci D, Crowley JJ, Ryan C, Krueger JG, Tsai TF, Flack M, Gu Y, Williams DA, Thompson EHZ, Paul C. Risankizumab compared with adalimumab in patients with moderate-to-severe plaque psoriasis (IMMvent): a randomised, double-blind, active-comparator-controlled phase 3 trial. Lancet. 2019 Aug 17;394(10198):576-586. doi: 10.1016/S0140-6736(19)30952-3. Epub 2019 Jul 4.
PubMed 31280967
Blauvelt A, Leonardi CL, Gooderham M, Papp KA, Philipp S, Wu JJ, Igarashi A, Flack M, Geng Z, Wu T, Camez A, Williams D, Langley RG. Efficacy and Safety of Continuous Risankizumab Therapy vs Treatment Withdrawal in Patients With Moderate to Severe Plaque Psoriasis: A Phase 3 Randomized Clinical Trial. JAMA Dermatol. 2020 Jun 1;156(6):649-658. doi: 10.1001/jamadermatol.2020.0723.
PubMed 32267471

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Children and Adolescent Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
Not yet recruitingPhase 3
Efficacy of Crisaborole 2% Ointment Versus Tacrolimus 0.1% Ointment in the Treatment of Intertriginous and/or Anogenital Psoriasis: A Prospective Randomized Controlled Study.
Psoriasis, Psoriasis Genital
Enrolling by invitation
Combined High-Intensity Aerobic Training and Resistance Training in Psoriatic Arthritis
Psoriatic Arthritis
RecruitingPhase 2
An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 4
Topical Diacerein in Psoriasis Vulgaris
Psoriasis Vulgaris

All Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Decreasing Resident Memory T Cells While Increasing Clinical Durability: Higher Induction Doses of Risankizumab for Moderate-to-severe Plaque Psoriasis
ClinicalTrials.gov ID: NCT05283135
Acronym / sponsor ID: KNOCKOUT / B20-433
Conditions: Psoriasis
Keywords: Psoriasis, Risankizumab, Plaque, Skyrizi
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Oregon Medical Research CenterUniversity, hospital or other
Collaborators: AbbVie
Study start: 1 Mar 2022 (actual)
Primary completion: 7 Aug 2023 (actual)
Study completion: 10 Jul 2024 (actual)
First posted: 16 Mar 2022 (actual)
Results: Posted 24 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
risankizumab subcutaneous injection 600 mg (4x dosing) at Weeks 0, 4, and 16	Experimental	Drug: risankizumab
risankizumab subcutaneous injection 300 mg (2x dosing) at Weeks 0, 4, and 16	Experimental	Drug: risankizumab

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (13 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
risankizumabAlso: SkyriziRisankizumab (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.	Drug	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

Primary outcome

CD8+ Trm1 Cells in Lesional Skin at Baseline and Week 52
Time frame: 52 weeks
The number of lesional CD8+ Trm1 cells at baseline and Week 52 was calculated by longitudinal single-cell RNA-sequencing of full-thickness skin biopsy samples. Uniform Manifold Approximation Projection (UMAP) was used for T cell subtype visualization and CD8+ Trm1 cells were identified as IFNγ+/CD8+/CD69+ T cells.
CD8+ Trm17 Cells in Lesional Skin at Baseline and Week 52
Time frame: 52 weeks
The number of lesional CD8+ Trm17 cells at baseline and Week 52 was calculated by longitudinal single-cell RNA-sequencing of full-thickness skin biopsy samples. Uniform Manifold Approximation Projection (UMAP) was used for T cell subtype visualization and CD8+ Trm17 cells were identified as IFNγ+/CD8+/CD69+ T cells.

2 secondary outcomes

PASI 100 Results 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
Time frame: Enrollment to Week 52

Results and safety

Results posted to the registry on 24 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
600 mg Dose Group	10	3
300 mg Dose Group	10	3

Primary outcome: CD8+ Trm1 Cells in Lesional Skin at Baseline and Week 52

Time frame: 52 weeks. Mean (95% Confidence Interval). Unit: number of cells

Measure	600 mg Baseline n = 5	300 mg Baseline n = 8	600 mg Week 52 n = 5	300 mg Week 52 n = 8
Value	9.60 (-1.97 to 21.17)	26.71 (7.00 to 46.43)	1.60 (0.18 to 3.02)	16.63 (0.15 to 33.10)

Population analysed: Cell counts from all participants were analyzed together at baseline given the exploratory nature of this study, the small number of overall participants and the selection of trial participants on the basis of clinical parameters that assume a similar degree of memory cell infiltrate in lesional psoriasis plaques.

Primary outcome: CD8+ Trm17 Cells in Lesional Skin at Baseline and Week 52

Time frame: 52 weeks. Mean (95% Confidence Interval). Unit: number of cells

Measure	600 mg Baseline n = 5	300 mg Baseline n = 8	600 mg Week 52 n = 5	300 mg Week 52 n = 8
Value	19.67 (-28.52 to 67.86)	22.88 (5.94 to 39.81)	3.20 (-5.01 to 11.41)	5.00 (-1.00 to 11.00)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 100 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
600 mg Dose Group	0 of 10 (0%)	7 of 10 (70%)	0 of 10
300 mg Dose Group	1 of 10 (10%)	9 of 10 (90%)	0 of 10

Limitations and caveats (from the sponsor): Small sample size

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 30097359Gordon KB, Strober B, Lebwohl M, Augustin M, Blauvelt A, Poulin Y, Papp KA, Sofen H, Puig L, Foley P, Ohtsuki M, Flack M, Geng Z, Gu Y, Valdes JM, Thompson EHZ, Bachelez H. 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. Lancet. 2018 Aug 25;392(10148):650-661. doi: 10.1016/S0140-6736(18)31713-6. Epub 2018 Aug 7.
Background: PubMed 31280967Reich K, Gooderham M, Thaci D, Crowley JJ, Ryan C, Krueger JG, Tsai TF, Flack M, Gu Y, Williams DA, Thompson EHZ, Paul C. Risankizumab compared with adalimumab in patients with moderate-to-severe plaque psoriasis (IMMvent): a randomised, double-blind, active-comparator-controlled phase 3 trial. Lancet. 2019 Aug 17;394(10198):576-586. doi: 10.1016/S0140-6736(19)30952-3. Epub 2019 Jul 4.
Background: PubMed 32267471Blauvelt A, Leonardi CL, Gooderham M, Papp KA, Philipp S, Wu JJ, Igarashi A, Flack M, Geng Z, Wu T, Camez A, Williams D, Langley RG. Efficacy and Safety of Continuous Risankizumab Therapy vs Treatment Withdrawal in Patients With Moderate to Severe Plaque Psoriasis: A Phase 3 Randomized Clinical Trial. JAMA Dermatol. 2020 Jun 1;156(6):649-658. doi: 10.1001/jamadermatol.2020.0723.
Individual participant dataSharing planned: No

Related trials for Psoriasis

RecruitingPhase 3
A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Children and Adolescent Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
Not yet recruitingPhase 3
Efficacy of Crisaborole 2% Ointment Versus Tacrolimus 0.1% Ointment in the Treatment of Intertriginous and/or Anogenital Psoriasis: A Prospective Randomized Controlled Study.
Psoriasis, Psoriasis Genital
Enrolling by invitation
Combined High-Intensity Aerobic Training and Resistance Training in Psoriatic Arthritis
Psoriatic Arthritis
RecruitingPhase 2
An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 4
Topical Diacerein in Psoriasis Vulgaris
Psoriasis Vulgaris

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Benjamin D Ehst, MD, PhD principal investigator

Oregon Medical Research Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing risankizumab in people with Psoriasis, run by Oregon Medical Research Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CD8+ Trm1 Cells in Lesional Skin at Baseline and Week 52 (time frame: 52 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05283135, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2025.