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A Study to Evaluate Lu AG06466 in Participants With Fibromyalgia

Primary Purpose

Fibromyalgia

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Lu AG06466

Placebo

About this trial

This is an interventional treatment trial for Fibromyalgia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

The participant has a body mass index (BMI) of ≥18.5 and ≤38.0 kilograms (kg)/square meter (m^2).
The participant has a fibromyalgia diagnosis, with self-reported pain visual analogue scale (VAS) score >4, based on a self-reported pain diary assessed for a minimum of 4 out of 7 days prior to the Baseline Visit.
The participant is, in the opinion of the investigator, eligible based on medical history, a physical examination, a neurological examination, vital signs (including orthostatic vital signs), an electrocardiogram (ECG), and the results of the clinical chemistry, hematology, urinalysis, serology, and other laboratory tests.

Exclusion Criteria:

The participant has a disease, including clinically significant liver disease of any origin, or takes medication that could, in the investigator's opinion, interfere with the assessments of safety, tolerability, or efficacy, or interfere with the conduct or interpretation of the study.
The participant has any other disorder for which the treatment takes priority over the treatment of fibromyalgia in this study or is likely to interfere with the study treatment or impair treatment compliance.

Other inclusion and exclusion criteria may apply.

Sites / Locations

Collaborative NeuroScience Network LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lu AG06466

Placebo

Arm Description

Participants will receive an oral titrated dose of Lu AG06466 once daily for 22 days in 1 of 2 treatment periods.

Participants will receive an oral dose of placebo matching to Lu AG06466 once daily for 22 days in 1 of 2 treatment periods.

Outcomes

Primary Outcome Measures

Blood Oxygene Level Dependent (BOLD) Response in the Evoked-Pain Test

BOLD response was evaluated using Functional Magnetic Resonance Imaging (fMRI). During the evoked-pain test, each participant will undergo a block design scan, during which 3 cuff pressures ('light touch' = 30 millimeter of mercury [mmHg]; 'equal pressure' = 120 mmHg; 'equal pain' = 40 to 60/100 Numeric Rating Scale [NRS] units) will be applied to the left calf using the pressure cuff device in pseudo random order.

Change in Resting State fMRI (rsfMRI) Functional Connectivity, Assessed by Voxelwise Connectivity Maps Based in Seed Voxels

Each participant will undergo a task-free resting state scan, where in they will be instructed to focus on a static fixation cross.

fMRI Data: BOLD Percent Signal Change Under Conditions of Visual Stimulation Versus Fixation

Each participant will undergo a block design scan, with alternating blocks of flashing checkerboard and a static fixation cross.

Secondary Outcome Measures

Full Information

NCT ID

NCT04974359

First Posted

June 28, 2021

Last Updated

January 28, 2022

Sponsor

H. Lundbeck A/S

1. Study Identification

Unique Protocol Identification Number

NCT04974359

Brief Title

A Study to Evaluate Lu AG06466 in Participants With Fibromyalgia

Official Title

Interventional, Randomized, Double-Blind, Crossover, Placebo-Controlled, Multiple-Dose Lu AG06466 Phase IB Study in Patients With Fibromyalgia Using Neuroimaging to Investigate Its Pharmacodynamic Effects on Central Pain Processing and Neuroinflammation

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Terminated

Why Stopped

Study terminated due to enrolment challenges.

Study Start Date

June 24, 2021 (Actual)

Primary Completion Date

January 26, 2022 (Actual)

Study Completion Date

January 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

H. Lundbeck A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The purpose of this study is to find out the effect of Lu AG06466 on the body in participants with fibromyalgia by assessing pain levels, brain signal changes, and psychiatric (mental) assessments.

Detailed Description

This study will include 2 treatment periods and will utilize a crossover study design with a 7- to 14-day washout period between each 22-day treatment period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fibromyalgia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lu AG06466

Arm Type

Experimental

Arm Description

Participants will receive an oral titrated dose of Lu AG06466 once daily for 22 days in 1 of 2 treatment periods.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Participants will receive an oral dose of placebo matching to Lu AG06466 once daily for 22 days in 1 of 2 treatment periods.

Intervention Type

Drug

Intervention Name(s)

Lu AG06466

Intervention Description

Lu AG06466 - capsules

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo - capsules

Primary Outcome Measure Information:

Title

Blood Oxygene Level Dependent (BOLD) Response in the Evoked-Pain Test

Description

Time Frame

Day 22 of each 22-day treatment period

Title

Change in Resting State fMRI (rsfMRI) Functional Connectivity, Assessed by Voxelwise Connectivity Maps Based in Seed Voxels

Description

Each participant will undergo a task-free resting state scan, where in they will be instructed to focus on a static fixation cross.

Time Frame

Day 22 of each 22-day treatment period

Title

fMRI Data: BOLD Percent Signal Change Under Conditions of Visual Stimulation Versus Fixation

Description

Each participant will undergo a block design scan, with alternating blocks of flashing checkerboard and a static fixation cross.

Time Frame

Day 22 of each 22-day treatment period

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The participant has a body mass index (BMI) of ≥18.5 and ≤38.0 kilograms (kg)/square meter (m^2). The participant has a fibromyalgia diagnosis, with self-reported pain visual analogue scale (VAS) score >4, based on a self-reported pain diary assessed for a minimum of 4 out of 7 days prior to the Baseline Visit. The participant is, in the opinion of the investigator, eligible based on medical history, a physical examination, a neurological examination, vital signs (including orthostatic vital signs), an electrocardiogram (ECG), and the results of the clinical chemistry, hematology, urinalysis, serology, and other laboratory tests. Exclusion Criteria: The participant has a disease, including clinically significant liver disease of any origin, or takes medication that could, in the investigator's opinion, interfere with the assessments of safety, tolerability, or efficacy, or interfere with the conduct or interpretation of the study. The participant has any other disorder for which the treatment takes priority over the treatment of fibromyalgia in this study or is likely to interfere with the study treatment or impair treatment compliance. Other inclusion and exclusion criteria may apply.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Email contact via H. Lundbeck A/S

Organizational Affiliation

LundbeckClinicalTrials@Lundbeck.com

Official's Role

Study Director

Facility Information:

Facility Name

Collaborative NeuroScience Network LLC

City

Long Beach

State/Province

California

ZIP/Postal Code

90806

Country

United States

12. IPD Sharing Statement

Learn more about this trial

A Study to Evaluate Lu AG06466 in Participants With Fibromyalgia

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