External controls can augment low populations in rare disease trials
The use of external data and computational analysis can bolster clinical trial data in rare and or paediatric trials.
28 November 2023
28 November 2023
The use of external data and computational analysis can bolster clinical trial data in rare and or paediatric trials.
Aldeyra has submitted new trial plans to the FDA with anticipated NDA resubmission in H1 2024.
The Phase I data showed that RLYB212 was well tolerated by patients.
Based on brepocitinib’s favourable safety and tolerability profile in the trial, Priovant will advance it for other indications.
The trial, which is expected to commence in the first half of 2024 across US sites, will test the safety and effectiveness of the dermal matrix.
The randomised trial was launched in 2017.
XEN1101 was found to be well-tolerated, with comparable adverse event rates across all treatment groups.
The trial is designed to analyse the safety and efficacy of 30mg and 60mg doses of ACP-204 versus those of placebo.
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