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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 Status
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 Status
Clinica Gaias Santiago Santiago De Compostela Spain
Pratia Pardubice a.s. Pardubice Czechia
University Multiprophy Hospital For Active Treatment – Plovdiv AD Plovdiv Bulgaria
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Sofia Bulgaria
Medical Centre Pratia Clinic EOOD Plovdiv Bulgaria
Revita Kft. Budapest Hungary
Medical Center Excelsior OOD Sofia Bulgaria
Dkc Fokus-5 Lzip OOD Sofia Bulgaria
MBAL Serdika Ltd. Sofia Bulgaria
Hospital Quirón Salud Infanta Luisa Sevilla Spain
Obudai Egeszseguegyi Centrum Kft. Dunaújváros Hungary
Pratia S.A. Skorzewo Poland
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Hospital General Universitario Gregorio Maranon Madrid Spain
Ai Centrum Medyczne Sp. z o.o. Poznan Poland
University Multiprofile Hospital For Active Treatment Kaspela EOOD Plovdiv Bulgaria
Qualiclinic Kft. Budapest Hungary
Medical Center Teodora EOOD Ruse Bulgaria
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH Hamburg Germany
CCR Ostrava s.r.o. Moravska Ostrava A Privoz Czechia
Rheumatologische Schwerpunktpraxis Berlin Germany
PV-Medical s.r.o. Zlin Czechia
Complex Rendelo Med Zrt. Szekesfehervar Hungary
Accellacare Espana S.L. Alcobendas Spain
INTER CLINIC Piotr Adrian Klimiuk Bialystok Poland
Fakultni Thomayerova nemocnice Prague Czechia
Rheumazentrum Ratingen Ratingen Germany
Fraunhofer Institute for Translational Medicine and Pharmacology ITMP Frankfurt Germany
Vital Medical Center Veszprem Hungary
PRATIA MCM Kraków Cracow Poland
Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p. Elblag Poland
MUDR. Zuzana URBANOVA Prague Czechia
Mauvnlcpa Irpjxhljxc Cksbqgef Sszdggem Sde z ocfp Warsaw Poland
Pmzusk Szzh Gdynia Poland
Phylnhxl Pbhxaxjd Lvwtgmmc Pnfw Dv Hpg Mfq Pvpkx Hmkeiv Poznan Poland
Vndregis supopg Moravska Ostrava A Privoz Czechia
Mipnjij Cuoius Peogcn Cwprnm Emdw Lovech Bulgaria
Cfiabzwyl Sqoivhvq svdcrg Butovice Czechia
Cjtzkrh Myzokyzo Pipihp Ckyhkhsaxfk Czestochowa Poland
Rkaubfnzfmetibyg Sxvlbvkzgkvvgqgtc Dli Jdjngs Wsyzht Rendsburg Germany
Mozwldz Cbjisk Myfbmzqwiv Phdnjq Oaa Pleven Bulgaria
Mmvuagi Czahqq Mwqgofjdzh &okzehu Bevuxh Burgas Bulgaria
Mydmblb Cczjiz Hgtjbglnt Difokgd Fyysel Budapest Hungary
Jrqizd Bpa Kalocsa Hungary

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

Trial status

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

Trial locations

Investigated drugs:

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.

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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