A Proof-of-concept Study to Evaluate the Efficacy and Saf... | NCT05643794 | Trialant
NCT05643794
Sponsor
UCB Biopharma SRL
Status
Completed
Last Update Posted
Jul 1, 2025Actual
Enrollment
63Actual
Phase
Phase 2
Conditions
Fibromyalgia
Interventions
rozanolixizumab
Placebo
Countries
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT05643794
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
FM0001
Secondary IDs
Not provided
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
Acronym
Not provided
Organization
UCB PharmaINDUSTRY
Status Module
Record Verification Date
Jun 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 21, 2022Actual
Primary Completion Date
May 28, 2024Actual
Completion Date
Jul 9, 2024Actual
First Submitted Date
Nov 30, 2022
First Submission Date that Met QC Criteria
Nov 30, 2022
First Posted Date
Dec 9, 2022Actual
Results Waived
Not provided
Results First Submitted Date
May 21, 2025
Results First Submitted that Met QC Criteria
Jun 26, 2025
Results First Posted Date
Jul 1, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 26, 2025
Last Update Posted Date
Jul 1, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
UCB Biopharma SRLINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
No
FDAAA801 Violation
Not provided
Description Module
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).
Detailed Description
Not provided
Conditions Module
Conditions
Fibromyalgia
Keywords
Phase 2
Fibromyalgia
rozanolixizumab
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
63Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Treatment sequence 1
Experimental
Study participants on Treatment sequence 1 will receive rozanolixizumab and Placebo during the dosing period at pre-specified timepoints.
Drug: rozanolixizumab
Other: Placebo
Treatment sequence 2
Experimental
Study participants on Treatment sequence 2 will receive rozanolixizumab and Placebo during the dosing period at pre-specified timepoints.
Drug: rozanolixizumab
Other: Placebo
Treatment sequence 3
Placebo Comparator
Study participants on Treatment sequence 3 will receive Placebo during the dosing period at pre-specified timepoints.
Other: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
rozanolixizumab
Drug
Study participants will receive rozanolixizumab during the dosing periods as pre-defined.
Treatment sequence 1
Treatment sequence 2
Outcomes Module
Primary Outcomes
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 Outcomes
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.
Other Outcomes
Not provided
Eligibility Module
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
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
70 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
UCB Cares
001 844 599 2273 (UCB)
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Fm0001 4405
Blackpool
United Kingdom
Fm0001 4406
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Yes
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.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
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.
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.
The Participant Flow refers to the Randomized Set.
Recruitment Details
The study started to enroll participants in December 2022 and concluded in July 2024.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Sequence 1: RLZ 12w + RLZ 12w
Participants received placebo, subcutaneously (SC), once weekly (QW) for 2 weeks (Run-in Period), then rozanolixizumab (RLZ) 560 milligrams (mg), SC, QW, weekly (w) for 24 weeks (Treatment Period 1 + Treatment Period 2), followed by placebo SC, QW for 2 weeks (Runout Period). The safety follow-up (SFU) included all the participants who received the investigational medicinal product (IMP), regardless of discontinuation.
Study participants will receive Placebo during the dosing periods as pre-defined.
Treatment sequence 1
Treatment sequence 2
Treatment sequence 3
PBO
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
Cannock
United Kingdom
Fm0001 4407
Leeds
United Kingdom
Fm0001 4404
Liverpool
United Kingdom
Fm0001 4402
Manchester
United Kingdom
Fm0001 4403
Stockton-on-Tees
United Kingdom
Fm0001 4401
Tankersley
United Kingdom
FG001
Sequence 2: PBO + RLZ 12w
Participants received placebo SC, QW for 2 weeks (Run-in Period), then placebo SC, QW for 12 weeks (Treatment Period 1), followed by rozanolixizumab 560 mg, SC, QW for 12 weeks (Treatment Period 2), followed by placebo SC, QW for 2 weeks (Runout Period). The SFU included all the participants who received the IMP, regardless of discontinuation.
FG002
Sequence 3: PBO + PBO
Participants received placebo SC, QW for 2 weeks (Run-in Period), then placebo SC, QW for 24 weeks (Treatment Period 1 + Treatment Period 2), followed by placebo SC, QW for 2 weeks (Run-out Period). The SFU included all the participants who received the IMP, regardless of discontinuation.
FG00022 subjects
FG00120 subjects
FG00221 subjects
COMPLETED
FG00022 subjects
FG00120 subjects
FG00221 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
Treatment Period 1 (12 Weeks)
Type
Comment
Milestone Data
STARTED
FG00022 subjects
FG00120 subjects
FG00221 subjects
COMPLETED
FG00019 subjects
FG00119 subjects
FG00220 subjects
NOT COMPLETED
FG0003 subjects
FG0011 subjects
FG0021 subjects
Type
Comment
Reasons
Adverse Event
FG0002 subjects
FG0010 subjects
FG0021 subjects
Lost to Follow-up
FG000
Treatment Period 2 (12 Weeks)
Type
Comment
Milestone Data
STARTED
FG00019 subjects
FG00119 subjects
FG00220 subjects
COMPLETED
FG00017 subjects
FG00118 subjects
FG00220 subjects
NOT COMPLETED
FG0002 subjects
FG0011 subjects
FG0020 subjects
Type
Comment
Reasons
Lack of Efficacy
FG0000 subjects
FG0011 subjects
FG0020 subjects
Consent Withdrawn by Study Participant (Not Due to Adverse Event)
FG000
Run-Out Period (2 Weeks)
Type
Comment
Milestone Data
STARTED
FG00017 subjects
FG00118 subjects
FG00220 subjects
COMPLETED
FG00017 subjects
FG00118 subjects
FG00220 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
Safety Follow-up Period (5 Weeks)
Type
Comment
Milestone Data
STARTED
FG00022 subjectsThe SFU included all the participants who received the IMP at any point in the study, regardless of treatment discontinuation.
FG00120 subjectsThe SFU included all the participants who received the IMP at any point in the study, regardless of treatment discontinuation.
FG00221 subjectsThe SFU included all the participants who received the IMP at any point in the study, regardless of treatment discontinuation.
COMPLETED
FG00022 subjects
FG00120 subjects
FG00221 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
The Randomized Set (RS) included all enrolled participants who were randomized into the study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Sequence 1: RLZ 12w + RLZ 12w
Participants received placebo, subcutaneously (SC), once weekly (QW) for 2 weeks (Run-in Period), then rozanolixizumab (RLZ) 560 milligrams (mg), SC, QW, weekly (w) for 24 weeks (Treatment Period 1 + Treatment Period 2), followed by placebo SC, QW for 2 weeks (Runout Period). The safety follow-up (SFU) included all the participants who received the investigational medicinal product (IMP), regardless of discontinuation.
BG001
Sequence 2: PBO + RLZ 12w
Participants received placebo SC, QW for 2 weeks (Run-in Period), then placebo SC, QW for 12 weeks (Treatment Period 1), followed by rozanolixizumab 560 mg, SC, QW for 12 weeks (Treatment Period 2), followed by placebo SC, QW for 2 weeks (Runout Period). The SFU included all the participants who received the IMP, regardless of discontinuation.
BG002
Sequence 3: PBO + PBO
Participants received placebo SC, QW for 2 weeks (Run-in Period), then placebo SC, QW for 24 weeks (Treatment Period 1 + Treatment Period 2), followed by placebo SC, QW for 2 weeks (Run-out Period). The SFU included all the participants who received the IMP, regardless of discontinuation.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00022
BG00120
BG00221
BG00363
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00046.3± 9.9
BG00147.8± 10.7
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00021
BG00117
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Asian
BG0000
BG0010
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
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.
Full Analysis Set (FAS) included all study participants who received any study treatment, including during the run-in period, had a baseline value and at least one post-baseline efficacy endpoint assessment.
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
At 12 weeks of treatment
ID
Title
Description
OG000
Placebo (PBO)
Participants received a PBO SC QW exposure up to 12 weeks and/or extended exposure from 12 to 24 weeks.
OG001
RLZ 12 Weeks
Participants who received 12 weeks of RLZ 560 mg SC treatment during any sequence.
Units
Counts
Participants
OG00041
OG00141
Title
Denominators
Categories
Title
Measurements
OG0006.30(5.59 to 7.01)
OG0015.76(5.11 to 6.41)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Longitudinal linear mixed effect model
0.129
Difference from Placebo
-0.54
2-Sided
95
-1.24
0.16
The difference presented is RLZ 12 weeks minus Placebo.
Superiority
Secondary
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.
The Safety Set as treated (SS-t) included all study participants who received any study treatment, including during Run-In period.
Posted
Count of Participants
Participants
From Baseline till end of Safety Follow-up (up to Week 33)
ID
Title
Description
OG000
Run-In-PBO
Participants received a PBO SC QW for 2 weeks in Run-In period. All study participants received placebo during the Run-in Period.
OG001
TP1-RLZ
Participants received a RLZ 560 mg SC in Treatment Period 1 (TP1) up to Week 12.
OG002
TP1-PBO
Secondary
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.
The SS-t included all study participants who received any study treatment, including during Run-In period.
Posted
Count of Participants
Participants
From Baseline till end of Safety Follow-up (up to Week 33)
ID
Title
Description
OG000
Run-In-PBO
Participants received a PBO SC QW for 2 weeks in Run-In period. All study participants received placebo during the Run-in Period.
OG001
TP1-RLZ
Participants received RLZ 560 mg SC in TP1 up to Week 12.
OG002
TP1-PBO
Participants received PBO SC QW in TP1 up to Week 12. Pooled data is reported for placebo (Sequence 2 and Sequence 3).
OG003
Secondary
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.
FAS included all study participants who received any study treatment, including during the run-in period, had a baseline value and at least one post-baseline efficacy endpoint assessment. Here 'overall number of participants analyzed' signifies participants evaluable for this Outcome measure.
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
At 24 weeks of treatment
ID
Title
Description
OG000
Placebo
Participants received a PBO SC QW exposure up to 12 weeks and/or extended exposure from 12 to 24 weeks.
OG001
RLZ 24 Weeks
Participants who received 24 weeks of RLZ 560 mg SC treatment during any sequence.
Secondary
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.
FAS included all study participants who received any study treatment, including during the run-in period, had a baseline value and at least one post-baseline efficacy endpoint assessment.
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
At 12 weeks of treatment
ID
Title
Description
OG000
Placebo (PBO)
Participants received a PBO SC QW exposure up to 12 weeks and/or extended exposure from 12 to 24 weeks.
OG001
RLZ 12 Weeks
Participants who received 12 weeks of RLZ 560 mg SC treatment during any sequence.
Secondary
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.
FAS included all study participants who received any study treatment, including during the run-in period, had a baseline value and at least one post-baseline efficacy endpoint assessment.
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
At 12 Weeks of treatment
ID
Title
Description
OG000
Placebo
Participants received a PBO SC QW exposure up to 12 weeks and/or extended exposure from 12 to 24 weeks.
OG001
RLZ 12 Weeks
Participants who received 12 weeks of RLZ 560 mg SC treatment during any sequence.
Units
Counts
Participants
Secondary
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.
FAS included all study participants who received any study treatment, including during the run-in period, had a baseline value and at least one post-baseline efficacy endpoint assessment.
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
At 12 weeks of treatment
ID
Title
Description
OG000
Placebo (PBO)
Participants received a PBO SC QW exposure up to 12 weeks and/or extended exposure from 12 to 24 weeks.
OG001
RLZ 12 Weeks
Participants who received 12 weeks of RLZ 560 mg SC treatment during any sequence.
Units
Counts
Participants
Time Frame
From Baseline till end of Safety Follow-up (up to Week 33)
Description
TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Run-In-PBO
Participants received a PBO SC QW for 2 weeks in Run-In period. All study participants received placebo during the Run-in Period.
0
63
0
63
24
63
EG001
TP1-RLZ
Participants received RLZ 560 mg SC in TP1 up to Week 12.
0
22
0
22
21
22
EG002
TP1-PBO
Participants received PBO SC QW in TP1 up to Week 12. Pooled data is reported for placebo (Sequence 2 and Sequence 3).
0
41
3
41
37
41
EG003
TP2-RLZ/RLZ
Participants who received RLZ in TP1 continued RLZ 560 mg SC in Treatment Period 2 (TP2) up to Week 24. One participant of "TP2-RLZ/RLZ" arm started TP2 but discontinued before receiving IMP.
0
18
0
18
18
18
EG004
TP2-PBO/RLZ
Participants who received PBO in TP1 continued RLZ 560 mg SC in Treatment Period 2 (TP2) up to Week 24.
0
19
0
19
19
19
EG005
TP2-PBO/PBO
Participants who received PBO in TP1 continued PBO SC in Treatment Period 2 (TP2) up to Week 24.
0
20
0
20
16
20
EG006
Run-Out and SFU-RLZ/RLZ
Participants who received RLZ in TP1 and continued RLZ 560 mg SC up to Week 24 in TP2 received placebo SC, QW for 2 weeks in Run-Out period and had safety-follow-up (SFU), up to 5 weeks.
0
22
0
22
3
22
EG007
Run-Out and SFU-PBO/RLZ
Participants who received PBO in TP1 and continued RLZ 560 mg SC up to Week 24 in TP2 received placebo SC, QW for 2 weeks in Run-Out period and had SFU, up to 5 weeks.
0
20
1
20
8
20
EG008
Run-Out and SFU-PBO/PBO
Participants who received PBO in TP1 and continued PBO SC up to Week 24 in TP2 received placebo SC, QW for 2 weeks in Run-Out period and had SFU, up to 5 weeks.
Consent Withdrawn by Study Participant (Not Due to Adverse Event)
FG0000 subjects
FG0011 subjects
FG0020 subjects
1 subjects
FG0010 subjects
FG0020 subjects
New Work Commitments
FG0001 subjects
FG0010 subjects
FG0020 subjects
0
Between 18 and 65 years
BG00021
BG00120
BG00220
BG00361
>=65 years
BG0001
BG0010
BG0021
BG0032
47.3
± 9.5
BG00347.1± 9.9
17
BG00355
Male
BG0001
BG0013
BG0024
BG0038
1
BG0031
Black or African American
BG0000
BG0011
BG0021
BG0032
White
BG00022
BG00119
BG00219
BG00360
1
BG0031
Not Hispanic or Latino
BG00022
BG00120
BG00220
BG00362
Participants received a PBO SC QW in TP1 up to Week 12. Pooled data is reported for placebo (Sequence 2 and Sequence 3).
OG003
TP2-RLZ/RLZ
Participants who received RLZ in TP1 continued RLZ 560 mg SC in Treatment Period 2 (TP2) up to Week 24. One participant of "TP2-RLZ/RLZ" arm started TP2 but discontinued before receiving IMP.
OG004
TP2-PBO/RLZ
Participants who received PBO in TP1 continued RLZ 560 mg SC in Treatment Period 2 (TP2) up to Week 24.
OG005
TP2-PBO/PBO
Participants who received PBO in TP1 continued PBO SC in Treatment Period 2 (TP2) up to Week 24.
OG006
Run-Out and SFU-RLZ/RLZ
Participants who received RLZ in TP1 and continued RLZ 560 mg SC up to Week 24 in TP2 received placebo SC, QW for 2 weeks in Run-Out period and had safety-follow-up (SFU), up to 5 weeks.
OG007
Run-Out and SFU-PBO/RLZ
Participants who received PBO in TP1 and continued RLZ 560 mg SC up to Week 24 in TP2 received placebo SC, QW for 2 weeks in Run-Out period and had SFU, up to 5 weeks.
OG008
Run-Out and SFU-PBO/PBO
Participants who received PBO in TP1 and continued PBO SC up to Week 24 in TP2 received placebo SC, QW for 2 weeks in Run-Out period and had SFU, up to 5 weeks.
Units
Counts
Participants
OG00063
OG00122
OG00241
OG00318
OG00419
OG00520
OG00622
OG00720
OG00821
Title
Denominators
Categories
Title
Measurements
OG00044
OG00122
OG00241
OG00318
OG00419
OG00519
OG00610
OG00712
OG00811
TP2-RLZ/RLZ
Participants who received RLZ in TP1 continued RLZ 560 mg SC in Treatment Period 2 (TP2) up to Week 24. One participant of "TP2-RLZ/RLZ" arm started TP2 but discontinued before receiving IMP.
OG004
TP2-PBO/RLZ
Participants who received PBO in TP1 continued RLZ 560 mg SC in Treatment Period 2 (TP2) up to Week 24.
OG005
TP2-PBO/PBO
Participants who received PBO in TP1 continued PBO SC in Treatment Period 2 (TP2) up to Week 24.
OG006
Run-Out and SFU-RLZ/RLZ
Participants who received RLZ in TP1 and continued RLZ 560 mg SC up to Week 24 in TP2 received placebo SC, QW for 2 weeks in Run-Out period and had safety-follow-up (SFU), up to 5 weeks.
OG007
Run-Out and SFU-PBO/RLZ
Participants who received PBO in TP1 and continued RLZ 560 mg SC up to Week 24 in TP2 received placebo SC, QW for 2 weeks in Run-Out period and had SFU, up to 5 weeks.
OG008
Run-Out and SFU-PBO/PBO
Participants who received PBO in TP1 and continued PBO SC up to Week 24 in TP2 received placebo SC, QW for 2 weeks in Run-Out period and had SFU, up to 5 weeks.
Units
Counts
Participants
OG00063
OG00122
OG00241
OG00318
OG00419
OG00520
OG00622
OG00720
OG00821
Title
Denominators
Categories
Title
Measurements
OG0000
OG0013
OG0021
OG0030
OG0040
OG0051
OG0060
OG0070
OG0082
Units
Counts
Participants
OG00041
OG00118
Title
Denominators
Categories
Title
Measurements
OG0006.30(5.59 to 7.01)
OG0015.79(4.97 to 6.60)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Longitudinal mixed effects model
0.358
Difference from Placebo
-0.51
2-Sided
95
-1.60
0.58
The difference presented is RLZ 24 weeks minus PBO 24 weeks.
Superiority
Units
Counts
Participants
OG00041
OG00141
Title
Denominators
Categories
Title
Measurements
OG00070.70(64.90 to 76.50)
OG00162.30(57.32 to 67.28)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Longitudinal mixed effects model
0.003
Difference from Placebo
-8.40
2-Sided
95
-13.84
-2.96
The difference presented is RLZ 12 weeks minus Placebo
Superiority
OG00041
OG00141
Title
Denominators
Categories
Title
Measurements
OG0006.59(5.96 to 7.21)
OG0016.63(6.09 to 7.18)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Longitudinal mixed effects model
0.878
Differences from Placebo
0.05
2-Sided
95
-0.55
0.64
The differences presented is RLZ 12 weeks minus Placebo.
Superiority
OG00041
OG00141
Title
Denominators
Categories
Title
Measurements
OG0007.26(6.66 to 7.86)
OG0016.98(6.45 to 7.51)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Longitudinal mixed effects model
0.352
Difference from Placebo
-0.28
2-Sided
95
-0.86
0.31
The difference presented is RLZ 12 weeks minus Placebo.