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.
Who Can Participate?
Eligibility
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)
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
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).
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
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
ATYR1923-C-005_SSc-ILD_EFZO-CONNECT
Principal Investigator
Hakim
Ali
Protocol Number
PRO00116457
Phase
II
Enrollment Status
Pending Open to Enrollment