Study to Evaluate the Efficacy, Safety, and Tolerability of Efzofitimod in Patients With Systemic Sclerosis (SSc)-Related Interstitial Lung Disease (ILD) (SSc-ILD)

Conditions

• Interstitial Lung Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• efzofitimod 450 mg — DRUG
  IV infusion over approximately 60 minutes every 4 weeks
• efzofitimod 270 mg — DRUG
  IV infusion over approximately 60 minutes every 4 weeks
• Placebo — DRUG
  IV infusion over approximately 60 minutes every 4 weeks

Study Details

This is a 2-Part study with Part A, a double-blind, randomized, placebo-controlled, PoC study to evaluate the efficacy, safety, and tolerability of efzofitimod in patients with SSc-ILD. The primary objective of the study is to evaluate the PoC for efficacy in a population with SSc-ILD. While improvement of ILD is the outcome of interest, the study will also evaluate changes in the skin. After initial screening (up to 4 weeks), approximately 25 eligible participants will be randomized 2:2:1 to 1 of 2 active (experimental) dose arms or placebo, administered every 4 weeks up to and including Week 20. Part B is an optional open-label extension to Part A in which participants can receive 450 mg efzofitimod every 4 weeks for 6 doses.

Key Dates

Start date

Oct 26, 2023

Status verified

May 2025

Primary completion

Apr 30, 2026

Completion

Apr 30, 2026

Study Design

Enrollment

25 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: efzofitimod 450 mg
  Administered IV infusion
• Experimental: efzofitimod 270 mg
  Administered IV infusion
• Placebo Comparator: Placebo
  Administered IV infusion

Primary Outcome Measure

Absolute change from baseline in forced vital capacity (FVC) in mL [ Time Frame: 24 weeks ]

Central Contacts

• aTyr Pharma Clinical Research
  877-215-5731
  [email protected]

Locations (15)

Find similar trials in Los Angeles, CA

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