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

No results posted yet for this study

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

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04700267 on ClinicalTrials.gov