Study of Efficacy, Safety, Tolerability and Pharmacokinetics of MIJ821 in Participants With Treatment- Resistant Depression (TRD)

NCT05454410 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: CMIJ821B122012021-005992-38
• Study Type: interventional
• Target: 60
• Locations: 4 countries
• Sites: 16

Brief Summary

The main purpose of this study was to evaluate safety and efficacy of a single injection of MIJ821 in addition to standard of care (SoC) pharmacological anti-depressant treatment in participants with treatment-resistant depression (TRD)

Conditions

Treatment-Resistant Depression

Keywords

Treatment-Resistant Depression; Major Depressive Episode; Major Depressive Disorder; MIJ821; Anti-depressive Agent; Subcutaneous; Placebo; Adult

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score 24 Hours (Day 2) After Injection

  The Montgomery Åsberg Depression Rating Scale (MADRS, SIGMA version), is a clinician rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 0 - 60. Higher scores represent a more severe condition. The MADRS evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts and suicidal thoughts. The MADRS scores were collected electronically by qualified personnel.

  Baseline and 24 hours after SC injection

Secondary Outcomes (10)

• Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Including Adverse Events of Special Interest (AESIs)

  From Day 1 after SC injection to end of study, up to 29 Days

• Pharmacokinetics (PK) of MIJ821 in Plasma for Area Under the Curve From the Time of Dosing to the Time of the Last Measurable Concentration (AUClast)

  Baseline, 0.17 hour, 0.33 hour, 0.5 hour, 0.75 hour, 1, 1.5, 2, 4 and 24 hours post injection

• PK of MIJ821 in Plasma for Maximum Serum Concentration (Cmax)

  Baseline, 0.17 hour, 0.33 hour, 0.5 hour, 0.75 hour, 1, 1.5, 2, 4 and 24 hours post injection

• PK of MIJ821 in Plasma for Time to Maximum Drug Concentration (Tmax)

  Baseline, 0.17 hour, 0.33 hour, 0.5 hour, 0.75 hour, 1, 1.5, 2, 4 and 24 hours post injection

• Change From Baseline in the MADRS Total Scores at Day 8, 15, 22 and 29 Visits

  Baseline, Days 8, 15, 22 and 29

Study Arms (4)

MIJ821 1 mg

EXPERIMENTAL

Participants received a single dose of 1 mg MIJ821 administered as a subcutaneous (SC) injection on Day 1.

Drug: MIJ821 Subcutaneous Injection 1 mg

MIJ821 4 mg

EXPERIMENTAL

Participants received a single dose of 4 mg MIJ821 administered as an SC injection on Day 1.

Drug: MIJ821 Subcutaneous Injection 4 mg

MIJ821 10 mg

EXPERIMENTAL

Participants received a single dose of 10 mg MIJ821 administered as an SC injection on Day 1.

Drug: MIJ821 Subcutaneous Injection 10 mg

Placebo

PLACEBO COMPARATOR

Participants received a single dose of 0.9% sodium chloride solution administered as an SC injection on Day 1.

Drug: Placebo Subcutaneous Injection

Interventions

MIJ821 Subcutaneous Injection 1 mg DRUG

MIJ821 supplied in vials as a powder for solution for injection, reconstituted and administered as a single SC injection on Day 1.

MIJ821 1 mg

MIJ821 Subcutaneous Injection 4 mg DRUG

MIJ821 supplied in vials as a powder for solution for injection, reconstituted and administered as a single SC injection on Day 1.

MIJ821 4 mg

MIJ821 Subcutaneous Injection 10 mg DRUG

MIJ821 supplied in vials as a powder for solution for injection, reconstituted and administered as a single SC injection on Day 1.

MIJ821 10 mg

Placebo Subcutaneous Injection DRUG

0.9% sodium chloride solution administered as a single SC injection on Day 1.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent obtained prior to participation in the study
• Male and female participants, 18 to 65 years of age (inclusive) at screening
• DSM-5 defined major depressive disorder (MDD) and a current major depressive episode (MDE)
• MADRS score ≥ 24
• Failure to respond to 2 or more antidepressant treatments where the two failed treatments are two different antidepressants

You may not qualify if:

• Any prior or current diagnosis of MDD with psychotic features, bipolar disorder, schizophrenia, or schizoaffective disorder
• Participants with acute alcohol or substance use disorder or withdrawal symptoms requiring detoxification, or participants who went through detoxification treatment within 1 month before Screening
• Participants with current borderline personality disorder or antisocial personality disorder
• Current clinical diagnosis of autism, dementia, or intellectual disability

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (16)

25Uni of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Research Centers of America LLC

Oakland Park, Florida, 33334, United States

Location

Interventional Psychiatry Tampa Bay

Tampa, Florida, 33629, United States

Location

Novartis Investigative Site

Yokohama, Kanagawa, 236-0004, Japan

Location

Novartis Investigative Site

Kodaira, Tokyo, 187-8551, Japan

Location

Novartis Investigative Site

Mitaka, Tokyo, 181-8611, Japan

Location

Novartis Investigative Site

Bialystok, 15 276, Poland

Location

Novartis Investigative Site

Gdansk, 80 952, Poland

Location

Novartis Investigative Site

Swiecie North West, 86-100, Poland

Location

Novartis Investigative Site

Seville, Andalusia, 41013, Spain

Location

Novartis Investigative Site

Sabadell, Barcelona, 08208, Spain

Location

Novartis Investigative Site

Sant Boi de Llobregat, Barcelona, 08830, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08035, Spain

Location

Novartis Investigative Site

Pamplona, Navarre, 31008, Spain

Location

Novartis Investigative Site

Barcelona, 08025, Spain

Location

Novartis Investigative Site

Barcelona, 08041, Spain

Location

Related Links

• A Plain Language Trial Summary is available on www.novctrd.com

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

+1 862 778 8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: July 12, 2022
• Study Start: March 13, 2023
• Primary Completion: November 28, 2023
• Study Completion: November 28, 2023
• Last Updated: April 13, 2025
• Results First Posted: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

PL (3); US (3); ES (7); JP (3)