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Efficacy and Safety of Intravenous Efzofitimod in Patients With Pulmonary Sarcoidosis

NCT05415137 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 268

Last updated 2025-05-20

No results posted yet for this 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

  • Pulmonary Sarcoidosis

Interventions

DRUG

Efzofitimod 3 mg/kg

EfzofitimodIV infusion every 4 weeks for a total of 12 doses

DRUG

Efzofitimod 5 mg/kg

EfzofitimodIV infusion every 4 weeks for a total of 12 doses

DRUG

Placebo

Placebo IV infusion every 4 weeks for a total of 12 doses

Sponsors & Collaborators

  • Kyorin Pharmaceutical Co.,Ltd

    collaborator INDUSTRY

  • aTyr Pharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Lisa Carey · aTyr Pharma, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-15
Primary Completion
2025-07-31
Completion
2025-08-31
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • France
  • Germany
  • Italy
  • Japan
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT05415137 on ClinicalTrials.gov