Trial · NCT04596995
A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)
NCT04596995, Phase 3, Terminated, UCB Biopharma SRL; results first posted 2024-02-05
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP). Trials, record NCT04596995. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04596995
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)
- NCT number
- NCT04596995
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 43 participants, actual
- Lead sponsor
- UCB Biopharma SRL
- Conditions
- Primary Immune Thrombocytopenia
- Interventions
- Rozanolixizumab
- First posted
- 2020-10-22
- Last updated
- 2024-02-05
- Other registries' IDs
- eudract:2019-000883-40
- Results first posted
- 2024-02-05
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | From Baseline to end of Safety Follow-Up Period (up to Week 60) | 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 can 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. TEAEs are defined as AEs starting after the time of first IMP administration up to and including 8 weeks (56 days) after the final dose. |
| Primary | Percentage of Participants With TEAEs Leading to Permanent Withdrawal of Rozanolixizumab (ie, Study Discontinuation) | From Baseline to end of Safety Follow-Up Period (up to Week 60) | 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 can 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. TEAEs are defined as AEs starting after the time of first IMP administration up to and including 8 weeks (56 days) after the final dose. |
| Secondary | Percentage of Participants With Stable Clinically Meaningful Response Without Rescue Therapy at ≥70% of the Visits Over the Planned 52-week Treatment Period Starting at Week 4 | Over the 52-week Treatment Period (starting at Week 4) | Stable Clinically Meaningful Response was defined as Clinically Meaningful Response (ie, platelet count ≥50×10\^9/L) without rescue therapy at ≥70% of the visits over the planned 52-week Treatment Period starting at Week 4. |
| Secondary | Change From Baseline in Immune Thrombocytopenia-Patient Assessment Questionnaire (ITP-PAQ) to Week 53 or 55 Symptoms Domain Score | Week 53 or 55, compared to Baseline | The ITP-PAQ Version 1 is a 44 item disease-specific Health-Related Quality of Life questionnaire developed for use in adults with chronic ITP. It includes 10 scales, Four of the scales measure physical health: Symptoms (6 items), Bother (3 items), Fatigue (4 items), and Activity (2 items). Two of the scales measure emotional health: Fear (5 items) and Psychological (5 items) Health. The remaining four scales measure other aspects of quality of life (QOL): Work QOL (4 items), Social QOL (4 items), Women's Reproductive QOL (6 items) and Overall QOL (5 items). Each item is rated on a Likert-type scale containing 4 to 7 responses. All item scores are transformed to a 0 to 100 continuum and are weighted equally to derive individual scale scores and the total score (0-100) is calculated as per the formula: Sum of item scores within the scale/raw sum range\*100. Higher scores indicate better health status. |
Source ClinicalTrials.gov
Outcomes4
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 Treatment-emergent Adverse Events (TEAEs) | From Baseline to end of Safety Follow-Up Period (up to Week 60) | Safety Set included all study participants who received at least 1 dose of IMP (partial or full). | percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants With TEAEs Leading to Permanent Withdrawal of Rozanolixizumab (ie, Study Discontinuation) | From Baseline to end of Safety Follow-Up Period (up to Week 60) | Safety Set included all study participants who received at least 1 dose of IMP (partial or full). | percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Stable Clinically Meaningful Response Without Rescue Therapy at ≥70% of the Visits Over the Planned 52-week Treatment Period Starting at Week 4 | Over the 52-week Treatment Period (starting at Week 4) | Safety Set included all study participants who received at least 1 dose of IMP (partial or full). | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Immune Thrombocytopenia-Patient Assessment Questionnaire (ITP-PAQ) to Week 53 or 55 Symptoms Domain Score | Week 53 or 55, compared to Baseline | Safety Set included all study participants who received at least 1 dose of IMP (partial or full). Here, number of participants analyzed signifies those who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable at specified time points. Week 53 was used for study participants who finished the study on weekly dosing, and Week 55 was used for study participants who finished the study on biweekly dosing. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group5
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 Treatment-emergent Adverse Events (TEAEs) | Rozanolixizumab | 90.7 | percentage of Participants | ||
| Percentage of Participants With TEAEs Leading to Permanent Withdrawal of Rozanolixizumab (ie, Study Discontinuation) | Rozanolixizumab | 0 | percentage of Participants | ||
| Percentage of Participants With Stable Clinically Meaningful Response Without Rescue Therapy at ≥70% of the Visits Over the Planned 52-week Treatment Period Starting at Week 4 | Rozanolixizumab | 16.3 | percentage of participants | ||
| Change From Baseline in Immune Thrombocytopenia-Patient Assessment Questionnaire (ITP-PAQ) to Week 53 or 55 Symptoms Domain Score | Rozanolixizumab | Week 53 | 2.98 | Standard Deviation 11.21 | score on a scale |
| Change From Baseline in Immune Thrombocytopenia-Patient Assessment Questionnaire (ITP-PAQ) to Week 53 or 55 Symptoms Domain Score | Rozanolixizumab | Week 55 | 4.17 | Standard Deviation 12.50 | score on a scale |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rozanolixizumab | 43 | |
| Overall Study | COMPLETED | Rozanolixizumab | 14 | |
| Overall Study | NOT COMPLETED | Rozanolixizumab | 29 |
Source ClinicalTrials.gov
Adverse events26
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 | Anaemia | Blood and lymphatic system disorders | Rozanolixizumab | 3 | 43 | 11 |
| other | Diarrhoea | Gastrointestinal disorders | Rozanolixizumab | 5 | 43 | 5 |
| other | Nausea | Gastrointestinal disorders | Rozanolixizumab | 5 | 43 | 9 |
| other | Vomiting | Gastrointestinal disorders | Rozanolixizumab | 3 | 43 | 7 |
| other | Fatigue | General disorders | Rozanolixizumab | 5 | 43 | 6 |
| other | Pyrexia | General disorders | Rozanolixizumab | 9 | 43 | 26 |
| other | COVID-19 | Infections and infestations | Rozanolixizumab | 7 | 43 | 8 |
| other | Pharyngitis | Infections and infestations | Rozanolixizumab | 4 | 43 | 4 |
| other | Upper respiratory tract infection | Infections and infestations | Rozanolixizumab | 3 | 43 | 4 |
| other | Contusion | Injury, poisoning and procedural complications | Rozanolixizumab | 3 | 43 | 3 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rozanolixizumab | 0 | 43 |
| Total, other adverse events | Rozanolixizumab | 31 | 43 |
| Total, serious adverse events | Rozanolixizumab | 9 | 43 |
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 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/NCT04596995
GET https://conductscience.org/api/trials/v1/NCT04596995/events?page=2