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GLPG3667 for Dermatomyositis (GALARISSO Trial)

Phase 2

Recruiting

Research Sponsored by Galapagos NV

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant has reduced muscle strength and at least 2 additional abnormal core set measurements at screening

Be older than 18 years old

Must not have

Participant has taken any prohibited therapies within the defined washout periods before screening, and during screening as listed in the study protocol

Participant has cancer-associated myositis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 24

Summary

This trial will study how safe and effective a drug is for treating dermatomyositis over 24 weeks.

Who is the study for?

Adults with dermatomyositis diagnosed within the last 3 years, who have had a cancer screening in the past year. They should have tried first-line treatments without success or cannot tolerate them and must be on up to two stable DM treatments for at least 4 weeks. Those with permanent muscle weakness from non-DM causes, cancer-associated myositis, other types of myositis except secondary Sjogren's syndrome overlap, or recent use of prohibited therapies can't join.

What is being tested?

The trial is testing GLPG3667, an oral medication taken daily for 24 weeks against a placebo to see its effects on adults with dermatomyositis. It will assess how well it works (efficacy), safety, tolerability, and how the body processes it (pharmacokinetics/pharmacodynamics).

What are the potential side effects?

While specific side effects are not listed here, common ones may include issues related to digestion, skin reactions at drug application sites if topical treatment is involved in standard care for DM patients participating in this study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have weak muscles and at least two other unusual test results.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not taken any prohibited medications recently.

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I have muscle inflammation related to my cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants With at Least Minimal Improvement at Week 24 According to the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Criteria

Secondary study objectives

Change From Baseline in Modified-Cutaneous DM Disease Area and Severity Index Activity Score (m-CDASI-A) at Week 24

Change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 24

Change from baseline in the manual muscle test (MMT-8) at Week 24

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: GLPG3667 During DB + During OLEExperimental Treatment1 Intervention

Participants will receive GLPG3667 dose A orally once daily for 24 weeks in the double-blind (DB) treatment period. Eligible participants will roll-over to an open-label extension (OLE) period to receive the same dose for another 24 weeks.

Group II: Placebo During DB + GLPG3667 During OLEPlacebo Group2 Interventions

Participants will receive placebo matching to GLPG3667 orally once daily for 24 weeks in the DB treatment period. Eligible participants will roll-over to an OLE period to receive GLPG3667 dose A orally once daily for another 24 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

GLPG3667

2021

Completed Phase 1

~90

0 / 3Eligibility criteria met