- |||||||||| asengeprast (FT011) / Certa Therap, OccuRx
Trial completion: Effects of FT011 in Systemic Sclerosis (clinicaltrials.gov) - Dec 19, 2023 P2, N=30, Completed, FT011 shows promising efficacy after 12 weeks of treatment using a new composite score, CRISS-25, and this clinical benefit coincides with a downregulation of fibrotic genes and pathways in SSc skin. Active, not recruiting --> Completed
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FT011 for the Treatment of Systemic Sclerosis. Results from a Phase II Study (Room 32A-B; in person) - Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_2106; P2 Active, not recruiting --> Completed These results demonstrate promising efficacy and safety data for FT011 OD after 12 weeks of treatment and therefore warrants a confirmatory phase III study to assess its potential to improve this debilitating condition.
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Identification of Noninvasive Surrogates as Predictors of Response to FT011 in Kidney Disease (Exhibit Hall, Orange County Convention Center, West Building) - Oct 13, 2022 - Abstract #KIDNEYWEEK2022KIDNEY_WEEK_3815; Conclusion FT011 treatment reduced a fibrosis-associated transcriptional profile in the STNx rat model. The signature was highly significant in human kidney disease profiles, associated with more advanced disease, and strongly correlated with non-invasive biomarkers, offering a promise of identifying patients with an intrarenal profile best responsive to FT011 in clinical trials.
- |||||||||| asengeprast (FT011) / Certa Therap, OccuRx
Enrollment closed, Trial completion date, Trial primary completion date: Effects of FT011 in Systemic Sclerosis (clinicaltrials.gov) - Jul 21, 2022 P2, N=30, Active, not recruiting, The signature was highly significant in human kidney disease profiles, associated with more advanced disease, and strongly correlated with non-invasive biomarkers, offering a promise of identifying patients with an intrarenal profile best responsive to FT011 in clinical trials. Recruiting --> Active, not recruiting | Trial completion date: Apr 2022 --> Nov 2022 | Trial primary completion date: Mar 2022 --> Oct 2022
- |||||||||| asengeprast (FT011) / Certa Therap, OccuRx
Enrollment open, Trial initiation date: Effects of FT011 in Systemic Sclerosis (clinicaltrials.gov) - Sep 30, 2021 P2, N=30, Recruiting, Recruiting --> Active, not recruiting | Trial completion date: Apr 2022 --> Nov 2022 | Trial primary completion date: Mar 2022 --> Oct 2022 Not yet recruiting --> Recruiting | Initiation date: Feb 2021 --> Jul 2021
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