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Efficacy and Safety of Intravenous Efzofitimod in Patients With Pulmonary Sarcoidosis

Study Purpose

This is a multicenter, randomized, double-blind, placebo-controlled, study comparing the efficacy and safety of intravenous (IV) efzofitimod 3 mg/kg and 5 mg/kg versus placebo after 48 weeks of treatment. This study will enroll adults with histologically confirmed pulmonary sarcoidosis receiving stable treatment with oral corticosteroid (OCS), with or without immunosuppressant therapy.

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:

- Documented history of pulmonary sarcoidosis for at least 6 months, supported by the following evidence: documented histologically proven diagnosis of sarcoidosis by tissue biopsy and documented evidence of parenchymal lung involvement by historical radiological evidence.

- Evidence of symptomatic pulmonary sarcoidosis, as demonstrated by the following criteria: Modified Medical Research Council (MRC) dyspnea scale grade of at least 1 and KSQ-Lung score ≤70.

- Patients must be receiving treatment with OCS of ≥ 3 months at Day 1 with a starting dose between ≥ 7.5 and ≤ 25 mg/day ≥ 4 weeks prior to Day 1.

- Body weight ≥ 40 kg and < 160 kg.

Exclusion Criteria:

- Treatment with > 1 immunosuppressant therapy.

- Treatment with biological immunomodulators, such as tumor necrosis factor-alpha (TNF-α) inhibitors or antifibrotics or interleukin inhibitors.

- Likelihood of significant pulmonary fibrosis as shown by any 1 or more of the following: High resolution CT fibrosis > 20% within the last 12 months; FVC percent predicted (FVCPP) < 50% and KSQ-Lung score < 30.

- In the opinion of the investigator, clinically significant pulmonary hypertension.

- Patients with active cardiac, neuro, or renal sarcoidosis requiring organ-specific therapy in the past 2 years.

- Patients with cutaneous or ocular sarcoidosis, which in the opinion of the Investigator, are at risk for exacerbation, necessitating OCS rescue or other systemic therapy.

- History of Addisonian symptoms that precluded previous OCS taper attempts.

- Is an active, heavy smoker of tobacco/nicotine-containing products.

- History of anti-synthetase syndrome or Jo-1 positive at Screening.

- Patients with active tuberculosis or those currently undergoing treatment for tuberculosis

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.	NCT05415137
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 3
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	Brazil, France, Germany, Italy, Japan, Netherlands, Puerto Rico, Spain, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pulmonary Sarcoidosis

Arms & Interventions

Arms

Experimental: Efzofitimod 3 mg/kg

Experimental: Efzofitimod 5 mg/kg

Placebo Comparator: Placebo

Interventions

Drug: - Efzofitimod 3 mg/kg

EfzofitimodIV infusion every 4 weeks for a total of 12 doses

Drug: - Efzofitimod 5 mg/kg

EfzofitimodIV infusion every 4 weeks for a total of 12 doses

Drug: - Placebo

Placebo IV infusion every 4 weeks for a total of 12 doses

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, Birmingham, Alabama

Status

Recruiting

Address

aTyr Investigative Site

Birmingham, Alabama, 35294

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