GLPG3667 for Lupus
(GALACELA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new oral treatment called GLPG3667 to evaluate its effectiveness and safety for people with active Systemic Lupus Erythematosus (SLE), an autoimmune disease affecting various body parts. Participants will receive one of two different doses of GLPG3667 or a placebo (a non-active substance) for 48 weeks. Individuals diagnosed with SLE for at least 24 weeks, experiencing symptoms like joint pain or skin issues, and on stable background therapy might be suitable for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to the development of a potentially effective new therapy.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that GLPG3667 has been tested for safety in other conditions, such as psoriasis. In one study with psoriasis patients, the treatment was administered for 4 weeks and demonstrated positive effects without major safety issues.
Now that GLPG3667 is in a Phase 2 trial for lupus, it has already passed initial safety tests in earlier stages. This indicates it is generally considered safe enough for further testing in people. However, it is important to note that GLPG3667 remains an experimental drug and has not been approved by health authorities like the FDA for any condition.
Participants should remember that while early results are promising, a complete understanding of its safety will emerge after more studies.12345Why are researchers excited about this trial's treatments?
Researchers are excited about GLPG3667 for lupus because it targets the TYK2 enzyme, which is a new approach compared to current treatments like corticosteroids and immunosuppressants. Most existing treatments aim to broadly suppress the immune system, but GLPG3667 offers a more precise mechanism that could potentially reduce inflammation with fewer side effects. This selective targeting might lead to better disease control and improve quality of life for patients with lupus.
What evidence suggests that this trial's treatments could be effective for Lupus?
Research has shown that GLPG3667 could be a promising treatment because it specifically targets TYK2, an enzyme involved in the immune system. In lab tests, GLPG3667 effectively focused on TYK2 more than other similar enzymes. This specific targeting might result in fewer side effects compared to other treatments. Previous studies with psoriasis patients showed noticeable improvements in just four weeks, indicating its potential effectiveness. While direct evidence for lupus is still being gathered, these findings provide a strong basis for its potential in treating Systemic Lupus Erythematosus (SLE). Participants in this trial will receive either GLPG3667 or a placebo to evaluate its effectiveness for lupus.12456
Who Is on the Research Team?
Galapagos Study Director
Principal Investigator
Galapagos NV
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive GLPG3667 or placebo orally once daily for 48 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
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.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
Participant will receive a dose B of GLPG3667 capsules orally (q.d.) for 48 weeks.
Participant will receive a dose A of GLPG3667 capsules orally once daily (q.d.) for 48 weeks.
Participant will receive placebo matched to GLPG3667 capsules orally q.d for 48 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Galapagos NV
Lead Sponsor
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
NCT05856448 | A Study Evaluating the Effects of ...
A study evaluating the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GLPG3667 administered orally once daily for 48 ...
Galapagos to Present In Vitro Data at ACR Convergence ...
The data show that the in vitro pharmacological profile of GLPG3667 suggests differentiation from other TYK2 inhibitors at their clinical dose ...
Galapagos announces start of Phase 2 study with selective ...
A once-daily oral administration of GLPG3667 or placebo will be investigated in approximately 140 adult patients with SLE for 32 weeks. The ...
AB0144 PHARMACOLOGICAL CHARACTERIZATION OF ...
GLPG3667 demonstrated selectivity for TYK2 relative to the three other JAK family members in biochemical and cellular assays, and in human whole blood assays.
Discovery of GLPG3667, a Selective ATP Competitive ...
GLPG3667 also completed a phase 1b study (NCT04594928) in patients with moderate-to-severe psoriasis where clinical effect was shown within the 4 weeks of ...
AB0144 PHARMACOLOGICAL CHARACTERIZATION OF ...
GLPG3667 demonstrated selectivity for TYK2 relative to the three other JAK family members in biochemical and cellular assays, and in human whole blood assays.
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