GLPG3667 for Lupus

(GALACELA Trial)

Recruiting at 87 trial locations

Overseen By Galapagos Medical Information

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Galapagos NV

Must be taking: Immunosuppressants, Antimalarials

Disqualifiers: Severe lupus nephritis, Catastrophic antiphospholipid syndrome, Active neuropsychiatric lupus, Chronic hepatitis B, Chronic hepatitis C, Immunosuppressive condition, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 48 weeks

186 Participants Needed

Trial Summary

What is the purpose of this trial?

A study evaluating the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GLPG3667 administered orally once daily for 48 weeks in approximately 180 adult participants with active Systemic Lupus Erythematosus (SLE).

Will I have to stop taking my current medications?

The trial requires that you stay on at least one of your current medications, such as an immunosuppressant or antimalarial, for at least 12 weeks before the screening and throughout the study. Your medication must remain stable during this time.

Will I have to stop taking my current medications?

The trial requires that you stay on at least one of your current medications, such as an immunosuppressant or antimalarial, and keep it stable throughout the study. You may also continue taking oral corticosteroids or NSAIDs if they are stable before the trial starts.

Research Team

Galapagos Study Director

Principal Investigator

Galapagos NV

Eligibility Criteria

Adults with active Systemic Lupus Erythematosus (SLE) who meet specific disease activity criteria, have stable medication use, and no severe lupus nephritis or neuropsychiatric manifestations. Participants must not have certain infections like chronic hepatitis B/C or tuberculosis, nor be pregnant or breastfeeding.

Inclusion Criteria

My lupus symptoms match specific research criteria.

I have been diagnosed with lupus for at least 24 weeks.

I have tested positive for specific autoimmune markers.

Exclusion Criteria

I have severe lupus affecting my kidneys and might need strong medication.

I have kidney disease but it's under control, with specific blood and urine test results.

Participants with a history of catastrophic antiphospholipid syndrome

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 48 weeks

48 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 drug given daily for 48 weeks to see if it's effective and safe in treating SLE. It will be compared to a placebo. The study will also look at how the body processes the drug and its effects on the disease.

Participant Groups

Group I: GLPG3667 - Treatment B Experimental Treatment 1 Intervention

Participant will receive a dose B of GLPG3667 capsules orally (q.d.) for 48 weeks.

Group II: GLPG3667 - Treatment A Experimental Treatment 1 Intervention

Participant will receive a dose A of GLPG3667 capsules orally once daily (q.d.) for 48 weeks.

Group III: Placebo Placebo Group 1 Intervention

Participant will receive placebo matched to GLPG3667 capsules orally q.d for 48 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