NCT03997760

A Study of SHP655 (rADAMTS13) in Sickle Cell Disease

A Phase 1 Randomized, Double-blind, Placebo-controlled, Multicenter, Ascending Dose, Safety and PK/PD Study of SHP655 (rADAMTS13) in Sickle Cell Disease at Baseline Health

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

TAK-755 (previously known as SHP655) is a medicine used to treat sickle cell disease (SCD). The main aim of the study is to measure the safety and tolerability of TAK-755 in SCD participants. Study participants will receive TAK-755 or placebo on Day 1. Their SCD will be treated by their doctor according to their doctor's usual clinical practice. During the study, participants will be asked to follow-up on 13 days following SHP655 or placebo administration for safety assessment. Maximum duration of participation is expected to be about 2 months.

Conditions

• Sickle Cell Disease

Interventions

Type	Name	Description
DRUG	TAK-755	Participants will receive TAK-755 as a single IV infusion at one of the 3 dose levels of 40 IU/kg, 80 IU/kg, or 160 IU/kg.
OTHER	Placebo	Participants will receive placebo matched to TAK-755 of the 3 dose levels of 40 IU/kg, 80 IU/kg, and 160 IU/kg as single IV infusion.

Timeline

• Start date: 2019-10-21
• Primary completion: 2022-10-26
• Completion: 2022-10-26
• First posted: 2019-06-25
• Last updated: 2024-04-23
• Results posted: 2024-04-23

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study