A Study to Evaluate Lu AG06466 in Participants With Fibromyalgia

• ClinicalTrials.gov Identifier: NCT04974359
• Recruitment Status: Terminated
• First Posted: July 23, 2021
• Last Update Posted: February 11, 2022
• Sponsor: H. Lundbeck A/S
• Information provided by (Responsible Party): H. Lundbeck A/S

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.

Condition or disease	Intervention/treatment	Phase
Fibromyalgia	Drug: Lu AG06466; Drug: Placebo	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 3 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: June 24, 2021
• Actual Primary Completion Date: January 26, 2022
• Actual Study Completion Date: January 26, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Blood Oxygene Level Dependent (BOLD) Response in the Evoked-Pain Test [ Time Frame: Day 22 of each 22-day treatment period ]
   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.
2. Change in Resting State fMRI (rsfMRI) Functional Connectivity, Assessed by Voxelwise Connectivity Maps Based in Seed Voxels [ Time Frame: Day 22 of each 22-day treatment period ]
   Each participant will undergo a task-free resting state scan, where in they will be instructed to focus on a static fixation cross.
3. fMRI Data: BOLD Percent Signal Change Under Conditions of Visual Stimulation Versus Fixation [ Time Frame: Day 22 of each 22-day treatment period ]
   Each participant will undergo a block design scan, with alternating blocks of flashing checkerboard and a static fixation cross.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, California

Collaborative NeuroScience Network LLC

Long Beach, California, United States, 90806

Sponsors and Collaborators

H. Lundbeck A/S

Investigators

• Study Director: Email contact via H. Lundbeck A/S; LundbeckClinicalTrials@Lundbeck.com

More Information

• Responsible Party: H. Lundbeck A/S
• ClinicalTrials.gov Identifier: NCT04974359
• Other Study ID Numbers: 19365A
• First Posted: July 23, 2021
• Last Update Posted: February 11, 2022
• Last Verified: January 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Fibromyalgia; Myofascial Pain Syndromes; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases