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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 2 predose until week 24

Awards & highlights

GALARISSO Trial 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.Check my eligibility

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).See study design

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.

GALARISSO Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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

GALARISSO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 2 predose until week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 2 predose until week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 2 predose until week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Area Under the Plasma Concentration-Time Curve (AUC) of GLPG3667

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

+4 more

GALARISSO Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: GLPG3667Experimental Treatment1 Intervention

Participants will receive GLPG3667 dose A orally once daily for 24 weeks.

Group II: PlaceboPlacebo Group1 Intervention

Participants will receive placebo matching to GLPG3667 orally once daily for 24 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

GLPG3667

2021

Completed Phase 1

~90

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Galapagos NVLead Sponsor

137 Previous Clinical Trials

22,861 Total Patients Enrolled

Galapagos Study DirectorStudy DirectorGalapagos NV

21 Previous Clinical Trials

13,064 Total Patients Enrolled

Media Library

GLPG3667 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05695950 — Phase 2

Dermatomyositis Research Study Groups: GLPG3667, Placebo

Dermatomyositis Clinical Trial 2023: GLPG3667 Highlights & Side Effects. Trial Name: NCT05695950 — Phase 2

GLPG3667 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05695950 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To whom does this trial apply in terms of participant requirements?

"Eligible applicants must have dermatomyositis and lie within the 18-75 age bracket. 62 individuals are required in order to complete this clinical trial's sample size."

Answered by AI

Are individuals of age 18 and over eligible for this research program?

"The requisite age range for admission into this clinical trial is 18 to 75 years old. Moreover, there are separate studies available for people below the age of consent as well as seniors who are 65 and above."

Answered by AI

Has regulatory approval been granted to GLPG3667?

"GLPG3667 is assessed to be of a relative safety grade 2 out of 3, as it has been tested in Phase II clinical trials demonstrating its safety but not necessarily efficacy."

Answered by AI

Does this clinical experiment have any open slots for prospective participants?

"Evidently, this clinical trial is not currently accepting new participants as per data hosted on clinicaltrials.gov. The experiment was first publicized on February 1st 2023 and has since been revised on the 13th of January 2023. Nevertheless, there are 26 other studies presently looking for volunteers to join their trials immediately."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Study Evaluating the Effects of GLPG3667 Given as Oral Treatment for up to 24 Weeks in Adults With Dermatomyositis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05695950.

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