Skyrizi for Psoriasis

Recruiting at 2 trial locations

Overseen By Recruitment Specialist

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Jaehwan Kim

Must not be taking: Biologics, Immunosuppressives, Topicals, Investigational

Disqualifiers: Non-plaque psoriasis, Infections, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the Skyrizi trial?

Yes, you will need to stop taking certain medications before joining the trial. Specifically, you must not have used biologic agents in the last 3 months, immunosuppressive medications in the last 4 weeks, or topical psoriasis treatments in the last 2 weeks before starting the trial.

What data supports the effectiveness of the drug Skyrizi for treating psoriasis?

Research shows that Skyrizi (risankizumab) is effective for treating moderate-to-severe plaque psoriasis. In clinical trials, it was more effective than placebo and other treatments like ustekinumab and adalimumab, with many patients experiencing significant improvement in their skin condition. ^{1 2 3 4 5}

Is Skyrizi (Risankizumab) safe for treating psoriasis?

Skyrizi (Risankizumab) has been shown to be generally safe in humans, with clinical trials demonstrating its safety for treating moderate-to-severe plaque psoriasis. It was well tolerated in both short- and long-term studies. ^{1 2 3 6 7}

How is the drug Skyrizi (Risankizumab) different from other psoriasis treatments?

Skyrizi (Risankizumab) is unique because it specifically targets the p19 subunit of interleukin-23 (IL-23), a protein involved in inflammation, making it highly effective for moderate-to-severe plaque psoriasis. It has shown superior results compared to other treatments like ustekinumab and adalimumab in clinical trials, with more patients achieving significant skin clearance. ^{1 2 3 6 7}

Research Team

Jaehwan Kim, MD, PhD

Principal Investigator

The Rockefeller University

Eligibility Criteria

Adults with plaque psoriasis for at least 6 months, a PASI score over 12, and more than 10% body surface area affected. Participants must not use other psoriasis treatments or live vaccines during the trial and cannot be pregnant.

Inclusion Criteria

Over 10% of my body is covered by plaque psoriasis.

I have been diagnosed with plaque psoriasis for at least 6 months.

Your Psoriasis Area Severity Index (PASI) score is higher than 12 before starting the trial.

Exclusion Criteria

Any investigational study medication within previous 6 months prior to visit 0

I haven't taken immunosuppressive drugs in the last 4 weeks.

I currently have or recently had a serious infection that is not under control.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

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

16 weeks

Regular visits as per FDA-approved indications

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a focus on regulatory immune cell changes

36 weeks

Periodic visits for monitoring and biopsy

Treatment Details

Interventions

• Punch biopsies of the skin at baseline visit
• Punch biopsies of the skin at week 28 visit
• Risankizumab-Rzaa

Trial Overview The study tests Risankizumab's ability to maintain long-term remission in psoriasis patients. It involves comparing skin biopsies before and after treatment to understand immune changes correlating with disease progression.

Participant Groups

Group I: Psoriasis treatment with risankizumab Experimental Treatment 3 Interventions

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

Who Is Running the Clinical Trial?

Jaehwan Kim

Lead Sponsor

Trials

1

Recruited

20+

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

Collaborator

Trials

508

Recruited

1,090,000+

AbbVie

Industry Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Findings from Research

Risankizumab-rzaa (Skyrizi®) is an effective treatment for moderate-to-severe psoriasis, as demonstrated in four pivotal Phase III trials involving adult patients, showing both efficacy and safety.

The drug works by targeting interleukin-23p19 (IL-23p19), a key player in the inflammatory process of psoriasis, which helps reduce the symptoms of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Evaluation of Risankizumab-rzaa in the Treatment of Plaque Psoriasis. Reddy, V., Yang, EJ., Myers, B., et al.[2020]

Risankizumab is a monoclonal antibody that effectively targets IL-23, showing superior efficacy compared to placebo and other treatments like ustekinumab and adalimumab in pivotal phase III trials involving adults with moderate to severe plaque psoriasis.

In long-term studies, risankizumab demonstrated durable efficacy and improved quality of life for patients, with a favorable safety profile over more than 2.5 years of continuous treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risankizumab: A Review in Moderate to Severe Plaque Psoriasis. Blair, HA.[2021]

Risankizumab, a monoclonal antibody targeting IL-23, received its first global approval in March 2019 in Japan for treating various forms of psoriasis, including psoriasis vulgaris and psoriatic arthritis.

The drug is currently approved in multiple regions, including the USA and EU, for moderate-to-severe plaque psoriasis and is undergoing further clinical trials for other conditions like Crohn's disease and ulcerative colitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risankizumab: First Global Approval. McKeage, K., Duggan, S.[2020]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Clinical Evaluation of Risankizumab-rzaa in the Treatment of Plaque Psoriasis. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Long-term safety of risankizumab from 17 clinical trials in patients with moderate-to-severe plaque psoriasis. [2022]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Risankizumab: A Review in Moderate to Severe Plaque Psoriasis. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Continuous Risankizumab Therapy vs Treatment Withdrawal in Patients With Moderate to Severe Plaque Psoriasis: A Phase 3 Randomized Clinical Trial. [2021]

5. England pubmed.ncbi.nlm.nih.gov

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. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Risankizumab for the Treatment of Moderate to Severe Plaque Psoriasis. [2020]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Risankizumab: First Global Approval. [2020]