Trial record 1 of 1 for:
TP0003
A Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) (myOpportunITy1)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04200456 |
Recruitment Status :
Terminated
(Strategic Business Decision; Not a safety decision)
First Posted : December 16, 2019
Results First Posted : August 8, 2023
Last Update Posted : August 8, 2023
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Sponsor:
UCB Biopharma SRL
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma SRL )
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Primary Immune Thrombocytopenia |
Interventions |
Drug: Rozanolixizumab Other: Placebo |
Enrollment | 33 |
Participant Flow
Recruitment Details | The study started to enroll study participants in Jan 2020 and terminated on April 2022. |
Pre-assignment Details | Participant Flow refers to the Randomized Set. |
Arm/Group Title | Placebo | Rozanolixizumab |
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Arm/Group Description | Participants received a fixed-unit starting dose of placebo subcutaneous (sc) infusion matched to rozanolixizumab Dose A on Day 1. Following the initial dose, participants received a fixed-unit dose of placebo sc infusion matched to rozanolixizumab Dose B every 2 weeks until Week 23. Participants were followed up to a maximum of Week 31. | Participants received a fixed-unit starting dose of rozanolixizumab sc infusion equivalent to Dose A on Day 1. Following the initial dose, participants received a fixed-unit dose of rozanolixizumab sc infusion equivalent to Dose B every 2 weeks until Week 23. After protocol amendment 3, the starting dose was removed and the frequency of administration of the Dose B was changed to weekly. Participants were followed up to a maximum of Week 31. |
Period Title: Overall Study | ||
Started | 12 | 21 |
Completed | 9 | 15 |
Not Completed | 3 | 6 |
Reason Not Completed | ||
Physician Decision | 0 | 1 |
Withdrawal by Subject | 2 | 2 |
Lack of Efficacy | 1 | 1 |
Adverse event, non-fatal | 0 | 1 |
Administration of Rescue and concern about IMP | 0 | 1 |
Baseline Characteristics
Arm/Group Title | Placebo | Rozanolixizumab | Total | |
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Arm/Group Description | Participants received a fixed-unit starting dose of placebo sc infusion matched to rozanolixizumab Dose A on Day 1. Following the initial dose, participants received a fixed-unit dose of placebo sc infusion matched to rozanolixizumab Dose B every 2 weeks until Week 23. Participants were followed up to a maximum of Week 31. | Participants received a fixed-unit starting dose of rozanolixizumab sc infusion equivalent to Dose A on Day 1. Following the initial dose, participants received a fixed-unit dose of rozanolixizumab sc infusion equivalent to Dose B every 2 weeks until Week 23. After protocol amendment 3, the starting dose was removed and the frequency of administration of the Dose B was changed to weekly. Participants were followed up to a maximum of Week 31. | Total of all reporting groups | |
Overall Number of Baseline Participants | 12 | 21 | 33 | |
Baseline Analysis Population Description |
Baseline Characteristics refer to Randomized Set which consisted of all enrolled study participants who were randomized.
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 12 participants | 21 participants | 33 participants | |
<=18 years |
0 0.0%
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1 4.8%
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1 3.0%
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Between 18 and 65 years |
10 83.3%
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18 85.7%
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28 84.8%
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>=65 years |
2 16.7%
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2 9.5%
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4 12.1%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 12 participants | 21 participants | 33 participants | |
51.4 (15.9) | 41.4 (12.8) | 45.1 (14.6) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 12 participants | 21 participants | 33 participants | |
Female |
11 91.7%
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12 57.1%
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23 69.7%
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Male |
1 8.3%
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9 42.9%
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10 30.3%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 12 participants | 21 participants | 33 participants | |
Asian |
1 8.3%
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4 19.0%
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5 15.2%
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White |
11 91.7%
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16 76.2%
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27 81.8%
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Missing |
0 0.0%
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1 4.8%
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1 3.0%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 12 participants | 21 participants | 33 participants | |
Hispanic or Latino |
0 0.0%
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1 4.8%
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1 3.0%
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Not Hispanic or Latino |
12 100.0%
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20 95.2%
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32 97.0%
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Platelet count
Mean (Standard Deviation) Unit of measure: cells*10^9/L |
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Number Analyzed | 12 participants | 21 participants | 33 participants | |
17.2 (11.3) | 17.0 (9.4) | 17.1 (9.9) |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | UCB |
Organization: | Cares |
Phone: | 001 844 599 2273 |
EMail: | UCBCares@ucb.com |
Responsible Party: | UCB Pharma ( UCB Biopharma SRL ) |
ClinicalTrials.gov Identifier: | NCT04200456 |
Other Study ID Numbers: |
TP0003 2019-000884-26 ( EudraCT Number ) |
First Submitted: | December 13, 2019 |
First Posted: | December 16, 2019 |
Results First Submitted: | May 15, 2023 |
Results First Posted: | August 8, 2023 |
Last Update Posted: | August 8, 2023 |