Trial · NCT05643794
A Proof-of-concept Study to Evaluate the Efficacy and Safety of Rozanolixizumab to Treat Adult Study Participants With Severe Fibromyalgia Syndrome
NCT05643794, Phase 2, Completed, UCB Biopharma SRL; results first posted 2025-07-01
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. A Proof-of-concept Study to Evaluate the Efficacy and Safety of Rozanolixizumab to Treat Adult Study Participants With Severe Fibromyalgia Syndrome. Trials, record NCT05643794. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05643794
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Proof-of-concept Study to Evaluate the Efficacy and Safety of Rozanolixizumab to Treat Adult Study Participants With Severe Fibromyalgia Syndrome
- NCT number
- NCT05643794
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 63 participants, actual
- Lead sponsor
- UCB Biopharma SRL
- Conditions
- Fibromyalgia
- Interventions
- rozanolixizumab, Placebo
- First posted
- 2022-12-09
- Last updated
- 2025-07-01
- Results first posted
- 2025-07-01
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Brief Pain Inventory Short Form (BPI-SF) Average Interference Score at 12 Weeks of Treatment | 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. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study | From Baseline till end of Safety Follow-up (up to Week 33) | 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. |
| Secondary | Number of Participants With TEAEs Leading to Withdrawal of IMP | From Baseline till end of Safety Follow-up (up to Week 33) | 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. |
| Secondary | Brief Pain Inventory Short Form (BPI-SF) Average Interference Score at 24 Weeks of Treatment | 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. |
| Secondary | Revised Fibromyalgia Impact Questionnaire (FIQR) Score at 12 Weeks of Treatment | 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. |
| Secondary | Mean 7-day Average Daily Pain Score Assessed With Pain Numeric Rating Scale (NRS) at 12 Weeks of Treatment | 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. |
| Secondary | Mean 7-day Fatigue Score Assessed With Fatigue Numeric Rating Scale at 12 Weeks of Treatment | 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Brief Pain Inventory Short Form (BPI-SF) Average Interference Score at 12 Weeks of Treatment | At 12 weeks of treatment | 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. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study | From Baseline till end of Safety Follow-up (up to Week 33) | The Safety Set as treated (SS-t) included all study participants who received any study treatment, including during Run-In period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With TEAEs Leading to Withdrawal of IMP | From Baseline till end of Safety Follow-up (up to Week 33) | The SS-t included all study participants who received any study treatment, including during Run-In period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Brief Pain Inventory Short Form (BPI-SF) Average Interference Score at 24 Weeks of Treatment | At 24 weeks of treatment | 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. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Revised Fibromyalgia Impact Questionnaire (FIQR) Score at 12 Weeks of Treatment | At 12 weeks of treatment | 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. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean 7-day Average Daily Pain Score Assessed With Pain Numeric Rating Scale (NRS) at 12 Weeks of Treatment | At 12 Weeks of treatment | 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. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean 7-day Fatigue Score Assessed With Fatigue Numeric Rating Scale at 12 Weeks of Treatment | At 12 weeks of treatment | 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. | score on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Brief Pain Inventory Short Form (BPI-SF) Average Interference Score at 12 Weeks of Treatment | Placebo (PBO) | 6.30 | 95% Confidence Interval 5.59 to 7.01 | score on a scale | |
| Brief Pain Inventory Short Form (BPI-SF) Average Interference Score at 12 Weeks of Treatment | RLZ 12 Weeks | 5.76 | 95% Confidence Interval 5.11 to 6.41 | score on a scale | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study | Run-In-PBO | 44 | Participants | ||
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study | TP1-RLZ | 22 | Participants | ||
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study | TP1-PBO | 41 | Participants | ||
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study | TP2-RLZ/RLZ | 18 | Participants | ||
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study | TP2-PBO/RLZ | 19 | Participants | ||
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study | TP2-PBO/PBO | 19 | Participants | ||
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study | Run-Out and SFU-RLZ/RLZ | 10 | Participants | ||
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study | Run-Out and SFU-PBO/RLZ | 12 | Participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow45
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Run-In (2 Weeks) | STARTED | Sequence 1: RLZ 12w + RLZ 12w | 22 | |
| Run-In (2 Weeks) | STARTED | Sequence 2: PBO + RLZ 12w | 20 | |
| Run-In (2 Weeks) | STARTED | Sequence 3: PBO + PBO | 21 | |
| Run-In (2 Weeks) | COMPLETED | Sequence 1: RLZ 12w + RLZ 12w | 22 | |
| Run-In (2 Weeks) | COMPLETED | Sequence 2: PBO + RLZ 12w | 20 | |
| Run-In (2 Weeks) | COMPLETED | Sequence 3: PBO + PBO | 21 | |
| Run-In (2 Weeks) | NOT COMPLETED | Sequence 1: RLZ 12w + RLZ 12w | 0 | |
| Run-In (2 Weeks) | NOT COMPLETED | Sequence 2: PBO + RLZ 12w | 0 | |
| Run-In (2 Weeks) | NOT COMPLETED | Sequence 3: PBO + PBO | 0 | |
| Treatment Period 1 (12 Weeks) | STARTED | Sequence 1: RLZ 12w + RLZ 12w | 22 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 participant flowAdverse events828
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Run-In-PBO | 4 | 63 | 4 |
| other | Diarrhoea | Gastrointestinal disorders | TP1-RLZ | 3 | 22 | 7 |
| other | Diarrhoea | Gastrointestinal disorders | TP1-PBO | 3 | 41 | 4 |
| other | Diarrhoea | Gastrointestinal disorders | TP2-RLZ/RLZ | 1 | 18 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | TP2-PBO/RLZ | 7 | 19 | 7 |
| other | Diarrhoea | Gastrointestinal disorders | TP2-PBO/PBO | 1 | 20 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Run-Out and SFU-RLZ/RLZ | 0 | 22 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Run-Out and SFU-PBO/RLZ | 0 | 20 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Run-Out and SFU-PBO/PBO | 0 | 21 | 0 |
| other | Headache | Nervous system disorders | Run-In-PBO | 11 | 63 | 13 |
1 to 10 of 828Source ClinicalTrials.gov
See all 828 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Run-In-PBO | 0 | 63 |
| Total, all-cause mortality | TP1-RLZ | 0 | 22 |
| Total, all-cause mortality | TP1-PBO | 0 | 41 |
| Total, all-cause mortality | TP2-RLZ/RLZ | 0 | 18 |
| Total, all-cause mortality | TP2-PBO/RLZ | 0 | 19 |
| Total, all-cause mortality | TP2-PBO/PBO | 0 | 20 |
| Total, all-cause mortality | Run-Out and SFU-RLZ/RLZ | 0 | 22 |
| Total, all-cause mortality | Run-Out and SFU-PBO/RLZ | 0 | 20 |
| Total, all-cause mortality | Run-Out and SFU-PBO/PBO | 0 | 21 |
| Total, other adverse events | Run-In-PBO | 24 | 63 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42748952 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT05643794/results?page=2