Study to Evaluate the Efficacy, Safety, and Tolerability of Efzofitimod in Patients With Systemic Sclerosis (SSc)-Related Interstitial Lung Disease (ILD) (SSc-ILD)
NCT ID: NCT05892614
Last Updated: 2025-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
25 participants
INTERVENTIONAL
2023-10-26
2026-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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efzofitimod 450 mg
Administered IV infusion
efzofitimod 450 mg
IV infusion over approximately 60 minutes every 4 weeks
efzofitimod 270 mg
Administered IV infusion
efzofitimod 270 mg
IV infusion over approximately 60 minutes every 4 weeks
Placebo
Administered IV infusion
Placebo
IV infusion over approximately 60 minutes every 4 weeks
Interventions
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efzofitimod 450 mg
IV infusion over approximately 60 minutes every 4 weeks
efzofitimod 270 mg
IV infusion over approximately 60 minutes every 4 weeks
Placebo
IV infusion over approximately 60 minutes every 4 weeks
Eligibility Criteria
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Inclusion Criteria
2. Overall duration of SSc \< 84 months from the first non-Raynaud symptom manifestation prior to Day 1
3. HRCT obtained at the Screening Visit or within the 3 months prior to Screening consistent with SSc-ILD (adjudicated by a central reader) AND with pulmonary involvement \> 10%
4. Clinical presentation at Screening consistent with lcSSc (up to 40% of patients) or dcSSc
5. MMF of ≥ 2 gm/day (or equivalent doses of other mycophenolate based compounds) for 3 months prior to Day 1 OR When documented intolerance to mycophenolates (in discussion with the Medical Monitor): treatment with maximum tolerated dose of MMF is acceptable, if \< 2 gm/day, provided the cumulative duration of dosing has exceeded 3 months, OR An adequate dose and duration of an alternate immunosuppressant with a stable dose for the 4 weeks prior to baseline is also allowed.
Exclusion Criteria
2. Participants with pulmonary artery hypertension on parenteral therapy or with clinical evidence of right heart failure
3. HRCT obtained in the 3 months prior to Screening consistent with other confounding pathology.
4. Treatment with corticosteroids (\> 10 mg/day of prednisone or equivalent) within 2 weeks prior to Day 1
5. Treatment with more than 1 immunosuppressant (e.g., MMF, methotrexate \[MTX\], azathioprine \[AZA\], or leflunomide)
6. Any treatment in the 12 months prior to Day 1 with any of the following: rituximab, intravenous immune globulin (IVIG), tocilizumab, cyclophosphamide, pirfenidone, tyrosine-kinase inhibitors (e.g., imatinib, nilotinib, dasatinib)
7. Rheumatic autoimmune disease other than SSc, Is an active, heavy smoker of tobacco/nicotine-containing products
8. History of (anti-Jo-1) anti-synthetase syndrome or Jo-1 positive at Screening
18 Years
ALL
No
Sponsors
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aTyr Pharma, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Lisa Carey
Role: STUDY_DIRECTOR
aTyr Pharma, Inc.
Locations
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aTyr Investigative Site
Los Angeles, California, United States
aTyr Investigative Site
San Diego, California, United States
aTyr Investigative Site
Miami, Florida, United States
aTyr Investigative Site
Chicago, Illinois, United States
aTyr Investigative Site
Chicago, Illinois, United States
aTyr Investigative Site
Chicago, Illinois, United States
aTyr Investigative Site
New Orleans, Louisiana, United States
aTyr Investigative Site
New York, New York, United States
aTyr Investigative Site
Cleveland, Ohio, United States
aTyr Investigative Site
Oklahoma City, Oklahoma, United States
aTyr Investigative Site
Charleston, South Carolina, United States
aTyr Investigative Site
Dallas, Texas, United States
aTyr Investigative Site
Houston, Texas, United States
aTyr Investigative Site
Salt Lake City, Utah, United States
aTyr Investigative Site
Richmond, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Other Identifiers
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ATYR1923-C-005
Identifier Type: -
Identifier Source: org_study_id
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