FibromyalgiaPhase 2NCT05643794

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

A Phase 2 study testing rozanolixizumab in people with Fibromyalgia, run by UCB Biopharma SRL at 7 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Fibromyalgia
What is being tested?: rozanolixizumab
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 63 participants
Where: 7 sitesUnited Kingdom
Study dates: 21 Dec 2022to 9 Jul 2024
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 12Show fewer

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

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United Kingdom7 sites

Fm0001 4405
Blackpool
Fm0001 4406
Cannock
Fm0001 4407
Leeds
Fm0001 4404
Liverpool
Fm0001 4402
Manchester
Fm0001 4403
Stockton-on-Tees
Fm0001 4401
Tankersley

Other trials in United Kingdom

About this study

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

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

Conditions: Fibromyalgia
Being tested: rozanolixizumab, Placebo
Keywords: Phase 2, Fibromyalgia, rozanolixizumab
Medical subject headings: Fibromyalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

rozanolixizumabDrug
Also called UCB7665
Study participants will receive rozanolixizumab during the dosing periods as pre-defined.
PlaceboOther
Also called PBO
Study participants will receive Placebo during the dosing periods as pre-defined.

Study groups in NCT05643794
Study group	Role	What they receive
Treatment sequence 1	Experimental	Study participants on Treatment sequence 1 will receive rozanolixizumab and Placebo during the dosing period at pre-specified timepoints. Receives: 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. Receives: 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. Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: At 12 weeks of treatment

Secondary outcomes (6)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 12 weeks of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Dec 20229 Jul 2024

First posted9 Dec 2022
Study start21 Dec 2022
Primary completion28 May 2024
Study completion9 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for FibromyalgiaStudies of the same condition, open and under way.
More trials run by UCB Biopharma SRLThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 63 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05643794
Sponsor's protocol ID: FM0001
Status last verified: Jun 2025
First submitted: 30 Nov 2022
Last updated: 1 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

Goebel A, Meisner P, Rydevik G, Vugler A, Ioannou Y, Tankisheva E, Ewen C, Lambert J, Shaw S, Matthews I. Efficacy and safety of rozanolixizumab in severe fibromyalgia: a phase 2A randomised, double-blind, placebo-controlled, multicentre trial. Lancet Rheumatol. 2026 Sep 16:S2665-9913(26)00252-3. doi: 10.1016/S2665-9913(26)00252-3. Online ahead of print.
PubMed 42748952

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Fibromyalgia trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05643794
Acronym / sponsor ID: FM0001
Conditions: Fibromyalgia
Keywords: Phase 2, Fibromyalgia, rozanolixizumab
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 63 participants (actual)
Lead sponsor: UCB Biopharma SRLIndustry (pharma, biotech, devices)
Study start: 21 Dec 2022 (actual)
Primary completion: 28 May 2024 (actual)
Study completion: 9 Jul 2024 (actual)
First posted: 9 Dec 2022 (actual)
Results: Posted 1 Jul 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Treatment sequence 1	Experimental	Drug: rozanolixizumab, Other: PlaceboStudy participants on Treatment sequence 1 will receive rozanolixizumab and Placebo during the dosing period at pre-specified timepoints.
Treatment sequence 2	Experimental	Drug: rozanolixizumab, Other: PlaceboStudy participants on Treatment sequence 2 will receive rozanolixizumab and Placebo during the dosing period at pre-specified timepoints.
Treatment sequence 3	Placebo comparator	Other: PlaceboStudy participants on Treatment sequence 3 will receive Placebo during the dosing period at pre-specified timepoints.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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
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

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
rozanolixizumabAlso: UCB7665Study participants will receive rozanolixizumab during the dosing periods as pre-defined.	Drug	Treatment sequence 1, Treatment sequence 2
PlaceboAlso: PBOStudy participants will receive Placebo during the dosing periods as pre-defined.	Other	Treatment sequence 1, Treatment sequence 2, Treatment sequence 3

Primary outcome

Brief Pain Inventory Short Form (BPI-SF) Average Interference Score at 12 Weeks of Treatment
Time frame: 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.

6 secondary outcomes

Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study
Time frame: From Baseline till end of Safety Follow-up (up to Week 33)
Number of Participants With TEAEs Leading to Withdrawal of IMP
Time frame: 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
Time frame: At 24 weeks of treatment
Revised Fibromyalgia Impact Questionnaire (FIQR) Score at 12 Weeks of Treatment
Time frame: At 12 weeks of treatment
Mean 7-day Average Daily Pain Score Assessed With Pain Numeric Rating Scale (NRS) at 12 Weeks of Treatment
Time frame: At 12 Weeks of treatment
Mean 7-day Fatigue Score Assessed With Fatigue Numeric Rating Scale at 12 Weeks of Treatment
Time frame: At 12 weeks of treatment

Results and safety

Results posted to the registry on 1 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1: RLZ 12w + RLZ 12w	22	22
Sequence 2: PBO + RLZ 12w	20	20
Sequence 3: PBO + PBO	21	21

Primary outcome: Brief Pain Inventory Short Form (BPI-SF) Average Interference Score at 12 Weeks of Treatment

Time frame: At 12 weeks of treatment. Least squares mean (95% Confidence Interval). Unit: score on a scale

Measure	Placebo (PBO) n = 41	RLZ 12 Weeks n = 41
Value	6.30 (5.59 to 7.01)	5.76 (5.11 to 6.41)

Placebo (PBO) vs RLZ 12 Weeks: Difference from Placebo: -0.54 (95% CI -1.24 to 0.16), p = 0.129, Longitudinal linear mixed effect model

Population analysed: 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.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Baseline till end of Safety Follow-up (up to Week 33). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Run-In-PBO	0 of 63 (0%)	24 of 63 (38.1%)	0 of 63
TP1-RLZ	0 of 22 (0%)	21 of 22 (95.5%)	0 of 22
TP1-PBO	3 of 41 (7.3%)	37 of 41 (90.2%)	0 of 41
TP2-RLZ/RLZ	0 of 18 (0%)	18 of 18 (100%)	0 of 18
TP2-PBO/RLZ	0 of 19 (0%)	19 of 19 (100%)	0 of 19
TP2-PBO/PBO	0 of 20 (0%)	16 of 20 (80%)	0 of 20
Run-Out and SFU-RLZ/RLZ	0 of 22 (0%)	3 of 22 (13.6%)	0 of 22
Run-Out and SFU-PBO/RLZ	1 of 20 (5%)	8 of 20 (40%)	0 of 20
Run-Out and SFU-PBO/PBO	2 of 21 (9.5%)	3 of 21 (14.3%)	0 of 21

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42748952Goebel A, Meisner P, Rydevik G, Vugler A, Ioannou Y, Tankisheva E, Ewen C, Lambert J, Shaw S, Matthews I. Efficacy and safety of rozanolixizumab in severe fibromyalgia: a phase 2A randomised, double-blind, placebo-controlled, multicentre trial. Lancet Rheumatol. 2026 Sep 16:S2665-9913(26)00252-3. doi: 10.1016/S2665-9913(26)00252-3. Online ahead of print.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

UCB Cares study director

001 844 599 2273 (UCB)

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing rozanolixizumab in people with Fibromyalgia, run by UCB Biopharma SRL at 7 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Brief Pain Inventory Short Form (BPI-SF) Average Interference Score at 12 Weeks of Treatment (time frame: At 12 weeks of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05643794, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.