Skyrizi for Psoriasis

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how a single dose of the new treatment, risankizumab (also known as Skyrizi), affects immune cells in people with plaque psoriasis. Researchers seek to determine if this drug can clear the disease for an extended period without continuous medication. The trial seeks participants who have had moderate-to-severe plaque psoriasis for at least six months and are willing to pause other psoriasis treatments during the study. As a Phase 4 trial, this research focuses on how an already FDA-approved and effective treatment can benefit more patients.

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 is the safety track record for this treatment?

Research has shown that Skyrizi (risankizumab) is generally safe for treating psoriasis. In studies involving people with psoriasis, the most common side effects were mild, including colds, headaches, fatigue, and injection site reactions. Some participants also reported a fungal infection called tinea.

Long-term use of Skyrizi did not reveal any new safety concerns, and most people tolerated it well over several years. However, serious allergic reactions, including anaphylaxis, can occur, though they are rare. This treatment is also used for other conditions like psoriatic arthritis, which supports its safety.

In summary, Skyrizi is safe for most people, with usually manageable side effects. However, always consult a healthcare provider if there are any concerns. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Risankizumab-Rzaa is unique because it specifically targets a protein called IL-23, which plays a key role in the inflammatory process of psoriasis. Unlike some treatments that affect the entire immune system, this medication hones in on just one part, potentially reducing side effects. Researchers are excited about its potential for longer-lasting relief with less frequent dosing compared to other treatments like methotrexate or cyclosporine. This could mean more convenience and comfort for patients with moderate-to-severe psoriasis.

What is the effectiveness track record for Skyrizi in treating psoriasis?

Research has shown that risankizumab, also known as Skyrizi, effectively treats moderate to severe psoriasis. Studies found that after one year, 81-82% of patients experienced significant improvement, and 60% achieved completely clear skin. Long-term evidence suggests that risankizumab remains effective and safe for up to six years of continuous use. In some cases, patients maintained clear skin for up to five years. These findings highlight risankizumab's potential for long-term psoriasis management. ^{6 7 8 9 10}

Who Is on the Research Team?

Jaehwan Kim, MD, PhD

Principal Investigator

The Rockefeller University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

Citations

1. skyrizihcp.com skyrizihcp.com/dermatology/psoriasis-efficacy

SKYRIZI® Efficacy In Moderate to Severe Plaque Psoriasis ... PASI 90 ACHIEVED BY 81% OF PATIENTS AT 1 YEAR · PASI 90 ACHIEVED BY 82% OF PATIENTS AT 1 YEAR · PASI 100 achieved by 60% of patients at 1 year · PASI 100 achieved ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40728772/

Long-Term Safety and Efficacy of Risankizumab to Treat ... Conclusions: Long-term risankizumab was well tolerated and demonstrated high and durable efficacy through 6 years of continuous treatment.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39904971/

Real-World Effectiveness of Risankizumab in Patients with ... In this prospective study, risankizumab demonstrated higher effectiveness, longer drug survival, and better improvement of patient-reported outcomes at 25 ...

4. skyrizi.com skyrizi.com/psoriasis/psoriasis-treatment/skyrizi-results

Results | SKYRIZI® (risankizumab‐rzaa) Completely clear skin even at 5 years. In another study, most people had 90% clearer skin, and the majority of people had 100% clear skin at 5 years*.

5. news.abbvie.com news.abbvie.com/2023-07-26-SKYRIZI-R-risankizumab-Achieved-Superiority-Versus-Apremilast-for-Co-Primary-Endpoints-Among-Adult-Patients-with-Moderate-Plaque-Psoriasis-in-Phase-4-Head-to-Head-Study

SKYRIZI® (risankizumab) Achieved Superiority Versus ... After 52 weeks of continuous treatment, 73.7% of risankizumab patients achieved the pre-specified endpoints of PASI 90 and 63.6% PASI 100, with ...

6. skyrizihcp.com skyrizihcp.com/dermatology/pso-psa-safety-profile

SAFETY PROFILE ESTABLISHED IN Ps AND PsA 1 Most common adverse reactions (≥1%) associated with SKYRIZI include upper respiratory infections, headache, fatigue, injection site reactions, and tinea ...

7. skyrizi.com skyrizi.com/important-safety-information

Important Safety Information | SKYRIZI® (risankizumab-rzaa) The most common side effects of SKYRIZI in people treated for plaque psoriasis and psoriatic arthritis include: upper respiratory infections, headache, feeling ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11393270/

Long-Term Safety of Risankizumab in Patients with ... The results support the favourable safety profile of risankizumab for long-term treatment of psoriatic disease with no new safety concerns.

9. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2022/761262s000lbl.pdf

skyrizi - accessdata.fda.gov WARNINGS AND PRECAUTIONS. • Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylaxis, may occur (5.1). • Infections: SKYRIZI ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S0190962223024167

Long-term safety and efficacy of risankizumab for the ... Long-term continuous risankizumab treatment for up to 5 years was well tolerated and demonstrated high and durable efficacy.