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

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

Official Title
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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

Conditions
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Fibromyalgia

Intervention / Treatment
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* Drug: rozanolixizumab
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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: Brief Pain Inventory-short form (BPI-SF) interference score ≥6. Study participant has been diagnosed with fibromyalgia syndrome (FMS) for at least 6 months. 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Pain Inventory short form (BPI-SF) average interference score after 12 weeks of treatment | The short form of the BPI is 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 include: general activity, mood, walking ability, normal work (including housework), relations with other people, sleep, and enjoyment of life. Each item is rated on a 0 (does not interfere) to 10 (completely interferes) scale with a recall period of 24 hours. The arithmetic mean of the 7 interference items can be used as a measure of pain interference. | After 12 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage 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. | From Baseline till end of Safety Follow-up (up to 32 Weeks) | 
| Percentage of participants with TEAEs leading to withdrawal of investigational medicinal product (IMP) | 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. | From Baseline till end of Safety Follow-up (up to 32 Weeks) | 
| Brief Pain Inventory short form (BPI-SF) average interference score after 24 weeks of treatment | The short form of the BPI is 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 include: general activity, mood, walking ability, normal work (including housework), relations with other people, sleep, and enjoyment of life. Each item is rated on a 0 (does not interfere) to 10 (completely interferes) scale with a recall period of 24 hours. The arithmetic mean of the 7 interference items can be used as a measure of pain interference. | After 24 weeks of treatment | 
| Revised Fibromyalgia Impact Questionnaire (FIQR) score after 10 weeks of treatment | The Revised Fibromyalgia Impact Questionnaire (FIQR) is a 21-item questionnaire with a recall period of 7 days. The FIQR includes 3 domains: function, overall impact, and symptoms. Each item is based on an 11-point numeric rating scale. The total score ranges from 0 to 100, with 0 denoting the best possible condition and 100 denoting the worst possible condition. | After 10 weeks of treatment | 
| Mean 7-day average daily pain score assessed with Pain Numeric Rating Scale after 10 weeks of treatment | The Pain Numeric Rating Scale (NRS) is a numeric version of the Visual Analogue Scale (VAS) in which a respondent selects a whole number that best describes How much pain have you experienced on average over the past 24 hours? The 11-point Pain NRS ranges from 0 (no pain) to 10 (pain as bad as you can imagine). | After 10 weeks of treatment | 
| Mean 7-day fatigue score assessed with Fatigue Numeric Rating Scale after 10 weeks of treatment | The Fatigue Numeric Rating Scale (NRS) is a numeric version of the Visual Analogue Scale (VAS) in which a respondent selects a whole number that best describes How much fatigue have you experienced on average over the past 24 hours? The 11-point Fatigue NRS ranges from 0 (no fatigue) to 10 (fatigue as bad as you can imagine). | After 10 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibromyalgia, Phase 2, rozanolixizumab