Trial · NCT06331624
Biomarker Modulation and the Inhibition of NKT1 Cells by Oral GRI-0621 in Patients With IPF
NCT06331624, Phase 2, Completed, GRI Bio Operations, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Biomarker Modulation and the Inhibition of NKT1 Cells by Oral GRI-0621 in Patients With IPF. Trials, record NCT06331624. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06331624
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Biomarker Modulation and the Inhibition of NKT1 Cells by Oral GRI-0621 in Patients With IPF
- NCT number
- NCT06331624
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 35 participants, actual
- Lead sponsor
- GRI Bio Operations, Inc.
- Conditions
- Idiopathic Pulmonary Fibrosis, IPF
- Interventions
- Tazarotene (GRI-0621), Placebo
- First posted
- 2024-03-26
- Last updated
- 2025-10-30
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety and Tolerability of oral GRI-0621 | 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) |
| Secondary | Change from baseline biomarkers | 12 Weeks | Change from baseline in biomarkers (PRO-C3, PRO-C6, C1M, C3M, C6M, VICM, CPa9-HNE, PRO-C4, PRO-C5, CTX-III, ELP-3, C4Ma3) |
| Secondary | Plasma concentrations of GRI-0621 | 12 Weeks | Pharmacokinetic analysis |
| Secondary | Pharmacodynamics of GRI-0621 in blood (Study Population) | 6 Weeks and 12 Weeks | Measure of NKT1 cell activation inhibition in blood |
| Secondary | Pharmacodynamics of GRI-0621 in BAL fluid (Optional Sub-Study) | 12 Weeks | Measure of NKT1 cell activation inhibition from bronchoalveolar lavage (BAL) fluid |
| Other | Exploratory - Pulmonary Function | 6 Weeks and 12 Weeks | Effect of GRI-0621 on pulmonary function (FEV1, FVC, and FEV1/FVC ratio) at baseline and after 6 weeks and 12 weeks of treatment. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06331624
GET https://conductscience.org/api/trials/v1/NCT06331624/registered