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Risankizumab Long-term Remission Study

Primary Purpose

Psoriasis

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Risankizumab-Rzaa

Punch biopsies of the skin at baseline visit

Punch biopsies of the skin at week 28 visit

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Psoriasis, Risankizumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

VA Northern California Health Care SystemRecruiting
University of California Davis Medical Center
The Rockefeller UnivesityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Psoriasis treatment with risankizumab

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Validation of predictive models that anticipate disease recurrence after risankizumab treatment

Sensitivity (range from 0 to 100%) and specificity (range from 0 to 100%) of statistical prediction models with single-cell genomic data from the skin biopsy tissues that predict 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.

Full Information

NCT ID

NCT04630652

First Posted

November 9, 2020

Last Updated

July 27, 2023

Sponsor

Jaehwan Kim

Collaborators

AbbVie, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

1. Study Identification

Unique Protocol Identification Number

NCT04630652

Brief Title

Risankizumab Long-term Remission Study

Official Title

Immune Modification of Psoriasis by Selective IL-23 Blockade Using Risankizumab

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 7, 2021 (Actual)

Primary Completion Date

February 28, 2026 (Anticipated)

Study Completion Date

July 28, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Jaehwan Kim

Collaborators

AbbVie, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

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.

Detailed Description

Although the newly developed biologics targeting IL-23/Th17 axis 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 our phase I psoriasis clinical trial was groundbreaking that just a single dose of anti-IL-23p19 antibody administration produced disease clearance up to 66 weeks in 46% (6 of 13) of patients. Since FoxP3 mRNA levels remained high in posttreatment biopsy specimens of these patients, we hypothesized that IL-23p19 inhibition increased regulatory T-cell levels or function in resolved psoriatic skin. However, there is a lack of understanding about regulatory immune cell promotion by IL-23p19 inhibition in human skin. Our overall objectives of the study, are to (i) identify regulatory immune cell alterations induced by anti-IL-23p19 antibody 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 after short-term anti-IL-23p19 antibody injection. The rationale for this project is that molecular evidence of immune tolerance induction by IL-23p19 inhibition in human skin is likely to offer a strong clinical framework whereby new strategies to prevent recurrence of chronic inflammatory diseases can be developed. In this study, subjects with moderate-to-severe psoriasis will receive FDA-approved anti-IL-23p19 antibody (Generic name: Risankizumab, Product name: SKYRIZI™ or risankizumab-rzaa) up to 4 months following the FDA-approved indications, usage, dosage, and administration in the FDA-approved dosage forms and strengths through week 16, after which, dosing stops.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis

Keywords

Psoriasis, Risankizumab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Psoriasis treatment with risankizumab

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Risankizumab-Rzaa

Other Intervention Name(s)

SKYRIZI

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Punch biopsies of the skin at baseline visit

Intervention Description

Two 6 mm punch biopsies of the skin at baseline visit

Intervention Type

Procedure

Intervention Name(s)

Punch biopsies of the skin at week 28 visit

Intervention Description

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

Primary Outcome Measure Information:

Title

Determination of regulatory immune cell changes induced by risankizumab

Description

Time Frame

week 52

Secondary Outcome Measure Information:

Title

Validation of predictive models that anticipate disease recurrence after risankizumab treatment

Description

Time Frame

week 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Recruitment Specialist

Phone

800-782-2737

rucares@rockefeller.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jaehwan Kim, MD, PhD

Organizational Affiliation

The Rockefeller University

Official's Role

Principal Investigator

Facility Information:

Facility Name

VA Northern California Health Care System

City

Sacramento

State/Province

California

ZIP/Postal Code

95655

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jaehwan Kim, MD, PhD

Facility Name

University of California Davis Medical Center

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jaehwan Kim, MD, PhD

Facility Name

The Rockefeller Univesity

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Recuitment Specialist

Phone

800-782-2737

rucares@rockefeller.edu

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26763436

Citation

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.

Results Reference

background

PubMed Identifier

27185339

Citation

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.

Results Reference

background

PubMed Identifier

27028481

Citation

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.

Results Reference

background

PubMed Identifier

28927890

Citation

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.

Results Reference

background

PubMed Identifier

27686018

Citation

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.

Results Reference

background

PubMed Identifier

25769911

Citation

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.

Results Reference

background

PubMed Identifier

29890167

Citation

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.

Results Reference

background

PubMed Identifier

28423301

Citation

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.

Results Reference

background

PubMed Identifier

14707118

Citation

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.

Results Reference

background

PubMed Identifier

30097359

Citation

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.

Results Reference

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Risankizumab Long-term Remission Study

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