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NCT05415137 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety of Intravenous Efzofitimod in Patients With Pulmonary Sarcoidosis

A Phase 3 study of Pulmonary Sarcoidosis, sponsored by aTyr Pharma.

Active
Registry status
Phase 3
Development phase
268
Enrollment target
20
Study locations

NCT05415137 is a Phase 3 study of Pulmonary Sarcoidosis that is active but no longer recruiting, run by aTyr Pharma. The registered enrollment target is 268 participants, below the 761-participant average among 5 other Pulmonary Sarcoidosis trials with a reported enrollment target (65% lower). The trial reports 20 study locations across 14 states.

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The verdict

NCT05415137, a Phase 3 study of Pulmonary Sarcoidosis, is active but no longer recruiting, sponsored by aTyr Pharma.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
268 participants
Enrollment target
20
Study locations

Study Summary

This is a multicenter, randomized, double-blind, placebo-controlled, study comparing the efficacy and safety of intravenous (IV) efzofitimod 3 mg/kg and 5 mg/kg versus placebo after 48 weeks of treatment. This study will enroll adults with histologically confirmed pulmonary sarcoidosis receiving stable treatment with oral corticosteroid (OCS), with or without immunosuppressant therapy.

Conditions Studied

Pulmonary Sarcoidosis

Interventions

  • DRUG Placebo
  • DRUG Efzofitimod 3 mg/kg
  • DRUG Efzofitimod 5 mg/kg

Study Locations (20)

Florida

  • aTyr Investigative Site - Gainesville
  • aTyr Investigative Site - Tampa
  • aTyr Investigative Site - Weston

California

  • aTyr Investigative Site - Los Angeles
  • aTyr Investigative Site - Sacramento

Illinois

  • aTyr Investigative Site - Chicago
  • aTyr Investigative Site - Chicago

Michigan

  • aTyr Investigative Site - Ada
  • aTyr Investigative Site - Detroit

Minnesota

  • aTyr Investigative Site - Minneapolis
  • aTyr Investigative Site - Rochester

Alabama

  • aTyr Investigative Site - Birmingham

Arizona

  • aTyr Investigative Site - Phoenix

Colorado

  • aTyr Investigative Site - Denver

Trial Details

FieldValue
Enrollment Target 268 participants
Start Date 2022-09-15
Est. Completion 2025-08-31
Phase Phase 3

Sponsor

aTyr Pharma

9 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05415137

The ClinicalTrials.gov registry entry for NCT05415137 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 268 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 761-participant average among 5 other Pulmonary Sarcoidosis trials with a reported enrollment target (65% lower). The listed sponsor is aTyr Pharma, which has 9 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Pulmonary Sarcoidosis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT05415137 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Florida, California, Illinois.

Frequently Asked Questions

What is clinical trial NCT05415137 about?

NCT05415137 is a clinical study titled "Efficacy and Safety of Intravenous Efzofitimod in Patients With Pulmonary Sarcoidosis". This is a multicenter, randomized, double-blind, placebo-controlled, study comparing the efficacy and safety of intravenous (IV) efzofitimod 3 mg/kg and 5 mg/kg versus placebo after 48 weeks of treatment. This study will enroll adults with histologically confirmed pulmonary sarcoidosis receiving sta...

What is the current status of trial NCT05415137?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 268 participants. The study started on 2022-09-15. Estimated completion is 2025-08-31.

What conditions does trial NCT05415137 study?

This clinical trial studies the following conditions: Pulmonary Sarcoidosis.

What interventions are being tested in trial NCT05415137?

The interventions under investigation include: Placebo (DRUG), Efzofitimod 3 mg/kg (DRUG), Efzofitimod 5 mg/kg (DRUG).

Who is sponsoring clinical trial NCT05415137?

This trial is sponsored by aTyr Pharma, which has 9 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05415137 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.