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ATYR1923-C-005_SSc-ILD_EFZO-CONNECT (Systemic Sclerosis-Related Interstitial Lung Disease) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if an experimental drug called efzofitimod (the study drug) is a safe and effective option for people with SSc-ILD. We want to know how well the study drug works against the skin and lung effects caused by SSc-ILD.

What is the Condition Being Studied?

Systemic Sclerosis-Related Interstitial Lung Disease (SSc-ILD)

Who Can Participate in the Study?

Adults ages 18+ who:

  • Are diagnosed with SSc-ILD
  • Have been taking mycophenolate mofetil (MMF) for at list 6 months, or if not on MMF,

    taking a different immunosuppressant for SSc-ILD
  • Have lung disease caused by scleroderma (i.e. ILD), confirmed by high-resolution

    computed tomography (HRCT)

For more information, contact the study team at wendy.curry@duke.edu.

Age Group
Adults

What is Involved?

If you choose to join this study, you will get a random assignment (fair chance) to either take the study drug or a placebo (inactive substance that has no drug in it). You will have a 4-in-5 chance of taking the study drug and a 1-in-5 chance of taking a placebo.

You will visit our clinic 9 times while you take part in the study. During these visits, you will have physical exams, breathing tests, and skin biopsies (2 visits only - at the beginning of the study and after 3 months of taking the study drug/placebo).

Study Details

Full Title
Randomized, Double-Blind, Placebo-Controlled Proof-of-Concept Study to Evaluate the Efficacy, Safety, and Tolerability of Efzofitimod in Patients with systemic sclerosis-related interstitial lung disease ATYR1923-C-005_SSc-ILD_EFZO-CONNECT
Principal Investigator
Pulmonologist
Protocol Number
IRB: PRO00116457
Phase
Phase II
Enrollment Status
Open for Enrollment Soon