Clinical Trials

The Yale ILD Center of Excellence is the only one of its kind in Connecticut. Our program offers comprehensive care, clinical expertise, participation in experimental trials of novel agents, and is at the forefront of scientific research in the fields of pulmonary fibrosis, systemic sclerosis, and sarcoidosis. Patients are referred for expert management of all forms of interstitial lung disease and enrollment in clinical trials aimed at developing new treatments for IPF and other forms of fibrotic interstitial lung disease. We also work tirelessly to conduct research into the causes and potential cures for ILD, we have a long history of participation in clinical trials for IPF and contributed to the approval of two antifibrotic drugs by the FDA.

Our active clinical trials:

1. Study Name: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (IPF)
FGCL-3019-091

HIC# 2000028820

Summary of Study: The overall objective of this trial is to evaluate the efficacy and safety of pamrevlumab as compared to placebo in people with Idiopathic Pulmonary Fibrosis.

Study Visits: every 3 weeks
Treatment Period: 48 weeks

Study Treatment infusion of study drug Pamrevlumab/Placebo: IV Infusion: 1:1 randomization ratio

Eligibility Criteria:

Inclusion Criteria:

Age 40 to 85 years
Diagnosis of IPF
IPF diagnosis within the past 7 years
FVC 50-80% predicted
DLCO 25-90% predicted
Interstitial pulmonary fibrosis defined by HRCT scan at Screening with 10-50% fibrosis and < 25% honeycombing
Not currently receiving treatment for IPF with an approved therapy (i.e., pirfenidone or nintedanib) NOTE: no patient should discontinue approved therapy for the purpose of enrolling in this study.
Male participants with partners of childbearing potential and female participants of childbearing potential must use double barrier contraception methods during the conduct of the study, and for 3 months after the last dose of study drug.
Able to understand and sign a written informed consent form.

Exclusion Criteria:

Previous exposure to pamrevlumab.
Evidence of significant obstructive lung disease
Female s who are pregnant or nursing.
Smoking within 3 months of Screening and/or unwilling to avoid smoking throughout the study.
Interstitial lung disease (ILD) other than IPF
Sustained improvement in the severity of IPF during the 12 months prior to Screening
History of other types of respiratory diseases
Medical conditions (e.g., MI/stroke within the past 6 month), or logistical challenges that in the opinion of the Investigator precludes the patient’s adequate participation in the study.
Poorly controlled chronic heart failure or severe pulmonary arterial hypertension
Clinically important abnormal laboratory tests
Ongoing acute IPF exacerbation
High likelihood of lung transplantation within 6 months
Use of any investigational drugs or unapproved therapies, or participation in a clinical trial with an investigational new drug, within 30 days prior to screening
Daily use of PDE-5 inhibitor drugs (e.g., sildenafil, tadalafil) except for treatment of severe pulmonary artery hypertension.
Any current malignancy
History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies.
Any condition (other than IPF) that is likely to result in the death of the patient within the next year.
The Investigator judges that the patient will be unable to fully participate in the study and complete it for any reason, including inability to comply with study procedures and treatment or any other relevant medical or psychiatric conditions

2. Study Name: GALACTIC-1 - A randomized, double-blind, multicenter, parallel, placebo-controlled Phase 2b study in subjects with idiopathic pulmonary fibrosis (IPF) investigating the efficacy and safety of TD139, an inhaled galectin-3 inhibitor administered via a dry powder inhaler over 52 weeks

HIC# 2000025337

Summary of Study: This is a multicenter, randomized, double-blind, placebo-controlled phase 2b trial in patients diagnosed with IPF. The study is designed to evaluate the efficacy and safety of TD139 administered by dry powder inhalation over 52 weeks of dosing in addition to the patient’s current standard of care therapy (including treatment with either pirfenidone or nintedanib)

Study Visits: every 4 weeks, then about every 12 weeks
Treatment Period:116 weeks
Study Treatment: TD139 10mg daily /TD139 3mg daily / Placebo: daily inhaled form: 1:1:1 ratio

Eligibility Criteria:

Inclusion Criteria:

Male and female patients aged = 40 years of age
Diagnosis of IPF established during the previous three years
Standard of care treatment e.g., pirfenidone or nintedanib, must be deemed as stable by the PI/treating physician before randomization into the study.
Participants must sign and date a written, informed consent form and any required authorization prior to initiation of any study procedures
FVC > 45% of the predicted value at screening
DLCO (corrected for Hb) of 30% to 79% of the predicted value at screening

Exclusion Criteria:

Currently has significant airways obstruction
Has clinical evidence of active infection
Has a history of malignancy within the last 2 years
Has any condition other than IPF that, in the opinion of the investigator, is likely to result in death within the next 2 years.
Presence of other disease that may interfere with testing procedures or in the judgement of the Investigator may interfere with trial participation or may put the patient at risk when participating in this trial
Is likely to receive lung transplantation within the next 12 months.
Currently receiving high dose corticosteroid, cytotoxic, vasodilator therapy for pulmonary hypertension and or investigational therapy for IPF or administration of such therapeutics within 4 weeks of initial screening. A current dose of less than or equal to 15 mg/day of prednisone or its equivalent is acceptable if the dose is anticipated to remain stable during the study.
Has a history of unstable or deteriorating cardiac or pulmonary disease (other than IPF) within the previous six months
If female, pregnant or lactating

3. Study Name: Saracatinib (AZD0530) in the Treatment of Patients with Idiopathic Pulmonary Fibrosis Short Title: STOP IPF

HIC# 2000028835

Summary of Study: While two anti-fibrotic drugs have recently been approved for treating PF of unknown cause (idiopathic pulmonary fibrosis or IPF), neither drug is curative, and nearly 40% of patients stop taking the prescribed drug within a year because of side effects. We propose to study the use of saracatinib, an investigational drug originally developed to treat certain types of cancers, in the treatment of IPF in a Phase 1b/2a clinical trial

Study Visits: every 3-4 weeks
Treatment Period: 28 weeks
Study Treatment: Saracatinib 125mg/Placebo: oral tablet: 1:1 randomization ratio

Eligibility Criteria:

Inclusion Criteria:

IPF of any duration
FVC >45% predicted
Single breath DLCO 30 - 79% predicted
Women or men >40 years of age at the time of screening
Provision of signed/dated written informed consent prior to any study-specific procedures
Females must be of nonchildbearing potential or postmenopausal or use a highly effective method of contraception for the duration of the study and for 3 months after the last dose in study
Males must be surgically sterile or using an acceptable method of contraception for the duration of the study and for 3 months after the last dose of drug/matching placebo to prevent pregnancy in a partner.
Male participants must not donate or bank sperm for the duration of the study and for 3 months after the last dose of drug/matching placebo.

Exclusion Criteria:

Requirement for supplemental oxygen > 4 L/min at rest to maintain saturation > 90%
Active infection at screening or randomization
Known active or latent hepatitis B or C
Life expectancy for disease other than IPF < 2.5 years (Investigator assessment)
Listed for lung transplantation
Taking pirfenidone or nintedanib in the last 4 weeks
Pregnancy or lactation
Known allergic reactions to components of saracatinib
Treatment with another investigational drug or other intervention within 8 weeks
Current smoker or tobacco use within 4 months
Major surgery within the past 2 months
Advanced hematologic, renal, hepatic, any lung disease determined by the investigator to be non-IPF related or metabolic disease at the discretion of the PI
Previous lung transplantation
Inability to attend scheduled study visits
Inability to give informed consent
Inability to perform pulmonary function testing
History of malignancy in the past two years, other than squamous or basal cell skin cancer
Previous acute exacerbation of IPF requiring hospitalization and/or antibiotics within 90 days before the first dose of the investigational product
Abnormal Liver function test results =3× upper limit of normal (ULN) liver enzymes AST, ALT, GGT or ALP (AST) or =2×ULN total bilirubin.
Creatinine clearance <30 mL/min calculated by Cockcroft–Gault formula
Known pulmonary hypertension (PH) requiring PH-specific treatment
Chronic oral corticosteroids at doses greater than prednisone 10 mg/day (or equivalent)

4. Study Name: A randomized, double-blind, dose-ranging, placebo-controlled Phase 2a evaluation of the safety, tolerability and pharmacokinetics of PLN-74809 in participants with idiopathic pulmonary fibrosis (IPF) (INTEGRIS-IPF)
PLN-74809-IPF-202

HIC# 2000027545

Summary of Study: The main purpose of the study is to confirm that PLN-74809 is well tolerated by patients with IPF, whether as single therapy or as an add-on to standard of care (SoC), and that the drug concentrations are like those previously found in healthy participants

Study Visits: every 2 weeks
Treatment Period: 17 weeks
Study Treatment: PLN-74809 or Placebo: daily dosing tablet 3:1 randomization ratio

Eligibility Criteria:

Inclusion Criteria:

Participants, aged 40 years or older
Diagnosis of IPF for up to 5 years
FVC percent of predicted = 45%
Diffusing capacity for carbon monoxide (DLCO) (hemoglobin-adjusted) = 30%;
Participants currently receiving treatment for IPF with nintedanib or pirfenidone are allowed, provided these drugs have been given at a stable dose for at least 3 months before the Screening visit
Estimated glomerular filtration rate = 50 mL/min, according to the Cockcroft-Gault equation
Female participants of nonchildbearing potential must be either surgically sterile or postmenopausal, defined as spontaneous amenorrhea for at least 2 years
Female participants of childbearing potential (ie, ovulating, premenopausal, and not surgically sterile) and all male participants with sexual partners of childbearing potential must use highly effective methods of birth control during their participation in the study and for 90 days after the last administration of study drug.
Participants must agree to abstain from egg or sperm donation through 30 or 90 days, respectively, after administration of the last dose of study drug
Able to read and sign a written informed consent form (ICF)

Exclusion Criteria:

Receiving any nonapproved agent intended for treatment of fibrosis in IPF
Clinical evidence of active infection
Any other condition that prevents the correct assessment of spirometry performance (for example a broken rib or chest pain of other origin that prevents adequate forced breathing)
Known acute IPF exacerbation or suspicion by the Investigator of such, within 6 months of screening
The extent of fibrotic changes is greater than the extent of emphysema on the most recent HRCT scan
Diagnosis of severe pulmonary hypertension
Smoking of any kind (not limited to tobacco) within 3 months of screening or unwilling to avoid smoking throughout the study
Lower respiratory tract infection requiring antibiotics within 4 weeks prior to screening and/or during the screening period
History of malignancy within the past 5 years
Hepatic impairment or end-stage liver disease
Renal impairment or end-stage kidney disease requiring dialysis
History of unstable or deteriorating cardiac or pulmonary disease (other than IPF) within the 6 months prior to screening
Note: participants currently receiving nintedanib or pirfenidone as IPF SoC treatment, who have previously presented any liver function test elevations associated with nintedanib or pirfenidone treatment greater than total bilirubin >1.5 × the upper limit of normal (ULN); aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 × ULN; alkaline phosphatase >2.5 × ULN or resulting in dose reduction, treatment interruption, or discontinuation are not eligible.
Any of the following at screening: hemoglobin < 10.0 g/dL, or neutrophils < 1500 /mm3, or platelets < 100,000 /mL
Pregnant or lactating females
Daily use of phosphodiesterase-5 (PDE-5) inhibitor drugs (e.g., sildenafil, tadalafil, other) (Note: Intermittent use for erectile dysfunction is allowed.)
A medical or surgical condition known to affect drug absorption (e.g., major gastric surgery)
Surgical procedures planned to occur during the study period
Uncontrolled systemic arterial hypertension
Has participated in a clinical study with an investigational agent in the 30 days prior to screening
Likely to have lung transplantation during the study (being on transplantation list is acceptable)
Any medical condition that, in the opinion of the Investigator, may make candidates not suitable for the study, including, but not limited to, suspected infection with COVID-19
Hypersensitivity to PLN-74809 or to any of the excipients, or placebo
Currently receiving and expected to remain on treatment during the study with: potent and concomitant inhibitors or inducers of CYP3A4, 2C9 and 2C19 (i.e., simultaneous inhibition or induction of all 3 CYP isoforms); potent inhibitors or inducers of P-gp, BCRP or OATP1B1/1B3 transporters; digoxin (a P-gp substrate with a narrow therapeutic window).

5. Study Name: An Open-Label Study to Evaluate the Safety, Tolerability, Kinetics, and Repeatability of the Novel Lysophosphatidic Acid Receptor 1 (LPA1) Positron Emission Tomography (PET) Ligand 18F-BMS-98632

HIC# 2000026009

Summary of Study: The purpose of this research is to study a new radioactive compound (or radiotracer), called 18F-BMS-986327, which attaches to a protein called the lysophosphatidic acid 1 (LPA1) receptor. This radiotracer has not yet been studied in humans. We will be studying people with idiopathic pulmonary fibrosis (IPF). IPF is a chronic, progressive disease that results in the tissue deep in the lungs becoming thick and stiff, or scarred, over time. ‘Idiopathic’ means that the cause of the disease is unknown. We know, however, that LPA1 accumulates in the lungs of people with IPF where, when stimulated, it will activate several processes involved in wound healing and fibrous tissue formation

Study Visits: 2
Treatment Period: up to 2 months
Study Procedure: A single PET/CT scan to study LPA1 receptors throughout the whole body and how well it stays in the lung, in IPF patients only

Eligibility Criteria:

Inclusion Criteria:

Male and female participants aged 40 to 90 years
Have clinical symptoms consistent with IPF before Screening.
Have received first diagnosis of IPF less than 6 years before randomization
Diagnosis to be consistent with IPF, as determined by the Investigator
Participants who show an indeterminate UIP on HRCT are eligible only when there is a historic histopathology report that shows UIP
no features supporting an alternative diagnosis on transbronchial biopsy, bronchoalveolar lavage, or surgical lung biopsy, if performed.
have percent predicted post-bronchodilator forced vital capacity (FVC) between 40% and 90%, inclusive, based on historical measures within 12 months of screening.
have carbon monoxide diffusing capacity (DLCO) between 30% and 80% (adjusted for hemoglobin and altitude), inclusive, based on historical measures within 12 months of screening
Women must be postmenopausal, or premenopausal with at least 1 of the following: Documented hysterectomy, documented bilateral salpingectomy, documented bilateral oophorectomy
In addition, females under the age of 55 years must have a serum follicle stimulating hormone, (FSH) level > 40 mIU/mL to confirm menopause.

Exclusion Criteria:

Participants with severe motor problems that prevent them from lying still for PET imaging procedure
Participants who do not have adequate venous access for PET tracer injection or insertion of IV line
History of any significant drug allergy (such as anaphylaxis) or hepatotoxicity
Participants who have received a therapeutic radiopharmaceutical within 7 days prior to study drug administration in this study
Participants who have had additional clinical/investigational PET-CT scans (eg, fluorodeoxyglucose- PET) within a duration of = 10 half-lives of the agent prior to injection of 18F-BMS-986327
Participants who are currently involved in another clinical study
Donation of blood or plasma (excluding the screening visit) within 2 months prior to the first PET-CT scan day
Participants who are unable to communicate effectively with the investigator and comply with all study requirements, restrictions, and directions of the clinical staff
Participants who are unable to medically tolerate the procedures involved in the performance of the PET-CT scans
Any history of significant bleeding or hemorrhagic tendencies or are currently taking anticoagulants (such as Coumadin, Heparin, Pradaxa, or Xarelto)
Inability to comply with restrictions: not permitted to consume alcohol-containing beverages from 3 days prior to Day 1 until study discharge. Subjects are not permitted to smoke while residing at the clinical facility.
Has had an acute exacerbation of IPF within 2 months prior to screening
Has a history of clinically significant environmental exposure known to cause pulmonary fibrosis
Has a known explanation for interstitial lung disease, including, but not limited to, radiation, drug toxicity, sarcoidosis, hypersensitivity pneumonitis, bronchiolitis obliterans, organizing pneumonia, human immunodeficiency virus (HIV), viral hepatitis, and cancer
Has a clinical diagnosis of any connective tissue disease
Currently has clinically significant asthma or chronic obstructive pulmonary disease
Is expected to receive a lung transplant within 1 year from Day 1 or is on a lung transplant waiting list
Has clinical evidence of active infection
Has any history of malignancy
Has a history of end-stage liver disease
Has a history of end-stage renal disease requiring dialysis
Has a history of unstable or deteriorating cardiac or pulmonary disease (other than IPF)
Any vascular disease that the Investigator feels will affect safety of participant to take part in trial
Has taken known potent OATP inhibitors (e.g., rifampicin, riponavir, erythromycin) with 4 weeks prior to Screening (list to be provided in full protocol) or during the study
Liver function -abnormal results test
Has creatinine clearance less than 30 mL/minute
Has ECG result with a QT interval by Fridericia’s correction (QTcF) of = 500 msec at Screening.
Has Raynaud's disease
Has a history of uncontrolled hypertension or hormonal- or endocrine-related hypotension or hypertension
Has a history of severe pulmonary hypertension requiring pharmacologic therapy
Has a known hypersensitivity to any of the components of study treatment
Has a history of LPA1 antagonists within 4 weeks of Screening or during the study
Women who are of childbearing potential or are breastfeeding
Has smoked cigarettes within 4 weeks of Screening and/or is unwilling to avoid tobacco products throughout the study

Clinical Trials contact information
Phone: 203-785-4177
Email: ildinfo@yale.edu