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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-21

Study Completion Date

2024-07-09

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).

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Detailed Description

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Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment sequence 1

Study participants on Treatment sequence 1 will receive rozanolixizumab and Placebo during the dosing period at pre-specified timepoints.

Group Type EXPERIMENTAL

rozanolixizumab

Intervention Type DRUG

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

Placebo

Intervention Type OTHER

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

Treatment sequence 2

Study participants on Treatment sequence 2 will receive rozanolixizumab and Placebo during the dosing period at pre-specified timepoints.

Group Type EXPERIMENTAL

rozanolixizumab

Intervention Type DRUG

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

Placebo

Intervention Type OTHER

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

Treatment sequence 3

Study participants on Treatment sequence 3 will receive Placebo during the dosing period at pre-specified timepoints.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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rozanolixizumab

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

Intervention Type DRUG

Placebo

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

Intervention Type OTHER

Other Intervention Names

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UCB7665 PBO

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:

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No