Risankizumab for Plaque Psoriasis

(DREAM Trial)

Recruiting at 22 trial locations

Overseen By Julieta Gonzalez Blanco

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: AbbVie

Must be taking: Risankizumab

Must not be taking: Biologics, JAK inhibitors

Disqualifiers: Sleep disorder, Recent trial, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 2.5 years

700 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how risankizumab affects the quality of life for adults with moderate-to-severe plaque psoriasis, a condition characterized by thick, scaly skin patches. Risankizumab is an approved treatment, and participants will continue to receive it as prescribed by their doctors. Suitable candidates for this trial have been diagnosed with moderate-to-severe plaque psoriasis, and their doctors have determined that risankizumab is the appropriate treatment. The trial involves no additional burden beyond regular doctor visits. Participants cannot join if they are currently being treated for sleep disorders or using certain other medications.

As a Phase 4 trial, this research seeks to understand how this FDA-approved and effective treatment benefits more patients, offering valuable insights into improving patient care.

Will I have to stop taking my current medications?

If you are currently taking other biologic treatments or certain small molecule drugs like JAK inhibitors, TYK2 inhibitors, or PDE4 inhibitors, you will need to stop those before joining this trial. The protocol does not specify about other medications, so it's best to discuss with your doctor.

What is the safety track record for this treatment?

Research has shown that risankizumab is safe for treating psoriasis. Most people tolerate it well over time. Common side effects, occurring in more than 1% of users, include mild infections, headaches, fatigue, and injection site reactions. These side effects are usually mild and manageable.

Long-term studies have found no new safety issues with risankizumab, even after more than six years of use in some cases. The FDA has approved risankizumab for treating psoriasis, further supporting its safety for this condition. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Risankizumab is unique because it targets a specific protein called IL-23 that plays a key role in causing inflammation in moderate-to-severe plaque psoriasis. This is different from many current treatments that often target a broader range of immune responses, such as IL-17 or TNF-alpha inhibitors. Researchers are excited about risankizumab because it offers a more precise approach, potentially leading to better skin clearance and fewer side effects. Plus, it requires less frequent dosing, which can be a big advantage for patients looking for convenience in their treatment routine.

How effective has risankizumab been for patients with plaque psoriasis?

Research has shown that risankizumab effectively treats moderate to severe plaque psoriasis. In one study, about 81% of patients achieved 90% clearer skin after one year, and 60% had completely clear skin. Another report found that nearly 75% of participants saw their skin 90% clearer within four months. Long-term use has proven safe and remains highly effective over six years. In everyday use, many patients experience clear or nearly clear skin and report an improved quality of life. Risankizumab is a proven treatment for psoriasis, offering lasting results for most individuals. ^{6 7 8 9 10}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

Inclusion Criteria

I am eligible for risankizumab treatment according to local guidelines.

My treatment with risankizumab was decided before joining this study.

I have been diagnosed with moderate-to-severe plaque psoriasis, possibly affecting my joints.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive risankizumab as prescribed by their physician according to routine clinical practice

Up to 2.5 years

Regular visits at a hospital or clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Risankizumab

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

Citations

1. 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.

2. 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 ...

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

Results | SKYRIZI® (risankizumab‐rzaa) 90% Clearer skin. 3 out of 4 people achieved 90% clearer skin at 4 months · 100% Clear skin. Nearly 4 out of 10 achieved 100% clear skin at 4 months—and nearly 6 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0190962223028487

Real-world effectiveness of risankizumab in patients with ... Among 287 patients with persistent risankizumab use at 1 year, most achieved clear or clear/almost clear skin and reported significant reductions in Dermatology ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jdv.19748

Efficacy of long‐term risankizumab treatment for moderate‐ ... Risankizumab demonstrated generally consistent efficacy through 256 weeks across patient subgroups and showed durable long-term efficacy for psoriatic disease ...

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. 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.

8. abbviepro.com abbviepro.com/gb/en/immunology/dermatology/products/skyrizi-home/safety.html

Safety Safety Profile in Psoriasis · Consistent safety profile through to 324 weeks⁷ · SKYRIZI demonstrated a consistent safety profile in the UltiMMa OLE at 2.5 years⁵.

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

Long-term safety and efficacy of risankizumab for the ... Risankizumab's safety profile remained favorable and consistent with profiles reported in short-term studies, with sustained high rates of efficacy through ...

10. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2022/761105s014lbl.pdf

SKYRIZI® (risankizumab-rzaa) injection, for subcutaneous use The overall safety profile observed in subjects with psoriatic arthritis treated with SKYRIZI is generally consistent with the safety profile in subjects with ...