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Trial record 1 of 1 for:    TP0006
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A Study to Assess the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) (myOpportunITy2)

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: NCT04224688
Recruitment Status : Terminated (Strategic Business Decision; Not a safety decision)
First Posted : January 13, 2020
Results First Posted : August 8, 2023
Last Update Posted : August 8, 2023
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma SRL )

Study Type Interventional
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 30
Recruitment Details The study started to enroll study participants in June 2020 and terminated in May 2022.
Pre-assignment Details Participant Flow refers to the Randomized Set.
Arm/Group Title Placebo Rozanolixizumab
Hide 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 10 20
Completed 8 13
Not Completed 2 7
Reason Not Completed
Withdrawal by Subject             1             3
Lack of Efficacy             1             1
Adverse event, not fatal             0             2
COVID-19             0             1
Arm/Group Title Placebo Rozanolixizumab Total
Hide 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 10 20 30
Hide Baseline Analysis Population Description
Baseline Characteristics refer to Randomized Set which consisted of all enrolled study participants who were randomized.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 20 participants 30 participants
<=18 years
0
   0.0%
1
   5.0%
1
   3.3%
Between 18 and 65 years
10
 100.0%
17
  85.0%
27
  90.0%
>=65 years
0
   0.0%
2
  10.0%
2
   6.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 20 participants 30 participants
41.9  (14.5) 42.3  (15.7) 42.2  (15.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 20 participants 30 participants
Female
6
  60.0%
13
  65.0%
19
  63.3%
Male
4
  40.0%
7
  35.0%
11
  36.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 20 participants 30 participants
Asian
3
  30.0%
6
  30.0%
9
  30.0%
White
7
  70.0%
13
  65.0%
20
  66.7%
Missing
0
   0.0%
1
   5.0%
1
   3.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 20 participants 30 participants
Hispanic or Latino
0
   0.0%
2
  10.0%
2
   6.7%
Not Hispanic or Latino
10
 100.0%
18
  90.0%
28
  93.3%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
Platelet count  
Mean (Standard Deviation)
Unit of measure:  cells*10^9/L
Number Analyzed 10 participants 20 participants 30 participants
14.10  (7.77) 14.65  (8.18) 14.46  (7.91)
1.Primary Outcome
Title 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 Weeks
Hide Description 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 weeks were reported.
Time Frame During the last 12 weeks (Week 13 to Week 25)
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized Set consisted of all enrolled study participants who were randomized. No formal analysis was carried out as the program was terminated.
Arm/Group Title Placebo Rozanolixizumab
Hide 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.
Overall Number of Participants Analyzed 10 20
Measure Type: Number
Unit of Measure: Percentage of participants
0 5
2.Secondary Outcome
Title Cumulative Number of Weeks With Clinically Meaningful Platelet Response of ≥50×10^9/L Over the 24-week Treatment Period
Hide Description Total number of weeks with platelet counts ≥50×10^9/L over the 24-week Treatment Period of the study (Week 1 to Week 25) were reported.
Time Frame Week 1 up to Week 25
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized Set consisted of all enrolled study participants who were randomized.
Arm/Group Title Placebo Rozanolixizumab
Hide 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.
Overall Number of Participants Analyzed 10 20
Median (Full Range)
Unit of Measure: Weeks
0.0
(0 to 10)
1.0
(0 to 18)
3.Secondary Outcome
Title 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/L
Hide Description Time from starting treatment to achievement of first Clinically Meaningful Platelet Response of ≥50×10^9/L was defined as date of first clinically meaningful response - date of first treatment + 1. Median was calculated based upon the Kaplan-Meier estimate.
Time Frame Time from starting treatment to achievement of first response of ≥50×10^9/L (up to Week 25)
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized Set consisted of all enrolled study participants who were randomized.
Arm/Group Title Placebo Rozanolixizumab
Hide 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.
Overall Number of Participants Analyzed 10 20
Median (95% Confidence Interval)
Unit of Measure: Days
NA [1] 
(4.0 to NA)
8.0 [2] 
(5.0 to NA)
[1]
NA for median signifies that the probability of participants achieving a CMPR did not reach 0.5 so the Kaplan-Meier median could not be estimated. NA signifies that upper confidence limit for placebo is not provided for the 95% CI of the median time to first CMPR as there is no time at which the upper bound of the CI for the Kaplan-Meier estimator is less than or equal to 0.5.
[2]
NA signifies that upper confidence limit for rozanolixizumab is not provided for the 95% CI of the median time to first CMPR as there is no time at which the upper bound of the CI for the Kaplan-Meier estimator is less than or equal to 0.5.
4.Secondary Outcome
Title Percentage of Participants With Clinically Meaningful Platelet Response of ≥50×10^9/L by Day 8
Hide Description Clinically meaningful platelet response was defined as platelet count of ≥50×10^9/L.
Time Frame Baseline to Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized Set consisted of all enrolled study participants who were randomized.
Arm/Group Title Placebo Rozanolixizumab
Hide 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.
Overall Number of Participants Analyzed 10 20
Measure Type: Number
Unit of Measure: Percentage of participants
10.0 45.0
5.Secondary Outcome
Title 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
Hide Description Response was 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.
Time Frame From Baseline during Treatment Period (up to Week 25)
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized Set consisted of all enrolled study participants who were randomized.
Arm/Group Title Placebo Rozanolixizumab
Hide 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.
Overall Number of Participants Analyzed 10 20
Measure Type: Number
Unit of Measure: Percentage of participants
10.0 20.0
6.Secondary Outcome
Title Time to First Rescue Therapy
Hide Description Time to first rescue therapy was defined as date of first rescue therapy use - date of first treatment + 1. Median was calculated based upon the Kaplan-Meier estimate.
Time Frame From Baseline to first rescue therapy (up to Week 25)
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized Set consisted of all enrolled study participants who were randomized.
Arm/Group Title Placebo Rozanolixizumab
Hide 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.
Overall Number of Participants Analyzed 10 20
Median (95% Confidence Interval)
Unit of Measure: Days
NA [1] 
(4.0 to NA)
NA [2] 
(46.0 to NA)
[1]

NA for median signifies that the probability of participants requiring rescue medication did not reach 0.5 so the Kaplan-Meier median could not be estimated.

NA signifies that upper confidence limit for placebo is not provided for the 95% CI of the median time to rescue therapy as there is no time at which the upper bound of the CI for the Kaplan-Meier estimator is less than or equal to 0.5.

[2]

NA for median signifies that the probability of participants requiring rescue medication did not reach 0.5 so the Kaplan-Meier median could not be estimated.

NA signifies that upper confidence limit for rozanolixizumab is not provided for the 95% CI of the median time to rescue therapy as there is no time at which the upper bound of the CI for the Kaplan-Meier estimator is less than or equal to 0.5.

7.Secondary Outcome
Title Change From Baseline to Week 25 in Primary Immune Thrombocytopenia Patient Assessment Questionnaire (ITP-PAQ) Symptoms Score
Hide Description 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.
Time Frame From Baseline during Treatment Period (up to Week 25)
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized Set consisted of all enrolled study participants who were randomized. Here, Number of Participants analyzed signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Placebo Rozanolixizumab
Hide 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.
Overall Number of Participants Analyzed 8 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.5  (17.0) 4.2  (12.9)
8.Secondary Outcome
Title Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Hide Description 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.
Time Frame From Baseline to end of Safety Follow-Up Period (up to Week 31)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set included all randomized study participants who received at least one dose of IMP.
Arm/Group Title Placebo Rozanolixizumab
Hide 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.
Overall Number of Participants Analyzed 10 20
Measure Type: Number
Unit of Measure: Percentage of participants
60.0 95.0
9.Secondary Outcome
Title Percentage of Participants With TEAEs Leading to Withdrawal of Investigational Medicinal Product (ie, Study Discontinuation)
Hide Description An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of 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.
Time Frame From Baseline to end of Safety Follow-Up Period (up to Week 31)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set included all randomized study participants who received at least one dose of IMP.
Arm/Group Title Placebo Rozanolixizumab
Hide 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.
Overall Number of Participants Analyzed 10 20
Measure Type: Number
Unit of Measure: Percentage of participants
0 10
Time Frame From Baseline to end of Safety Follow-Up Period (up to Week 31)
Adverse Event Reporting Description 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. TEAEs were analyzed for Safety Set.
 
Arm/Group Title Placebo Rozanolixizumab
Hide 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.
All-Cause Mortality
Placebo Rozanolixizumab
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)      0/20 (0.00%)    
Hide Serious Adverse Events
Placebo Rozanolixizumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/10 (10.00%)      5/20 (25.00%)    
Blood and lymphatic system disorders     
Thrombocytopenia * 1  1/10 (10.00%)  1 0/20 (0.00%)  0
Gastrointestinal disorders     
Vomiting * 1  0/10 (0.00%)  0 1/20 (5.00%)  1
Infections and infestations     
Pneumonia viral * 1  0/10 (0.00%)  0 1/20 (5.00%)  1
Injury, poisoning and procedural complications     
Head injury * 1  0/10 (0.00%)  0 1/20 (5.00%)  1
Limb injury * 1  0/10 (0.00%)  0 1/20 (5.00%)  1
Skin injury * 1  0/10 (0.00%)  0 1/20 (5.00%)  1
Investigations     
Platelet count decreased * 1  1/10 (10.00%)  1 1/20 (5.00%)  1
Nervous system disorders     
Headache * 1  0/10 (0.00%)  0 1/20 (5.00%)  1
Dizziness * 1  0/10 (0.00%)  0 1/20 (5.00%)  1
Skin and subcutaneous tissue disorders     
Urticaria * 1  0/10 (0.00%)  0 1/20 (5.00%)  1
1
Term from vocabulary, MedDRA v24.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Rozanolixizumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/10 (60.00%)      18/20 (90.00%)    
Blood and lymphatic system disorders     
Anaemia * 1  0/10 (0.00%)  0 2/20 (10.00%)  2
Hypofibrinogenaemia * 1  1/10 (10.00%)  1 0/20 (0.00%)  0
Eye disorders     
Eye pain * 1  1/10 (10.00%)  1 0/20 (0.00%)  0
Gastrointestinal disorders     
Nausea * 1  0/10 (0.00%)  0 3/20 (15.00%)  3
Diarrhoea * 1  0/10 (0.00%)  0 2/20 (10.00%)  3
Gingival bleeding * 1  0/10 (0.00%)  0 2/20 (10.00%)  3
Abdominal pain * 1  1/10 (10.00%)  1 1/20 (5.00%)  1
Constipation * 1  1/10 (10.00%)  1 1/20 (5.00%)  1
Abdominal distension * 1  1/10 (10.00%)  1 0/20 (0.00%)  0
General disorders     
Pyrexia * 1  0/10 (0.00%)  0 6/20 (30.00%)  22
Fatigue * 1  0/10 (0.00%)  0 2/20 (10.00%)  4
Asthenia * 1  1/10 (10.00%)  1 1/20 (5.00%)  4
Infusion site pain * 1  1/10 (10.00%)  1 0/20 (0.00%)  0
Infections and infestations     
Upper respiratory tract infection * 1  1/10 (10.00%)  1 2/20 (10.00%)  2
COVID-19 * 1  1/10 (10.00%)  1 1/20 (5.00%)  1
Urinary tract infection * 1  1/10 (10.00%)  1 1/20 (5.00%)  1
Pharyngitis * 1  1/10 (10.00%)  1 0/20 (0.00%)  0
Investigations     
Platelet count decreased * 1  1/10 (10.00%)  1 0/20 (0.00%)  0
White blood cell count increased * 1  1/10 (10.00%)  1 0/20 (0.00%)  0
Metabolism and nutrition disorders     
Decreased appetite * 1  1/10 (10.00%)  1 0/20 (0.00%)  0
Hyperkalaemia * 1  1/10 (10.00%)  4 0/20 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Myalgia * 1  0/10 (0.00%)  0 2/20 (10.00%)  3
Arthralgia * 1  1/10 (10.00%)  1 1/20 (5.00%)  3
Nervous system disorders     
Headache * 1  2/10 (20.00%)  2 12/20 (60.00%)  25
Somnolence * 1  1/10 (10.00%)  1 0/20 (0.00%)  0
Psychiatric disorders     
Insomnia * 1  1/10 (10.00%)  1 1/20 (5.00%)  1
Renal and urinary disorders     
Haematuria * 1  0/10 (0.00%)  0 2/20 (10.00%)  2
Respiratory, thoracic and mediastinal disorders     
Epistaxis * 1  0/10 (0.00%)  0 2/20 (10.00%)  2
Oropharyngeal pain * 1  0/10 (0.00%)  0 2/20 (10.00%)  2
Skin and subcutaneous tissue disorders     
Urticaria * 1  0/10 (0.00%)  0 2/20 (10.00%)  2
Petechiae * 1  1/10 (10.00%)  2 1/20 (5.00%)  2
Blister * 1  1/10 (10.00%)  1 0/20 (0.00%)  0
Hirsutism * 1  1/10 (10.00%)  1 0/20 (0.00%)  0
Vascular disorders     
Haemorrhage * 1  1/10 (10.00%)  1 0/20 (0.00%)  0
1
Term from vocabulary, MedDRA v24.0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB
Organization: Cares
Phone: 001 844 599 2273
EMail: UCBCares@ucb.com
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB Biopharma SRL )
ClinicalTrials.gov Identifier: NCT04224688    
Other Study ID Numbers: TP0006
2019-003451-11 ( EudraCT Number )
First Submitted: January 8, 2020
First Posted: January 13, 2020
Results First Submitted: May 15, 2023
Results First Posted: August 8, 2023
Last Update Posted: August 8, 2023