Study on Deucravacitinib for Patients with Active Psoriatic Arthritis New to Biologic Treatments

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What is this study about?

This clinical trial is focused on studying the effects of a medication called deucravacitinib in individuals with Psoriatic Arthritis. Psoriatic Arthritis is a condition that causes joint pain and swelling, often accompanied by skin symptoms like psoriasis. The medication being tested, deucravacitinib, is taken as a film-coated tablet and is being compared to a placebo, which looks like the medication but does not contain the active ingredient.

The purpose of the study is to evaluate how effective and safe deucravacitinib is for people with active Psoriatic Arthritis who have not previously been treated with biologic disease-modifying anti-rheumatic drugs. Participants in the study will be randomly assigned to receive either deucravacitinib or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo during the trial.

Throughout the study, participants will take the medication or placebo for a period of time, and their health will be monitored to assess any changes in their condition. The main goal is to see if there is an improvement in joint symptoms and overall health after 16 weeks of treatment. The study will also look at other health measures to understand the full impact of the treatment. This research aims to provide valuable information about the potential benefits of deucravacitinib for people living with Psoriatic Arthritis.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, your eligibility will be confirmed based on specific criteria, such as having psoriatic arthritis for at least 3 months and meeting certain medical conditions.

You will undergo various assessments, including joint examinations and blood tests, to ensure you meet the study requirements.

2 randomization

After confirming eligibility, you will be randomly assigned to one of two groups. One group will receive the active medication, deucravacitinib, and the other will receive a placebo, which looks like the medication but has no active ingredients.

This process is double-blind, meaning neither you nor the study team will know which group you are in.

3 medication administration

If you are in the active medication group, you will take a deucravacitinib 6 mg tablet once daily by mouth. If you are in the placebo group, you will take a placebo tablet once daily by mouth.

The duration of this phase is 16 weeks, during which you will continue taking the assigned tablet daily.

4 follow-up visits

Throughout the 16-week period, you will have regular follow-up visits. These visits are essential for monitoring your health and the effects of the treatment.

During these visits, you will undergo various assessments, including joint examinations, blood tests, and questionnaires about your health and symptoms.

5 end of treatment evaluation

At the end of the 16-week treatment period, you will have a final evaluation. This will include a comprehensive assessment of your condition and any changes in your symptoms.

The study team will review the results to determine the effectiveness and safety of the treatment.

Who Can Join the Study?

Must have been diagnosed with psoriatic arthritis (PsA) for at least 3 months before joining the study.
Must meet the Classification Criteria for Psoriatic Arthritis (CASPAR) at the time of joining the study. This is a set of guidelines used to confirm the diagnosis of psoriatic arthritis.
Must have active plaque psoriatic skin lesions or a documented medical history of plaque psoriasis (PsO) at the time of joining the study. Plaque psoriasis is a skin condition that causes red, scaly patches.
Must have active arthritis with at least 3 swollen joints and 3 tender joints at the time of joining the study and on the first day of the study.
Must have a high sensitivity C-reactive protein (hsCRP) level of 3 mg/L or higher at the time of joining the study. hsCRP is a blood test marker for inflammation in the body.
Must have at least one PsA-related joint erosion in the hand or foot, confirmed by an X-ray during the screening period.
Both male and female participants are eligible.

Who Cannot Join the Study?

Having any other active autoimmune disease. This means your immune system is attacking your own body, causing other health problems.
Having a serious infection. This is an illness caused by bacteria, viruses, or other germs that can make you very sick.
Having a history of cancer within the last 5 years, except for some types of skin cancer. Cancer is a disease where cells in the body grow uncontrollably.
Being pregnant or breastfeeding. This means you are expecting a baby or feeding a baby with your milk.
Having liver disease. This is a condition where your liver is not working properly.
Having kidney disease. This is a condition where your kidneys are not working properly.
Having a history of heart attack or stroke. A heart attack is when blood flow to the heart is blocked, and a stroke is when blood flow to the brain is blocked.
Using certain medications that might interfere with the study. This means taking drugs that could affect the results of the trial.
Having a history of drug or alcohol abuse. This means using drugs or alcohol in a way that is harmful to your health.
Being unable to follow the study procedures. This means not being able to do what the study requires.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Osteo-Medic s.c. Artur Racewicz, Jerzy Supronik	Bialystok	Poland
Reumedika s.c.	Poznan	Poland
Synexus Polska Sp. z o.o.	Poznan	Poland
Krakowskie Centrum Medyczne Sp. z o.o.	Cracow	Poland
Synexus Polska Sp. z o.o.	Wroclaw	Poland
Synexus Polska Sp. z o.o.	Czestochowa	Poland
Synexus Polska Sp. z o.o.	Gdansk	Poland
Synexus Polska Sp. z o.o.	Warsaw	Poland
Synexus Polska Sp. z o.o.	Katowice	Poland

Other Sites

Site Name	City	Country
Turku University Hospital	Turku	Finland
Pratia Prague s.r.o.	Prague	Czechia
Revita Kft.	Budapest	Hungary
Clinexpert Kft.	Budapest	Hungary
RK MedCenter SRL	Iasi	Romania
Connolly Hospital	Dublin	Ireland
Medyczne Centrum Hetmanska	Poznan	Poland
Medical Center Artmed Ltd.	Plovdiv	Bulgaria
Reumatop Grzegorz Rozumek Karin Pistorius Sp. j.	Wroclaw	Poland
Bekes Varmegyei Koezponti Korhaz	Gyula	Hungary
Arthrohelp s.r.o.	Pardubice	Czechia
Rheuma Medicus Sp. z o.o.	Warsaw	Poland
Complex Rendelo Med Zrt.	Szekesfehervar	Hungary
Centrum Medyczne Amed Sp. z o.o.	Warsaw	Poland
MICS Centrum Medyczne Warszawa	Warsaw	Poland
Allmedica Badania Kliniczne Sp. z o.o.	Nowy Targ	Poland
Małopolskie Badania Kliniczne Sp Z o.o.	Cracow	Poland
Obudai Egeszseguegyi Centrum Kft.	Budapest	Hungary
Rejfebstxmvunl Uyobm	Prague	Czechia
Hdqxgnbl Uunerilezcumr do A Ccbect	A Coruna Galicia	Spain
Fortpwdm ngogqcviu Mftzt a Hjmnmdz	Prague	Czechia
Fhtniwwhjy Ivbil Pilxlhhehho Sny Mbnfsk	Pavia	Italy
Ubisxmqbjffmtbzgp Dwcxh Stelc Df Vprzqy	Verona	Italy
Hotdxash Utqcedloaq Cvskrvo Hmvlfzlx	Helsinki	Finland
Cjaweh Hcsayncnafx Roscixto Uecaomzfkqzzd Dd Twkcv	Tours	France
Iabot Oxwymvyr Pvizvahtkbn Srh Mcsdptw	Genoa	Italy
Ciwykg Hyxibltwmel Uneyqwmbldscp Dr Mlcrnkjqcqu	Montpellier	France
Aybllzj Stunkohyo Utaaygsgavntm Fdmwev Csqxsmwc	Udine	Italy
Fyiyxbusk Pzlz Lu Ifygjpnrxbkjp Bkzadzccb Dta Hnqlpmno Uabmciprtbvbm Lw Ppf	Madrid	Spain
Celtnxm Mzncwut Dz Dthyemjckt Sp Tvptppgoi Axskkmsjt Ncxuah Sqvydk	Brasov	Romania
Dqzdh Hndzgd Cgsg Sbmzmk	Bucharest	Romania
Utnhgfbhac Mhqcpsfpczkj Heqoilfh Frq Aqcyfb Tbznzsssv Srsar Gapdbg Eny	Plovdiv	Bulgaria
Hpllkoex Mhyasfh Sqioleiu Smrwqs	Bucharest	Romania
Pwml Tivcu Hcrvlvax Ufwqzjaiqsnd	Sabadell	Spain
Srjwnqtp Czyltn Cdfdqbnie Bzgnikpcb	Bucharest	Romania
Mzdgeaqpndknizi Sgfcfu	Ramnicu Valcea	Romania
Bpnsrkvetk Ijbzyxhzqjlx Bcakz Idxhmkfgcqqqg Kbdzky	Budapest	Hungary
Ursdnv Molibic Coohjz Ezvf	Plovdiv	Bulgaria
Dycawsbadi Cdfipzegui Cefpwf Xkib Sncni Lhze	Sofia	Bulgaria
Cnzrsao du Kzpxopuxnwjqx sd Mtaot Bkulu Sal	Timisoara	Romania
Aqvhilz Pvlmacqmgt Sbp	Iasi	Romania
Uveuo Cs Sqe z oiei	Dabrowka	Poland
Myordfg Dxxcdqlabw Supfss	Craiova	Romania
Kewp Kuxvkbjct Vqaukjyc Jgmzfuvymos	Czestochowa	Poland
Uzbtxmwbnk Mwhckblkdpnt Hgvvjkpe Flq Akygds Tawtuqtrp Eapntzgjdqqa Pvhiqlk Lyec	Plovdiv	Bulgaria
Sgqwe Cm Seb z ozcz szxdh	Lodz	Poland
Sbcovns Oq	Kuopio	Finland
Salks Mzjdm Hzpofefw	Bucharest	Romania
Mabpkew Pgpr sbotay	Uherske Hradiste	Czechia
Eujqr Oozqbns Bpjwb Kgrcnelggxj Tlreqq Pnkqs Szdbnm	Olsztyn	Poland
Rvleqt Syw z ocmd	Lublin	Poland
Ozc Leyju Hyndvgqc Mkhrtwgtgcgvh	Sligo	Ireland
Umqjinqjld Mzvhyoqrkdwz Hotqibsx Fxg Ahossj Tnitiziky Klqbhfi Emqw	Plovdiv	Bulgaria
Qklfpqqffey Kriv	Budapest	Hungary
Phbpdimtszq Cwtw Szgyhz	Bucharest	Romania
Mjcjuqmbmhh Cceoluz Kmyjxadqv	Cracow	Poland
Cbywvzx Mprpcpza Apqrzan Bddlsdb Kiuetlsol	Cracow	Poland
Aghtxhhfb sitfho	Trebovice	Czechia
Daeexewpwf Cbblnsbovyqw Cqeyyr Ebokcw Ore	Varna	Bulgaria
Pd Mhzrbig Seyimmjn sramaa	Zlin	Czechia
Kwyv Cmjziot Mproobyo	Wołomin	Poland
Mzyskna Czwizn Sil z oyex	Nadarzyn	Poland
Rtbibmqwy sqjl Wlfrgnlh i Łuammo Pvzmospi	Poznan	Poland
Lhszrbjas Cpxaicu Dovoqfyhgwkkz	Swidnik	Poland
Cuehxym Msvhsehq Rpzjk Pgzm	Warsaw	Poland
Atljlyhw Cfbe Cnjsrt Dtlfxedbwe Aus Cepogpuclkcp Cbsjrn Lvhp	Sofia	Bulgaria
Pusgzv Styy	Gdynia	Poland
Ajhzjmjcof Pyfyzmdd Hvngcnlh Ds Petnq	Paris	France
Omlndc Epmazihpbqbzw Cxsplwt Knqx	Zalaegerszeg	Hungary

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	07.07.2021
Czechia	Not recruiting	07.07.2021
Finland	Not recruiting	07.07.2021
France	Not recruiting	07.07.2021
Hungary	Not recruiting	07.07.2021
Ireland	Not recruiting	07.07.2021
Italy	Not recruiting	07.07.2021
Poland	Not recruiting	07.07.2021
Romania	Not recruiting	07.07.2021
Spain	Not recruiting	07.07.2021

Trial locations

Investigated Drugs:

Deucravacitinib

Deucravacitinib is a medication being studied for its potential to help people with active psoriatic arthritis, a condition that causes joint pain and swelling. This medication works by targeting specific pathways in the immune system that are involved in inflammation. By doing so, it aims to reduce the symptoms of psoriatic arthritis, such as pain and swelling, and improve the overall quality of life for those affected by this condition. The study is focused on people who have not previously been treated with biologic drugs, which are a type of advanced therapy for autoimmune diseases.

Investigated Diseases:

Psoriatic arthropathy

Psoriatic Arthritis – Psoriatic Arthritis is a chronic inflammatory disease that affects the joints and areas where tendons and ligaments connect to bone. It often occurs in people who have psoriasis, a condition characterized by red patches of skin topped with silvery scales. The disease can cause joint pain, stiffness, and swelling, which may worsen over time. It typically affects the fingers and toes, but can also involve the spine and other joints. As the disease progresses, it can lead to joint damage and reduced range of motion. Enthesitis, dactylitis, and changes in nail appearance are also common features of this condition.

Trial ID:

2023-506256-25-00

Protocol code:

IM011-054

NCT ID:

NCT04908202

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Deucravacitinib for Patients with Active Psoriatic Arthritis New to Biologic Treatments

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?