MedTrace Logo

Study of Edecesertib in Participants With Cutaneous Lupus Erythematosus (CLE)

NCT04809623 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2024-04-05

Study results available
· View outcomes & findings →

Summary

The primary objective of this study is to evaluate the safety and tolerability of edecesertib (formerly GS-5718) in participants with cutaneous lupus erythematosus (CLE) with or without systemic lupus erythematosus (SLE).

Conditions

  • Cutaneous Lupus Erythematosus

Interventions

DRUG

Edecesertib

Tablets administered orally

DRUG

Placebo

Placebo to match edecesertib tablets administered orally

DRUG

Standard of Care

Immunosuppressive/immunomodulatory agents including but not limited to antimalarials (i.e. hydroxychloroquine), methotrexate, azathioprine and corticosteroids (i.e. prednisone)

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2022-10-18
Completion
2022-10-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT04809623 on ClinicalTrials.gov