Study on Anifrolumab for Adults with Polymyositis or Dermatomyositis

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What is this study about?

This clinical trial is focused on studying two specific diseases: Polymyositis and Dermatomyositis. These are types of idiopathic inflammatory myopathies, which are conditions that cause muscle inflammation and weakness. The study will evaluate the effectiveness and safety of a treatment called Anifrolumab, which is administered as a solution for injection. Anifrolumab is being compared to a placebo, both of which are added to the standard care that participants are already receiving.

The purpose of the study is to determine if Anifrolumab can provide a moderate improvement in disease activity over a period of 52 weeks. Participants will receive either Anifrolumab or a placebo through subcutaneous injections, which means the medication is injected under the skin. The study will follow a double-blind method, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo, to ensure unbiased results.

Throughout the study, participants will continue their usual treatments for Polymyositis or Dermatomyositis, and their progress will be monitored to assess any changes in their condition. The trial aims to provide valuable information on whether Anifrolumab can be a beneficial addition to the current standard of care for these conditions.

1 joining the study

Upon joining the study, eligibility is confirmed based on criteria such as age (18-75 years), body weight (40 kg – ≤ 100 kg), and a diagnosis of polymyositis or dermatomyositis.

Participants must have moderate or severe disease activity and be on a stable dose of oral prednisone or other treatments for these conditions.

2 treatment initiation

Participants receive either anifrolumab or a placebo. Both are administered as a subcutaneous injection.

The treatment is added to the standard care already being received by the participant.

3 treatment duration

The treatment continues for a period of 52 weeks.

Participants are monitored for any changes in disease activity and overall health.

4 monitoring and assessments

Regular assessments are conducted to evaluate the improvement in disease activity.

The primary goal is to achieve at least a moderate improvement in disease activity without meeting criteria for confirmed deterioration at two consecutive visits.

5 end of study

The study concludes after 52 weeks of treatment.

Final assessments are conducted to determine the overall efficacy and safety of the treatment.

Who Can Join the Study?

  • Age between 18 and 75 years old.
  • Body weight between 40 kg and 100 kg.
  • Must have a “probable” or “definite” diagnosis of polymyositis (PM) or dermatomyositis (DM) according to specific medical guidelines from 2017. These are conditions that affect the muscles and skin.
  • Have moderate or severe disease activity based on certain medical measurements.
  • Currently taking oral prednisone or other treatments for polymyositis or dermatomyositis at a stable dose. Prednisone is a medication used to reduce inflammation.
  • No history of active tuberculosis or severe COVID-19. Tuberculosis is a serious infectious disease that mainly affects the lungs, and COVID-19 is a viral infection that can cause respiratory illness.
  • Male and female participants must follow guidelines for preventing pregnancy during the study.

Who Cannot Join the Study?

  • Patients who do not meet the 2017 EULAR/ACR classification criteria for polymyositis or dermatomyositis. These are specific guidelines used to diagnose these conditions.
  • Patients who are not within the specified age range for the study. The study has certain age limits that participants must fall within.
  • Patients who are not part of the specified clinical trial groups. The study is looking for participants from certain groups.
  • Patients who are considered part of a vulnerable population. This term refers to groups of people who might be at a higher risk of harm or exploitation, such as children, pregnant women, or those with certain disabilities.

Where you can join this trial?

Verified and Recommended Sites

Verified Sites

Other Sites

Site Name City Country Status
Revmatologicky Ustav Prague Czechia
Azienda Ospedaliera di Padova Padua Italy
Hospital Universitario Ramon Y Cajal Madrid Spain
Centre Hospitalier Universitaire Rouen Rouen France
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Diagnostics And Consultation Center Convex Ltd. Sofia Bulgaria
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Ospedale San Raffaele S.r.l. Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Centre Hospitalier Universitaire De Toulouse Toulouse France
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Centre Hospitalier Le Mans Le Mans France
Universita’ Politecnica Delle Marche Ancona Italy
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Kerckhoff-Klinik GmbH Bad Nauheim Germany
Medical Center Artmed Ltd. Plovdiv Bulgaria
Rigshospitalet Copenhagen Denmark
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr Herne Germany
Azienda Ospedaliero-Universitaria Sant Andre Rome Italy
Universitair Ziekenhuis Gent Gent Belgium
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Del Mar Barcelona Spain
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Italy
Hospital Universitario Rio Hortega Valladolid Spain
University Multiprofile Hospital For Active Treatment Kaspela EOOD Plovdiv Bulgaria
Malopolskie Badania Kliniczne Sp. z o.o. Cracow Poland
Uniwersytecki Szpital Kliniczny Nr 2 Uniwersytetu Medycznego W Lodzi SPZOZ Lodz Poland
Linden Sp. z o.o. sp.k. Cracow Poland
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
Hospital Universitario Reina Sofía Cordoba Spain
Universita’ Campus Bio-medico Di Roma Rome Italy
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Ludwig Maximilian University Of Munich Munich Germany
Gasthuiszusters Antwerpen Antwerp Belgium
Centre Hospitalier Lyon Sud Pierre Benite France
Semmelweis University Budapest Hungary
Medical Center Teodora EOOD Ruse Bulgaria
University Of Szeged Szeged Hungary
University Of Debrecen Debrecen Hungary
Odense University Hospital Odense Denmark
Ortopedyczno-Rehabilitacyjny Szpital Kliniczny Im Wiktora Degi Uniwersytetu Medycznego Im Karola Marcinkowskiego W Poznaniu Poznan Poland
University Hospital Consorziale Policlinico Bari Italy
Medyczne Centrum Hetmanska Piotr Leszczyński Poznan Poland
Mswefytdc Ikyibyetld Cyuxirls Sdzoqdgg Srh z ovij Warsaw Poland
Ppco Tiuyk Hrcjzrvl Ujgkyiztmudl Sabadell Spain
Bxgrajvwpm Ifbhmmwnzvpf Bqxvo Iucxeadjdhmwk Kizfic Budapest Hungary
Auemwiaumr Pxziqxeq Hysdrbna Dw Pgmyp Paris France
Hkewdbss Dm Lt Soxnx Cvpy I Sjdy Pdt Barcelona Spain
Cvykuk Hitrzlgulbh Uwwfujumwabyz Rtrrg Reims France
Ajzvoep Oakppfvtbdy Unxwoqcptobnv Sykmsg Siena Italy
Acandxzck Upm Amsterdam The Netherlands
Ueneibmauh Dqaie Ssayg Ds Rkdv Lr Syeslvpq Rome Italy
Cnbuxz Hgonoujykii Rvbtgeka Ddfkrzuxmojhvq Angers France
Uxqxcmn Uebhzapozu Hqxzbxzg Uppsala Sweden
Apimnk Uiwayafhye Hxkotvvq Aarhus Denmark
Uuymbowpan Huuegrznv Ptciu Sjtoqrpqipl Cjroear Ffup Paris France
Mhubcpc Ugxqqcefmu oc Gtqc Graz Austria
Hadtiswb Vffx dfhtgzsn Barcelona Spain
Drpnzcjphk Cwffngsrtj Ccehyu 1 Vvtpommmj Eavu Velingrad Bulgaria
Hhpnuykm Ukwzcruoisaon dr A Cyqmcs A Coruna Galicia Spain
Hqnovzng Unjwnnsskzrlwy Sympunvgvp &mojuse Hmopbyl ds Hsothgxcqjr STRASBOURG, Alsace France

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

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
03.09.2024
Belgium Belgium
Recruiting
03.09.2024
Bulgaria Bulgaria
Recruiting
03.09.2024
Czechia Czechia
Recruiting
03.09.2024
Denmark Denmark
Recruiting
03.09.2024
France France
Recruiting
03.09.2024
Germany Germany
Recruiting
03.09.2024
Hungary Hungary
Recruiting
03.09.2024
Italy Italy
Recruiting
03.09.2024
Poland Poland
Recruiting
03.09.2024
Spain Spain
Recruiting
03.09.2024
Sweden Sweden
Recruiting
03.09.2024
The Netherlands The Netherlands
Recruiting
03.09.2024

Trial locations

Investigated drugs:

Anifrolumab is a medication being studied for its effectiveness and safety in treating idiopathic inflammatory myopathies, specifically polymyositis and dermatomyositis. It is administered as a subcutaneous injection and is added to the standard care treatment. The goal of the trial is to see if anifrolumab can provide a moderate improvement in disease activity over a period of 52 weeks.

Investigated diseases:

Polymyositis – Polymyositis is an inflammatory disease that causes muscle weakness, primarily affecting the muscles closest to the trunk of the body. It progresses gradually, leading to increasing difficulty in performing tasks such as climbing stairs, lifting objects, or rising from a seated position. The condition can also affect muscles involved in swallowing and breathing. Over time, the inflammation can cause muscle tissue to break down, resulting in muscle atrophy. The exact cause of polymyositis is unknown, but it is believed to involve an autoimmune response where the body’s immune system attacks its own muscle fibers.

Dermatomyositis – Dermatomyositis is a rare inflammatory disease characterized by muscle weakness and a distinctive skin rash. The rash often appears as a violet or dusky red discoloration, typically on the face, eyelids, knuckles, elbows, knees, chest, and back. Muscle weakness usually affects the muscles closest to the trunk, similar to polymyositis, and can progress over weeks or months. This weakness can make everyday activities challenging, such as lifting objects or climbing stairs. The cause of dermatomyositis is not fully understood, but it is thought to involve an autoimmune reaction.

Trial ID:
2023-504022-19-01
Protocol code:
D3463C00003, JASMINE
Trial Phase:
Therapeutic confirmatory (Phase III)

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