Trial · NCT05681715
A Phase 3, Open-label, Crossover Study to Evaluate Self-administration of Rozanolixizumab by Study Participants With Generalized Myasthenia Gravis (gMG)
NCT05681715, Phase 3, Completed, UCB Biopharma SRL; results first posted 2025-05-07
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. A Phase 3, Open-label, Crossover Study to Evaluate Self-administration of Rozanolixizumab by Study Participants With Generalized Myasthenia Gravis (gMG). Trials, record NCT05681715. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05681715
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 3, Open-label, Crossover Study to Evaluate Self-administration of Rozanolixizumab by Study Participants With Generalized Myasthenia Gravis (gMG)
- NCT number
- NCT05681715
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 62 participants, actual
- Lead sponsor
- UCB Biopharma SRL
- Conditions
- Generalized Myasthenia Gravis
- Interventions
- Rozanolixizumab
- First posted
- 2023-01-12
- Last updated
- 2025-11-06
- Other registries' IDs
- eudract:2022-003870-21
- Results first posted
- 2025-05-07
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Successful Self-administration of Rozanolixizumab (With Correct Use of Syringe Driver and Manual Push, Respectively) During the Self-administration Period at Visit 13 (Week 12) | Week 12 (last dose of Self-administration Period 1) | Successful self-administration was defined by the participant (i) choosing the correct infusion site, (ii) administering SC, and (iii) delivering the intended dose. |
| Primary | Percentage of Participants With Successful Self-administration of Rozanolixizumab (With Correct Use of Syringe Driver and Manual Push, Respectively) During the Self-administration Period at Visit 19 (Week 18) | Week 18 (last dose of Self-administration Period 2) | Successful Self-administration was defined by the participant (i) choosing the correct infusion site, (ii) administering SC, and (iii) delivering the intended dose. |
| Secondary | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) After Syringe Driver or Manual Push Self-administration From Visit 2 (Week 1) up to the End of Study Visit (Visit 21 [Week 26]) | From Week 1 up to the End of Study Visit (Week 26) | An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE was defined as an AE starting on or after the date of first administration of rozanolixizumab in the study, up to and including 8 weeks (56 days) after the final dose. |
| Secondary | Percentage of Participants With Local Site Reactions up to 24 Hours After Each Administration During the Training Period and Self-administration Periods | Up to 24 hours after each administration during the Training Period (Baseline to Week 6) and Self-administration Periods (Week 7 to Week 18) | The local site reactions up to 24 hours after each administration were defined as AEs reported as local site reactions as per case report form within one day after RLZ administration. |
| Secondary | Percentage of Participants With Medication Errors Associated With Adverse Reactions During the 2 Self-administration Periods of the Study | During the Self-administration Periods (Week 7 to Week 18) | Medication errors were defined as an unintended failure in the drug treatment process that leads to, or has the potential to lead to, harm to the study participant. Medication Errors associated with adverse reactions during the 2 Self-administration Periods were measured. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Successful Self-administration of Rozanolixizumab (With Correct Use of Syringe Driver and Manual Push, Respectively) During the Self-administration Period at Visit 13 (Week 12) | Week 12 (last dose of Self-administration Period 1) | The Full Analysis Set (FAS) consisted of all participants who were included in SS, were randomized, and completed both self-administration periods in accordance with the randomization scheme. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Successful Self-administration of Rozanolixizumab (With Correct Use of Syringe Driver and Manual Push, Respectively) During the Self-administration Period at Visit 19 (Week 18) | Week 18 (last dose of Self-administration Period 2) | FAS consisted of all participants who were included in SS, were randomized, and completed both self-administration periods in accordance with the randomization scheme. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) After Syringe Driver or Manual Push Self-administration From Visit 2 (Week 1) up to the End of Study Visit (Visit 21 [Week 26]) | From Week 1 up to the End of Study Visit (Week 26) | SS included all study participants who received at least 1 dose of investigational medicinal product (partial or full). The Randomized Safety Set (RSS) consisted of all participants who were included in SS and were randomized. Here, number of participants analyzed included those participants who were evaluable for the outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Local Site Reactions up to 24 Hours After Each Administration During the Training Period and Self-administration Periods | Up to 24 hours after each administration during the Training Period (Baseline to Week 6) and Self-administration Periods (Week 7 to Week 18) | SS included all study participants who received at least 1 dose of investigational medicinal product (partial or full). Here, number of participants analyzed included those participants who were evaluable for the outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Medication Errors Associated With Adverse Reactions During the 2 Self-administration Periods of the Study | During the Self-administration Periods (Week 7 to Week 18) | RSS consisted of all participants who were included in SS and were randomized. Here, number of participants analyzed included those participants who were evaluable for the outcome measure. | 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 |
|---|---|---|---|---|---|
Percentage of Participants With Successful Self-administration of Rozanolixizumab (With Correct Use of Syringe Driver and Manual Push, Respectively) During the Self-administration Period at Visit 13 (Week 12) | Period 1: RLZ SRD | 100 | percentage of participants | ||
Percentage of Participants With Successful Self-administration of Rozanolixizumab (With Correct Use of Syringe Driver and Manual Push, Respectively) During the Self-administration Period at Visit 13 (Week 12) | Period 1: RLZ MP | 100 | percentage of participants | ||
Percentage of Participants With Successful Self-administration of Rozanolixizumab (With Correct Use of Syringe Driver and Manual Push, Respectively) During the Self-administration Period at Visit 19 (Week 18) | Period 2: RLZ SRD | 100 | percentage of participants | ||
Percentage of Participants With Successful Self-administration of Rozanolixizumab (With Correct Use of Syringe Driver and Manual Push, Respectively) During the Self-administration Period at Visit 19 (Week 18) | Period 2: RLZ MP | 100 | percentage of participants | ||
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) After Syringe Driver or Manual Push Self-administration From Visit 2 (Week 1) up to the End of Study Visit (Visit 21 [Week 26]) | Period 1: RLZ SRD | 35.7 | percentage of participants | ||
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) After Syringe Driver or Manual Push Self-administration From Visit 2 (Week 1) up to the End of Study Visit (Visit 21 [Week 26]) | Period 1: RLZ MP | 29.6 | percentage of participants | ||
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) After Syringe Driver or Manual Push Self-administration From Visit 2 (Week 1) up to the End of Study Visit (Visit 21 [Week 26]) | Period 2: RLZ SRD | 26.9 | percentage of participants | ||
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) After Syringe Driver or Manual Push Self-administration From Visit 2 (Week 1) up to the End of Study Visit (Visit 21 [Week 26]) | Period 2: RLZ MP | 38.5 | percentage of participants | ||
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) After Syringe Driver or Manual Push Self-administration From Visit 2 (Week 1) up to the End of Study Visit (Visit 21 [Week 26]) | RLZ Total | 75.8 | percentage of participants | ||
| Percentage of Participants With Local Site Reactions up to 24 Hours After Each Administration During the Training Period and Self-administration Periods | All Participants: Training Period | 0 | percentage of participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Training Period (6-weeks) | STARTED | All Participants: Training Period | 62 | |
| Training Period (6-weeks) | STARTED | Sequence 1: RLZ Syringe Driver (SRD) - RLZ Manual Push (MP) | 0 | |
| Training Period (6-weeks) | STARTED | Sequence 2: RLZ MP - RLZ SRD | 0 | |
| Training Period (6-weeks) | COMPLETED | All Participants: Training Period | 55 | |
| Training Period (6-weeks) | COMPLETED | Sequence 1: RLZ Syringe Driver (SRD) - RLZ Manual Push (MP) | 0 | |
| Training Period (6-weeks) | COMPLETED | Sequence 2: RLZ MP - RLZ SRD | 0 | |
| Training Period (6-weeks) | NOT COMPLETED | All Participants: Training Period | 7 | |
| Training Period (6-weeks) | NOT COMPLETED | Sequence 1: RLZ Syringe Driver (SRD) - RLZ Manual Push (MP) | 0 | |
| Training Period (6-weeks) | NOT COMPLETED | Sequence 2: RLZ MP - RLZ SRD | 0 | |
| Self-administration Period 1 (6 Weeks) | STARTED | All Participants: Training Period | 0 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events44
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 | All Participants: Training Period | 4 | 62 | 4 |
| other | Diarrhoea | Gastrointestinal disorders | Self-Administration Period 1 and 2: RLZ SRD | 0 | 54 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Self-Administration Period 1 and 2: RLZ MP | 1 | 53 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | RLZ Total | 5 | 62 | 5 |
| other | Pyrexia | General disorders | All Participants: Training Period | 4 | 62 | 4 |
| other | Pyrexia | General disorders | Self-Administration Period 1 and 2: RLZ SRD | 1 | 54 | 1 |
| other | Pyrexia | General disorders | Self-Administration Period 1 and 2: RLZ MP | 3 | 53 | 5 |
| other | Pyrexia | General disorders | RLZ Total | 6 | 62 | 10 |
| other | COVID-19 | Infections and infestations | All Participants: Training Period | 4 | 62 | 4 |
| other | COVID-19 | Infections and infestations | Self-Administration Period 1 and 2: RLZ SRD | 0 | 54 | 0 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Participants: Training Period | 0 | 62 |
| Total, all-cause mortality | Self-Administration Period 1 and 2: RLZ SRD | 0 | 54 |
| Total, all-cause mortality | Self-Administration Period 1 and 2: RLZ MP | 0 | 53 |
| Total, all-cause mortality | RLZ Total | 0 | 62 |
| Total, other adverse events | All Participants: Training Period | 19 | 62 |
| Total, other adverse events | Self-Administration Period 1 and 2: RLZ SRD | 6 | 54 |
| Total, other adverse events | Self-Administration Period 1 and 2: RLZ MP | 6 | 53 |
| Total, other adverse events | RLZ Total | 24 | 62 |
| Total, serious adverse events | All Participants: Training Period | 1 | 62 |
| Total, serious adverse events | Self-Administration Period 1 and 2: RLZ SRD | 3 | 54 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41074934 | RESULT |
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.
GET https://conductscience.org/api/trials/v1/NCT05681715
GET https://conductscience.org/api/trials/v1/NCT05681715/flow?page=2