GLPG3667 for Lupus
(GALACELA Trial)

Recruiting in Palo Alto (17 mi)

+87 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Galapagos NV

Must be taking: Immunosuppressants, Antimalarials

Disqualifiers: Severe lupus nephritis, Catastrophic antiphospholipid syndrome, Active neuropsychiatric lupus, Hepatitis B, Hepatitis C, HIV, SARS-CoV-2, Active TB, Chronic cardiac, pulmonary, renal disease, others

Prior Safety Data

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.

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.

+2 more

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

+12 more

Participant Groups

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.

3Treatment groups

Experimental Treatment

Placebo Group

Group I: GLPG3667 - Treatment BExperimental Treatment1 Intervention

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

Group II: GLPG3667 - Treatment AExperimental Treatment1 Intervention

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

Group III: PlaceboPlacebo Group1 Intervention

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