A Study to Evaluate Lu AG06466 in Participants With Fibromyalgia

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

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.

Study Overview

• Status: Terminated
• Conditions: Fibromyalgia
• Intervention / Treatment: Drug: Lu AG06466; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Long Beach, California, United States, 90806
      • Collaborative NeuroScience Network LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Lu AG06466; Participants will receive an oral titrated dose of Lu AG06466 once daily for 22 days in 1 of 2 treatment periods.	Drug: Lu AG06466; Lu AG06466 - capsules
PLACEBO_COMPARATOR: Placebo; Participants will receive an oral dose of placebo matching to Lu AG06466 once daily for 22 days in 1 of 2 treatment periods.	Drug: Placebo; Placebo - capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 22 of each 22-day treatment period
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.	Day 22 of each 22-day treatment period
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.	Day 22 of each 22-day treatment period

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 24, 2021
• Primary Completion (ACTUAL): January 26, 2022
• Study Completion (ACTUAL): January 26, 2022

Study Registration Dates

• First Submitted: June 28, 2021
• First Submitted That Met QC Criteria: July 13, 2021
• First Posted (ACTUAL): July 23, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 11, 2022
• Last Update Submitted That Met QC Criteria: January 28, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: 19365A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No