Study Comparing Risankizumab and Deucravacitinib for Adults with Moderate Plaque Psoriasis Eligible for Systemic Therapy

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What is this study about?

This clinical trial is focused on studying the effectiveness of two treatments for plaque psoriasis, a skin condition that causes red, scaly patches on the skin. The treatments being compared are risankizumab, known by the code name ABBV-066, and deucravacitinib. Risankizumab is administered as a solution for injection, while deucravacitinib is taken as a film-coated tablet. The purpose of the study is to determine which treatment is more effective for adults with moderate plaque psoriasis who are candidates for systemic therapy, which means they need treatment that affects the entire body.

The study will be conducted over a period of 52 weeks. Participants will be randomly assigned to receive either risankizumab or deucravacitinib. During the first 16 weeks, the effectiveness of each treatment will be assessed. If a participant does not achieve a significant improvement with deucravacitinib, they may switch to risankizumab for the remainder of the study. The main goal is to see if risankizumab can achieve a greater reduction in psoriasis symptoms compared to deucravacitinib.

Throughout the study, participants will be monitored to evaluate the reduction in psoriasis symptoms, using measures such as the Psoriasis Area and Severity Index (PASI) and the static Physician’s Global Assessment (sPGA). These assessments help determine the extent of improvement in the skin condition. The study aims to provide valuable information on the best treatment options for individuals with moderate plaque psoriasis.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria. This includes being an adult with moderate plaque psoriasis for at least six months and not having been treated with biologics before.

The condition should cover 10% to 15% of the body surface area, with a PASI score of 12 or more and a sPGA score of 3.

2 initial treatment phase (period a)

Participants are randomly assigned to receive either deucravacitinib or risankizumab.

Deucravacitinib is administered orally, while risankizumab is given as a subcutaneous injection.

The treatment lasts for 16 weeks, during which the effectiveness of the medications is assessed.

3 evaluation at week 16

At the end of 16 weeks, the primary goal is to determine if the treatment has achieved a 90% reduction in the PASI score and an improvement in the sPGA score.

Participants who do not achieve these results with deucravacitinib may be considered for a switch to risankizumab.

4 extended treatment phase (period b)

Participants who switch to risankizumab continue treatment until week 52.

The goal is to achieve a 90% reduction in the PASI score by the end of this period.

5 final evaluation

At week 52, the effectiveness of the treatment is evaluated again, focusing on achieving a 100% reduction in the PASI score and a significant improvement in the sPGA score.

Who Can Join the Study?

  • You must be an adult, which means you are 18 years or older.
  • You should have a condition called plaque psoriasis, which is a skin condition that causes red, scaly patches.
  • You should have had this condition for at least 6 months before starting the study.
  • You should not have been treated with biologics before. Biologics are special medicines made from living cells to treat certain diseases.
  • Your body surface area (BSA) affected by psoriasis should be between 10% and 15%. This means the percentage of your skin that has psoriasis.
  • Your PASI score should be 12 or higher. PASI is a way to measure the severity of psoriasis, with higher numbers indicating more severe psoriasis.
  • Your sPGA score should be 3, which means your psoriasis is considered moderate. sPGA is a scale from 0 to 4 used to rate the severity of psoriasis.
  • Both men and women can participate in the study.

Who Cannot Join the Study?

  • Patients who have any other skin conditions that might interfere with the study results.
  • Patients who have a history of severe allergic reactions to any of the study medications.
  • Patients who are currently participating in another clinical trial.
  • Patients who have used certain medications that might affect the study results within a specific time frame before the study starts.
  • Patients who have certain medical conditions that could make it unsafe for them to participate in the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have not followed the study instructions in previous clinical trials.
  • Patients who have certain infections that could affect the study results.
  • Patients who have been vaccinated with live vaccines within a specific time frame before the study starts.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
IRCCS Humanitas Research Hospital Rozzano Italy
Studienzentrum Dr. Beate Schwarz Langenau Germany

Other Sites

Site Name City Country Status
Universitair Ziekenhuis Gent Gent Belgium
Ippokratio General Hospital Of Thessaloniki Thessaloniki Greece
Beldio Research GmbH Memmingen Germany
Fachaerztliche Gemeinschaftspraxis fuer Dermatologie Und Venerologie Allergologie Umweltmedizin Lasermedizin GbR Blankenfelde-Mahlow Germany
University Of Debrecen Debrecen Hungary
General Hospital Of Thessaloniki Papageorgiou Thessaloniki Greece
Hospital Clinic De Barcelona Barcelona Spain
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Semmelweis University Budapest Hungary
Universita’ Di Pisa Pisa Italy
Andreas Syngros Hospital Of Venereal And Dermatological Diseases Athens Greece
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Spaarne Gasthuis Hoofddorp The Netherlands
University Of Szeged Szeged Hungary
Dznkmigut Kgce Kaposvar Hungary
Hitscghc Unpaearrrdtdp Dk Le Pqhoxzgq Madrid Spain
Tszvijhsmxk umh Svrfjvtnwey Bangtxrn Gopc Bad Bentheim Germany
Acwmakbst Ukl Amsterdam The Netherlands
Uibgnzuhiqwerzhjklncb Miuuvodk Acy Munster Germany
Ajmbqoa Uvvit Soskokztb Lreqpv Ds Bnbucuq Bologna Italy
Uss Mwscbva Tpriqc Kodr Budapest Hungary
Ueqqrdqlgi Grmdubz Huqxoikn Avvrqgp Athens Greece

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
01.08.2024
Germany Germany
Not recruiting
01.08.2024
Greece Greece
Not recruiting
01.08.2024
Hungary Hungary
Not recruiting
01.08.2024
Italy Italy
Not recruiting
01.08.2024
Spain Spain
Not recruiting
01.08.2024
The Netherlands The Netherlands
Not recruiting
01.08.2024

Trial locations

Risankizumab is a medication used in this trial to treat adults with moderate plaque psoriasis. It works by targeting specific proteins in the immune system that contribute to the inflammation and skin symptoms associated with psoriasis. The trial aims to show that risankizumab is more effective than another treatment in reducing the severity of psoriasis symptoms.

Deucravacitinib is another medication being tested in this trial for the treatment of moderate plaque psoriasis in adults. It functions by inhibiting certain enzymes that play a role in the immune response, which can help reduce the inflammation and skin lesions seen in psoriasis. The trial compares the effectiveness of deucravacitinib with risankizumab to determine which is more beneficial for patients.

Plaque Psoriasis – Plaque psoriasis is a chronic autoimmune condition that primarily affects the skin, leading to the development of thick, red, scaly patches known as plaques. These plaques are often itchy and can appear anywhere on the body, but are most commonly found on the elbows, knees, scalp, and lower back. The condition occurs when the immune system mistakenly attacks healthy skin cells, causing them to multiply rapidly. This results in the buildup of skin cells on the surface, forming the characteristic plaques. The severity of plaque psoriasis can vary, with some individuals experiencing only minor patches, while others may have extensive coverage. The disease often goes through cycles, with periods of flare-ups followed by times of remission.

Trial ID:
2023-509738-20-00
Protocol code:
M24-541
Trial Phase:
Therapeutic confirmatory (Phase III)

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