REL-1017-304 Protocol Summary

Relmada Therapeutics would like to invite you to take part in a feasibility assessment to identify participating sites for a Phase 3 A Randomized, Double-Blind, Placebo-Controlled Trial of REL‑1017 as Adjunctive Treatment for Major Depressive Disorder (RELIGHT)
 
We will be specifically looking for sites to support the following:
 
A multi-center, randomized, double-blind, placebo-controlled Phase 3 trial of REL-1017 in MDD, consisting of a screening period of up to 30 days, a 4-week treatment period in subjects with inadequate response to ongoing antidepressant treatment, and a 1-week safety follow up period. Following screening period, if eligible, subjects will be randomized into 1:1 ratio wither to the study drug (REL-1017) or placebo group for 4 weeks.
 
For screening and enrollment, we are expecting sites to screen 2 subjects/ month and randomize 1 subject/ month.
 
Treatment Period
 
REL-1017 in a 25 mg tablet for oral administration by mouth (PO)
The following dose schedule will be used in the study:

Day 1 – loading dose:
  • Three REL-1017 25 mg tablets (75 mg total) administered at the clinical study site
  • Three matching placebo tablets administered at the clinical study site
 
Day 2 to Day 28 – maintenance dose:
  • One REL-1017 25 mg tablet QD
  • One matching placebo tablet QD
 
Subjects will be asked to stay on a stable dosing regimen of the current antidepressant therapy (ADT) between Day 1 and Day 28, while exposed to REL-1017 or matching placebo. Dosing with REL-1017 should take place once daily at the same time as the first-line ADT is taken.

Following the study, the subjects will have the opportunity to enter an Expanded Access Program (EAP) separate from this protocol, to receive REL-1017 for a year following the end of this trial.
 
Please carefully review the protocol synopsis provided. If interested in taking part in the trial, please return this feasibility questionnaire within 3-5 business days, if possible.
 
We appreciate the time you have taken thus far and we look forward to reviewing your response. As always, if you have any questions you can reach out to lfrering@relmada.com or rdabhi@relmada.com.

Note: This document and its contents are the property of and confidential to Relmada Therapeutics, Inc. Any unauthorized copying or use of this document is prohibited.

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