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Trial · NCT04224688

Results by group18

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Percentage of Participants With Durable Clinically Meaningful Platelet Response of ≥50×10^9/L, for at Least 8 Out of 12 Weeks During the Last 12 WeeksPlacebo0Percentage of participants
Percentage of Participants With Durable Clinically Meaningful Platelet Response of ≥50×10^9/L, for at Least 8 Out of 12 Weeks During the Last 12 WeeksRozanolixizumab5.0Percentage of participants
Cumulative Number of Weeks With Clinically Meaningful Platelet Response of ≥50×10^9/L Over the 24-week Treatment PeriodPlacebo0.0Full Range 0 to 10Weeks
Cumulative Number of Weeks With Clinically Meaningful Platelet Response of ≥50×10^9/L Over the 24-week Treatment PeriodRozanolixizumab1.0Full Range 0 to 18Weeks
Time to First Clinically Meaningful Platelet Response (CMPR) of ≥50×10^9/L: Time From Starting Treatment to Achievement of First Response of ≥50×10^9/LPlaceboNA95% Confidence Interval 4.0 to NADays
Time to First Clinically Meaningful Platelet Response (CMPR) of ≥50×10^9/L: Time From Starting Treatment to Achievement of First Response of ≥50×10^9/LRozanolixizumab8.095% Confidence Interval 5.0 to NADays
Percentage of Participants With Clinically Meaningful Platelet Response of ≥50×10^9/L by Day 8Placebo10.0Percentage of participants
Percentage of Participants With Clinically Meaningful Platelet Response of ≥50×10^9/L by Day 8Rozanolixizumab45.0Percentage of participants
Percentage of Participants With Response Defined as Platelet Count ≥30*10^9/L and at Least Doubling of Baseline, at Least 2 Separate Occasions at Two Adjacent Nominal Visits at Least 7 Days Apart, and Absence of Bleeding
Placebo10.0Percentage of participants
Percentage of Participants With Response Defined as Platelet Count ≥30*10^9/L and at Least Doubling of Baseline, at Least 2 Separate Occasions at Two Adjacent Nominal Visits at Least 7 Days Apart, and Absence of Bleeding
Rozanolixizumab20.0Percentage of participants
Time to First Rescue TherapyPlaceboNA95% Confidence Interval 4.0 to NADays
Time to First Rescue TherapyRozanolixizumabNA95% Confidence Interval 46.0 to NADays
Change From Baseline to Week 25 in Primary Immune Thrombocytopenia Patient Assessment Questionnaire (ITP-PAQ) Symptoms ScorePlacebo-0.5Standard Deviation 17.0units on a scale
Change From Baseline to Week 25 in Primary Immune Thrombocytopenia Patient Assessment Questionnaire (ITP-PAQ) Symptoms ScoreRozanolixizumab4.2Standard Deviation 12.9units on a scale
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)Placebo60.0Percentage of participants
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)Rozanolixizumab95.0Percentage of participants
Percentage of Participants With TEAEs Leading to Withdrawal of Investigational Medicinal Product (ie, Study Discontinuation)Placebo0Percentage of participants
Percentage of Participants With TEAEs Leading to Withdrawal of Investigational Medicinal Product (ie, Study Discontinuation)Rozanolixizumab10.0Percentage of participants

Source ClinicalTrials.govtrials-2026-11-12-0.4.0

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.

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