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NCT04809623 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Gilead Sciences.

Terminated
Registry status
Phase 1
Development phase
3
Enrollment target

NCT04809623: Clinical Trial Phase 1 study, sponsored by Gilead Sciences.

NCT04809623 is a Phase 1 study that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04809623, a Phase 1 study, was terminated before completion, sponsored by Gilead Sciences.

TERMINATED
Registry status
Phase 1
Development phase
3 participants
Enrollment target

Study 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).

Primary Outcome

Treatment-emergent Adverse Events (TEAEs) were defined as AEs with onset dates on or after the study treatment start date and no later than 28 days after the permanent discontinuation of the study treatment and/or the AEs that led to premature discontinuation of study treatments.

Interventions

  • DRUG Placebo
  • DRUG Standard of Care
  • DRUG Edecesertib

Trial Details

FieldValue
Enrollment Target 3 participants
Start Date 2021-09-01
Est. Completion 2022-10-18
Phase Phase 1
Gilead Sciences

504 total trials

Why NCT04809623 stopped before completion

NCT04809623 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT04809623 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04809623 about?

NCT04809623 is a clinical study titled "Study of Edecesertib in Participants With Cutaneous Lupus Erythematosus (CLE)". 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).

What is the current status of trial NCT04809623?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2021-09-01. Estimated completion is 2022-10-18.

What interventions are being tested in trial NCT04809623?

The interventions under investigation include: Placebo (DRUG), Standard of Care (DRUG), Edecesertib (DRUG).

Who is sponsoring clinical trial NCT04809623?

This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04809623's enrollment target sits among peer trials

3 1999th of 2000 higher than 1 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04809623, the US trial registry maintained by the National Library of Medicine. NCT04809623 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.