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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Summary
This trial tests a drug to treat SLE, looking at its safety, effects, & how the body processes it in 140 adults for 32 weeks.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects of GLPG3667 are not listed here, common side effects for treatments in SLE may include gastrointestinal issues, skin reactions, headaches, fatigue, potential liver toxicity and increased risk of infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GLPG3667
2021
Completed Phase 1
~90
Find a Location
Who is running the clinical trial?
Galapagos NVLead Sponsor
139 Previous Clinical Trials
23,312 Total Patients Enrolled
Galapagos Study DirectorStudy DirectorGalapagos NV
24 Previous Clinical Trials
13,581 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility 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.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.I have lupus but do not have severe brain or nerve issues, except for certain nerve conditions.I have lupus caused by medication.I have chronic hepatitis B.I have been on a stable dose of an immunosuppressant or antimalarial for at least 12 weeks.I have a condition that weakens my immune system or have had serious infections.I have a chronic heart, lung, or kidney condition that is not well-managed.I have severe kidney problems.I have previously been treated with TYK2 inhibitors.I am not pregnant, breastfeeding, nor planning to become pregnant or breastfeed during the study.I have a chronic hepatitis C infection.I have not taken any prohibited medications recently.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: GLPG3667 - Treatment A
- Group 3: GLPG3667 - Treatment B
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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