Risankizumab Long-term Remission Study

NCT04630652 | Active Not Recruiting Phase 4 FDA Drug

• 2 other identifiers: JKI-1011K23AR080043
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief Summary

Although the newly developed biologics (drugs derived from living cells cultured in a laboratory) are highly effective in controlling psoriasis, all the biologics should be continuously injected to suppress recurrence of the disease. In this regard, the observation in the phase II clinical trial conducted by us (Laboratory for Investigative Dermatology at the Rockefeller University) was groundbreaking that just a single dose of anti-IL-23p19 antibody (risankizumab, trade name: Skyrizi, study drug in this clinical trial) administration produced disease clearance up to 66 weeks in 46% (6 of 13) of patients. However, there is a lack of understanding about immune regulation in human skin induced by anti-IL-23p19 antibody injection, and there is a need to conduct a psoriasis clinical trial for single-cell sequencing immune cells in human psoriasis skin before and after anti-IL-23p19 antibody administration, and to correlate regulatory immune cell alterations with clinical disease progression. The overall objective of the clinical trial is to study regulatory immune cell alterations induced by anti-IL-23p19 antibody administration in psoriasis patients who achieve long-term disease clearance off drugs.

Conditions

Psoriasis

Keywords

Psoriasis; Risankizumab

Outcome Measures

Primary Outcomes (1)

• Determination of regulatory immune cell changes induced by risankizumab

  Changes of regulatory immune cell proportions in total immune cells harvested from the skin biopsy tissues of subjects who have a reduction of 90% or more from baseline in the Psoriasis Area and Severity Index (PASI; range from 0 to 72) at week 12 and also maintain the 90% reduction in PASI at week 52.

  week 52

Secondary Outcomes (1)

• Validation of predictive models that anticipate disease recurrence after risankizumab treatment

  week 52

Study Arms (1)

Psoriasis treatment with risankizumab

EXPERIMENTAL

Moderate-to-severe psoriasis treatment with risankizumab for 16 weeks

Drug: Risankizumab-Rzaa; Procedure: Punch biopsies of the skin at baseline visit; Procedure: Punch biopsies of the skin at week 28 visit

Interventions

Risankizumab-Rzaa DRUG

Risankizumab at a dose of 150 mg with injections administered at baseline, week 4 and week 16 following FDA-approved dosage and time periods

Also known as: SKYRIZI

Psoriasis treatment with risankizumab

Punch biopsies of the skin at baseline visit PROCEDURE

Two 6 mm punch biopsies of the skin at baseline visit

Psoriasis treatment with risankizumab

Punch biopsies of the skin at week 28 visit PROCEDURE

One 6 mm punch biopsy of the skin at week 28 visit

Psoriasis treatment with risankizumab

Eligibility Criteria

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

You may qualify if:

• Adult males or females with a diagnosis of plaque psoriasis for at least 6 months.
• Baseline Psoriasis Area Severity Index (PASI) score \> 12.
• More than 10% body surface area has plaque psoriasis involvement.
• Willingness to forgo other available psoriasis therapies, live vaccines, and pregnancy during the trial.
• Ability and willingness to provide informed consent and comply with study requirements.

You may not qualify if:

• Non-plaque forms of psoriasis.
• Any previous treatment with agents targeting IL-12 or IL-23, including ustekinumab.
• Treatment with biologic agents within previous 3 months prior to visit 0, including adalimumab, etanercept, and infliximab.
• Treatment with immunosuppressive medications, including methotrexate, cyclosporine, oral retinoids, prednisone, or phototherapy within previous 4 weeks prior to visit 0.
• Topical psoriasis treatment within previous 2 weeks prior to visit 0, including topical corticosteroids, vitamin D analogues, retinoids, calcineurin inhibitors, salicylic acid, and coal tar.
• Any investigational study medication within previous 6 months prior to visit 0.
• History of recent or ongoing uncontrolled bacterial, viral, fungal, or other opportunistic infections.
• Positive QuantiFERON-TB Gold test. PPD tuberculin test may be substituted for QuantiFERON-TB Gold test.
• Receipt of a live vaccine (e.g., varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, and smallpox) in the previous 6 weeks prior to visit 0.
• Females who are pregnant, lactating, planning on pregnancy during the study period, or unwilling to use a medically acceptable method of birth control.
• Severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, or neurological disease, or any other medical condition that, in the investigator's opinion, places the participant at risk by participating in this study.
• Any medical history, including laboratory results, deemed by the investigator to be likely to interfere with their participation in the study, or to interfere with the interpretation of the results, or any social condition that, in the opinion of the Investigator, might pose additional risk to the participant or confound the results of the study.

Sponsors & Collaborators

• Jaehwan Kim: lead
• AbbVie: collaborator
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (3)

VA Northern California Health Care System

Sacramento, California, 95655, United States

Location

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

The Rockefeller Univesity

New York, New York, 10065, United States

Location

Related Publications (11)

• Kim J, Oh CH, Jeon J, Baek Y, Ahn J, Kim DJ, Lee HS, Correa da Rosa J, Suarez-Farinas M, Lowes MA, Krueger JG. Molecular Phenotyping Small (Asian) versus Large (Western) Plaque Psoriasis Shows Common Activation of IL-17 Pathway Genes but Different Regulatory Gene Sets. J Invest Dermatol. 2016 Jan;136(1):161-172. doi: 10.1038/JID.2015.378.

  PMID: 26763436 BACKGROUND

• Kim J, Bissonnette R, Lee J, Correa da Rosa J, Suarez-Farinas M, Lowes MA, Krueger JG. The Spectrum of Mild to Severe Psoriasis Vulgaris Is Defined by a Common Activation of IL-17 Pathway Genes, but with Key Differences in Immune Regulatory Genes. J Invest Dermatol. 2016 Nov;136(11):2173-2182. doi: 10.1016/j.jid.2016.04.032. Epub 2016 May 13.

  PMID: 27185339 BACKGROUND

• Kim J, Kim DJ, Ortenzio FS, Dare L, Frank C, Kost RG, Lowes MA. Patients With Psoriasis and Personalized Trade-offs in Treatment Decisions-Lessons Learned From Focus Groups. JAMA Dermatol. 2016 Jun 1;152(6):720-2. doi: 10.1001/jamadermatol.2016.0501. No abstract available.

  PMID: 27028481 BACKGROUND

• Kim J, Tomalin L, Lee J, Fitz LJ, Berstein G, Correa-da Rosa J, Garcet S, Lowes MA, Valdez H, Wolk R, Suarez-Farinas M, Krueger JG. Reduction of Inflammatory and Cardiovascular Proteins in the Blood of Patients with Psoriasis: Differential Responses between Tofacitinib and Etanercept after 4 Weeks of Treatment. J Invest Dermatol. 2018 Feb;138(2):273-281. doi: 10.1016/j.jid.2017.08.040. Epub 2017 Sep 18.

  PMID: 28927890 BACKGROUND

• Kim J, Krueger JG. Highly Effective New Treatments for Psoriasis Target the IL-23/Type 17 T Cell Autoimmune Axis. Annu Rev Med. 2017 Jan 14;68:255-269. doi: 10.1146/annurev-med-042915-103905. Epub 2016 Sep 23.

  PMID: 27686018 BACKGROUND

• Krueger JG, Ferris LK, Menter A, Wagner F, White A, Visvanathan S, Lalovic B, Aslanyan S, Wang EE, Hall D, Solinger A, Padula S, Scholl P. Anti-IL-23A mAb BI 655066 for treatment of moderate-to-severe psoriasis: Safety, efficacy, pharmacokinetics, and biomarker results of a single-rising-dose, randomized, double-blind, placebo-controlled trial. J Allergy Clin Immunol. 2015 Jul;136(1):116-124.e7. doi: 10.1016/j.jaci.2015.01.018. Epub 2015 Mar 11.

  PMID: 25769911 BACKGROUND

• Kim J, Lee J, Gonzalez J, Fuentes-Duculan J, Garcet S, Krueger JG. Proportion of CD4+CD49b+LAG-3+ Type 1 Regulatory T Cells in the Blood of Psoriasis Patients Inversely Correlates with Psoriasis Area and Severity Index. J Invest Dermatol. 2018 Dec;138(12):2669-2672. doi: 10.1016/j.jid.2018.05.021. Epub 2018 Jun 8. No abstract available.

  PMID: 29890167 BACKGROUND

• Papp KA, Blauvelt A, Bukhalo M, Gooderham M, Krueger JG, Lacour JP, Menter A, Philipp S, Sofen H, Tyring S, Berner BR, Visvanathan S, Pamulapati C, Bennett N, Flack M, Scholl P, Padula SJ. Risankizumab versus Ustekinumab for Moderate-to-Severe Plaque Psoriasis. N Engl J Med. 2017 Apr 20;376(16):1551-1560. doi: 10.1056/NEJMoa1607017.

  PMID: 28423301 BACKGROUND

• Lee E, Trepicchio WL, Oestreicher JL, Pittman D, Wang F, Chamian F, Dhodapkar M, Krueger JG. Increased expression of interleukin 23 p19 and p40 in lesional skin of patients with psoriasis vulgaris. J Exp Med. 2004 Jan 5;199(1):125-30. doi: 10.1084/jem.20030451.

  PMID: 14707118 BACKGROUND

• 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

• Kim J, Lee J, Lee J, Kim K, Li X, Zhou W, Cao J, Krueger JG. Psoriasis harbors multiple pathogenic type 17 T-cell subsets: Selective modulation by risankizumab. J Allergy Clin Immunol. 2025 Jun;155(6):1898-1912. doi: 10.1016/j.jaci.2025.02.008. Epub 2025 Feb 18.

  PMID: 39978685 DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

risankizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jaehwan Kim, MD, PhD

  The Rockefeller University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Instructor in Clinical Investigation

Model Details: The interventional study model is to treat moderate-to-severe psoriasis patients with risankizumab for 4 months and analyze pre- and post-treatment skin biopsy samples to (i) identify regulatory immune cell alterations induced by risankizumab administration in the skin of patients whose psoriasis is cleared without recurrence and (ii) develop pre-treatment predictive models for psoriasis patients that anticipate disease clearance and recurrence.

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: November 16, 2020
• Study Start: April 7, 2021
• Primary Completion: February 28, 2026
• Study Completion (Estimated): July 28, 2027
• Last Updated: November 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)