Subcutaneous Risankizumab for Psoriasis

(UnlIMMited Trial)

No longer recruiting at 50 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: AbbVie

Must not be taking: IL-23 inhibitors

Disqualifiers: Non-plaque psoriasis, Allergic reactions, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effectiveness of a drug called risankizumab for treating moderate to severe genital or scalp psoriasis. Psoriasis causes red, scaly patches on the skin. The study compares risankizumab to a placebo (a substance with no active drug) to determine if it reduces symptoms and is safe to use. It seeks participants who have had psoriasis for at least six months and struggle to control it with usual treatments like creams or light therapy. Participants will receive injections and attend regular check-ups over the course of a year. As a Phase 4 trial, risankizumab is already FDA-approved and proven effective, and this research aims to understand how it benefits more patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop your current medications. It's best to discuss this with the study team or your doctor.

What is the safety track record for risankizumab?

Research shows that risankizumab is generally well-tolerated by patients. In studies, most side effects were mild, with the most common being colds, headaches, fatigue, and injection site reactions, occurring in at least 1% of participants. Risankizumab has proven safe and effective for treating moderate to severe psoriasis, including sensitive areas like the genitals and scalp. More than 60% of patients achieved clear or nearly clear skin after treatment. Its approval for other types of psoriasis further supports its safety. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about risankizumab for psoriasis because it offers a new approach by targeting interleukin-23 (IL-23), a protein involved in inflammation. Unlike standard treatments like methotrexate or cyclosporine, which affect the immune system more broadly, risankizumab specifically blocks IL-23, potentially leading to fewer side effects. Additionally, risankizumab is administered subcutaneously, which might be more convenient compared to some current options requiring more frequent dosing or intravenous administration. This precise targeting and convenient delivery could offer a promising alternative for managing moderate to severe scalp and genital psoriasis.

What is the effectiveness track record for risankizumab in treating moderate to severe genital or scalp psoriasis?

Research shows that risankizumab effectively treats both scalp and genital psoriasis. In this trial, participants with scalp psoriasis will receive either risankizumab or a placebo, followed by risankizumab. A study on scalp psoriasis found that 60.8% of patients achieved clear or almost clear skin with risankizumab, compared to only 13% with a placebo. Similarly, participants with genital psoriasis will receive either risankizumab or a placebo, followed by risankizumab. Studies have shown that 69.1% of patients with genital psoriasis experienced clear or almost clear skin, while only 13% on placebo had similar results. This evidence indicates that risankizumab significantly improves skin condition compared to no treatment. The treatment is already approved for other types of psoriasis, demonstrating its effectiveness. ^{1 2 3 4 5}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

Adults with a 6-month history of chronic plaque psoriasis, including those with psoriatic arthritis, can join. They must have moderate to severe genital or scalp psoriasis that hasn't responded well to other treatments and are candidates for systemic therapy or phototherapy.

Inclusion Criteria

My psoriasis covers more than 1% of my body, and treatments haven't worked well.

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

I have moderate to severe genital or scalp psoriasis.

Exclusion Criteria

History of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class.

I have been treated with IL-23 inhibitors like guselkumab or ustekinumab.

I have a skin condition other than plaque psoriasis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive subcutaneous injections of risankizumab or placebo during the treatment period

52 weeks

Regular visits at a hospital or clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo for Risankizumab
• Risankizumab

Trial Overview

The trial is testing Risankizumab's safety and effectiveness against placebo in adults with genital or scalp psoriasis. Participants will receive subcutaneous injections over a period of up to 52 weeks, followed by an 8-week follow-up.

How Is the Trial Designed?

Group I: Study-S Risankizumab/Risankizumab (Period B) Experimental Treatment 1 Intervention

Participants with moderate to severe scalp psoriasis received 150 mg of risankizumab subcutaneously during Period A, and continued with this treatment at Weeks 16, 28, and 40 during Period B.

Group II: Study-S Risankizumab (Period A) Experimental Treatment 1 Intervention

Participants with moderate to severe scalp psoriasis received 150 mg of risankizumab subcutaneously at Weeks 0 and 4 during Period A.

Group III: Study-S Placebo/Risankizumab (Period B) Experimental Treatment 1 Intervention

Participants with moderate to severe scalp psoriasis received placebo for risankizumab during Period A, and 150 mg of risankizumab subcutaneously at Weeks 16, 28, and 40 during Period B.

Group IV: Study-G Risankizumab/Risankizumab (Period B) Experimental Treatment 1 Intervention

Participants with moderate to severe genital psoriasis received 150 mg of risankizumab subcutaneously during Period A, and continued with this treatment at Weeks 16, 28, and 40 during Period B.

Group V: Study-G Risankizumab (Period A) Experimental Treatment 1 Intervention

Participants with moderate to severe genital psoriasis received 150 mg of risankizumab subcutaneously at Weeks 0 and 4 during Period A.

Group VI: Study-G Placebo/Risankizumab (Period B) Experimental Treatment 1 Intervention

Participants with moderate to severe genital psoriasis received placebo for risankizumab during Period A, and 150 mg of risankizumab subcutaneously at Weeks 16, 28, and 40 during Period B.

Group VII: Study-G Placebo (Period A) Placebo Group 1 Intervention

Participants with moderate to severe genital psoriasis received placebo for risankizumab subcutaneously at Weeks 0 and 4 during Period A.

Group VIII: Study-S Placebo (Period A) Placebo Group 1 Intervention

Participants with moderate to severe scalp psoriasis received placebo for risankizumab subcutaneously at Weeks 0 and 4 during Period A.

Who Is Running the Clinical Trial?

AbbVie

Lead 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 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]

Tildrakizumab demonstrated significant efficacy in treating moderate-to-severe plaque psoriasis, with 62.3% of patients achieving a 75% improvement in the Psoriasis Area and Severity Index (PASI 75) at week 12, compared to only 5.6% in the placebo group.

The efficacy of tildrakizumab increased over time, with better responses observed in patients with lower body weight and those receiving the 200 mg dose, indicating that body weight may influence treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of tildrakizumab for moderate-to-severe plaque psoriasis: pooled analysis of three randomized controlled trials at weeks 12 and 28. Papp, KA., Reich, K., Blauvelt, A., et al.[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]

Citations

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Efficacy and Safety of Risankizumab in Genital or Scalp ...

In study-G, 69.1% of patients receiving risankizumab versus 13.0% of patients receiving placebo achieved sPGA-G 0/1 (P < 0.0001). In study-S, ...

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UnlIMMited Data Demonstrate Risankizumab Efficacy in ...

At week 16, 69.1% of patients in the genital psoriasis group and 60.8% in the scalp psoriasis group achieved clear or almost clear skin with ...

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NCT05969223 | Study to Assess the Safety and Efficacy of ...

This study will assess how safe and effective risankizumab is in adult participants with moderate to severe genital psoriasis or moderate to severe scalp ...

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Risankizumab Effective as Treatment for Psoriasis in ...

Risankizumab significantly improves genital and scalp psoriasis, achieving higher clearance rates than placebo in phase 4 trials. The UnlIMMited ...

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SAFETY PROFILE ESTABLISHED IN Ps AND PsA 1

Long-term data include all administered doses ranging from 18 mg to 180 mg of SKYRIZI in 3,658 patients. The FDA-approved dose is 150 mg at Week 0, Week 4, and ...