Study on Lutikizumab and Risankizumab for Adults with Active Psoriatic Arthritis

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What is this study about?

This clinical trial is focused on studying the treatment of Psoriatic Arthritis, a condition that causes joint pain and swelling in people who have psoriasis, a skin disease. The study will explore the effects of two medications: Lutikizumab and Risankizumab. Lutikizumab, also known by its code name ABT-981, and Risankizumab, referred to as ABBV-066, are both given as injections under the skin.

The purpose of the study is to evaluate how well these medications work when used together and separately in treating active psoriatic arthritis. Participants will receive either the combination of both medications, one of the medications alone, or a placebo. The study will monitor the participants over a period to see how their symptoms change and to ensure the treatments are safe and well-tolerated.

Throughout the study, participants will have regular check-ups to assess their response to the treatment. The main goal is to see if there is a significant improvement in joint symptoms and overall disease activity. The study will also look at the safety of the treatments to ensure they do not cause any harmful effects. This research aims to find more effective ways to manage psoriatic arthritis and improve the quality of life for those affected by this condition.

1 joining the study

Upon joining the study, you will be randomly assigned to receive either a combination therapy or a monotherapy. This means you will either receive both lutikizumab and risankizumab or just one of these medications.

The study is designed to evaluate the effectiveness and safety of these treatments for psoriatic arthritis.

2 treatment administration

You will receive the medication through a subcutaneous injection, which is an injection under the skin. The medication comes in a solution form, either in a pre-filled syringe or a regular syringe.

The frequency and dosage of the injections will be determined by the study protocol and communicated to you by the study team.

3 monitoring and assessments

Throughout the study, your health and response to the treatment will be closely monitored. This includes regular check-ups and assessments to track the number of tender and swollen joints, as well as any changes in your condition.

The primary goal is to see if there is a 50% improvement in your symptoms by week 16, as measured by the American College of Rheumatology criteria.

4 end of study evaluation

At the end of the study period, which is estimated to conclude by January 2028, a final evaluation will be conducted to assess the overall effectiveness and safety of the treatment.

The study aims to determine the percentage of participants who achieve significant improvement in their condition, including minimal disease activity and reduction in psoriasis severity.

Who Can Join the Study?

The person must be willing and able to follow the procedures required in the study.
The person must have a documented clinical diagnosis of Psoriatic Arthritis (PsA), with symptoms starting at least 6 months before the screening visit. They must also meet the Classification Criteria for Psoriatic Arthritis (CASPAR) at the screening visit.
The person must have active disease, which means having at least 3 tender joints (out of 68 possible) and at least 3 swollen joints (out of 66 possible) at both the screening visit and the start of the study.
The person must have active plaque Psoriasis (PsO) or a documented history of plaque Psoriasis.
Both males and females can participate in the study.

Who Cannot Join the Study?

Patients with any other serious health conditions that could interfere with the study.
Patients who have had a recent infection that required treatment with antibiotics or antiviral medications.
Patients who have received any live vaccines within the last 4 weeks. Live vaccines contain a small amount of the actual virus or bacteria they are meant to protect against.
Patients who have a history of allergic reactions to similar medications used in the study.
Patients who are currently participating in another clinical trial. A clinical trial is a research study to test new treatments.
Patients who have a history of drug or alcohol abuse within the past year.
Patients who are pregnant or breastfeeding.
Patients who have had a major surgery within the last 12 weeks.
Patients with uncontrolled high blood pressure. This means blood pressure that is not managed well with medication or lifestyle changes.
Patients with active cancer or a history of cancer within the last 5 years, except for certain types of skin cancer.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Osteo-Medic s.c. Artur Racewicz, Jerzy Supronik	Bialystok	Poland
CENTRUM MEDYCZNE REUMA PARK	Warsaw	Poland

Other Sites

Site Name	City	Country
Pellegrin Hospital	Bordeaux	France
Mcbk s.c. Iwona Czajkowska Anna Podrazka Szczepaniak	Grodzisk Mazowiecki	Poland
L.K.N. Arthrocentrum s.r.o.	Hlucin	Czechia
Revita Kft.	Budapest	Hungary
Complex Rendelo Med Zrt.	Szekesfehervar	Hungary
Medical Plus s.r.o.	Uherske Hradiste	Czechia
University Of Debrecen	Debrecen	Hungary
Clinique De L’infirmerie Protestante De Lyon	Caluire Et Cuire	France
Centre Hospitalier Universitaire d’Orléans	Orléans	France
Semmelweis University	Budapest	Hungary
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz	Miskolc	Hungary
Centre Hospitalier Universitaire De Nice	Nice	France
PV-Medical s.r.o.	Zlin	Czechia
Fakultni Thomayerova nemocnice	Prague	Czechia
Vital Medical Center	Veszprem	Hungary
Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p.	Elblag	Poland
Rzqfztqtxfta skzywo	Brno-Sever	Czechia
Milfsgjjl Ixyailzdrr Cnmbknlq Swtdvyft Saj z olcs	Warsaw	Poland
Cngmyw Hlzgwrbdrhi Rnrrvtxx Ujtxcusxiizss Dc Toohp	Tours	France

Trial status

Country	Status	Recruitment Start
Czechia	Recruiting	15.06.2025
France	Recruiting	15.06.2025
Hungary	Recruiting	15.06.2025
Poland	Recruiting	15.06.2025

Trial locations

Investigated drugs:

Lutikizumab is a medication being studied for its potential to help people with active psoriatic arthritis. It works by targeting specific proteins in the body that are involved in inflammation. By reducing inflammation, lutikizumab may help to relieve joint pain and swelling, which are common symptoms of psoriatic arthritis.

Risankizumab is another medication being tested in this study for treating active psoriatic arthritis. It is designed to block certain proteins in the immune system that can cause inflammation and lead to joint damage. By interfering with these proteins, risankizumab aims to reduce the symptoms of psoriatic arthritis, such as pain and stiffness, and improve the overall quality of life for patients.

Psoriatic Arthritis – Psoriatic arthritis is a chronic inflammatory condition that affects the joints and is associated with psoriasis, a skin disease. It typically causes joint pain, stiffness, and swelling, which can vary in severity. The disease often begins with mild symptoms and can progress to more severe joint damage over time. It may affect any joint in the body, including the spine, and can lead to reduced range of motion. The progression of psoriatic arthritis can be unpredictable, with periods of increased activity and remission. Skin symptoms, such as red patches covered with silvery scales, often accompany joint symptoms.

Trial ID:

2024-519291-11-00

Protocol code:

M25-191

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Lutikizumab and Risankizumab for Adults with Active Psoriatic Arthritis

What is this study about?

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