A Proof-of-concept Study to Evaluate the Efficacy and Safety of Rozanolixizumab to Treat Adult Study Participants With Severe Fibromyalgia Syndrome

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2A, Proof-Of-Concept Study to Evaluate the Efficacy and Safety of Rozanolixizumab to Treat Adult Study Participants With Severe Fibromyalgia Syndrome

The purpose of the study is to evaluate efficacy and safety of rozanolixizumab to treat adult study participants with severe fibromyalgia syndrome (FMS).

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Drug: rozanolixizumab; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • Blackpool, United Kingdom
    • Fm0001 4405
  • Cannock, United Kingdom
    • Fm0001 4406
  • Leeds, United Kingdom
    • Fm0001 4407
  • Liverpool, United Kingdom
    • Fm0001 4404
  • Manchester, United Kingdom
    • Fm0001 4402
  • Stockton-on-tees, United Kingdom
    • Fm0001 4403
  • Tankersley, United Kingdom
    • Fm0001 4401

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Study participant must be ≥18 years and ≤70 years of age at the time of signing the informed consent form (ICF)
• Study participant with a diagnosis of fibromyalgia as defined by the 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria (American College of Rheumatology Preliminary

Diagnostic Criteria) plus the following characteristics during the Screening Period:

1. Brief Pain Inventory-short form (BPI-SF) interference score ≥6.
2. Study participant has been diagnosed with fibromyalgia syndrome (FMS) for at least 6 months.
3. Study participant has been having FMS symptomatology for at least 2 years before enrollment - Capable of giving signed informed consent as described in the Protocol which includes compliance with the requirements and restrictions listed in the ICF and in the Study Protocol

Exclusion Criteria:

• Study participant has been diagnosed with fibromyalgia syndrome (FMS) for >15 years
• Study participant has any systemic autoimmune inflammatory disease
• Study participant has any medical or psychiatric or separate chronic pain condition that, in the opinion of the investigator, could jeopardize or would compromise the study participant's ability to participate in this study or the ability to assess FMS-related pain
• Study participant has severe renal impairment, defined as estimated glomerular filtration rate <30 mL/min/1.73 m^2, (calculated using Modification of Diet in Renal Disease [MDRD] study equation), at Screening visit
• Study participant has a clinically important active infection (including unresolved or not adequately treated infection) as assessed by the investigator
• Study participant has chronic inflammatory demyelinating polyneuropathy
• Study participant has a current or medical history of primary immunodeficiency
• Study participant is pregnant or lactating

• Study participant

  • Has suicide attempt in the past 2 years (including an active attempt, interrupted attempt, or aborted attempt),
  • OR had suicidal ideation with at least some intent to act in the past 6 months as indicated by a positive response (Yes) to either Question 4 or Question 5 of the Columbia Suicide Severity Rating Scale (C-SSRS) at Screening or Baseline (Visit 3);
  • OR is otherwise judged clinically to be at a serious suicidal risk based on the investigator's judgment

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment sequence 1; Study participants on Treatment sequence 1 will receive rozanolixizumab and Placebo during the dosing period at pre-specified timepoints.	Drug: rozanolixizumab; Study participants will receive rozanolixizumab during the dosing periods as pre-defined.; Other Names: UCB7665; Other: Placebo; Study participants will receive Placebo during the dosing periods as pre-defined.; Other Names: PBO
Experimental: Treatment sequence 2; Study participants on Treatment sequence 2 will receive rozanolixizumab and Placebo during the dosing period at pre-specified timepoints.	Drug: rozanolixizumab; Study participants will receive rozanolixizumab during the dosing periods as pre-defined.; Other Names: UCB7665; Other: Placebo; Study participants will receive Placebo during the dosing periods as pre-defined.; Other Names: PBO
Placebo Comparator: Treatment sequence 3; Study participants on Treatment sequence 3 will receive Placebo during the dosing period at pre-specified timepoints.	Other: Placebo; Study participants will receive Placebo during the dosing periods as pre-defined.; Other Names: PBO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brief Pain Inventory Short Form (BPI-SF) Average Interference Score at 12 Weeks of Treatment	The BPI-SF was a self-administered questionnaire used to evaluate the severity of a study participant's pain and the impact of this pain on the study participant's daily functioning. The BPI-SF assesses for the location of pain, pain intensity and functional interference from pain. The 7 BPI-SF interference items included: general activity, mood, walking ability, normal work (including housework), relations with other people, sleep, and enjoyment of life. Each item was rated on a 0 (did not interfere) to 10 (completely interfere) scale with a recall period of 24 hours. The BPI-SF interference score ranges 0-70. Higher scores indicated greater interference.	At 12 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study	An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. A TEAE was defined as any AE with an onset date on or after the first dose of investigational medicinal product (IMP) in Run-In and on or before the earliest of the following: the last date of infusion (including Run-Out) +56 days, final contact date, or death. A TEAE is also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.	From Baseline till end of Safety Follow-up (up to Week 33)
Number of Participants With TEAEs Leading to Withdrawal of IMP	An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. A TEAE was defined as any AE with an onset date on or after the first dose of IMP in Run-In and on or before the earliest of the following: the last date of infusion (including Run-Out) +56 days, final contact date, or death.	From Baseline till end of Safety Follow-up (up to Week 33)
Brief Pain Inventory Short Form (BPI-SF) Average Interference Score at 24 Weeks of Treatment	The BPI-SF was a self-administered questionnaire used to evaluate the severity of a study participant's pain and the impact of this pain on the study participant's daily functioning. The BPI-SF assesses for the location of pain, pain intensity and functional interference from pain. The 7 BPI-SF interference items included: general activity, mood, walking ability, normal work (including housework), relations with other people, sleep, and enjoyment of life. Each item was rated on a 0 (did not interfere) to 10 (completely interfere) scale with a recall period of 24 hours. The BPI-SF interference score ranges 0-70. Higher scores indicated greater interference.	At 24 weeks of treatment
Revised Fibromyalgia Impact Questionnaire (FIQR) Score at 12 Weeks of Treatment	The Revised Fibromyalgia Impact Questionnaire (FIQR) was a 21-item questionnaire with a recall period of 7 days. The FIQR included 3 domains: activities, overall impact, and symptoms. Each item was based on an 11-point numeric rating scale. The FIQR total score was calculated by taking the sum of the following: Activities domain subtotal divided by 3, overall impact" domain subtotal and symptoms domain subtotal divided by 2. The total score ranged from 0 to 100, with 0 denoting the best possible condition and 100 denoting the worst possible condition. Higher scores indicated more severe impact.	At 12 weeks of treatment
Mean 7-day Average Daily Pain Score Assessed With Pain Numeric Rating Scale (NRS) at 12 Weeks of Treatment	The Pain Numeric Rating Scale (NRS) was a scale in which a respondent selected a whole number that best described "How much pain have you experienced on average over the past 24 hours?" The 11-point Pain NRS ranged 0 (no pain) to 10 (pain as bad as you can imagine). Mean pain scores were derived the average of the daily assessment over the past 7 days. The higher score represented worst possible pain.	At 12 Weeks of treatment
Mean 7-day Fatigue Score Assessed With Fatigue Numeric Rating Scale at 12 Weeks of Treatment	The Fatigue Numeric Rating Scale (NRS) was a scale in which a respondent selected a whole number that best described "How much fatigue have you experienced on average over the past 24 hours?" The 11-point Fatigue NRS ranged 0 (no fatigue) to 10 (fatigue as bad as you can imagine). Mean fatigue scores were derived the average of the daily assessment over the past 7 days. Higher score represented worst possible fatigue.	At 12 weeks of treatment

Collaborators and Investigators

• Sponsor: UCB Biopharma SRL
• Investigators: Study Director: UCB Cares, 001 844 599 2273 (UCB)

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2022
• Primary Completion (Actual): May 28, 2024
• Study Completion (Actual): July 9, 2024

Study Registration Dates

• First Submitted: November 30, 2022
• First Submitted That Met QC Criteria: November 30, 2022
• First Posted (Actual): December 9, 2022

Study Record Updates

• Last Update Posted (Estimated): July 1, 2025
• Last Update Submitted That Met QC Criteria: June 26, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Fibromyalgia; Phase 2; rozanolixizumab
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Diseases; Rheumatic Diseases; Fibromyalgia; Myofascial Pain Syndromes; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Rozanolixizumab
• Other Study ID Numbers: FM0001; 2022-001523-32 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
• IPD Sharing Time Frame: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
• IPD Sharing Access Criteria: Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

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.: No