Study of Intravenous ATYR1923 for Pulmonary Sarcoidosis

Study Purpose

This randomized, double-blind, placebo-controlled, study will evaluate the safety, tolerability, immunogenicity, pharmacokinetic (PK), and preliminary efficacy of multiple ascending doses of IV ATYR1923 in patients with pulmonary sarcoidosis undergoing a protocol-guided oral corticosteroid (OCS) tapering regimen.This study will consist of 3 staggered multiple dose cohorts. Each eligible participant will participate in only one cohort during the study. Within each cohort, 12 participants will be randomized 2:1 to ATYR1923 (N=8) or placebo (N=4).

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 - 70 Years
Gender All
More Inclusion & Exclusion Criteria

Key

Inclusion Criteria:

  • - Diagnosis of pulmonary sarcoidosis for ≥6 months (cutaneous and ocular involvement allowed), defined as: - Histologically proven diagnosis of sarcoidosis by bronchoscopy, biopsy (any organ) or bronchioalveolar lavage - Parenchymal lung involvement by historical radiological evidence - Must have symptomatic and/or active pulmonary sarcoidosis as evidence by: - Modified Medical Research Council Dyspnea Scale grade of >= 1; and - Forced vital capacity ≥50 percent predicted; and - Positive 18F-fluorodeoxyglucose positron-emission tomography/computed tomography (18F-FDG-PET/CT) scan showing increased metabolic activity in lung parenchyma within 4 weeks prior to Day 1.
  • - Receiving treatment with 10 to 25 mg/day of oral prednisone (or equivalent), at a stable dose for ≥4 weeks prior to Day 1, and capable of undergoing the protocol-specified steroid taper regimen.
  • - Body weight ≥45 kg and <160 kg.
Key

Exclusion Criteria:

  • - Current disease presentation consistent with Lofgren's syndrome.
  • - History of severe allergic or anaphylactic reactions to therapeutic proteins or known sensitivity to ATYR1923 or to its inactive components (L-histidine, sodium chloride, sucrose, L-methionine, and polysorbate-20).
  • - Treatment with biological immunomodulators such as tumor necrosis factor-alpha inhibitors.
  • - Current evidence of clinically significant cardiovascular, hepatic, renal, hematological, metabolic, or gastrointestinal disease, or has a condition that requires other treatment.
  • - Clinically significant pulmonary hypertension requiring vasodilator treatment.
  • - Any history of tuberculosis or evidence of active systemic non-tuberculosis fungal or mycobacterial infection within 1 year of Screening.
  • - History of clinically significant cardiac, neurological, gastrointestinal, and/or renal manifestations of their sarcoidosis.
  • - Any condition that necessitated hospitalization within the 3 months prior to Day 1 or is likely to require so during the study.
  • - Participation in another clinical study of an investigational agent or device within 3 months (small molecules) / 6 months (biologics) or 5 half-lives (if known) of the agent, whichever is longer.
  • - History of or positive results of screening for hepatitis B, hepatitis C or human immunodeficiency virus.
  • - Has been an active smoker (including e-cigarettes or e-vaporizers) within 3 months prior to Screening.
  • - Active substance abuse or history of substance abuse within the 12 months prior to Screening.
  • - Patient has received a live vaccination within 8 weeks before Day 1 or inoculation with a live vaccine is planned during study participation.
  • - Positive for Jo-1 antibodies (Ab) at Screening, or past history of Jo-1 Ab positivity.
  • - Significant and/or acute illness within 5 days prior to drug administration that may impact safety assessments, in the opinion of the Investigator.

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.

NCT03824392
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 1/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.

Gennyne Walker
Principal Investigator Affiliation aTyr Pharma, Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

IndustryOther
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pulmonary Sarcoidosis

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.

Inova Fairfax Medical Center, Falls Church, Virginia

Status

Recruiting

Address

Inova Fairfax Medical Center

Falls Church, Virginia, 22042

Site Contact

Serina Zorrilla, RN, CCRC

serina.zorrilla@inova.org

703-776-6147

UT Southwestern Medical Center, Dallas, Texas

Status

Recruiting

Address

UT Southwestern Medical Center

Dallas, Texas, 75390

Site Contact

Fabiola Gianella

fabiola.gianella@utsouthwestern.edu

214-648-7875

Medical University of South Carolina, Charleston, South Carolina

Status

Recruiting

Address

Medical University of South Carolina

Charleston, South Carolina, 92425

Site Contact

Brooke Alexander, CRC

pulmonaryresearch@musc.edu

843-792-1221

aTyr Investigative Site, Philadelphia, Pennsylvania

Status

Recruiting

Address

aTyr Investigative Site

Philadelphia, Pennsylvania, 19104

Site Contact

clinicaltrials@atyrpharma.com

clinicaltrials@atyrpharma.com

877-215-5731

Cleveland Clinic, Cleveland, Ohio

Status

Recruiting

Address

Cleveland Clinic

Cleveland, Ohio, 44195

University of Cincinnati, Cincinnati, Ohio

Status

Recruiting

Address

University of Cincinnati

Cincinnati, Ohio, 45267

Site Contact

Rebecca Reeves, RN, BSN

reevessrc@ucmail.uc.edu

513-584-5226

East Carolina University, Greenville, North Carolina

Status

Recruiting

Address

East Carolina University

Greenville, North Carolina, 27858

Site Contact

Ogugua Obi, MD

obio@ecu.edu

252-744-4650

Albany Medical Center, Albany, New York

Status

Recruiting

Address

Albany Medical Center

Albany, New York, 12208

Site Contact

Marc Judson, MD

clinicaltrials@atyrpharma.com

877-215-5731

University of Iowa, Iowa City, Iowa

Status

Recruiting

Address

University of Iowa

Iowa City, Iowa, 52242

Site Contact

Brenda Werner

brenda-r-werner@uiowa.edu

319-353-8862

aTyr Investigative Site, Chicago, Illinois

Status

Recruiting

Address

aTyr Investigative Site

Chicago, Illinois, 60612

Northwestern University, Chicago, Illinois

Status

Recruiting

Address

Northwestern University

Chicago, Illinois, 60611

National Jewish Health, Denver, Colorado

Status

Recruiting

Address

National Jewish Health

Denver, Colorado, 80206

aTyr Investigative Site, Northridge, California

Status

Recruiting

Address

aTyr Investigative Site

Northridge, California, 91324

University of Alabama, Birmingham, Alabama

Status

Recruiting

Address

University of Alabama

Birmingham, Alabama, 35294-0006

Site Contact

Jospeh Barney, MD

jbarney@uabmc.edu

205-996-5864

Terms of Service

The PFF does not promote or represent that any investigational new drugs mentioned are safe or effective. The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. For a full description of terms please refer to our Terms, Conditions & Privacy.

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