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

September 25, 2025 updated by: AbbVie

A Phase 1 b Randomized, Double-blind, Placebo-Controlled, Experimental Medicine Study of Fosigotifator in Adults With Major Depressive Disorder

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sherman Oaks, California, United States, 91403
        • CenExel CNR /ID# 265866
    • Florida
      • Orlando, Florida, United States, 32801
        • Clinical Neuroscience Solutions - Orlando - East South Street /ID# 265060
    • Georgia
      • Decatur, Georgia, United States, 30030-3440
        • CenExel iResearch, LLC /ID# 265886
    • Washington
      • Bellevue, Washington, United States, 98007
        • Northwest Clinical Research Center /ID# 265057

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

- Primary psychiatric illness other than MDD.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fosigotifator
Participants will receive fosigotifator.
Drug: Fosigotifator
Oral Use
Other Names:
  • ABBV-CLS-7262
Placebo Comparator: Placebo
Participants will receive matching placebo for fosigotifator.
Drug: Placebo
Oral Use

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Experiencing Adverse Events (AEs)
Time Frame: Up to approximately 114 Days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 23, 2024

Primary Completion (Actual)

September 23, 2025

Study Completion (Actual)

September 23, 2025

Study Registration Dates

First Submitted

September 26, 2024

First Submitted That Met QC Criteria

September 26, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Estimated)

September 30, 2025

Last Update Submitted That Met QC Criteria

September 25, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M24-840
  • 2024-515120-36-00 (Other Identifier: EU CT)

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

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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