Study Evaluating Safety and Efficacy of Ropanicant in MDD Patients

An Open-Label Study Evaluating the Safety and Efficacy of Ropanicant in Participants With Moderate to Severe Major Depressive Disorder

This is an open-label, parallel-group study to evaluate the safety and efficacy of ropanicant in participants with moderate to severe Major Depressive Disorder (MDD).

Study Overview

• Status: Recruiting
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: Ropanicant

Detailed Description

Approximately 36 participants will be randomly assigned to receive ropanicant either 45 mg qd, 30 mg bid, or 45 mg bid for 2 weeks, in a ratio of 1:1:1 (12 participants in each treatment group). Following a screening period of up to 4 weeks, the participants will be treated for 2 weeks.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: +9140 2319 3956; Email: ropanicant@suven.com

Study Locations

• United States
  • California
    • Bellflower, California, United States, 90706
      • Recruiting
      • Clinical Innovations, Inc
    • Orange, California, United States, 92868
      • Recruiting
      • NRC Research Institute
    • Torrance, California, United States, 90504
      • Recruiting
      • Collaborative Neuroscience Research, LLC
  • Florida
    • Miami Lakes, Florida, United States, 33016
      • Recruiting
      • Innovative Clinical Research, Inc.
  • Georgia
    • Decatur, Georgia, United States, 30030
      • Recruiting
      • CenExel iResearch, LLC
    • Savannah, Georgia, United States, 31405
      • Recruiting
      • CenExel iResearch, LLC
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • Recruiting
      • Precise Research Centers
  • Ohio
    • North Canton, Ohio, United States, 44720
      • Recruiting
      • Neuro behavioral Clinical Research, Inc
  • Utah
    • Murray, Utah, United States, 84107
      • Recruiting
      • Cedar Clinical Research, Inc.
  • Washington
    • Everett, Washington, United States, 98201
      • Recruiting
      • Eastside Therapeutic Resource, Inc. dba Core Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants must meet the DSM-5 criteria for MDD without psychotic features and diagnosis confirmed by the Mini-International Neuropsychiatric Interview (MINI).
• Participants with a current major depressive episode of at least 4 weeks of duration prior to the screening visit.
• Participants must have an MADRS score of ≥25 at the screening and the baseline visits.
• Participants must have a score of ≥4 on Clinical Global Impression - Severity (CGI-S) Scale at the screening and the baseline visits.

Exclusion Criteria:

• Participants who meet criteria for treatment-resistant depression during the current major depressive episode, which will be defined as being non-responders (less than 50% of symptom improvement) to 2 or more depression treatment periods of adequate dose and duration as defined by the Massachusetts General Hospital (MGH) Antidepressant Treatment Response Questionnaire (ATRQ).
• Participants taking antidepressant treatment (SSRIs and SNRIs) or any medication that is contraindicated with the use of monoamine oxidase inhibitors (eg, opioids, stimulants) within 2 weeks (or 5 half-lives, whichever is longer) prior to baseline and until the end of study visit.
• Participants who do not agree to avoid tyramine rich diet from the start of dosing and until 2 weeks following last study drug administration.
• Participants who are habitual smokers or using nicotine products.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ropanicant 45 mg qd; The participant will take 1 tablet/day in the morning (for qd dosing)	Drug: Ropanicant; Tablet; Other Names: SUVN-911
Experimental: Ropanicant 30 mg bid; The participant will take 2 tablets/day (~12 hours apart for bid dosing).	Drug: Ropanicant; Tablet; Other Names: SUVN-911
Experimental: Ropanicant 45 mg bid; The participant will take 2 tablets/day (~12 hours apart for bid dosing).	Drug: Ropanicant; Tablet; Other Names: SUVN-911

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Frequency and severity of adverse events, treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations.	From Screening to Day 21

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montgomery-Åsberg Depression Rating Scale (MADRS) score.	Change from the baseline to the MADRS total score. The MADRS is a clinician-rated scale to assess depressive symptoms which consists from 10 items. The time frame for this scale is the past 7 days. Each item is scored on 7-point scale (0 [absence of symptoms] to 6 [severe]). The total score is the sum of 10 items and can take range from 0 to 60. A higher score represents a higher severity of the level of depression.	From Baseline to Day 14

Collaborators and Investigators

• Sponsor: Suven Life Sciences Limited

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2024
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: November 6, 2023
• First Submitted That Met QC Criteria: November 6, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Depression; MDD; Open label; SUVN-911; Phase-2
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: CTP2S1911A4B2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No