Study on the Effects of GLPG3667 for Adults with Dermatomyositis

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment for dermatomyositis, a rare inflammatory disease that affects the skin and muscles, causing muscle weakness and skin rashes. The treatment being tested is called GLPG3667, which is taken as a capsule once a day. The study will compare the effects of GLPG3667 with a placebo to see how well it works in reducing the symptoms of dermatomyositis.

The purpose of the study is to evaluate the effectiveness and safety of GLPG3667 over a period of 24 weeks. Participants will be randomly assigned to receive either the GLPG3667 capsule or a placebo. Throughout the study, participants will have regular check-ups to monitor their health and any changes in their symptoms. The study aims to determine if GLPG3667 can provide at least minimal improvement in the condition by the end of the 24 weeks.

In addition to assessing the improvement in symptoms, the study will also look at the safety and tolerability of GLPG3667. This includes monitoring any side effects that may occur during the treatment period. Participants who complete the initial 24-week period may have the opportunity to continue receiving GLPG3667 in an open-label extension, where all participants receive the active treatment. This extension will help further evaluate the long-term safety and benefits of the treatment.

1 joining the study

Upon joining the study, you will be randomly assigned to receive either the study medication, GLPG3667, or a placebo. A placebo is a substance with no active medication, used to compare the effects of the actual drug.

2 medication administration

You will take the assigned medication orally in the form of a capsule once daily. The duration of this phase is 24 weeks.

3 regular check-ups

Throughout the 24-week period, you will have regular check-ups to monitor your health and the effects of the medication. These check-ups will include assessments of your muscle strength, skin condition, and overall health.

4 end of initial treatment phase

At the end of the 24 weeks, your progress will be evaluated to determine the effectiveness of the treatment. This will involve measuring any improvements in your condition according to specific criteria.

5 open label extension

If you complete the initial 24-week treatment period, you may be eligible to continue in an open label extension phase. In this phase, all participants will receive GLPG3667 for further evaluation of its safety and tolerability.

6 final assessments

Throughout the open label extension, and at its conclusion, you will undergo final assessments to monitor any long-term effects and gather additional data on the medication’s impact.

Who Can Join the Study?

  • Participants must be female or male and between 18 to 75 years old on the date they sign the consent form.
  • Participants must have a diagnosis of dermatomyositis (DM) according to specific medical criteria for at least 3 months.
  • If diagnosed with dermatomyositis in the 3 years before the study, participants must have had a cancer screening within the last year.
  • Participants must show active disease through one of the following:
    • A specific type of rash with a score of 6 or more on a medical scale.
    • A creatinine kinase level more than 4 times the normal limit.
    • Evidence of active disease from a muscle biopsy within the last 3 months.
    • Signs of inflammation in muscles from a muscle MRI within the last 3 months.
    • Changes in muscles from an electromyography test within the last 3 months.
    • Any other clinical evidence of active disease confirmed by experts.
  • Participants must have reduced muscle strength and at least two other abnormal test results, such as:
    • A doctor’s or patient’s disease activity score greater than 2 on a 10 cm scale.
    • Extra-muscular disease activity score greater than 2 on a 10 cm scale.
    • A disability score greater than 0.25 on a specific questionnaire.
    • Elevated levels of muscle enzymes with at least one enzyme more than 1.5 times the normal limit.
  • Participants must have previously shown failure or intolerance to first-line treatments, or have active disease despite treatment. They should currently be on a stable dose of up to three treatments for dermatomyositis for at least 3 months.
  • For the open-label extension part of the study, participants must have completed the initial 24-week treatment period and may benefit from further treatment according to the investigator’s judgment.

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 dermatomyositis 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 any condition that, in the opinion of the study doctor, makes them unsuitable for the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Poliklinika Vlatka Cavka d.o.o. Zagreb Croatia
Katholieke Universiteit te Leuven Leuven Belgium
Bellvitge University Hospital L'hospitalet De Llobregat Spain

Other Sites

Site Name City Country Status
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Centre Hospitalier Universitaire De Nice Nice France
Revmatologicky Ustav Prague Czechia
Hopitaux Universitaires Pitie Salpetriere Paris France
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Dkc Fokus-5 Lzip OOD Sofia Bulgaria
Spitalul Clinic Colentina Bucuresti Bucharest Romania
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Ospedale San Giovanni Bosco Turin Italy
Universita’ Di Pisa Pisa Italy
Poliklinika Solmed d.o.o. Zagreb Croatia
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer Barcelona Spain
Saint Maria Hospital Bucharest Romania
Universita Degli Studi Di Brescia Brescia Italy
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k. Cracow Poland
Reumed Sp. z o.o. Lublin Poland
Nova Reuma Domyslawska I Rusilowicz Lekarza Reumatologa I Fizjoterapeuty sp.p. Bialystok Poland
Klinika Ambroziak Sp. z o.o. Warsaw Poland
Hoafij Fsqhuhhapi Vnsaxwnqtqkbobbmo Gwoo Gommern Germany
Mcnrqfxdtuowjql Snlfxn Ramnicu Valcea Romania
Hovfqeto Vwoe detkqmcu Barcelona Spain
Huyywvha Ucolhzhzvwihii Sjsvqsfian &cwmkoe Hkudglv da Hxnorhfpqcx STRASBOURG, Alsace France

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
30.05.2023
Bulgaria Bulgaria
Not recruiting
30.05.2023
Croatia Croatia
Not recruiting
30.05.2023
Czechia Czechia
Not recruiting
30.05.2023
France France
Not recruiting
30.05.2023
Germany Germany
Not recruiting
30.05.2023
Italy Italy
Not recruiting
30.05.2023
Poland Poland
Not recruiting
30.05.2023
Romania Romania
Not recruiting
30.05.2023
Spain Spain
Not recruiting
30.05.2023

Trial locations

Investigated drugs:

GLPG3667 is a medication being tested in this clinical trial for its effectiveness in treating dermatomyositis, a condition that causes muscle weakness and skin rashes. The trial aims to see how well this medication works in reducing the symptoms of the disease. Participants in the study will take this medication orally once a day for 24 weeks. The trial also includes an open-label extension phase, where all participants will receive the medication to further assess its safety and how well people can tolerate it over time. This means that after the initial study period, everyone will know they are receiving the actual medication, not a placebo, to gather more information about its long-term effects.

Investigated diseases:

Dermatomyositis – Dermatomyositis is an inflammatory disease characterized by muscle weakness and a distinctive skin rash. It primarily affects the skin and muscles, leading to symptoms such as a violet or dusky red rash, often on the face, eyelids, knuckles, elbows, knees, chest, and back. Muscle weakness typically occurs in the hips, thighs, shoulders, upper arms, and neck, making it difficult to climb stairs, lift objects, or perform other daily tasks. The disease progresses with increasing muscle weakness and skin changes, which can vary in severity. Over time, dermatomyositis may also affect other organs, including the lungs and heart. The exact cause of dermatomyositis is unknown, but it is believed to involve an autoimmune response.

Trial ID:
2022-501097-19-00
Protocol code:
GLPG3667-CL-214
Trial Phase:
Therapeutic exploratory (Phase II)

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