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Tazarotene
Biomarker Modulation and the Inhibition of NKT1 Cells by Oral GRI-0621 in Patients With IPF
Ensayo de GRI Bio, Inc. en Idiopathic Pulmonary Fibrosis · IPF (del registro, en inglés).
Más ensayos de: Fibrosis pulmonar idiopática.
Lo que ha anunciado la empresa
La empresa anunció que alcanzó su objetivo principal…collagen turnover, lung tissue repair, and improvements in pulmonary function, further strengthening the overall clinical proof-of-concept for GRI-0621.” The Company previously reported that the study met its primary endpoint, demonstrating a safety and tolerability profile differentiated from that of existing treatment options. The study also met secondary endpoints suggestive of disease-modifying activity, reversal of fibrosis…
En un 8-K del 8 ene 2026, en una frase que nombra «GRI-0621». El documento en la SEC.
La empresa anunció que alcanzó su objetivo principalEX-99.1 2 ex991_pressreleasetoplined.htm EX-99.1 Exhibit 99.1 GRI Bio Announces Positive Topline Data from its Phase 2a Study in Idiopathic Pulmonary Fibrosis (“IPF”) Study met its primary endpoint demonstrating that GRI-0621 was well tolerated over 12 weeks of treatment, with no drug-related severe or serious adverse events and no increase in GI issues when used with existing approved treatments…
En un 8-K del 10 dic 2025, en una frase que nombra «GRI-0621». El documento en la SEC.
La empresa anunció que alcanzó su objetivo principal…) has received topline data from the Phase 2a GRI-0621-IPF-02 clinical trial evaluating GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis (“IPF”). This topline data indicates that the trial met its primary endpoint and certain secondary endpoints that have been evaluated to date demonstrating that GRI-0621 was well tolerated over a 12-week treatment period, consistent with earlier studies evaluating over 1,700 subjects…
En un 8-K del 8 dic 2025, en una frase que nombra «GRI-0621». El documento en la SEC.
- Fase
- Fase 2
- Estado
- Completado
- Participantes
- 35
- Centros
- 16
- Fin del objetivo primario
- sep 2025
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, triple ciego. Comenzó en abr 2024.
Qué mide
Safety and Tolerability of oral GRI-0621 (del registro, en inglés) (12 semanas)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis 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.
Más ensayos de GRI
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| Active Comparator:4.5mg GRI-0621 · GRI-201 | Fase 2 | Interrumpido | nov 2018 (real) |
Todos los de GRI, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT06331624), actualizada en oct 2025.