Trials / Terminated
TerminatedNCT04700267
A Study Evaluating the Effects of GLPG3970 Given as Oral Treatment for 12 Weeks in Adults With Systemic Lupus Erythematosus
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Orally Administered GLPG3970 for 12 Weeks in Adult Subjects With Active Systemic Lupus Erythematosus
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 11 (actual)
- Sponsor
- Galapagos NV · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | GLPG3970 film-coated tablet | GLPG3970 for oral administration |
| DRUG | Placebo film-coated tablet | Placebo for oral administration |
Timeline
- Start date
- 2020-12-28
- Primary completion
- 2021-10-06
- Completion
- 2021-10-06
- First posted
- 2021-01-07
- Last updated
- 2021-10-21
Locations
14 sites across 5 countries: Bulgaria, Moldova, Poland, Spain, Ukraine
Source: ClinicalTrials.gov record NCT04700267. Inclusion in this directory is not an endorsement.