Trial · NCT04875975
A Study to Test the Efficacy, Safety, and Pharmacokinetics of Rozanolixizumab in Adult Study Participants With Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis
NCT04875975, Phase 2, Terminated, UCB Biopharma SRL; results first posted 2025-05-31
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. A Study to Test the Efficacy, Safety, and Pharmacokinetics of Rozanolixizumab in Adult Study Participants With Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis. Trials, record NCT04875975. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04875975
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Test the Efficacy, Safety, and Pharmacokinetics of Rozanolixizumab in Adult Study Participants With Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis
- NCT number
- NCT04875975
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 12 participants, actual
- Lead sponsor
- UCB Biopharma SRL
- Conditions
- Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis
- Interventions
- Rozanolixizumab, Placebo
- First posted
- 2021-05-06
- Last updated
- 2025-05-31
- Other registries' IDs
- eudract:2019-004778-25
- Results first posted
- 2025-05-31
- Limitations and caveats
- Due to the early termination of the recruitment and insufficient participants, it was not feasible to carry out the statistical analyses as originally planned.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Seizure Free Study Participants at the End of the Treatment | From Baseline until the end of the Treatment (Week 25) | Seizure freedom was defined as a minimum of 28 consecutive days of no seizures of any type during the treatment and maintained until the end of the treatment (Week 25). |
| Secondary | Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Scale Index Score at the End of the Treatment | From Baseline to Week 5, 13, 21 and 25 | The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) consists of 12 subtests that contribute to 5 age-based domain index scores (immediate memory, visuospatial/constructional, language, attention, delayed memory) that were aggregated for a total scale index score. All index scores have an age-based mean of 100, with a standard deviation (SD) of 15. The total scale score was calculated by taking the mean of the sum of the five index scores. Total possible scale index scores range from 40-135. Higher scores reflect better neurocognitive performance. The total scale index score is the score typically used to reflect global neurocognitive status. Baseline of RBANS is defined as the screening (Visit 1, Week -1) value. |
| Secondary | Percentage of Participants With a Favorable Outcome in the Modified Rankin Scale (mRS) During the Treatment | From Baseline until the end of the Treatment (Week 25) | Percentage of participants with a favorable outcome in mRS during treatment, where favorable outcome defined as no worsening for participants with Baseline mRS score of ≤1 or improvement of ≥1 point for participants with Baseline mRS score of ≥2. The mRS is commonly used scale for measuring degree of disability or dependence in daily activities of people who suffered a stroke or other causes of neurological disability. The scale ranges from 0 (perfect health) to 6 (death). 0-No symptoms at all 1. No significant disability despite symptoms; able to carry out all usual activities 2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. Moderate disability; requiring some help, but able to walk without assistance 4. Moderately severe disability; unable to walk and attend to own bodily needs without assistance 5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. Dead |
| Secondary | Number of Participants Who Required Rescue Medication Due to an Absence or Loss of Clinical Benefit During the Treatment | From Baseline until the end of the Treatment (Week 25) | Study participants who required rescue medication due to an absence or loss of clinical benefit were discontinued blinded treatment and completed the assessments for the early discontinuation visit. |
| Secondary | Time to First Occurrence of Seizure Freedom During the Treatment | From Baseline until the end of the Treatment (Week 25) | The time to first occurrence of seizure freedom was defined by the number of days after randomization to the first day of the first 28 consecutive days without seizures during the treatment. Time to first occurrence of 28 consecutive days of seizure freedom (days) during the treatment was calculated as date of first day of occurrence of 28 consecutive days of seizure freedom - Date of Randomization + 1. |
| Secondary | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | From Baseline until the End of Study (Week 32) | An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP, whether or not related to the IMP. A TEAE was defined as an AE starting on or after the time of first administration of IMP or any unresolved event already present before the first administration of IMP that worsens in intensity following exposure to treatment up to the end of the Treatment and including the 8-week (56 days) Safety-Follow Up (SFU). |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Seizure Free Study Participants at the End of the Treatment | From Baseline until the end of the Treatment (Week 25) | The Randomized Set (RS) consisted of all enrolled study participants who were randomized to treatment arms. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Scale Index Score at the End of the Treatment | From Baseline to Week 5, 13, 21 and 25 | The Randomized Set (RS) consisted of all enrolled study participants who were randomized to treatment arms. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Here, number analyzed signifies participants who were evaluable at specified time points. | score on a scale | MEAN |
| SECONDARY | Percentage of Participants With a Favorable Outcome in the Modified Rankin Scale (mRS) During the Treatment | From Baseline until the end of the Treatment (Week 25) | The Randomized Set (RS) consisted of all enrolled study participants who were randomized to treatment arms. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Analysis datasets were not generated an output when the n \< 3, therefore, no data obtained and reported. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants Who Required Rescue Medication Due to an Absence or Loss of Clinical Benefit During the Treatment | From Baseline until the end of the Treatment (Week 25) | The Randomized Set (RS) consisted of all enrolled study participants who were randomized to treatment arms. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to First Occurrence of Seizure Freedom During the Treatment | From Baseline until the end of the Treatment (Week 25) | The Randomized Set (RS) consisted of all enrolled study participants who were randomized to treatment arms. | Weeks | MEDIAN |
| SECONDARY | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | From Baseline until the End of Study (Week 32) | The Safety Set (SS) consisted of all randomized study participants who received at least one dose of IMP. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Seizure Free Study Participants at the End of the Treatment | Placebo | 1 | Participants | ||
| Number of Seizure Free Study Participants at the End of the Treatment | Rozanolixizumab (RLZ) | 0 | Participants | ||
| Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Scale Index Score at the End of the Treatment | Placebo | Week 5 | 4.5 | Standard Deviation 2.6 | score on a scale |
| Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Scale Index Score at the End of the Treatment | Rozanolixizumab (RLZ) | Week 5 | 2.2 | Standard Deviation 11.3 | score on a scale |
| Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Scale Index Score at the End of the Treatment | Placebo | Week 13 | 7.0 | Standard Deviation 2.9 | score on a scale |
| Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Scale Index Score at the End of the Treatment | Rozanolixizumab (RLZ) | Week 13 | 12.3 | Standard Deviation 7.9 | score on a scale |
| Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Scale Index Score at the End of the Treatment | Placebo | Week 21 | 7.0 | Standard Deviation 7.3 | score on a scale |
| Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Scale Index Score at the End of the Treatment | Rozanolixizumab (RLZ) | Week 21 | NA | Standard Deviation NA | score on a scale |
| Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Scale Index Score at the End of the Treatment | Placebo | Week 25 | NA | Standard Deviation NA | score on a scale |
| Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Scale Index Score at the End of the Treatment | Rozanolixizumab (RLZ) | Week 25 | NA | Standard Deviation NA | score on a scale |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 6 | |
| Overall Study | STARTED | Rozanolixizumab (RLZ) | 6 | |
| Overall Study | COMPLETED | Placebo | 2 | |
| Overall Study | COMPLETED | Rozanolixizumab (RLZ) | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 4 | |
| Overall Study | NOT COMPLETED | Rozanolixizumab (RLZ) | 6 |
Source ClinicalTrials.gov
Adverse events152
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 | Lymphopenia | Blood and lymphatic system disorders | Placebo | 1 | 6 | 2 |
| other | Lymphopenia | Blood and lymphatic system disorders | Rozanolixizumab (RLZ) | 1 | 6 | 1 |
| other | Lacrimation increased | Eye disorders | Placebo | 1 | 6 | 1 |
| other | Lacrimation increased | Eye disorders | Rozanolixizumab (RLZ) | 0 | 6 | 0 |
| other | Vision blurred | Eye disorders | Placebo | 1 | 6 | 1 |
| other | Vision blurred | Eye disorders | Rozanolixizumab (RLZ) | 1 | 6 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 1 | 6 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | Rozanolixizumab (RLZ) | 3 | 6 | 7 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 0 | 6 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Rozanolixizumab (RLZ) | 1 | 6 | 1 |
1 to 10 of 152Source ClinicalTrials.gov
See all 152 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 6 |
| Total, all-cause mortality | Rozanolixizumab (RLZ) | 0 | 6 |
| Total, other adverse events | Placebo | 6 | 6 |
| Total, other adverse events | Rozanolixizumab (RLZ) | 6 | 6 |
| Total, serious adverse events | Placebo | 3 | 6 |
| Total, serious adverse events | Rozanolixizumab (RLZ) | 3 | 6 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Rozanolixizumab (RLZ) vs Placebo: deaths from any cause | Trial comparisons |
| Rozanolixizumab (RLZ) vs Placebo: Number of Participants Who Required Rescue Medication Due to an Absence or Loss of Clinical Benefit During the Treatment | Trial comparisons |
| Rozanolixizumab (RLZ) vs Placebo: Number of Seizure Free Study Participants at the End of the Treatment | Trial comparisons |
| Rozanolixizumab (RLZ) vs Placebo: serious adverse events | Trial comparisons |
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.
GET https://conductscience.org/api/trials/v1/NCT04875975
GET https://conductscience.org/api/trials/v1/NCT04875975/events?page=2