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GLPG3667 for Lupus (GALACELA Trial)

Phase 2
Recruiting
Research Sponsored by Galapagos NV
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 predose every 4 weeks from week 2 to week 32 and 0.5-2h , 2h-4h , 4h-6h postdose at week 4, predose every 8 weeks from week 32 to week 48
Awards & highlights

GALACELA Trial 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.Check my eligibility
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.See study design
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.

GALACELA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose every 4 weeks from week 2 to week 32 and 0.5-2h , 2h-4h , 4h-6h postdose at week 4, predose every 8 weeks from week 32 to week 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose every 4 weeks from week 2 to week 32 and 0.5-2h , 2h-4h , 4h-6h postdose at week 4, predose every 8 weeks from week 32 to week 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants who Achieved the SLE Responder Index (SRI)-4 Response at Week 32
Secondary outcome measures
Change from Baseline in the 28-joint Count for Swollen joints at Week 32 and Week 48
Change from Baseline in the 28-joint Count for Tender + Swollen (active) joints at Week 32 and Week 48
Change from Baseline in the 28-joint Count for Tender joints at Week 32 and Week 48
+8 more

GALACELA 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
137 Previous Clinical Trials
22,743 Total Patients Enrolled
Galapagos Study DirectorStudy DirectorGalapagos NV
21 Previous Clinical Trials
12,946 Total Patients Enrolled

Media Library

GLPG3667 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05856448 — Phase 2
Lupus Research Study Groups: Placebo, GLPG3667 - Treatment A, GLPG3667 - Treatment B
Lupus Clinical Trial 2023: GLPG3667 Highlights & Side Effects. Trial Name: NCT05856448 — Phase 2
GLPG3667 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05856448 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the criteria for participation limit applicants to those over 75 years of age?

"This medical study requires individuals between 18 and 75 to qualify for enrollment. There are 26 trials currently available for minors, as well as 122 studies designed for seniors aged 65 or older."

Answered by AI

To what extent is the current clinical trial being utilized by participants?

"To facilitate the successful completion of this trial, 140 qualified participants need to register with either San Marcus Research Clinic in Miami, Florida or Advanced Pharma - Miami in Charlotte, North carolina."

Answered by AI

Are there any open slots for participation in this research study?

"Affirmative, information available on clinicaltrials.gov attests to the fact that this trial is recruiting participants at present. The study was first advertised on June 28th 2023 and has most recently been updated on July 19th of the same year. 140 individuals will be accepted from 4 distinct medical centres."

Answered by AI

What sort of risks does GLPG3667 pose to those utilizing the treatment?

"The safety of GLPG3667 was given a score of 2 due to the lack of available clinical data supporting efficacy, though there is some evidence that it may be safe."

Answered by AI

Am I eligible to join the trial?

"This medical trial calls for 140 participants with a diagnosis of systemic lupus erythematosus (SLE) between ages 18 and 75. All candidates must have evidence that their disease has been present for more than 24 weeks, as well as a total Systemic Lupus Erythematosus Disease Activity Index 2000 score of 6 or higher and a clinical SLEDAI-2K score of 4 or greater. Furthermore, applicants should exhibit either positive antinuclear antibodies ≥1:80 ,positive anti-double stranded deoxyribonucleic acid levels, or an elevation in the amount of anti-Smiths"

Answered by AI

Who else is applying?

What site did they apply to?
Southwest Arthritis
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study Evaluating the Effects of GLPG3667 Administered as Oral Treatment in Adult Participants With Active Systemic Lupus Erythematosus
2023. "A Study Evaluating the Effects of GLPG3667 Administered as Oral Treatment in Adult Participants With Active Systemic Lupus Erythematosus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05856448.
All > Systemic Lupus Erythematosus > Tucson
~118 spots leftby Dec 2025
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