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

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ClinicalTrials.gov Identifier: NCT05892614
Recruitment Status : Recruiting
First Posted : June 7, 2023
Last Update Posted : November 3, 2023
Sponsor:
Information provided by (Responsible Party):
aTyr Pharma, Inc.

Study Description
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Brief Summary:
This is 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.

Condition or disease Intervention/treatment Phase
Interstitial Lung Disease Drug: efzofitimod 450 mg Drug: efzofitimod 270 mg Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
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 : October 26, 2023
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: efzofitimod 450 mg
Administered IV infusion
 Drug: efzofitimod 450 mg
IV infusion over approximately 60 minutes every 4 weeks
Experimental: efzofitimod 270 mg
Administered IV infusion
 Drug: efzofitimod 270 mg
IV infusion over approximately 60 minutes every 4 weeks
Placebo Comparator: Placebo
Administered IV infusion
 Drug: Placebo
IV infusion over approximately 60 minutes every 4 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Absolute change from baseline in forced vital capacity (FVC) in mL [ Time Frame: 24 weeks ]
  2. Annual rate of decline in FVC in mL [ Time Frame: 24 weeks ]
  3. Annual rate of decline in FVC in percent predicted [ Time Frame: 24 weeks ]
  4. Proportion of patients with > 5% and ≥ 10% decline in absolute FVC [ Time Frame: Baseline to week 24 ]
  5. Proportion of patients with > 5% and ≥ 10% decline in percent predicted FVC [ Time Frame: Baseline to Week 24 ]
  6. Change in HRCT fibrosis score [ Time Frame: Baseline to Week 24 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of SSc based on ACR/ EULAR criteria (2013)
  2. Overall duration of SSc < 48 months from the first non-Raynaud symptom manifestation
  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. Presence of at least:

    Any 1 laboratory marker for active disease

    OR

    Clinically significant decline in FVC % predicted (%pred) based on ≥ 105% relative decline over the preceding one year (two readings from the same pulmonary function laboratory)

  6. MMF of ≥ 2 gm/day (or equivalent doses of other mycophenolate based compounds) for 6 months

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 baseline
  5. SSc-ILD treatments other than MMF OR MMF < 2 gm/day
  6. Any previous treatment with any of the following: rituximab, intravenous immune globulin (IVIG), nintedanib, 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05892614


Contacts
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Contact: aTyr Pharma Clinical Research 877-215-5731 clinicaltrials@atyrpharma.com

Locations
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United States, California
aTyr Investigative Site Not yet recruiting
Los Angeles, California, United States, 90024
Contact    877-689-4494    SScILD@cssienroll.com   
United States, Illinois
aTyr Investigative Site Not yet recruiting
Chicago, Illinois, United States, 60612
Contact    877-689-4494    SScILD@cssienroll.com   
United States, Louisiana
aTyr Investigative Site Recruiting
New Orleans, Louisiana, United States, 70115
Contact    877-689-4494    SScILD@cssienroll.com   
United States, Ohio
aTyr Investigative Site Recruiting
Cleveland, Ohio, United States, 44195
Contact    877-689-4494    SScILD@cssienroll.com   
United States, Oklahoma
aTyr Investigative Site Not yet recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact    877-689-4494    SScILD@cssienroll.com   
United States, South Carolina
aTyr Investigative Site Not yet recruiting
Charleston, South Carolina, United States, 29425
Contact    877-689-4494    SScILD@cssienroll.com   
United States, Texas
aTyr Investigative Site Not yet recruiting
Dallas, Texas, United States, 75246
Contact    877-689-4494    SScILD@cssienroll.com   
aTyr Investigative Site Not yet recruiting
Houston, Texas, United States, 77030
Contact    877-689-4494    SScILD@cssienroll.com   
Sponsors and Collaborators
aTyr Pharma, Inc.
Investigators
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Study Director: Lisa Carey aTyr Pharma, Inc.
More Information
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Responsible Party: aTyr Pharma, Inc.
ClinicalTrials.gov Identifier: NCT05892614    
Other Study ID Numbers: ATYR1923-C-005
First Posted: June 7, 2023    Key Record Dates
Last Update Posted: November 3, 2023
Last Verified: November 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by aTyr Pharma, Inc.:
ILD
SSc-ILD
Interstitial Lung Disease
lung inflammation
 fibrosis
pulmonary function
efzofitimod
systemic sclerosis
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Interstitial
Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
 Pathologic Processes
Respiratory Tract Diseases
Connective Tissue Diseases
Skin Diseases