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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06331624




Registration number
NCT06331624
Ethics application status
Date submitted
1/02/2024
Date registered
26/03/2024
Date last updated
7/03/2025

Titles & IDs
Public title
Biomarker Modulation and the Inhibition of NKT1 Cells by Oral GRI-0621 in Patients with IPF
Scientific title
Biomarker Modulation and the Inhibition of Natural Killer Type 1 (NKT1) Cells by Oral GRI-0621 in Patients with Idiopathic Pulmonary Fibrosis (IPF)
Secondary ID [1] 0 0
GRI-0621-IPF-02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Pulmonary Fibrosis 0 0
IPF 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tazarotene (GRI-0621)
Treatment: Drugs - Placebo

Experimental: GRI-0621 - GRI-0621 (tazarotene) 4.5mg, administered orally once daily (QD)

Experimental: Placebo - Placebo 4.5mg, administered orally once daily (QD)


Treatment: Drugs: Tazarotene (GRI-0621)
Oral 4.5mg soft gel capsule

Treatment: Drugs: Placebo
Oral 4.5mg soft gel capsule
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and Tolerability of oral GRI-0621
Timepoint [1] 0 0
12 Weeks
Secondary outcome [1] 0 0
Change from baseline biomarkers
Timepoint [1] 0 0
12 Weeks
Secondary outcome [2] 0 0
Plasma concentrations of GRI-0621
Timepoint [2] 0 0
12 Weeks
Secondary outcome [3] 0 0
Pharmacodynamics of GRI-0621 in blood (Study Population)
Timepoint [3] 0 0
6 Weeks and 12 Weeks
Secondary outcome [4] 0 0
Pharmacodynamics of GRI-0621 in BAL fluid (Optional Sub-Study)
Timepoint [4] 0 0
12 Weeks

Eligibility
Key inclusion criteria
1. Male or female subjects 40 through 85 years of age, inclusive.
2. Confirmed diagnosis of IPF with clinical features consistent with the current clinical practice guidelines for IPF.
3. FVC > 50% predicted value within 4 weeks of Screening.
4. FEV1/FVC ratio > 0.65 within 4 weeks of Screening.
5. Diffusion capacity for carbon monoxide corrected for hemoglobin (DLCOc) > 30%predicted value within 4 weeks of Screening.
6. Life expectancy of at least 12 months.
7. 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.
8. Willing and able to provide written informed consent prior to study-related procedures.
Minimum age
40 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Initiation of any approved or investigational IPF therapy or oral corticosteroids (> 10 mg/day) within 4 weeks of Screening. Subjects already on approved IPF therapies must remain on their current medication from Screening until the last study visit.
2. High resolution computerized tomography (HRCT) pattern showing emphysema more than the extent of fibrosis of the lung area within 12 months of Screening.
3. Acute exacerbation of IPF within 6 months of Screening (Collard et al., 2016).
4. 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.
5. Any condition with unacceptable risk for bronchoscopy (for Sub-Study subjects only).
6. 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.
7. Significant coronary artery disease (i.e., myocardial infarction within 6 months or unstable angina within 1 month of Screening).
8. An upper or lower respiratory tract infection, presence of or suspected emphysema, within 4 weeks of Screening.
9. Eye exam indicating night blindness within 6 months of Screening, or at Screening.
10. Bone Mineral Density t-score of -4.0 (severe osteoporosis) within 6 months of Screening, or at Screening.
11. Screening QT of >450 for men and >470 for women.
12. History of renal impairment as deemed clinically relevant by the investigator OR eGFR <60ml/min/1.73m2 within 60 days of Screening and a Screening eGFR of <60ml/min/1.73m2.
13. History of hepatic impairment as deemed clinically relevant by the investigator OR ALT or AST >2 x ULN OR moderate and severe hepatic impairment as defined using the Child-Pugh scoring system (i.e., Child-Pugh B and C).
14. A history of hypertriglyceridemia (documented TG of >2.0mmol/L at Screening); a history 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 optimized treatment.
15. 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 of GRI-0621 administration.
16. 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 any positive scores for SB) during Screening or any past history thereof.
17. Current smoker (i.e., use of tobacco products within the last 3 months) of Screening.
18. Current or recent history of drug or alcohol abuse within 12 months of Screening.
19. Participation in any other investigational drug study within 4 weeks of Screening or within 5 times the elimination half-life of an investigational drug.
20. Females who are pregnant or breastfeeding, or if of child-bearing potential unwilling to practice two highly 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).
21. Males, if sexually active, unwilling to practice two highly effective forms of contraception during the study (e.g., condom, or surgical sterilization).
22. History of hypersensitivity or intolerance to oral tazarotene.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/04/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2025
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW
Recruitment hospital [1] 0 0
The Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Concord General Repatriation Hospital - Concord
Recruitment hospital [3] 0 0
St. George Hospital - Kogarah
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
North Carolina
Country [5] 0 0
United States of America
State/province [5] 0 0
South Carolina
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Scotland
Country [7] 0 0
United Kingdom
State/province [7] 0 0
Birmingham
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Cambridge
Country [9] 0 0
United Kingdom
State/province [9] 0 0
Derry/Londonderry
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Exeter
Country [11] 0 0
United Kingdom
State/province [11] 0 0
London
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Norwich
Country [13] 0 0
United Kingdom
State/province [13] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GRI Bio Operations, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06331624