Phase 2 Study of NV-5138 in Adults With Treatment Resistant Depression

• ClinicalTrials.gov Identifier: NCT05066672
• Recruitment Status: Recruiting
• First Posted: October 4, 2021
• Last Update Posted: March 25, 2022
• Sponsor: Navitor Pharmaceuticals, Inc.
• Collaborator: Supernus Pharmaceuticals, Inc.
• Information provided by (Responsible Party): Navitor Pharmaceuticals, Inc.

Study Description

Brief Summary:

This study will evaluate the efficacy and safety of NV-5138 in adults with TRD

Condition or disease	Intervention/treatment	Phase
Treatment Resistant Depression	Drug: NV-5138; Drug: matched placebo	Phase 2

Detailed Description:

The is a multicenter, randomized, double-blind, flexible- dose, placebo-controlled, parallel design of adjunctive NV-5138 in adults with TRD.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: randomized, double-blind, placebo-controlled
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Masking Description: matched placebo
• Primary Purpose: Treatment
• Official Title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of NV-5138 in Adults With Treatment Resistant Depression
• Actual Study Start Date: February 28, 2022
• Estimated Primary Completion Date: May 2023
• Estimated Study Completion Date: May 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: NV-5138 400 mg oral capsules; Either 2 or 4 400 mg oral capsules administered once daily	Drug: NV-5138; NV-5138 is a novel, orally bioavailable, selective, direct activator of mTORC1 cellular signaling; Other Name: SPN820
Placebo Comparator: matched placebo; 2 or 4 oral capsules administered once daily	Drug: matched placebo; matched placebo oral capsules; Other Names: placebo; PBO

Outcome Measures

Primary Outcome Measures :

1. Evaluation of the efficacy of NV-5138 as measured by the Montgomery-Asberg Depression Rating scale [ Time Frame: 5 weeks ]
   Change from Baseline to end of treatment period on the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score. MADRS captures a clinician-rated score on a seven-point Likert scale for a score ranging from 0 to 60, with higher scores reflecting greater depression severity.

Secondary Outcome Measures :

1. Evaluation of the efficacy as measured by Clinical Global Impression-Severity (CGI-s) score [ Time Frame: 5 weeks ]
   Change from baseline to end of treatment period on the Clinical Global Impression-Severity score for NV-5138 treated patients as compared to placebo. The CGI-S is a clinican-rated seven point scale from 0-7 where a higher rating represents higher severity of illness.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Male or female, aged 18 to 70 years at Screening.
• Diagnosis of Major Depressive Disorder (MDD) according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) for either recurrent or single episode MDD without psychotic features that is confirmed by the Mini International Neuropsychiatric Interview (MINI).
• Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of ≥26 for the current MDE at all Screening visits and Baseline (Day 1).
• CGI-S score of ≥4 (moderately ill or worse) at all Screening visits and Baseline.
• History of inadequate response to ≥2 but ≤4 prior ADT therapies (including the current ADT for the current MDE) ≥ 2 weeks at Screening and ≥ 8 weeks at Baseline.
• Stable therapeutic dose of one of the following ADTs for the current MDE for ≥2 weeks prior to Screening and maintain the therapeutic dose throughout the study: citalopram, escitalopram, paroxetine, fluoxetine, sertraline, duloxetine, venlafaxine (IR or XR), desvenlafaxine, or vortioxetine.
• Detectable blood level of the approved ADT at Visits 1 and 2 of the Screening Period.

Exclusion Criteria:

• MADRS Total Score improvement of ≥25% from the highest to the lowest score at any visit during the Screening Period.
• Clinically significant abnormal laboratory profiles, vital signs, or electrocardiograms (ECGs), per Investigator judgment.
• Judged by the Investigator to be at significant risk for suicide, violence, or homicide; or answers 'Yes' to items 4 or 5 on the Suicidal Ideation section of the C-SSRS at Screening or at Baseline; or has attempted suicide within the 6 months prior to Screening.
• History of psychotic disorder, including but not limited to schizophrenia, MDD with psychotic features, or bipolar I/II disorder with psychotic features.
• History of PTSD, OCD, panic disorder, intellectual disability, autism, acute stress disorder, or Cluster A or B personality disorder (per DSM-5 criteria).
• Any condition or procedure that may interfere with the absorption, metabolism, or elimination of the study medication (e.g., cholecystectomy or gastric bypass).
• In the Investigator's opinion, is unlikely to comply with the protocol or is unsuitable for any other reason.
• History of alcohol and/or substance use disorder within 6 months prior to Screening or is currently using or has positive results at Screening for drugs of abuse or has a positive alcohol result at any Screening or Baseline visit.

Contacts and Locations

Contacts

Contact: Samuel Schaffer, MD; 240-403-5758; samuel.schaffer@premier-research.com

Locations

United States, Washington

Northwest Clinical Research Center, Inc.; Recruiting

Bellevue, Washington, United States, 98007

Contact: Rachel Hall rhall@nwcrc.net

Principal Investigator: Arifulla Khan

Sponsors and Collaborators

Navitor Pharmaceuticals, Inc.

Supernus Pharmaceuticals, Inc.

Investigators

• Study Director: Randy Owen, MD; Medical Monitor

More Information

• Responsible Party: Navitor Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT05066672
• Other Study ID Numbers: NAV-17A-007; SPN820 ( Other Identifier: Supernus Pharmaceuticals, Inc. )
• First Posted: October 4, 2021
• Last Update Posted: March 25, 2022
• Last Verified: March 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant; Behavioral Symptoms; Mood Disorders; Mental Disorders