High Dose Risankizumab for Psoriasis

NCT05283135 | Completed Phase 2 Results FDA Drug

• 1 other identifier: B20-433
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psoriasis

Keywords

Psoriasis; Risankizumab; Plaque; Skyrizi

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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.

  Enrollment to Week 52

• Safety Events

  Enrollment to Week 52

Study Arms (2)

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

Interventions

risankizumab 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.

Also known as: Skyrizi

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Medical Research Center: lead
• AbbVie: collaborator

Study Sites (1)

Oregon Medical Research Center

Portland, Oregon, 97201, United States

Location

Related Publications (3)

• 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.

  PMID: 30097359 BACKGROUND

• 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.

  PMID: 31280967 BACKGROUND

• 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.

  PMID: 32267471 BACKGROUND

MeSH Terms

Conditions

Psoriasis; Plaque, Amyloid

Interventions

risankizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Small sample size

Results Point of Contact

• Title: Benjamin Ehst, MD, PhD
• Organization: Oregon Medical Research Center, PC

behst@oregonmedicalresearch.com

5032451525

Study Officials

• Benjamin D Ehst, MD, PhD

  Oregon Medical Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: March 16, 2022
• Study Start: March 1, 2022
• Primary Completion: August 7, 2023
• Study Completion: July 10, 2024
• Last Updated: October 24, 2025
• Results First Posted: October 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)