NCT05454410

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

A Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Single Subcutaneous MIJ821 Injection in Addition to Standard of Care in Participants With Treatment-resistant Depression

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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)

Detailed description

The trial included a screening period of up to 28 days. On Day 1, after screening, eligible participants were randomized to one of the treatment arms (1 mg, 4 mg, or 10 mg of MIJ821) or placebo and received study treatment administered as a single subcutaneous injection. Participants remained at the clinic for at least 4 hours after administration of study treatment for safety observation including assessment of local tolerability by visual inspection of the injection area. Post-dose clinic visits occurred 24 hours post dose (Day 2), Days 8, 15, 22 and 29 to evaluate efficacy and safety. Efficacy assessments included the Montgomery-Asberg Depression Scale (MADRS) and other clinical outcome assessments (COAs). Safety assessments included laboratory tests, ECGs, vital signs and physical examinations. In addition, phone calls were conducted 3 days after each on-site clinic visit with the exception of the End-of-study (EOS) visit. EOS visit was completed on site on Day 29. Including screening, participants were in the study for up to 8 weeks (57 days).

Conditions

• Treatment-Resistant Depression

Interventions

Type	Name	Description
DRUG	MIJ821 Subcutaneous Injection 1 mg	MIJ821 supplied in vials as a powder for solution for injection, reconstituted and administered as a single SC injection on Day 1.
DRUG	MIJ821 Subcutaneous Injection 4 mg	MIJ821 supplied in vials as a powder for solution for injection, reconstituted and administered as a single SC injection on Day 1.
DRUG	MIJ821 Subcutaneous Injection 10 mg	MIJ821 supplied in vials as a powder for solution for injection, reconstituted and administered as a single SC injection on Day 1.
DRUG	Placebo Subcutaneous Injection	0.9% sodium chloride solution administered as a single SC injection on Day 1.

Timeline

• Start date: 2023-03-13
• Primary completion: 2023-11-28
• Completion: 2023-11-28
• First posted: 2022-07-12
• Last updated: 2025-04-13
• Results posted: 2025-04-04

Locations

16 sites across 4 countries: United States, Japan, Poland, Spain

Regulatory

• FDA-regulated drug study