Back to resultsA Proof-of-concept Study to Evaluate the Efficacy and Safety of Rozanolixizumab to Treat Adult Study Participants With Severe Fibromyalgia Syndrome
Primary Purpose
Fibromyalgia
Status
Recruiting
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
rozanolixizumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring Phase 2, Fibromyalgia, rozanolixizumab
Eligibility Criteria
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
Sites / Locations
- Fm0001 4405Recruiting
- Fm0001 4406Recruiting
- Fm0001 4407Recruiting
- Fm0001 4404Recruiting
- Fm0001 4402Recruiting
- Fm0001 4403Recruiting
- Fm0001 4401Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Treatment sequence 1
Treatment sequence 2
Treatment sequence 3
Arm Description
Study participants on Treatment sequence 1 will receive rozanolixizumab and Placebo during the dosing period at pre-specified timepoints.
Study participants on Treatment sequence 2 will receive rozanolixizumab and Placebo during the dosing period at pre-specified timepoints.
Study participants on Treatment sequence 3 will receive Placebo during the dosing period at pre-specified timepoints.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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).
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).
Full Information
NCT ID
NCT05643794
First Posted
November 30, 2022
Last Updated
September 21, 2023
Sponsor
UCB Biopharma SRL
1. Study Identification
Unique Protocol Identification Number
NCT05643794
Brief Title
A Proof-of-concept Study to Evaluate the Efficacy and Safety of Rozanolixizumab to Treat Adult Study Participants With Severe Fibromyalgia Syndrome
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 21, 2022 (Actual)
Primary Completion Date
September 11, 2024 (Anticipated)
Study Completion Date
September 11, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Biopharma SRL
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the study is to evaluate efficacy and safety of rozanolixizumab to treat adult study participants with severe fibromyalgia syndrome (FMS).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Phase 2, Fibromyalgia, rozanolixizumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment sequence 1
Arm Type
Experimental
Arm Description
Study participants on Treatment sequence 1 will receive rozanolixizumab and Placebo during the dosing period at pre-specified timepoints.
Arm Title
Treatment sequence 2
Arm Type
Experimental
Arm Description
Study participants on Treatment sequence 2 will receive rozanolixizumab and Placebo during the dosing period at pre-specified timepoints.
Arm Title
Treatment sequence 3
Arm Type
Placebo Comparator
Arm Description
Study participants on Treatment sequence 3 will receive Placebo during the dosing period at pre-specified timepoints.
Intervention Type
Drug
Intervention Name(s)
rozanolixizumab
Other Intervention Name(s)
UCB7665
Intervention Description
Study participants will receive rozanolixizumab during the dosing periods as pre-defined.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
PBO
Intervention Description
Study participants will receive Placebo during the dosing periods as pre-defined.
Primary Outcome Measure Information:
Title
Brief Pain Inventory short form (BPI-SF) average interference score after 12 weeks of treatment
Description
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.
Time Frame
After 12 weeks of treatment
Secondary Outcome Measure Information:
Title
Percentage of participants with treatment-emergent adverse events (TEAEs) during the study
Description
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.
Time Frame
From Baseline till end of Safety Follow-up (up to 32 Weeks)
Title
Percentage of participants with TEAEs leading to withdrawal of investigational medicinal product (IMP)
Description
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.
Time Frame
From Baseline till end of Safety Follow-up (up to 32 Weeks)
Title
Brief Pain Inventory short form (BPI-SF) average interference score after 24 weeks of treatment
Description
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.
Time Frame
After 24 weeks of treatment
Title
Revised Fibromyalgia Impact Questionnaire (FIQR) score after 10 weeks of treatment
Description
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.
Time Frame
After 10 weeks of treatment
Title
Mean 7-day average daily pain score assessed with Pain Numeric Rating Scale after 10 weeks of treatment
Description
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).
Time Frame
After 10 weeks of treatment
Title
Mean 7-day fatigue score assessed with Fatigue Numeric Rating Scale after 10 weeks of treatment
Description
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).
Time Frame
After 10 weeks of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
UCB Cares
Phone
001 844 599 2273
Email
ucbcares@ucb.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
001 844 599 2273 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
Fm0001 4405
City
Blackpool
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Fm0001 4406
City
Cannock
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Fm0001 4407
City
Leeds
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Fm0001 4404
City
Liverpool
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Fm0001 4402
City
Manchester
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Fm0001 4403
City
Stockton-on-tees
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Fm0001 4401
City
Tankersley
Country
United Kingdom
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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 URL
http://www.vivli.org/
Learn more about this trial
A Proof-of-concept Study to Evaluate the Efficacy and Safety of Rozanolixizumab to Treat Adult Study Participants With Severe Fibromyalgia Syndrome
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