Trial Profile
A Phase IIa, Double-Blind, Randomised, Intracohort Placebo-Controlled, Multicentre Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of EHP-101 in Patients With Diffuse Cutaneous Systemic Sclerosis
Status:
Suspended
Phase of Trial:
Phase II
Latest Information Update: 26 Sep 2023
Price :
$35
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At a glance
- Drugs Etrinabdione (Primary)
- Indications Diffuse scleroderma
- Focus Adverse reactions
- Sponsors Emerald Health Pharmaceuticals
- 16 Sep 2023 Status changed from recruiting to suspended as sponsor ceasing all operations due to company's shut down.
- 27 Oct 2022 According to an Emerald Health Pharmaceuticals media release, As per the FDA's review protocol, since the FDA has not responded to the amendment within the mandated 30-day period the Company is now authorized to carry out these changes to cohorts 3 and 4 of the SSc trial.
- 27 Oct 2022 According to an Emerald Health Pharmaceuticals media release, the company has submitted protocol amendment to the FDA to increase the size of cohorts 3 and 4 from 18 to 48 subjects and to increase the treatment duration from 12 weeks to 24 weeks. The Company applied for this amendment to create a pathway to advance directly into a Phase 3 clinical trial once the Phase 2a trial is completed, rather than having to first conduct a Phase 2b before continuing to a Phase 3 trial.