Ensayos clínicos

Inclusion Criteria:  

• Male or female subjects 40 through 85 years of age, inclusive.
• Confirmed diagnosis of IPF with clinical features consistent with the current clinical practice guidelines for IPF.
• FVC > 50% predicted value within 4 weeks of Screening.
• FEV1/FVC ratio > 0.65 within 4 weeks of Screening.
• Diffusion capacity for carbon monoxide corrected for hemoglobin (DLCOc) > 30% predicted value within 4 weeks of Screening.
• Life expectancy of at least 12 months.
• Willing and able to follow the study required visits and assessments. For Sub-Study subjects, willing and able to undergo BAL procedures at Screening and at Week 12.
• Willing and able to provide written informed consent prior to study-related procedures.

Exclusion Criteria: 

• Initiation of any approved or investigational IPF therapy or oral corticosteroids (> 10 mg/day) within 4 weeks of Screening.
• High resolution computerized tomography (HRCT) pattern showing emphysema more than the extent of fibrosis of the lung area within 12 months of Screening.
• Acute exacerbation of IPF within 6 months of Screening (Collard et al., 2016).
• Requiring supplemental O2 > 4 liters/min to maintain peripheral arterial O2 saturation (SpO2) > 88% at rest. O2 saturation at screening or baseline that is < 88% at rest.
• Any condition with unacceptable risk for bronchoscopy (for Sub-Study subjects only).
• Current or recent history of clinically significant medical condition, laboratory abnormality, or illness that could place the subject at risk or compromise the quality of the study data as determined by the Investigator.
• Significant coronary artery disease (i.e., myocardial infarction within 6 months or unstable angina within 1 month of Screening).
• An upper or lower respiratory tract infection, presence of or suspected emphysema, within 4 weeks of Screening.
• Eye exam indicating night blindness within 6 months of Screening, or at Screening.
• Bone Mineral Density t-score of -4.0 (severe osteoporosis) within 6 months of Screening, or at Screening.
• Screening QT of > 450 for men and > 470 for women.
• History of renal impairment as deemed clinically relevant by the investigator OR eGFR 2 x ULN.
• Use of moderate or strong inhibitors of CYP2C8 (e.g. gemfibrazol, trimethoprim, clopidogrel) or inducers of CYP2C8 (e.g. rifampin) from 7 days before the first administration of GRI-0621 until cessation of GRI-0621 administration.
• Patients on proton pump inhibitors (PPIs) who cannot switch to H2 inhibitors (or cannot stop PPI therapy entirely) at least 3 days before their first dose of GRI-0621 and for the duration of the study.
• Subjects who report any active suicidal ideation (SI) or behavior (SB) (i.e. Columbia Suicide Severity Scale (C-SSRS) scores 4 or greater for SI and any positive scores for SB) during Screening or any past history thereof.
• Current smoker (i.e., use of tobacco products within the last 3 months) of Screening.
• Current or recent history of drug or alcohol abuse within 12 months of Screening.
• Participation in any other investigational drug study within 4 weeks of Screening or within 5 times the elimination half-life of an investigational drug.
• Females who are pregnant or breastfeeding, or if of child-bearing potential unwilling to practice effective forms of contraception for at least 1 month prior to initiation of the study drug, during the study, and for 1 month after discontinuing the study drug (e.g., abstinence, intrauterine device or system, combination of barrier and spermicide, hormonal contraceptive, surgical sterilization, or male partner sterilization).
• Males, if sexually active, unwilling to practice effective forms of contraception during the study (e.g., condom, or surgical sterilization).
• History of hypersensitivity or intolerance to oral tazarotene.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 9/20/23. Questions regarding updates should be directed to the study team contact.