Phase
Condition
Cystic Fibrosis
Pulmonary Fibrosis
Lung Injury
Treatment
Placebo
Tazarotene (GRI-0621)
Clinical Study ID
Ages 40-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female subjects 40 through 85 years of age, inclusive.
Confirmed diagnosis of IPF with clinical features consistent with the currentclinical 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-Studysubjects, willing and able to undergo BAL procedures at Screening and at Week 12.
Willing and able to provide written informed consent prior to study-relatedprocedures.
Exclusion
Exclusion Criteria:
Initiation of any approved or investigational IPF therapy or oral corticosteroids (> 10 mg/day) within 4 weeks of Screening. Subjects already on approved IPF therapiesmust remain on their current medication from Screening until the last study visit.
High resolution computerized tomography (HRCT) pattern showing emphysema more thanthe 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 O2saturation (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, laboratoryabnormality, or illness that could place the subject at risk or compromise thequality of the study data as determined by the Investigator.
Significant coronary artery disease (i.e., myocardial infarction within 6 months orunstable 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 ofScreening, or at Screening.
Screening QT of >450 for men and >470 for women.
History of renal impairment as deemed clinically relevant by the investigator OReGFR <60ml/min/1.73m2 within 60 days of Screening and a Screening eGFR of <60ml/min/1.73m2.
History of hepatic impairment as deemed clinically relevant by the investigator ORALT or AST >2 x ULN OR moderate and severe hepatic impairment as defined using theChild-Pugh scoring system (i.e., Child-Pugh B and C).
A history of hypertriglyceridemia (documented TG of >2.0mmol/L at Screening); ahistory of pancreatitis from any cause; uncontrolled dyslipidemia with LDL-c >4.9mmol/L and an HDL-c <1.3 mmol/L for women and <1.0 for men, despite optimizedtreatment.
Use of moderate or strong inhibitors of CYP2C8 (e.g. gemfibrazol, trimethoprim,clopidogrel) or inducers of CYP2C8 (e.g. rifampin) from 7 days or 5 half-lives,whichever is longer, before the first administration of GRI-0621 until cessation ofGRI-0621 administration.
Subjects who report any active suicidal ideation (SI) or behavior (SB) (i.e.Columbia Suicide Severity Rating Scale (C-SSRS) scores 4 or greater for SI and anypositive scores for SB) during Screening or any past history thereof.
Current smoker (i.e., use of tobacco products within the last 3 months) ofScreening.
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 orwithin 5 times the elimination half-life of an investigational drug.
Females who are pregnant or breastfeeding, or if of child-bearing potentialunwilling to practice two highly effective forms of contraception for at least 1month prior to initiation of the study drug, during the study, and for 1 month afterdiscontinuing the study drug (e.g., abstinence, intrauterine device or system,combination of barrier and spermicide, hormonal contraceptive, surgicalsterilization, or male partner sterilization).
Males, if sexually active, unwilling to practice two highly effective forms ofcontraception during the study (e.g., condom, or surgical sterilization).
History of hypersensitivity or intolerance to oral tazarotene.
Study Design
Connect with a study center
The Canberra Hospital
Garran, Australian Capital Territory 2605
AustraliaActive - Recruiting
Concord General Repatriation Hospital
Concord, New South Wales 2139
AustraliaActive - Recruiting
St. George Hospital
Kogarah, New South Wales 2217
AustraliaActive - Recruiting
Royal Infirmary Edinburgh
Edinburgh, Scotland EH16 4SA
United KingdomActive - Recruiting
University Hospital Birmingham, Queen Elizabeth Hospital
Birmingham, B15 2GW
United KingdomActive - Recruiting
Royal Papworth Hospital NHS Foundation Trust
Cambridge, CB2 0BB
United KingdomActive - Recruiting
Western Health and Social Care Trust (WHSCT)
Derry/Londonderry, BT47 6SB
United KingdomActive - Recruiting
Royal Devon and University Healthcare NHS Foundation Trust
Exeter, EX2 5DW
United KingdomActive - Recruiting
University College London Hospitals
London, London
United KingdomActive - Recruiting
Norfolk & Norwich University Hospital
Norwich, Norwich
United KingdomActive - Recruiting
Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 7LE
United KingdomActive - Recruiting
Mayo Clinic
Phoenix, Arizona 85054
United StatesSite Not Available
Newport Native MD, Inc.
Newport Beach, California 92663
United StatesActive - Recruiting
Mayo Clinic
Jacksonville, Florida 32224
United StatesActive - Recruiting
Montefiore Medical Center
Bronx, New York 10467
United StatesActive - Recruiting
Southeastern Research Center
Winston Salem, North Carolina 27103
United StatesActive - Recruiting
Southeastern Research Center
Winston-Salem, North Carolina 27103
United StatesSite Not Available
MUSC Pulmonary Research
Charleston, South Carolina 29425
United StatesActive - Recruiting
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