A Study Evaluating the Effects of GLPG3970 Given as Oral Treatment for 12 Weeks in Adults With Systemic Lupus Erythematosus
NCT04700267 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11
Last updated 2021-10-21
Summary
This is a first exploration of GLPG3970 in subjects with active systemic lupus erythematosus (SLE) to evaluate the effect on disease biomarkers and to determine its pharmacokinetics (PK) profile, safety and tolerability, and pharmacodynamics (PD) biomarkers related to the investigational product (IP) mechanism of action and the pathophysiology of SLE.
Conditions
Interventions
- DRUG
-
GLPG3970 film-coated tablet
GLPG3970 for oral administration
- DRUG
-
Placebo film-coated tablet
Placebo for oral administration
Sponsors & Collaborators
-
Galapagos NV
lead INDUSTRY
Principal Investigators
-
Catherine Vincent, MD · Galapagos NV
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-12-28
- Primary Completion
- 2021-10-06
- Completion
- 2021-10-06
Countries
- Bulgaria
- Moldova
- Poland
- Spain
- Ukraine
Study Locations
More Related Trials
-
An Investigational Study to Evaluate the Safety and Effectiveness of BMS-986165 With Background Treatment in Participants With Lupus Nephritis
NCT03943147 ·Status: TERMINATED ·Phase: PHASE2
-
A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus
NCT04294667 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus
NCT01262365 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus (SLE)
NCT01261793 ·Status: COMPLETED ·Phase: PHASE3
-
A Phase 2 Efficacy and Safety Study of Dapirolizumab Pegol (DZP) in Systemic Lupus Erythematosus
NCT02804763 ·Status: COMPLETED ·Phase: PHASE2
-
A Safety and Tolerability Study of MEDI-570 in Systemic Lupus Erythematosus
NCT01127321 ·Status: TERMINATED ·Phase: PHASE1
-
A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of AMG 623 in Subjects With Systemic Lupus Erythematosus
NCT02411136 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Efficacy and Safety of CC-220 in Subjects With Active Systemic Lupus Erythematosus
NCT03161483 ·Status: COMPLETED ·Phase: PHASE2
-
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effect of GSK2646264 in Cutaneous Lupus Erythematosus Subjects
NCT02927457 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of D-2570 in Patients With Active Systemic Lupus Erythematosus (SLE)
NCT07311200 ·Status: RECRUITING ·Phase: PHASE2
-
Efficacy and Safety of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus
NCT02446899 ·Status: COMPLETED ·Phase: PHASE3
-
Safety Study of AMG 557 in Subjects With Lupus Arthritis
NCT01683695 ·Status: COMPLETED ·Phase: PHASE1
-
BI 705564 in Patients With Systemic Lupus Erythematosus (SLE)
NCT03771885 ·Status: WITHDRAWN ·Phase: PHASE1
-
A Study of Guselkumab in Participants With Active Lupus Nephritis
NCT04376827 ·Status: TERMINATED ·Phase: PHASE2
-
A Multiple Dose Study Of PD-0360324 In Patients With Active Cutaneous Lupus Erythematosus
NCT01470313 ·Status: TERMINATED ·Phase: PHASE1
-
A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus Erythematosus
NCT05620407 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus
NCT04877691 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythematosus
NCT02265744 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus
NCT06015737 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Study of APG-2575 in Patients With Mild-to-moderate Systemic Lupus Erythematosus.
NCT06182969 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Safety and Efficacy of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Proliferative Lupus Nephritis
NCT02547922 ·Status: COMPLETED ·Phase: PHASE2
-
Proof of Concept Study of SAR443122 in Patients With Cutaneous Lupus Erythematosus
NCT04781816 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of the Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus
NCT02908100 ·Status: COMPLETED ·Phase: PHASE2
-
An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus
NCT03252587 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus
NCT02446912 ·Status: COMPLETED ·Phase: PHASE3