A Study of IMR-687 in Subjects With Beta Thalassemia
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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
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Sponsor:
Imara, Inc.
Information provided by (Responsible Party):
Imara, Inc.
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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 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | TDT High Dose | TDT Low Dose | TDT Placebo | NTDT High Dose | NTDT Low Dose | NTDT Placebo |
---|---|---|---|---|---|---|
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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 |
Baseline Characteristics
Arm/Group Title | TDT High Dose | TDT Low Dose | TDT Placebo | NTDT High Dose | NTDT Low Dose | NTDT Placebo | Total | |
---|---|---|---|---|---|---|---|---|
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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 | |
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Safety Analysis Set
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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 |
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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%
|
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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%
|
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BMI
Mean (Standard Deviation) Unit of measure: Kg/m2 |
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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 |
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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) |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Rahul Ballal |
Organization: | Imara, Inc. |
Phone: | 617-206-2020 |
EMail: | rballal@imaratx.com |
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 |