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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-507067-19-00 | EU Trial (CTIS) Number |
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The goal of this clinical study is to evaluate povetacicept in adults with autoimmune cytopenias of immune thrombocytopenia, autoimmune hemolytic anemia, and cold agglutinin disease to determine if povetacicept is safe and potentially beneficial in treating these diseases. During the study treatment period participants will receive povetacicept approximately every 4 weeks for 6 months, with the possibility of participating in a 6-month study treatment extension period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Povetacicept 240mg | Experimental | Participants grouped in 3 cohorts by diagnosis will be administered Povetacicept |
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| Part 2: Povetacicept Dose A | Experimental | Based on the findings of Part 1, one or two dose levels may be assessed in Part 2; if two dose levels are assessed participants will be randomized to receive one of the two dose levels of Povetacicept |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| povetacicept | Drug | Administered by subcutaneous injection every 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability as Assessed by Adverse events (AEs) and Serious adverse events (SAEs) | Study Day 1 through 30 days after last dose of study drug |
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Key Inclusion Criteria:
Indication-specific Criteria
Immune Thrombocytopenia (ITP)
Warm Autoimmune Hemolytic Anemia (wAIHA)
Cold Agglutinin Disease (CAD)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site (230) | Los Angeles | California | 90033 | United States | ||
| Investigational Site (401) |
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| Washington D.C. |
| District of Columbia |
| 20007 |
| United States |
| Investigational Site (419) | Cooper City | Florida | 33024 | United States |
| Investigational Site (425) | Miami | Florida | 33143 | United States |
| Investigational Site (219) | Iowa City | Iowa | 52242 | United States |
| Investigational Site (435) | Columbia | Maryland | 21044 | United States |
| Investigational site (405) | Lake Success | New York | 11042 | United States |
| Investigational Site (423) | New Hyde Park | New York | 11040 | United States |
| Investigational Site (421) | New York | New York | 10028 | United States |
| Investigational Site (404) | New York | New York | 10065 | United States |
| Investigational Site (420) | Shirley | New York | 11967 | United States |
| Investigational Site (422) | The Bronx | New York | 10469 | United States |
| Investigational Site (414) | Charlotte | North Carolina | 28204 | United States |
| Investigational Site (402) | Greenville | North Carolina | 27834 | United States |
| Investigational Site (411) | Seattle | Washington | 98109 | United States |
| Investigational Site (410) | Box Hill | 3128 | Australia |
| Investigational Site (519) | Concord | 2139 | Australia |
| Investigational Site (517) | Douglas | 4814 | Australia |
| Investigational Site (413) | Liverpool | 2170 | Australia |
| Investigational Site (407) | West Perth | 6005 | Australia |
| Investigational Site (409) | Westmead | 2145 | Australia |
| Investigational Site (434) | Vienna | 1090 | Austria |
| Investigational Site (406) | Greenfield Park | J4V2H1 | Canada |
| Investigational Site (403) | Hamilton | L8S 4K1 | Canada |
| Investigational Site (444) | Toronto | M5B 1W8 | Canada |
| Investigational Site (438) | Essen | 45147 | Germany |
| Investigational Site (432) | Meldola | 47014 | Italy |
| Investigational Site (428) | Milan | 20122 | Italy |
| Investigational Site (431) | Novara | 28100 | Italy |
| Investigational Site (443) | Trieste | 34128 | Italy |
| Investigational Site (433) | Grålum | 1714 | Norway |
| Investigational Site (437) | Trondheim | 7030 | Norway |
| Investigational Site (436) | Barcelona | 08003 | Spain |
| Investigational Site (429) | Burgos | 9006 | Spain |
| Investigational Site (430) | Madrid | 28007 | Spain |
| Investigational Site (426) | Murcia | 30008 | Spain |
| Investigational Site (427) | Seville | 41013 | Spain |
| Investigational Site (415) | Ankara | 06200 | Turkey (Türkiye) |
| Investigational Site (416) | Ankara | 06800 | Turkey (Türkiye) |
| Investigational Site (418) | Istanbul | 34718 | Turkey (Türkiye) |
| Investigational Site (442) | Leeds | SE1 9RT | United Kingdom |
| Investigational Site (439) | London | E1 1BB | United Kingdom |
| Investigational Site (441) | London | SE1 9RT | United Kingdom |
| Investigational Site (440) | London | W12 0HS | United Kingdom |
| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| D000744 | Anemia, Hemolytic, Autoimmune |
| D000743 | Anemia, Hemolytic |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D000740 | Anemia |
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