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Dermatomyositis clinical trials

View clinical trials related to Dermatomyositis.

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NCT ID: NCT05832034 Recruiting - Dermatomyositis Clinical Trials

Add-on Intravenous Immunoglobulins in Early Myositis

TIMEISMUSCLE
Start date: September 13, 2021
Phase: Phase 2
Study type: Interventional

In patients with myositis early immunomodulation by intensive treatment ("hit-early/hit-hard" principle) may induce faster reduction of disease activity and prevent chronic disability. Intravenous immunoglobulin (IVIg) in addition to standard treatment with glucocorticoids may be beneficial for this purpose: add-on IVIg improved symptoms in steroid-resistant myositis, and first-line monotherapy IVIg led to a fast and clinically relevant response in a pilot study in nearly 50% of patients with myositis.

NCT ID: NCT05695950 Recruiting - Dermatomyositis Clinical Trials

A Study Evaluating the Effects of GLPG3667 Given as Oral Treatment for up to 24 Weeks in Adults With Dermatomyositis

GALARISSO
Start date: February 27, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of orally administered GLPG3667 once daily for 24 weeks in adult participants with dermatomyositis (DM).

NCT ID: NCT05669014 Recruiting - Clinical trials for Idiopathic Inflammatory Myositis

A Phase 2 Proof of Concept Study to Evaluate the Efficacy and Safety of Daxdilimab in Participants With Dermatomyositis (DM) or Anti-synthetase Inflammatory Myositis (ASIM)

Start date: December 4, 2023
Phase: Phase 2
Study type: Interventional

The primary efficacy objective: To evaluate the effect of daxdilimab compared with placebo in reducing disease activity at Week 24. The secondary efficacy objectives include: 1. To evaluate the effect of daxdilimab compared with placebo in reducing disease activity at Week 24. 2. To evaluate the effect of daxdilimab compared with placebo on skin symptoms at Week 24. 3. To evaluate the effect of daxdilimab on decreasing the use of corticosteroid at Week 24. Other secondary objectives include: 1. To characterize the pharmacokinetics (PK) and immunogenicity of daxdilimab in participants. 2. To evaluate the safety and tolerability of daxdilimab in participants.

NCT ID: NCT05650567 Recruiting - Dermatomyositis Clinical Trials

Study of M5049 in DM and PM Participants (NEPTUNIA)

Start date: January 19, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of orally administered M5049 in idiopathic inflammatory myopathies, specifically dermatomyositis (DM) and polymyositis (PM) participants for 24 weeks.

NCT ID: NCT05545839 Recruiting - Autoimmune Diseases Clinical Trials

Transition to Adulthood Through Coaching and Empowerment in Rheumatology

TRACER
Start date: October 17, 2022
Phase: N/A
Study type: Interventional

TRACER is a study aiming to investigate the feasibility of transition coaching sessions for patients moving from paediatric to adult rheumatology care.

NCT ID: NCT05524311 Recruiting - Clinical trials for Juvenile Dermatomyositis

Baricitinib in the Treatment of New-onset Juvenile Dermatomyositis (MYOCIT)

MYOCIT
Start date: November 10, 2022
Phase: Phase 2
Study type: Interventional

The MYOCIT study aims to evaluate the efficacy and safety of baricitinib in association with corticosteroids in new-onset patients with juvenile dermatomyositis (JDM) in a phase II trial with the objective to obtain a better efficacy than the conventional combination methotrexate (MTX) and corticosteroids over the 24 week study period. Thus, the investigators hypothesize that baricitinib could be used as a first line treatment in all forms of DMJ, including the most severe one, with a good safety profile.

NCT ID: NCT05523167 Recruiting - Dermatomyositis Clinical Trials

A Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Active Idiopathic Inflammatory Myopathy.

ALKIVIA
Start date: October 12, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

This study's purpose is to measure the treatment response from efgartigimod PH20 SC compared with placebo in participants with Idiopathic Inflammatory Myopathy (IIM). Participants with the IIM subtypes of dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM), or certain other subtypes of polymyositis (PM; including antisynthetase syndrome [ASyS]) will be included in the study. Treatment response will be measured by Total improvement score (TIS). Additional information can be found on https://myositis-study.com/.

NCT ID: NCT05437263 Recruiting - Dermatomyositis Clinical Trials

A Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Dermatomyositis

VALOR
Start date: October 31, 2022
Phase: Phase 3
Study type: Interventional

This is a phase 3, multicenter, randomized, placebo-controlled, double-blind study of treatment with brepocitinib (TYK2/JAK1 inhibitor) in adults with dermatomyositis (DM). The primary objective of this study is to assess the efficacy of two dose levels of brepocitinib in comparison to placebo, as measured by differences in the Total Improvement Score (TIS). After 52 weeks of double-blind treatment, participants have the option to continue therapy in a 52 week open-label extension phase where all participants will receive brepocitinib.

NCT ID: NCT05402670 Recruiting - Clinical trials for Gastric Mucosal Manifestations in Patients With Dermatomyositis

Gastric Mucosal Changes in Patients With Dermatomyositis

Start date: June 1, 2022
Phase:
Study type: Observational

There are a large number of reports in the literature that patients with dermatomyositis often have various malignant tumors, and reports of gastric cancer are not rare. At present, the widely recognized gastric cancer occurrence patterns are: normal gastric mucosa-chronic superficial gastritis-chronic atrophic gastritis-intestinal metaplasia-dysplasia-gastric cancer, so the research about the gastric mucosal performance of patients with dermatomyositis is clinically meaningful

NCT ID: NCT05375435 Recruiting - Clinical trials for Interstitial Lung Disease

Efficacy and Safety of Triple Therapy in Patients With Anti-MDA5 Antibody-positive Dermatomyositis

Start date: January 1, 2022
Phase: Phase 4
Study type: Interventional

We conduct this study to investigate the efficacy of triple therapy (high-dose glucocorticoids + cyclophosphamide + calcineurin inhibitor) compared with dual-therapy regimens (high-dose glucocorticoids + cyclophosphamide/calcineurin inhibitor) and whether it reduces the risk of poor pulmonary prognosis in patients with moderate to high risk anti-MDA5+ DM.