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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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), 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05892614
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	aTyr Pharma, Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Lisa Carey
Principal Investigator Affiliation	aTyr Pharma, Inc.
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Interstitial Lung Disease

Arms & Interventions

Arms

Experimental: efzofitimod 450 mg

Administered IV infusion

Experimental: efzofitimod 270 mg

Administered IV infusion

Placebo Comparator: Placebo

Administered IV infusion

Interventions

Drug: - efzofitimod 450 mg

IV infusion over approximately 60 minutes every 4 weeks

Drug: - efzofitimod 270 mg

IV infusion over approximately 60 minutes every 4 weeks

Drug: - Placebo

IV infusion over approximately 60 minutes every 4 weeks

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

aTyr Investigative Site, Los Angeles, California

Status

Not yet recruiting

Address

aTyr Investigative Site

Los Angeles, California, 90024

Site Contact

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