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

NCT05643794 | Completed Phase 2 Results DMC

• 1 other identifier: FM0001
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 7

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).

Conditions

Fibromyalgia

Keywords

Phase 2; Fibromyalgia; rozanolixizumab

Outcome Measures

Primary Outcomes (1)

• 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 (6)

• Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study

  From Baseline till end of Safety Follow-up (up to Week 33)

• Number of Participants With TEAEs Leading to Withdrawal of IMP

  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

  At 24 weeks of treatment

• Revised Fibromyalgia Impact Questionnaire (FIQR) Score at 12 Weeks of Treatment

  At 12 weeks of treatment

• Mean 7-day Average Daily Pain Score Assessed With Pain Numeric Rating Scale (NRS) at 12 Weeks of Treatment

  At 12 Weeks of treatment

Study Arms (3)

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

rozanolixizumab DRUG

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

Also known as: UCB7665

Treatment sequence 1; Treatment sequence 2

Placebo OTHER

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

Also known as: PBO

Treatment sequence 1; Treatment sequence 2; Treatment sequence 3

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB Biopharma SRL: lead

Study Sites (7)

Fm0001 4405

Blackpool, United Kingdom

Location

Fm0001 4406

Cannock, United Kingdom

Location

Fm0001 4407

Leeds, United Kingdom

Location

Fm0001 4404

Liverpool, United Kingdom

Location

Fm0001 4402

Manchester, United Kingdom

Location

Fm0001 4403

Stockton-on-Tees, United Kingdom

Location

Fm0001 4401

Tankersley, United Kingdom

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

rozanolixizumab

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Results Point of Contact

• Title: UCB
• Organization: Cares

UCBCares@ucb.com

001 844 599 2273

Study Officials

• UCB Cares

  001 844 599 2273 (UCB)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 9, 2022
• Study Start: December 21, 2022
• Primary Completion: May 28, 2024
• Study Completion: July 9, 2024
• Last Updated: July 1, 2025
• Results First Posted: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

GB (7)