Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SHP655 · 1 trial · 1 indication
ADAMTS-13 Activity Levels was assessed by fluorescence resonance energy transfer (FRETS) ADAMTS13 activity, with or without SHP655 Supplementation. Schedule A (Days 1, 2, 3, 4, 6, 8, 11, and every 3 days thereafter) or Schedule B (Days 1, 2, 3, 5, 7, 9, 12, and every 3 days thereafter). Data is reported for multiple timepoints as Within 15 minutes pre-PEX and post-PEX; Within 15 minutes, 0.5-3 hours, 4-6 hours post end of investigational product (IP) infusion 1; Within 15 minutes, 0.5-3 hours post end IP infusion 2; 30 minutes pre-IP infusion 2 of Schedule A and Schedule B (up to Day 11 or 12).
The platelet counts are reported in units of 10\^9 per liter blood.
The lactate dehydrogenase levels are reported.
| Arm | Type | Description |
|---|---|---|
| Standard of Care (SoC) + Placebo | PLACEBO_COMPARATOR | Participants received SoC daily PEX followed by placebo immediately and 12 +/- 1 hours after completion of PEX until remission was achieved (up to approximately 6 months). |
| SoC + SHP655 + Placebo | EXPERIMENTAL | Participants received SoC daily PEX and SHP655 40 +/- 4 international units per kilogram (IU/kg), IV injection, QD, immediately after PEX and placebo 12 +/- 1 hours after completion of PEX until remission was achieved (up to approximately 6 months). |
| SoC + SHP655 | EXPERIMENTAL | Participants received SoC daily PEX and SHP655 40 +/- 4 IU/kg, IV injection, BID, immediately after PEX and 12 +/- 1 hours after completion of PEX until remission was achieved (up to approximately 6 months). |
| Name | Type | Description |
|---|---|---|
| Placebo | OTHER | Participants will receive injection of placebo matched to SHP655. |
| SHP655 | DRUG | Participants will receive injection of SHP655. |
| Standard of Care | OTHER | Participants will receive PEX as Standard of Care (SOC). |
Inclusion Criteria: * Participant or legally authorized representative voluntarily signs informed consent. For participants unable to provide consent, a fully recognized medical proxy may be used according to local laws. * Participant is 18 to 75 years old at the time of screening. * Participant ha...
SHP655 is an investigational small molecule being studied for the treatment of Acquired Thrombotic Thrombocytopenic Purpura (aTTP), a rare blood disorder. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
SHP655 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The drug is an investigational small molecule in Phase 2 clinical development for Acquired Thrombotic Thrombocytopenic Purpura (aTTP).
SHP655 is in Phase 2 clinical development. It is an investigational drug for Acquired Thrombotic Thrombocytopenic Purpura (aTTP) and has not been approved by regulatory authorities. One Phase 2 trial has been completed.
SHP655 has one completed Phase 2 clinical trial, NCT03922308, titled "Study of rADAMTS-13 (SHP655) in the Treatment of Participants With Acquired Thrombotic Thrombocytopenic Purpura (aTTP)." The trial enrolled 28 participants across the United States, Canada, France, Germany, Italy, Spain, and the United Kingdom.
Yes, SHP655 is also known as rADAMTS-13. The clinical trial NCT03922308 refers to the drug as rADAMTS-13 (SHP655) in its title, confirming that both names refer to the same investigational drug for Acquired Thrombotic Thrombocytopenic Purpura (aTTP).