GLPG3667 for Dermatomyositis

(GALARISSO Trial)

Recruiting at 75 trial locations

Overseen By Galapagos Medical Information

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Galapagos NV

Must be taking: Oral corticosteroids, immunosuppressants

Disqualifiers: Cancer-associated myositis, other myositis, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

62 Participants Needed

Trial Summary

What is the purpose of this trial?

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), followed by an open-label extension (OLE) period until Week 48.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it mentions that participants can continue on a stable dose of up to three treatments for dermatomyositis, such as oral corticosteroids and immunosuppressants, if they have been on them for at least 3 months. It also notes that some therapies are prohibited, but details are not provided.

Research Team

Galapagos Study Director

Principal Investigator

Galapagos NV

Eligibility Criteria

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.

Inclusion Criteria

I was diagnosed with diabetes within the last 3 years and had a cancer screening in the past year.

You must have clear signs of the disease based on specific criteria.

I have diabetes and my first treatment didn’t work or caused side effects. I’ve been on up to 2 stable treatments for at least 3 months.

Exclusion Criteria

I have a type of myositis, but it's not due to Sjogren's syndrome.

You have long-lasting muscle weakness from muscle damage or another cause, as decided by the researcher.

I have not taken any prohibited medications recently.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive GLPG3667 or placebo orally once daily for 24 weeks in the double-blind treatment period

24 weeks

Open-label extension

Eligible participants receive GLPG3667 dose A orally once daily for an additional 24 weeks

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• GLPG3667
• Placebo

Trial Overview 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).

Participant Groups

Group I: GLPG3667 During DB + During OLE Experimental Treatment 1 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 OLE Placebo Group 2 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.

Who Is Running the Clinical Trial?

Galapagos NV

Lead Sponsor

Trials

140

Recruited

23,500+

Dr. Walid Abi-Saab

Galapagos NV

Chief Medical Officer since 2017

MD from the American University of Beirut, specialization in Internal Medicine and Rheumatology

Dr. Paul Stoffels

Galapagos NV

Chief Executive Officer since 2022

MD from the University of Antwerp, specialization in Infectious Diseases and Tropical Medicine at the Institute of Tropical Medicine in Antwerp