Idiopathic Pulmonary FibrosisPhase 2NCT06331624
Biomarker Modulation and the Inhibition of NKT1 Cells by Oral GRI-0621 in Patients With IPF
A Phase 2 study testing Tazarotene (GRI-0621) in people with Idiopathic Pulmonary Fibrosis and IPF, run by GRI Bio Operations, Inc. at 16 sites in 3 countries.
Trial summary
This is a Phase 2a, randomized, double-blind, multi-center, placebo-controlled, parallel-design, 2-arm study. Approximately 36 subjects with IPF will be randomized in a 2:1 ratio for GRI-0621 4.5mg or Placebo. GRI-0621 dose of 4.5mg will be compared with placebo following once daily oral administration for 12 weeks. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis, IPF
- What is being tested?
- Tazarotene (GRI-0621)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 16 sitesin 3 countries
- Study dates
- 24 Apr 2024to 30 Sep 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- 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.
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- 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 <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 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).
- 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.
- 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.
- 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.
- 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 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).
- Males, if sexually active, unwilling to practice two highly effective forms of contraception during the study (e.g., condom, or surgical sterilization).
- History of hypersensitivity or intolerance to oral tazarotene.
Trial locations and contacts
16 sites in 3 countries.
16 sites in 3 countries
United Kingdom8 sites
University Hospital Birmingham, Queen Elizabeth Hospital
Birmingham, B15 2GW
Royal Papworth Hospital NHS Foundation Trust
Cambridge, CB2 0BB
Royal Infirmary Edinburgh
Edinburgh, Scotland, EH16 4SA
Royal Devon and University Healthcare NHS Foundation Trust
Exeter, EX2 5DW
University College London Hospitals
London, London
Western Health and Social Care Trust (WHSCT)
Londonderry, BT47 6SB
Norfolk & Norwich University Hospital
Norwich, Norwich
Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 7LE
United States5 sites
MUSC Pulmonary Research
Charleston, South Carolina, 29425
Mayo Clinic
Jacksonville, Florida, 32224
Newport Native MD, Inc.
Newport Beach, California, 92663
Montefiore Medical Center
The Bronx, New York, 10467
Southeastern Research Center
Winston-Salem, North Carolina, 27103
Australia3 sites
Concord General Repatriation Hospital
Concord, New South Wales, 2139
The Canberra Hospital
Garran, Australian Capital Territory, 2605
St. George Hospital
Kogarah, New South Wales, 2217
About this study
Official title: Biomarker Modulation and the Inhibition of Natural Killer Type 1 (NKT1) Cells by Oral GRI-0621 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
This is a Phase 2a, randomized, double-blind, multi-center, placebo-controlled, parallel-design, 2-arm study. Approximately 36 subjects with IPF will be randomized in a 2:1 ratio for GRI-0621 4.5mg or Placebo. GRI-0621 dose of 4.5mg will be compared with placebo following once daily oral administration for 12 weeks.
Concurrently, a Sub-Study will be conducted, examining the number and activity of NKT cells in BAL, for up to 12 eligible subjects (across various centers).
An early-stage patient variability assessment will be completed when 12 subjects have completed 2 weeks of treatment. Followed by an interim analysis performed when 24 subjects complete 6 weeks of treatment.
- Conditions
- Idiopathic Pulmonary Fibrosis, IPF
- Being tested
- Tazarotene (GRI-0621), Placebo
- Keywords
- Idiopathic Pulmonary Fibrosis, IPF, Biomarker Modulation, Inhibition of Natural Killer Type 1 (NKT1) Cells, NKT Cells, GRI-0621, Tazarotene
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tazarotene (GRI-0621)Drug
Oral 4.5mg soft gel capsule
PlaceboDrug
Oral 4.5mg soft gel capsule
| Study group | Role | What they receive |
|---|---|---|
| GRI-0621 | Experimental | GRI-0621 (tazarotene) 4.5mg, administered orally once daily (QD) Receives: Drug: Tazarotene (GRI-0621) |
| Placebo | Experimental | Placebo 4.5mg, administered orally once daily (QD) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of oral GRI-0621
General overall safety and tolerability of oral GRI-0621 as compared to placebo will be assessed by evaluating the following safety parameters:
- Adverse events (occurrence and type)
- Clinical Laboratory Measurements (normal/abnormal)
- Vital signs (normal/abnormal)
Measured: 12 Weeks
Secondary outcomes (4)
Change from baseline biomarkers
Change from baseline in biomarkers (PRO-C3, PRO-C6, C1M, C3M, C6M, VICM, CPa9-HNE, PRO-C4, PRO-C5, CTX-III, ELP-3, C4Ma3)
Measured: 12 Weeks
Plasma concentrations of GRI-0621
Pharmacokinetic analysis
Measured: 12 Weeks
Pharmacodynamics of GRI-0621 in blood (Study Population)
Measure of NKT1 cell activation inhibition in blood
Measured: 6 Weeks and 12 Weeks
Pharmacodynamics of GRI-0621 in BAL fluid (Optional Sub-Study)
Measure of NKT1 cell activation inhibition from bronchoalveolar lavage (BAL) fluid
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start24 Apr 2024
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- GRI Bio Operations, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06331624
- Sponsor's protocol ID
- GRI-0621-IPF-02
- Status last verified
- Oct 2025
- First submitted
- 1 Feb 2024
- Last updated
- 30 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker Modulation and the Inhibition of Natural Killer Type 1 (NKT1) Cells by Oral GRI-0621 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
- ClinicalTrials.gov ID
- NCT06331624
- Acronym / sponsor ID
- GRI-0621-IPF-02
- Conditions
- Idiopathic Pulmonary Fibrosis, IPF
- Keywords
- Idiopathic Pulmonary Fibrosis, IPF, Biomarker Modulation, Inhibition of Natural Killer Type 1 (NKT1) Cells, NKT Cells, GRI-0621, Tazarotene
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- GRI Bio Operations, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Apr 2024 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 26 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2a, randomized, double-blind, multi-center, placebo-controlled, parallel-design, 2-arm study. Approximately 36 subjects with IPF will be randomized in a 2:1 ratio for GRI-0621 4.5mg or Placebo. GRI-0621 dose of 4.5mg will be compared with placebo following once daily oral administration for 12 weeks.
Concurrently, a Sub-Study will be conducted, examining the number and activity of NKT cells in BAL, for up to 12 eligible subjects (across various centers).
An early-stage patient variability assessment will be completed when 12 subjects have completed 2 weeks of treatment. Followed by an interim analysis performed when 24 subjects complete 6 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GRI-0621 | Experimental | Drug: Tazarotene (GRI-0621)GRI-0621 (tazarotene) 4.5mg, administered orally once daily (QD) |
| Placebo | Experimental | Drug: PlaceboPlacebo 4.5mg, administered orally once daily (QD) |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tazarotene (GRI-0621)Oral 4.5mg soft gel capsule | Drug | GRI-0621 |
| PlaceboOral 4.5mg soft gel capsule | Drug | Placebo |
Primary outcome
Safety and Tolerability of oral GRI-0621
Time frame: 12 Weeks
General overall safety and tolerability of oral GRI-0621 as compared to placebo will be assessed by evaluating the following safety parameters: * Adverse events (occurrence and type) * Clinical Laboratory Measurements (normal/abnormal) * Vital signs (normal/abnormal)
4 secondary outcomes
Change from baseline biomarkers
Time frame: 12 Weeks
Plasma concentrations of GRI-0621
Time frame: 12 Weeks
Pharmacodynamics of GRI-0621 in blood (Study Population)
Time frame: 6 Weeks and 12 Weeks
Pharmacodynamics of GRI-0621 in BAL fluid (Optional Sub-Study)
Time frame: 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tazarotene (GRI-0621) in people with Idiopathic Pulmonary Fibrosis and IPF, run by GRI Bio Operations, Inc. at 16 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United Kingdom, United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability of oral GRI-0621 (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2025; AzTrials last refreshed its copy on 8 Nov 2026.