A Study to Assess Adverse Events of Fosigotifator (ABBV-C... | NCT06618118

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

NCT06618118

Sponsor

AbbVie

Status

Terminated

Last Update Posted

Sep 30, 2025Actual

Enrollment

20Actual

Phase

Phase 1

Conditions

Major Depressive Disorder (MDD)

Interventions

Fosigotifator
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2024-515120-36-00	Other Identifier	EU CT

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Company Decision

Expanded Access Info

Start Date

Oct 23, 2024Actual

Primary Completion Date

Sep 23, 2025Actual

Completion Date

Sep 23, 2025Actual

First Submitted Date

Sep 26, 2024

First Submission Date that Met QC Criteria

Sep 26, 2024

First Posted Date

Oct 1, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 25, 2025

Last Update Posted Date

Sep 30, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fosigotifator	Experimental	Participants will receive fosigotifator.	Drug: Fosigotifator
Placebo	Placebo Comparator	Participants will receive matching placebo for fosigotifator.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fosigotifator	Drug	Oral Use	Fosigotifator	ABBV-CLS-7262

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ABBVIE INC.	AbbVie	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CenExel CNR /ID# 265866		Sherman Oaks	California	91403	United States
Clinical Neuroscience Solutions - Orlando - East South Street /ID# 265060

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003865	Depressive Disorder, Major

Ancestor Terms

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided