A Study to Assess Adverse Events of Fosigotifator (ABBV-CLS-7262) in Adults With Major Depressive Disorder

NCT06618118 | Terminated Phase 1

• 2 other identifiers: M24-8402024-515120-36-00
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 4

Brief Summary

Major depressive disorder (MDD; depression) is a mood disorder that causes a continued feeling of sadness and loss of interest. It is a common and serious illness that can cause both emotional and physical symptoms such as feelings of sadness, irritability, not being able to focus on activities, tiredness, changes in eating habits, and aches and pains. The main goal of the study is to evaluate how safe and effective fosigotifator is in treating MDD. Fosigotifator (ABBV-CLS-7262) is a new treatment being developed for adult patients with depression. This study is double-blinded, which means that neither the patients nor the study doctors know who is given fosigotifator and who is given placebo. Participants will be randomly assigned to one of the two groups to receive fosigatofator or placebo. There is 1 in 2 chance that participants will receive placebo. Approximately 106 adult participants with MDD will be enrolled in approximately 15 sites across the world. Participants will receive oral fosigotifator or matching placebo. Duration of the study is approximately 144 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular weekly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Conditions

Major Depressive Disorder (MDD)

Keywords

Major Depressive Disorder (MDD); Fosigotifator; ABBV-CLS-7262

Outcome Measures

Primary Outcomes (1)

• Number of Participants Experiencing Adverse Events (AEs)

  An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

  Up to approximately 114 Days

Study Arms (2)

Fosigotifator

EXPERIMENTAL

Participants will receive fosigotifator.

Drug: Fosigotifator

Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo for fosigotifator.

Drug: Placebo

Interventions

Fosigotifator DRUG

Oral Use

Also known as: ABBV-CLS-7262

Fosigotifator

Placebo DRUG

Oral Use

Placebo

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index of 18 to 33 kg/m2 at the time of consent.
• Meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-5-TR) criteria for MDD based on the Structured Clinical Interview for DSM-5.
• Current major depressive episode of at least 6 weeks to less than 24 months in duration at Screening (Visit 1 ).
• Meets the following disease activity criteria mentioned in the protocol.
• Requires antidepressant therapy (ADT) per the investigator's opinion or, if currently taking ADT, must be able to safely discontinue ADT at least 7 days prior to the first dose of study drug at Baseline (Visit 2).

You may not qualify if:

• \- Primary psychiatric illness other than MDD.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (4)

CenExel CNR /ID# 265866

Sherman Oaks, California, 91403, United States

Location

Clinical Neuroscience Solutions - Orlando - East South Street /ID# 265060

Orlando, Florida, 32801, United States

Location

CenExel iResearch, LLC /ID# 265886

Decatur, Georgia, 30030-3440, United States

Location

Northwest Clinical Research Center /ID# 265057

Bellevue, Washington, 98007, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 1, 2024
• Study Start: October 23, 2024
• Primary Completion: September 23, 2025
• Study Completion: September 23, 2025
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)