Subcutaneous Risankizumab for Psoriasis

(UnlIMMited Trial)

Recruiting at 48 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

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: 52 weeks

214 Participants Needed

Trial Summary

What is the purpose of this trial?

Psoriasis (PsO) is a chronic disease characterized by marked inflammation of the skin that results in thick, red, scaly plaques. This study will assess how safe and effective risankizumab is in adult participants with moderate to severe genital psoriasis or moderate to severe scalp psoriasis. Adverse events and change in disease signs and symptoms will be monitored. Risankizumab (Skyrizi) is a drug being studied for the treatment of moderate to severe genital psoriasis or moderate to severe scalp psoriasis. Approximately 200 participants with moderate to severe genital psoriasis or moderate to severe scalp psoriasis will be enrolled across approximately 45 sites globally. The study will be broken up into 2 sub-studies by disease location, participants with moderate to severe genital psoriasis (Study G) and moderate to severe scalp psoriasis (Study S). In both sub-studies participants will receive subcutaneous (SC) injections of risankizumab during the 52 week treatment period, or SC injections of placebo risankizumab during the 16 week treatment period followed by SC injections of risankizumab during the 36 week treatment period, with an 8-week follow-up period after the 52 week treatment period. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

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 data supports the effectiveness of the drug Risankizumab for treating psoriasis?

Research shows that Risankizumab is effective for moderate to severe plaque psoriasis, with many patients experiencing significant improvement in their skin condition. It was more effective than other treatments like placebo, ustekinumab, and adalimumab in clinical trials, and it helped improve patients' quality of life. ^{1 2 3 4 5}

Is risankizumab safe for humans?

Risankizumab, also known as Skyrizi, has been shown to be safe in humans based on multiple clinical trials for conditions like moderate-to-severe plaque psoriasis. It was well tolerated in these studies, meaning most people did not experience serious side effects. ^{3 6 7 8 9}

How does the drug risankizumab differ from other treatments for psoriasis?

Risankizumab is unique because it specifically targets the p19 subunit of interleukin-23 (IL-23), a protein involved in inflammation, and is administered as a subcutaneous injection every 12 weeks after initial doses. This makes it different from other treatments that may target different proteins or require more frequent dosing. ^{3 5 6 7 10}

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: Study S Risankizumab Experimental Treatment 1 Intervention

Participants with moderate to severe scalp psoriasis will receive risankizumab during the 52 week treatment period, with an 8-week follow-up period after the 52 week treatment period.

Group II: Study S Placebo for Risankizumab Experimental Treatment 2 Interventions

Participants with moderate to severe scalp psoriasis will receive placebo for risankizumab during the16 week treatment period followed by risankizumab during the 36 week treatment period, with an 8-week follow-up period after the 52 week treatment period.

Group III: Study G Risankizumab Experimental Treatment 1 Intervention

Participants with moderate to severe genital psoriasis will receive risankizumab during the 52 week treatment period, with an 8-week follow-up period after the 52 week treatment period.

Group IV: Study G Placebo for Risankizumab Experimental Treatment 2 Interventions

Participants with moderate to severe genital psoriasis will receive placebo for risankizumab during the 16 week treatment period followed by risankizumab during the 36 week treatment period, with an 8-week follow-up period after the 52 week treatment period.

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

Findings from Research

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 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]

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]

References

1. England 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. [2020]

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

Real-world dose escalation of biologics for moderate-to-severe psoriasis in the United States. [2023]

3. England pubmed.ncbi.nlm.nih.gov

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

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

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

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]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Risankizumab for the Treatment of Moderate to Severe Plaque Psoriasis in the Russian Federation. [2022]

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

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

10. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical Pharmacokinetics and Pharmacodynamics of Risankizumab in Psoriasis Patients. [2021]