Clinical trial NCT05643794: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fibromyalgia
Keywords: Phase 2
Fibromyalgia
rozanolixizumab
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2022-12-09
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).


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:

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

Primary outcomes:
measure: Brief Pain Inventory short form (BPI-SF) average interference score after 12 weeks of treatment
timeFrame: After 12 weeks of treatment
Secondary outcomes:
measure: Percentage of participants with treatment-emergent adverse events (TEAEs) during the study
timeFrame: From Baseline till end of Safety Follow-up (up to 32 Weeks)
measure: Percentage of participants with TEAEs leading to withdrawal of investigational medicinal product (IMP)
timeFrame: From Baseline till end of Safety Follow-up (up to 32 Weeks)
measure: Brief Pain Inventory short form (BPI-SF) average interference score after 24 weeks of treatment
timeFrame: After 24 weeks of treatment
measure: Revised Fibromyalgia Impact Questionnaire (FIQR) score after 10 weeks of treatment
timeFrame: After 10 weeks of treatment
measure: Mean 7-day average daily pain score assessed with Pain Numeric Rating Scale after 10 weeks of treatment
timeFrame: After 10 weeks of treatment
measure: Mean 7-day fatigue score assessed with Fatigue Numeric Rating Scale after 10 weeks of treatment
timeFrame: After 10 weeks of treatment
Other outcomes:
Locations:
city: Blackpool
country: United Kingdom
facility: Fm0001 4405
city: Cannock
country: United Kingdom
facility: Fm0001 4406
city: Leeds
country: United Kingdom
facility: Fm0001 4407
city: Liverpool
country: United Kingdom
facility: Fm0001 4404
city: Manchester
country: United Kingdom
facility: Fm0001 4402
city: Stockton-on-tees
country: United Kingdom
facility: Fm0001 4403
city: Tankersley
country: United Kingdom
facility: Fm0001 4401
Study officials:
affiliation: 001 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References: