Thinking of joining a study?

Register your interest

Become a volunteer?

NCT05892614 | RECRUITING | Interstitial Lung Disease

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

aTyr Pharma, Inc.

Brief Summary:

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.

Condition or disease

Interstitial Lung Disease

Intervention/treatment

efzofitimod 450 mg

efzofitimod 270 mg

Placebo

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 25 participants
Masking : TRIPLE
Primary Purpose : TREATMENT
Official Title : Randomized, Double-blind, Placebo-controlled Proof-of-Concept (PoC) Study to Evaluate the Efficacy, Safety, and Tolerability of Efzofitimod in Patients With Systemic Sclerosis (SSc)-Related Interstitial Lung Disease (ILD) (SSc-ILD)
Actual Study Start Date : 2023-10-26
Estimated Primary Completion Date : 2026-04
Estimated Study Completion Date : 2026-04

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Diagnosis of SSc based on ACR/ EULAR criteria (2013)
  • 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
  • 1. Pulmonary disease with FVC %pred ≤ 45% OR DLco %pred ≤ 30%; FEV1/FVC ratio \< 0.7
  • 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
Study to Evaluate the Efficacy, Safety, and Tolerability of Efzofitimod in Patients With Systemic Sclerosis (SSc)-Related Interstitial Lung Disease (ILD) (SSc-ILD)

Location Details

NCT05892614

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

aTyr Investigative Site

Los Angeles, California, United States, 90024

RECRUITING

United States, California

aTyr Investigative Site

San Diego, California, United States, 92093

RECRUITING

United States, Florida

aTyr Investigative Site

Miami, florida, United States, 33146

RECRUITING

United States, Illinois

aTyr Investigative Site

Chicago, Illinois, United States, 60153

RECRUITING

United States, Illinois

aTyr Investigative Site

Chicago, Illinois, United States, 60611

RECRUITING

United States, Illinois

aTyr Investigative Site

Chicago, Illinois, United States, 60612

RECRUITING

United States, Louisiana

aTyr Investigative Site

New Orleans, Louisiana, United States, 70115

RECRUITING

United States, New York

aTyr Investigative Site

New York, New York, United States, 10027

RECRUITING

United States, Ohio

aTyr Investigative Site

Cleveland, Ohio, United States, 44195

RECRUITING

United States, Oklahoma

aTyr Investigative Site

Oklahoma City, Oklahoma, United States, 73104

RECRUITING

United States, South Carolina

aTyr Investigative Site

Charleston, South Carolina, United States, 29425

RECRUITING

United States, Texas

aTyr Investigative Site

dallas, Texas, United States, 75204

RECRUITING

United States, Texas

aTyr Investigative Site

Houston, Texas, United States, 77204

RECRUITING

United States, Utah

aTyr Investigative Site

Salt Lake City, Utah, United States, 84112

RECRUITING

United States, Virginia

aTyr Investigative Site

Richmond, Virginia, United States, 23284