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)
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
- 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.
- 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
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
- 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
- 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
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
- 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.
- 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)
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
- 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)
- 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
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
- 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.
- 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