Study on Izokibep for Improving Symptoms in Patients with Active Psoriatic Arthritis

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What is this study about?

This clinical trial is focused on studying the effects of a treatment called Izokibep on individuals with Psoriatic Arthritis. Psoriatic Arthritis is a condition that causes joint pain and swelling, often associated with the skin condition psoriasis. The study aims to determine if Izokibep can improve symptoms of this disease and assess its safety. Izokibep is administered as a solution for injection under the skin.

The trial involves comparing the effects of Izokibep with a placebo to see how well it works. Participants will receive either Izokibep or a placebo and will be monitored over a period of time to observe any changes in their symptoms. The main goal is to see if there is a 50% improvement in joint symptoms by the 16th week of the study.

Throughout the study, participants will have regular check-ups to monitor their health and any side effects. The study will also look at other aspects of Psoriatic Arthritis, such as the resolution of inflammation in certain areas and overall quality of life improvements. This research is important for understanding how effective Izokibep is in treating Psoriatic Arthritis and ensuring its safety for patients.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, you will receive detailed information about the study, and you will be asked to provide your signed informed consent. This consent confirms your agreement to participate and comply with the study requirements.

You will undergo a screening process to ensure you meet the study criteria. This includes a test for tuberculosis (TB) and a review of your medical history to confirm no active TB and no known exposure to TB.

2 baseline assessment

At the baseline assessment, your psoriatic arthritis symptoms will be evaluated. This includes checking for swollen and tender joints.

You will also be asked about your previous treatments and responses to medications such as NSAIDs, csDMARDs, and TNFi.

3 randomization and treatment

You will be randomly assigned to receive either the study medication, izokibep, or a placebo. The study is double-blind, meaning neither you nor the study team will know which treatment you are receiving.

If you receive izokibep, it will be administered as a subcutaneous injection (under the skin). The dosage will be 160 mg, given either once a week (QW) or once every two weeks (Q2W).

4 treatment period

The treatment period lasts for 16 weeks. During this time, you will continue to receive your assigned treatment according to the schedule.

You will be required to attend regular study visits to monitor your health and the effects of the treatment. This includes checking your joint symptoms and overall health.

5 end of treatment assessment

At the end of the 16-week treatment period, you will undergo a final assessment. This will evaluate the effectiveness of the treatment in improving your psoriatic arthritis symptoms.

The study team will also check for any side effects or changes in your health during the study.

Who Can Join the Study?

The person must have signed a form agreeing to participate in the study and follow the study rules.
The person must not have a known history of active tuberculosis (TB), which is a serious lung infection.
The person must have a negative TB test at the start of the study. If the test is positive, they can still participate if they have no TB symptoms, have started preventive treatment, have not been exposed to active TB, and have a clear chest X-ray.
Men and women must use birth control during the study and for at least 8 weeks after the last dose of the study drug. Men must use condoms, and women must use a highly effective birth control method.
The person must be between 18 and 75 years old.
The person must have a clinical diagnosis of Psoriatic Arthritis (PsA) for at least 6 months and meet specific criteria for this condition.
The person must have active PsA, shown by having at least 3 swollen and 3 tender joints at the start of the study.
The person must test negative for rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP), which are markers for another type of arthritis.
The person must have tried and not responded well to, or cannot take, at least one of the following treatments: NSAID (a type of pain reliever), csDMARD (a type of medication for arthritis), or TNFi (a type of medication that blocks a specific protein in the body).
If the person is using certain medications like methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, or apremilast, they must have been on a stable dose for at least 4 weeks before starting the study drug.
If the person is using corticosteroids (a type of medication that reduces inflammation), they must have been on a stable dose not exceeding 7.5 mg per day for at least 4 weeks before starting the study drug.
If the person is using NSAIDs or low potency opioid medications like tramadol, they must have been on a stable dose for at least 2 weeks before starting the study drug.

Who Cannot Join the Study?

Patients who have any other serious health conditions that could interfere with the study.
Patients who are currently participating in another clinical trial.
Patients who have had a recent infection that required treatment with antibiotics.
Patients who have a history of allergic reactions to similar medications.
Patients who are pregnant or breastfeeding.
Patients who have a history of drug or alcohol abuse.
Patients who have received certain treatments for psoriatic arthritis within a specific time frame before the study.
Patients who have been vaccinated with a live vaccine within a certain period before the study.
Patients who have a history of certain types of cancer.
Patients who have a history of certain blood disorders.

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
Rheumatologische Facharztpraxis	Magdeburg	Germany
Medicover Integrated Clinical Services Sp. z o.o.	Bydgoszcz	Poland
Futuremeds Łódź	Lodz	Poland
CENTRUM MEDYCZNE REUMA PARK	Warsaw	Poland

Other Sites

Site Name	City	Country
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Revita Kft.	Budapest	Hungary
Dkc Fokus-5 Lzip OOD	Sofia	Bulgaria
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD	Sofia	Bulgaria
Medical Center Teodora EOOD	Ruse	Bulgaria
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH	Hamburg	Germany
Rheumatologische Schwerpunktpraxis	Berlin	Germany
Complex Rendelo Med Zrt.	Szekesfehervar	Hungary
Accellacare Espana S.L.	Alcobendas	Spain
Vital Medical Center	Veszprem	Hungary
MUDR. Zuzana URBANOVA	Prague	Czechia
Mcytrepzh Idvancvcfm Cskenvzx Sxtpdwyz Scs z oaeb	Warsaw	Poland
Fezybwnytd Iximwoeqj fnv Tmhqbpwuoddwm Mhnjpxav aba Pmuedfqdakuh Itec	Frankfurt	Germany
Mufutvl Cnswyf &appzhu Uxggqyecqv Oc Fhdpjxph	Freiburg Im Breisgau	Germany
Mqgcltw Cwecnc Meyoftoqju Pvueuf Oed	Pleven	Bulgaria
Czqebfw Gxvsc Sniadhjp	Santiago De Compostela	Spain
Mpdgmjx Cebcrj Ebrtopllq Ona	Sofia	Bulgaria
Mmqf Sjhmotj Lxet	Sofia	Bulgaria
Cyeucou Mbbjheos Pxpgsw Cvztiissoqj	Czestochowa	Poland
Inspn Ckpgkh Pnhvz Axjrkm Kbopxfu	Bialystok	Poland
Rblguwlmaztpegcz Soxkgftflqejifkey Ddh Jrgnmb Wjhtpv	Rendsburg	Germany
Pqwgmrlg Pxltlfxq Lyfzrihn Pfpi Dc Hhp Mew Prqzl Hpdymc	Poznan	Poland
Ouqdqb Euppcyibdzhow Crirsvr Kcuc	Dunaújváros	Hungary
Pmtplc Prevquhac atrx	Pardubice	Czechia
Pnscgm Sxob	Gdynia	Poland
Mlrlwvx Cqrljz Pawvqy Chmylo Eoke	Plovdiv	Bulgaria
Mollgxh Cvhefy Mmckhrtzyg &woxhku Botapm	Burgas	Bulgaria
Fhehqhbz Tnybltgzvzw nyuhbaprc	Prague	Czechia
Mznrdle Cfnqsf Hsgqxapon Dxkkvxv Fozbdd	Budapest	Hungary
Pptqcu Smhs	Skorzewo	Poland
Umjzwlhwyl Mcioqyvtzzw Hfoiinsr Fen Autwox Tiekzalso &xekayi Pmrhbyb Ad	Plovdiv	Bulgaria
Vykfjsqt sujeyc	Moravska Ostrava A Privoz	Czechia
Mruzoxz Cwfscp Ppbxjz Cvkvhl Ekvs	Lovech	Bulgaria
Ak Creyauf Mvluynpp Smh z ojyo	Poznan	Poland
Uukggjvpwz Mmrpihwjhkwc Hiwoujtg Fse Arhakj Tnqnsqqyf Kptrshl Eosu	Plovdiv	Bulgaria
Qwvzfbvwfyk Ktgs	Budapest	Hungary
Cic Ocvzdqe sqnhye	Moravska Ostrava A Privoz	Czechia
Prphgzrsrb sfkypj	Zlin	Czechia
Coojpeajm Smhxyuqo sgvtiz	Butovice	Czechia
Rpumfnevyuqpt Rwyecttg	Ratingen	Germany
Jiiimy Bxg	Kalocsa	Hungary
Pjlvla Mrl Kindkv	Cracow	Poland
Cqajtnw Kbsseeuvzbtufdaoha Jhycmvhsoae Bqogjvklijprqdfhdtbglfhs Lgwgple sdbrn	Elblag	Poland

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	13.04.2023
Czechia	Not recruiting	13.04.2023
Germany	Not recruiting	13.04.2023
Hungary	Not recruiting	13.04.2023
Poland	Not recruiting	13.04.2023
Spain	Not recruiting	13.04.2023

Trial locations

Investigated Drugs:

Izokibep

Izokibep 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 proteins in the body that are involved in inflammation, which is a key part of psoriatic arthritis. By reducing inflammation, Izokibep aims to improve symptoms like joint pain and swelling, helping patients feel better and move more easily. The study is looking at how effective and safe Izokibep is for people with this condition.

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 skin condition characterized by red, scaly patches. The disease can cause joint pain, stiffness, and swelling, which may worsen over time. It typically affects the fingers, toes, and lower back, but can involve any joint. As the disease progresses, it can lead to joint damage and reduced range of motion. The severity and progression can vary widely among individuals.

Trial ID:

2022-501362-22-00

Protocol code:

22104

Trial Phase:

Therapeutic use (Phase IV)

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Study on Izokibep for Improving Symptoms in Patients with Active Psoriatic Arthritis

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