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A Study of IMR-687 in Subjects With Beta Thalassemia

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: NCT04411082
Recruitment Status : Terminated (IMR-BTL-201demonstrated that while IMR-687 was generally well-tolerated, it failed to show any meaningful benefit in transfusion burden or improvement in most disease-related biomarkers. So, the sponsor has decided to discontinue this study)
First Posted : June 2, 2020
Results First Posted : June 30, 2022
Last Update Posted : March 8, 2023
Sponsor:
Information provided by (Responsible Party):
Imara, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition β Thalassemia
Interventions Drug: IMR-687
Drug: Placebo
Enrollment 122
Recruitment Details  
Pre-assignment Details  
Arm/Group Title TDT High Dose TDT Low Dose TDT Placebo NTDT High Dose NTDT Low Dose NTDT Placebo
Hide Arm/Group Description TDT High dose TDT Low dose TDT Placebo NTDT High dose NTDT Low dose NTDT Placebo
Period Title: Overall Study
Started 29 25 20 24 12 12
Completed 18 16 16 10 8 6
Not Completed 11 9 4 14 4 6
Arm/Group Title TDT High Dose TDT Low Dose TDT Placebo NTDT High Dose NTDT Low Dose NTDT Placebo Total
Hide Arm/Group Description TDT High dose TDT Low dose TDT Placebo NTDT High dose NTDT Low dose NTDT Placebo Total of all reporting groups
Overall Number of Baseline Participants 29 25 20 24 12 12 122
Hide Baseline Analysis Population Description
Safety Analysis Set
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants 25 participants 20 participants 24 participants 12 participants 12 participants 122 participants
31.7  (12.06) 30.0  (9.95) 31.3  (8.57) 34.1  (12.64) 28.5  (8.21) 36.0  (9.56) 31.9  (10.69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 25 participants 20 participants 24 participants 12 participants 12 participants 122 participants
Female
15
  51.7%
15
  60.0%
9
  45.0%
10
  41.7%
6
  50.0%
8
  66.7%
63
  51.6%
Male
14
  48.3%
10
  40.0%
11
  55.0%
14
  58.3%
6
  50.0%
4
  33.3%
59
  48.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 25 participants 20 participants 24 participants 12 participants 12 participants 122 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
5
  17.2%
7
  28.0%
4
  20.0%
4
  16.7%
3
  25.0%
4
  33.3%
27
  22.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   3.4%
0
   0.0%
0
   0.0%
0
   0.0%
1
   8.3%
0
   0.0%
2
   1.6%
White
19
  65.5%
17
  68.0%
14
  70.0%
17
  70.8%
7
  58.3%
6
  50.0%
80
  65.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
4
  13.8%
1
   4.0%
2
  10.0%
3
  12.5%
1
   8.3%
2
  16.7%
13
  10.7%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 25 participants 20 participants 24 participants 12 participants 12 participants 122 participants
United Kingdom
1
   3.4%
0
   0.0%
0
   0.0%
2
   8.3%
0
   0.0%
1
   8.3%
4
   3.3%
Malaysia
4
  13.8%
6
  24.0%
4
  20.0%
3
  12.5%
3
  25.0%
2
  16.7%
22
  18.0%
Greece
9
  31.0%
2
   8.0%
1
   5.0%
5
  20.8%
0
   0.0%
2
  16.7%
19
  15.6%
Lebanon
0
   0.0%
4
  16.0%
3
  15.0%
0
   0.0%
1
   8.3%
0
   0.0%
8
   6.6%
Netherlands
0
   0.0%
0
   0.0%
0
   0.0%
2
   8.3%
0
   0.0%
1
   8.3%
3
   2.5%
Turkey
3
  10.3%
5
  20.0%
7
  35.0%
1
   4.2%
0
   0.0%
0
   0.0%
16
  13.1%
Morocco
1
   3.4%
1
   4.0%
0
   0.0%
2
   8.3%
0
   0.0%
2
  16.7%
6
   4.9%
Denmark
3
  10.3%
0
   0.0%
2
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
5
   4.1%
Italy
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   8.3%
1
   8.3%
2
   1.6%
Georgia
0
   0.0%
2
   8.0%
1
   5.0%
3
  12.5%
1
   8.3%
1
   8.3%
8
   6.6%
Israel
2
   6.9%
2
   8.0%
2
  10.0%
1
   4.2%
0
   0.0%
0
   0.0%
7
   5.7%
France
2
   6.9%
1
   4.0%
0
   0.0%
0
   0.0%
2
  16.7%
2
  16.7%
7
   5.7%
Tunisia
4
  13.8%
2
   8.0%
0
   0.0%
5
  20.8%
4
  33.3%
0
   0.0%
15
  12.3%
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 29 participants 25 participants 20 participants 24 participants 12 participants 12 participants 122 participants
22.900  (3.2252) 21.252  (2.2874) 22.699  (2.9968) 22.031  (3.5415) 21.1320  (3.5047) 21.9120  (3.5638) 22.0873  (3.1573)
Serum Ferritin  
Mean (Standard Deviation)
Unit of measure:  Micrograms per liter
Number Analyzed 29 participants 25 participants 20 participants 24 participants 12 participants 12 participants 122 participants
1724.4  (1857.66) 3449.1  (5093.24) 1793.3  (1844.72) 981.4  (951.29) 945.8  (962.09) 447.8  (222.32) 1726.69  (2740.18)
1.Primary Outcome
Title IMR-687 Safety and Tolerability
Hide Description Incidence and severity of Adverse Events Incidence and severity of Serious Adverse Events
Time Frame Baseline to Week 40
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis set
Arm/Group Title TDT High Dose TDT Low Dose TDT Placebo NTDT High Dose NTDT Low Dose NTDT Placebo
Hide Arm/Group Description:
TDT High dose
TDT Low dose
TDT Placebo
NTDT High dose
NTDT Low dose
NTDT Placebo
Overall Number of Participants Analyzed 29 25 20 24 12 12
Measure Type: Count of Participants
Unit of Measure: Participants
Treatment emergent Adverse Events
25
  86.2%
22
  88.0%
15
  75.0%
18
  75.0%
12
 100.0%
6
  50.0%
Treatment emergent Adverse Event related to study drug
19
  65.5%
15
  60.0%
8
  40.0%
11
  45.8%
7
  58.3%
4
  33.3%
Grade 3 or greater treatment emergent Adverse Event
4
  13.8%
9
  36.0%
2
  10.0%
4
  16.7%
1
   8.3%
1
   8.3%
2.Secondary Outcome
Title TDT Patients: Reduction in Red Blood Cell (RBC) Transfusion Burden With ≥33% Hematological Improvement From Week 12 to Week 24
Hide Description Proportion of patients with ≥33% hematological improvement (as measured by reduced transfusion burden) from Week 12 to Week 24 compared to the 12 weeks prior to Baseline (Day 1)
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Analysis
Arm/Group Title TDT High Dose TDT Low Dose TDT Placebo
Hide Arm/Group Description:
TDT High dose
TDT Low dose
TDT Placebo
Overall Number of Participants Analyzed 21 18 18
Measure Type: Count of Participants
Unit of Measure: Participants
2
   9.5%
1
   5.6%
2
  11.1%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TDT High Dose, TDT Low Dose, TDT Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.99
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title NTDT Patients: Proportion of Subjects With an Increase From Baseline of Hb at Week 12 to Week 24 in the Absence of Transfusions.
Hide Description Proportion of subjects with an increase from baseline of ≥1.0 g/dL in mean Hb values at Week 12 to Week 24 in the absence of transfusions.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol analysis
Arm/Group Title NTDT High Dose NTDT Low Dose NTDT Placebo
Hide Arm/Group Description:
NTDT High dose
NTDT Low dose
NTDT Placebo
Overall Number of Participants Analyzed 15 10 10
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NTDT High Dose, NTDT Low Dose, NTDT Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.99
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
4.Secondary Outcome
Title NTDT Patients: Proportion of Subjects With an Increase From Baseline of ≥3% in Mean HbF Values at Week 12 to Week 24 in Absence of Transfusions
Hide Description Proportion of subjects with an increase from baseline of ≥3% in mean HbF values at Week 12 to Week 24 in absence of transfusions
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Analysis
Arm/Group Title NTDT High Dose NTDT Low Dose NTDT Placebo
Hide Arm/Group Description:
NTDT High dose
NTDT Low dose
NTDT Placebo
Overall Number of Participants Analyzed 11 5 8
Measure Type: Count of Participants
Unit of Measure: Participants
1
   9.1%
1
  20.0%
0
   0.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NTDT High Dose, NTDT Low Dose, NTDT Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.99
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
5.Secondary Outcome
Title TDT Patients: Reduction in Red Blood Cell (RBC) Transfusion Burden With ≥33% Hematological Improvement From Week 24 to Week 36
Hide Description Proportion of patients with ≥33% hematological improvement from Week 24 to Week 36 compared to the 12 weeks prior to Baseline (Day 1)
Time Frame Baseline to Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Analysis
Arm/Group Title TDT High Dose TDT Low Dose TDT Placebo
Hide Arm/Group Description:
TDT High dose
TDT Low dose
TDT Placebo
Overall Number of Participants Analyzed 16 13 15
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
   7.7%
1
   6.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TDT High Dose, TDT Low Dose, TDT Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.4839
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
6.Secondary Outcome
Title TDT Patients: Reduction in Red Blood Cell (RBC) Transfusion Burden With ≥50 % Hematological Improvement From Week 12 to Week 24
Hide Description Proportion of patients with ≥50% hematological improvement from Week 12 to Week 24 compared to the 12 weeks prior to Baseline (Day 1)
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Analysis
Arm/Group Title TDT High Dose TDT Low Dose TDT Placebo
Hide Arm/Group Description:
TDT High dose
TDT Low dose
TDT Placebo
Overall Number of Participants Analyzed 21 18 18
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
2
  11.1%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TDT High Dose, TDT Low Dose, TDT Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2065
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
7.Secondary Outcome
Title TDT Patients: Reduction in Red Blood Cell (RBC) Transfusion Burden With ≥50% Hematological Improvement From Week 24 to Week 36
Hide Description Proportion of patients with ≥50% hematological improvement from Week 24 to Week 36 compared to the 12 weeks prior to Baseline (Day 1)
Time Frame Baseline to Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Analysis
Arm/Group Title TDT High Dose TDT Low Dose TDT Placebo
Hide Arm/Group Description:
TDT High dose
TDT Low dose
TDT Placebo
Overall Number of Participants Analyzed 16 13 15
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
   7.7%
1
   6.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TDT High Dose, TDT Low Dose, TDT Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4839
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
8.Secondary Outcome
Title NTDT Patients: Proportion of Subjects With an Increase From Baseline of Hb at Week 24 to Week 36 in the Absence of Transfusions
Hide Description Proportion of subjects with an increase from baseline of ≥1.0 g/dL in mean Hb values at Week 24 to Week 36 in the absence of transfusions.
Time Frame Baseline to Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Analysis
Arm/Group Title NTDT High Dose NTDT Low Dose NTDT Placebo
Hide Arm/Group Description:
NTDT High dose
NTDT Low dose
NTDT Placebo
Overall Number of Participants Analyzed 12 9 8
Measure Type: Count of Participants
Unit of Measure: Participants
1
   8.3%
1
  11.1%
0
   0.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NTDT High Dose, NTDT Low Dose, NTDT Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.99
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
9.Secondary Outcome
Title NTDT: Proportion of Subjects With an Increase From Baseline of ≥3% in Mean HbF Values at Week 24 to Week 36 in Absence of Transfusions
Hide Description Proportion of subjects with an increase from baseline of ≥3% in mean HbF values at Week 24 to Week 36 in absence of transfusions
Time Frame Baseline to Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Analysis
Arm/Group Title NTDT High Dose NTDT Low Dose NTDT Placebo
Hide Arm/Group Description:
NTDT High dose
NTDT Low dose
NTDT Placebo
Overall Number of Participants Analyzed 8 6 7
Measure Type: Count of Participants
Unit of Measure: Participants
1
  12.5%
0
   0.0%
0
   0.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NTDT High Dose, NTDT Low Dose, NTDT Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.99
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame 10 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title TDT High Dose TDT Low Dose TDT Placebo NTDT High Dose NTDT Low Dose NTDT Placebo
Hide Arm/Group Description TDT High dose TDT Low dose TDT Placebo NTDT High dose NTDT Low dose NTDT Placebo
All-Cause Mortality
TDT High Dose TDT Low Dose TDT Placebo NTDT High Dose NTDT Low Dose NTDT Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)      0/25 (0.00%)      0/20 (0.00%)      0/24 (0.00%)      0/12 (0.00%)      0/12 (0.00%)    
Hide Serious Adverse Events
TDT High Dose TDT Low Dose TDT Placebo NTDT High Dose NTDT Low Dose NTDT Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/29 (3.45%)      3/25 (12.00%)      1/20 (5.00%)      3/24 (12.50%)      0/12 (0.00%)      0/12 (0.00%)    
Hepatobiliary disorders             
Cholelithiasis   0/29 (0.00%)  0 0/25 (0.00%)  0 0/20 (0.00%)  0 1/24 (4.17%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0
Infections and infestations             
COVID19   0/29 (0.00%)  0 2/25 (8.00%)  2 0/20 (0.00%)  0 0/24 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0
Liver abscess   0/29 (0.00%)  0 1/25 (4.00%)  1 0/20 (0.00%)  0 0/24 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0
Pneumonia   0/29 (0.00%)  0 1/25 (4.00%)  1 0/20 (0.00%)  0 0/24 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0
Lower Respiratory Tract Infection   0/29 (0.00%)  0 0/25 (0.00%)  0 0/20 (0.00%)  0 1/24 (4.17%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0
Injury, poisoning and procedural complications             
Carbon Monoxide Poisoning   0/29 (0.00%)  0 0/25 (0.00%)  0 1/20 (5.00%)  1 0/24 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0
Transfusion Reaction   1/29 (3.45%)  1 0/25 (0.00%)  0 0/20 (0.00%)  0 0/24 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0
Lower Limb Fracture   0/29 (0.00%)  0 0/25 (0.00%)  0 0/20 (0.00%)  0 1/24 (4.17%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Back Pain   1/29 (3.45%)  1 0/25 (0.00%)  0 0/20 (0.00%)  0 0/24 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0
Skin and subcutaneous tissue disorders             
Rash   1/29 (3.45%)  1 0/25 (0.00%)  0 0/20 (0.00%)  0 0/24 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
TDT High Dose TDT Low Dose TDT Placebo NTDT High Dose NTDT Low Dose NTDT Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   25/29 (86.21%)      22/25 (88.00%)      15/20 (75.00%)      18/24 (75.00%)      12/12 (100.00%)      6/12 (50.00%)    
Blood and lymphatic system disorders             
Anemia   0/29 (0.00%)  1/25 (4.00%)  1/20 (5.00%)  2/24 (8.33%)  2/12 (16.67%)  1/12 (8.33%) 
Gastrointestinal disorders             
Nausea   11/29 (37.93%)  6/25 (24.00%)  1/20 (5.00%)  5/24 (20.83%)  1/12 (8.33%)  1/12 (8.33%) 
Diarrhoea   4/29 (13.79%)  1/25 (4.00%)  2/20 (10.00%)  1/24 (4.17%)  2/12 (16.67%)  0/12 (0.00%) 
Abdominal Distension   2/29 (6.90%)  0/25 (0.00%)  1/20 (5.00%)  0/24 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Abdominal Pain   2/29 (6.90%)  2/25 (8.00%)  0/20 (0.00%)  0/24 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Abdominal Pain Upper   2/29 (6.90%)  1/25 (4.00%)  1/20 (5.00%)  3/24 (12.50%)  3/12 (25.00%)  0/12 (0.00%) 
Vomitting   1/29 (3.45%)  0/25 (0.00%)  0/20 (0.00%)  3/24 (12.50%)  2/12 (16.67%)  0/12 (0.00%) 
General disorders             
Fatigue   1/29 (3.45%)  0/25 (0.00%)  0/20 (0.00%)  3/24 (12.50%)  2/12 (16.67%)  0/12 (0.00%) 
Infections and infestations             
Gastroenteritis   3/29 (10.34%)  0/25 (0.00%)  0/20 (0.00%)  0/24 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
COVID19   1/29 (3.45%)  3/25 (12.00%)  0/20 (0.00%)  3/24 (12.50%)  0/12 (0.00%)  2/12 (16.67%) 
Nervous system disorders             
Headache   10/29 (34.48%)  10/25 (40.00%)  7/20 (35.00%)  5/24 (20.83%)  2/12 (16.67%)  2/12 (16.67%) 
Dizziness   5/29 (17.24%)  5/25 (20.00%)  2/20 (10.00%)  1/24 (4.17%)  0/12 (0.00%)  1/12 (8.33%) 
Respiratory, thoracic and mediastinal disorders             
Cough   2/29 (6.90%)  0/25 (0.00%)  2/20 (10.00%)  1/24 (4.17%)  1/12 (8.33%)  0/12 (0.00%) 
Indicates events were collected by 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
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Name/Title: Rahul Ballal
Organization: Imara, Inc.
Phone: 617-206-2020
EMail: rballal@imaratx.com
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Responsible Party: Imara, Inc.
ClinicalTrials.gov Identifier: NCT04411082    
Other Study ID Numbers: IMR-BTL-201
2019-002989-12 ( EudraCT Number )
First Submitted: April 15, 2020
First Posted: June 2, 2020
Results First Submitted: June 6, 2022
Results First Posted: June 30, 2022
Last Update Posted: March 8, 2023