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

UCB Biopharma SRL63 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Fibromyalgia

Interventions

rozanolixizumabDRUG

Study participants will receive rozanolixizumab during the dosing periods as pre-defined.

PlaceboOTHER

Study participants will receive Placebo during the dosing periods as pre-defined.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (7)

Fm0001 4405

Blackpool, United Kingdom

Fm0001 4406

Cannock, United Kingdom

Fm0001 4407

Leeds, United Kingdom

Fm0001 4404

Liverpool, United Kingdom

Outcomes

Primary Outcomes

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.

Time frame: At 12 weeks of treatment

Secondary Outcomes

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.

Time frame: 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.

Time frame: From Baseline till end of Safety Follow-up (up to Week 33)

Data from ClinicalTrials.gov

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