Study on Anifrolumab for Adults with Polymyositis or Dermatomyositis

3 1 1

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

No sites found in this category

Verified Sites

Site Name City Country Status
Linden Sp. z o.o. sp.k. Cracow Poland
IRCCS Humanitas Research Hospital Rozzano Italy
Medical University Of Vienna Vienna Austria
Centre Hospitalier Universitaire De Lille Lille France
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Katholieke Universiteit te Leuven Leuven Belgium
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu Wroclaw Poland

Other Sites

Site Name City Country Status
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher Warsaw Poland
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Centre Hospitalier Universitaire Rouen Rouen France
Ospedale San Raffaele S.r.l. Milan Italy
Semmelweis University Budapest Hungary
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Hospital Del Mar Barcelona Spain
Centre Hospitalier Le Mans Le Mans France
Medical Center Artmed Ltd. Plovdiv Bulgaria
Medical Center Teodora EOOD Ruse Bulgaria
University Hospital Consorziale Policlinico Bari Italy
Rvqwipviaxpvlo Uptus Prague Czechia
Mhhgnotqf Iybxmzcddu Cqtwrmwf Stgnulmr Svw z oeti Warsaw Poland
Atjgmln Ofidjdreyzj dv Pfgrmq Padua Italy
Uzzjagvzdw Oc Dptexzbd Debrecen Hungary
Hefcjxfp Vumu dqoxuwrb Barcelona Spain
Hafdqcjz Uxdyrrgpadpvo dd A Cpblau A Coruna Galicia Spain
Ofrljc Ulepxdjflx Hokcwnry Odense Denmark
Uvdqnxxdxihihjolgaulk Tikrxebhw Ava Tuebingen Germany
Fminzmkkyx Ixmvl Pybdmjxmigt Sfc Mtntae Pavia Italy
Czalbu Hhdowzphaoc Umocrtebxlenq Dw Thfpotac Toulouse France
Uekgoew Ugmxiiflko Hgwmssak Uppsala Sweden
Cobswbn Uruucgqcohyzzgxzstrf Brhkyq Krn Berlin Germany
Unaweeakprhnvwmvm Prgkbabtmod Dgcab Mqncjy Ancona Italy
Gfgwegufqdnyhdd Ahivtxluu Antwerp Belgium
Mohtkqq Cjzfbr &keeaze Ugvgllvqwv Op Fraimvmn Freiburg Im Breisgau Germany
Uttldwzcww Ox Srxzop Szeged Hungary
Rziklxmblqrwip Copenhagen Denmark
Hdyjbjrv Df Ly Szgmz Ceyi I Setq Pag Barcelona Spain
Uxyeuiwpuy Dquwz Spqox Ds Rqcv Lj Sxunialn Rome Italy
Ucvtmpwdouxt Zihbcedfmh Gnfw Gent Belgium
Cgkiuq Hjsxtfylrjl Ltgf Sbl Pierre Benite France
Hbldfzlr Uqmfztkcdzyhy 1m Dd Ozvjtwq Madrid Spain
Clygkp Hotdeacpzmj Ryywjwab Dnzsdyonlrkalo Angers France
Hjqubpgy Ucrzwxicmzydz Rel Hbctzwc Valladolid Spain
Hmbgpcau Ueztvkkeumaixj Sodqyifvpz &ckqzgz Hnhfhfm dp Hchspdslyrd STRASBOURG, Alsace France
Ulslkfoend Mfzfobnawnqo Hhxinnns Fmi Aaxiul Tuspaypxb Srgel Ggqwma Exs Plovdiv Bulgaria
Paja Tzkql Hencbavk Uywphstamnwo Sabadell Spain
Azcqvcw Orgfuzstkpvgvrlynywqdcqui Pouhyuphmge Gc Rfuhvehbenhj Mroyw De Cmvmxah Catania Italy
Ddqhxbknxix Ayt Cxrznmotsmhe Cihpgo Csgysq Lycg Sofia Bulgaria
Bxtatbolre Inlubmtlbuyu Bctng Ikfhkxdqrfmhl Kyfqub Budapest Hungary
Mpvjcie Uxydqiykev oc Gdsy Graz Austria
Dnqhxqotnc Cscjxbeezr Cqqdrd 1 Vnpsrcjoz Emdq Velingrad Bulgaria
Abtwfmzxdu Pyloylwm Hpngfuat Dx Peqii Paris France
Uzuusbseqkjsahwjf Cfeepr Basggupyep Db Reqm Rome Italy
Ahignfd Ovoglrljgpo Uyvtxacefxuzl Sojkne Siena Italy
Auplkc Ufprjwtwce Hudyjjca Aarhus Denmark
Levigi Mzjfljuqdm Uqyhhcywmi Od Mcsvvl Munich Germany
Aumdacozt Ure Amsterdam The Netherlands
Khsoocmylvcbbifi Gmne Bad Nauheim Germany
Ssr Eursnidjb Gkkbgf Gena Kcupoykeemj Krmjphvj Rdtbjmihdd Herne Germany
Cjbinz Hhvkswlobmc Uchoogibzmguq Rbtkb Reims France
Afwvocv Otnhmnjsnnllbesrncamzqdzw Stug Armew Rome Italy
Arkzrdt Oavjbkuadpd Uewwujjyybfmr Pmhtcowsejk Pdwnc Gcbvpnln Palermo Italy
Ueocpfirri Hpwpbnsim Psoif Sweekdrblgw Cjbeyel Fnry Paris France
Uarmlyhhaw Mgzjcoggziux Heicpjax Fcx Aykrfk Tujncpzgl Kfslsnk Eczl Plovdiv Bulgaria
Mkbfhtvzvnk Baupvwf Kwrbpeyst Szg z osxq Cracow Poland
Ucakejylnmimw Sompaln Klhfvtezc Nx 2 Uaozuvguezfh Mnpfxsbsrn W Litkk Sojfm Lodz Poland
Oomcksaecgqpmatyxukeyuydobfy Sevubbx Kcxlxedbl It Wuijpxg Djib Ufwgswdaweye Msxgnpxclp Is Kmzbat Mzbmjuzllfgkyfc W Pgqipehs Poznan Poland
Msgyflsq Ckzggcb Hhhglgarp Porny Lqmwxfesjna Poznan Poland

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.

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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