GLPG3667 for Dermatomyositis

(GALARISSO Trial)

Not currently recruiting at 86 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness and safety of a new pill, GLPG3667, for treating dermatomyositis, a condition that causes muscle weakness and skin rashes. Participants will receive either GLPG3667 or a placebo (a pill with no active medicine) for 24 weeks. Afterward, all participants will receive the actual treatment for another 24 weeks to assess long-term effects. Ideal candidates are adults who have had dermatomyositis for at least three months and continue to experience symptoms despite current treatments. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that GLPG3667 is likely to be safe for humans?

Research shows that GLPG3667 is under evaluation for its safety in treating dermatomyositis, a condition affecting the muscles and skin. Earlier patients found GLPG3667, an oral medication, generally easy to tolerate. Past studies reported no major safety issues. However, like any treatment, some people might experience side effects. The current trial aims to further explore both the safety and patient tolerance of this medication over a longer period, providing more information about its overall safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for dermatomyositis?

Unlike the standard treatments for dermatomyositis, which often include corticosteroids and immunosuppressants like methotrexate or azathioprine, GLPG3667 offers a unique approach. Researchers are excited about GLPG3667 because it targets a specific pathway involved in immune response, potentially offering a more precise treatment with fewer side effects. This oral medication may provide a more convenient option and improved patient compliance compared to current injectable therapies. Overall, GLPG3667 could represent a significant advancement in treating dermatomyositis, offering hope for better outcomes with a more targeted action.

What evidence suggests that GLPG3667 might be an effective treatment for dermatomyositis?

Research has shown that GLPG3667, which participants in this trial may receive, could be a promising treatment for conditions like dermatomyositis. It blocks specific parts of the immune system that cause inflammation. Studies have found that GLPG3667 effectively blocks a pathway called IL-23, linked to autoimmune diseases. Early results suggest it can help reduce symptoms by targeting this part of the immune response. Although more research is needed, these initial findings are encouraging for its potential to treat dermatomyositis. ^{1 2 3 4 6}

Who Is on the Research Team?

Galapagos Study Director

Principal Investigator

Galapagos NV

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05695950

A Study Evaluating the Effects of GLPG3667 Given as Oral ... The purpose of this study is to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of orally administered ...

2. glpg.com glpg.com/press-releases/galapagos-to-present-in-vitro-data-at-acr-convergence-2025-suggesting-differentiation-of-glpg3667-from-other-tyk2-inhibitors/

Galapagos to Present In Vitro Data at ACR Convergence ... Two once-daily oral administration of GLPG3667 (75 mg and 150 mg) or placebo are being investigated in adult patients with SLE for 48 weeks. The ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11181332/

Discovery of GLPG3667, a Selective ATP Competitive ... Taken together, these data define a minimal effective dose of 3 mg/kg q.d. and define 9 as a selective TYK2 inhibitor that blocks the IL-23 pathway in vivo.

4. trialx.com trialx.com/clinical-trials/listings/252737/a-study-evaluating-the-effects-of-glpg3667-given-as-oral-treatment-for-up-to-24-weeks-in-adults-with-dermatomyositis/

A Study Evaluating the Effects of GLPG3667 Given as Oral ... The purpose of this study is to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of orally ...

5. glpg.com glpg.com/press-releases/galapagos-announces-start-of-phase-2-study-with-selective-tyk2-inhibitor-glpg3667-in-patients-with-dermatomyositis/

Galapagos announces start of Phase 2 study with selective ... The GALARISSO Phase 2 trial (NCT05695950) is a randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of GLPG3667.

6. pubs.acs.org pubs.acs.org/doi/10.1021/acs.jmedchem.4c00769

Discovery of GLPG3667, a Selective ATP Competitive ... Efficacy and safety results from the randomized, double-blind, placebo-controlled phase 2b trial of TYK2 inhibitor NDI-034858 in moderate-to- ...