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This is a Phase 2, multicenter, randomized, open-lable, dose ranging study to evaluate the efficacy and safety of AND017 for the treatment of anemia due to lower risk Myelodysplastic syndromes (MDS) in patients subjects who are Red blood cell (RBC) non-transfusion dependent (NTD) and low transfusion burden (LTB).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AND017 capsules 4 mg | Experimental |
| |
| AND017 capsules 8 mg | Experimental |
| |
| AND017 capsules 12 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AND017 | Drug | Administer AND017 once per day (QD) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of HI-E/RBC-TI responding subjects |
| From baseline to up to Week 25 |
| Measure | Description | Time Frame |
|---|---|---|
| For changes in mean transfusion units throughout the treatment period compared to baseline (mean transfusion units 16 weeks prior to first dose) | For changes in mean transfusion units throughout the treatment period compared to baseline (mean transfusion units 16 weeks prior to first dose) | Baseline, Week 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, and 25 |
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Inclusion Criteria:
Diagnosed of primary myelodysplastic syndrome with a PISS-R grading of very low, low or intermediate risk and a bone marrow primitive cell count < 5%, the time frame for this grading assessment should be at least 12 weeks prior to the first dose
Non-5q(del)-associated myelodysplastic syndrome.
Two non-transfused hemoglobin ≥ 6.0 g/dL and < 10.0 g/dL, averaged over the screening period, at least one week and more apart, and with no more than 1.3 g/dL difference between the two Hb.
Non-transfused subjects (NTD cohort) defined as no red blood cell transfusion in the 16 weeks prior to randomization or low transfusion load subjects defined as 3-7 pRBC units transfused in the 16 weeks prior to randomization and at least two different time points (LTB-1 cohort) or 1-2 pRBC units transfused at one time point in the 16 weeks prior to randomization ( LTB-2 cohort) (except in the case of transfusion for treatment of other comorbidities such as blood loss, surgery, etc.);
Baseline EPO level ≤ 500 mU/mL
Platelets ≥ 30,000 /mm3 and absolute neutrophil count ≥ 800/mm3
Adequate liver function with:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yusha Zhu, MD, PhD | Contact | 6467252552 | yushazhu@kindpharmaceutical.com |
| Name | Affiliation | Role |
|---|---|---|
| Yusha Zhu, MD, PhD | Kind Pharmaceuticals LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 30003 | China |
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| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| For LTB cohorts, the average time required to reach first transfusion independence throughout the treatment period | For LTB cohorts, the average time required to reach first transfusion independence throughout the treatment period | Baseline, Week 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, and 25 |
| Levels of reticulocyte count at each visit and change from baseline | Levels of reticulocyte count at each visit and change from baseline | Baseline, Week 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, and 25 |
| Levels of hematocrit at each visit and change from baseline | Levels of hematocrit at each visit and change from baseline | Baseline, Week 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, and 25 |
| Levels of mean corpuscular volume at each visit and change from baseline | Levels of mean corpuscular volume at each visit and change from baseline | Baseline, Week 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, and 25 |
| Levels of mean corpuscular hemoglobin at each visit and change from baseline | Levels of mean corpuscular hemoglobin at each visit and change from baseline | Baseline, Week 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, and 25 |
| Mean level and change from baseline in non-transfused Hb at each visit throughout the treatment period and | Mean level and change from baseline in non-transfused Hb at each visit throughout the treatment period | Baseline, Week 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, and 25 |
| Mean level and change from baseline in non-transfused Hb throughout the first 8 weeks of treatment | Mean level and change from baseline in non-transfused Hb throughout the first 8 weeks of treatment | Baseline, Week 3, 5, 7, and 9 |
| Percentage of visits in which non-transfused Hb was maintained in this range after reaching two consecutive increases of ≥1.5 g/dL and ≥1.0 g/dL from baseline, respectively, throughout the treatment period | Percentage of visits in which non-transfused Hb was maintained in this range after reaching two consecutive increases of ≥1.5 g/dL and ≥1.0 g/dL from baseline, respectively, throughout the treatment period | Baseline, Week 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, and 25 |
| Mean time required after two consecutive increases in non-transfused Hb ≥1.5 g/dL and ≥1.0 g/dL from baseline, respectively, throughout the treatment period | Mean time required after two consecutive increases in non-transfused Hb ≥1.5 g/dL and ≥1.0 g/dL from baseline, respectively, throughout the treatment period | Baseline, Week 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, and 25 |