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rADAMTS13

SHP655 for Sickle Cell Disease (RAISE Trial)

Phase 1
Waitlist Available
Research Sponsored by Shire
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose, 15 minutes, 1, 3, 8, 24, 72, 120, 168, 216, 288, and 744 hours post-dose
Awards & highlights

RAISE Trial Summary

This trial is testing a new medicine, SHP655, to see if it is safe and tolerated by people with sickle cell disease.

Eligible Conditions
  • Sickle Cell Disease

RAISE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose, 15 minutes, 1, 3, 8, 24, 72, 120, 168, 216, 288, and 744 hours post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose, 15 minutes, 1, 3, 8, 24, 72, 120, 168, 216, 288, and 744 hours post-dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of Participants With Binding and Inhibitory Antibodies to SHP655
Secondary outcome measures
Area Under the Curve (AUC) From Zero to Infinite Time (AUC0-Inf) of ADAMTS13 Activity and ADAMTS13 Antigen
Area Under the Curve (AUC) From Zero to Time of Last Quantifiable Concentration (AUC0-Last) of ADAMTS13 Activity and ADAMTS13 Antigen
Area Under the Curve Time Curve (AUC) From Zero to 72 hours Post-dose (AUC0-72) of ADAMTS13 Activity and ADAMTS13 Antigen
+13 more

Side effects data

From 2021 Phase 2 trial • 28 Patients • NCT03922308
22%
Thrombotic thrombocytopenic purpura
11%
Hypocalcaemia
11%
Catheter site pain
11%
Chest discomfort
11%
Catheter site bruise
11%
Anxiety
11%
Arthralgia
11%
Citrate toxicity
11%
Alanine aminotransferase increased
11%
Abnormal weight gain
11%
Aspartate aminotransferase increased
11%
Blood creatinine increased
11%
Constipation
11%
Deep vein thrombosis
11%
Delirium
11%
Tooth infection
11%
Vision blurred
11%
Thrombocytopenia
11%
Eye pain
11%
Gingival bleeding
11%
Headache
11%
Insomnia
11%
Pyrexia
11%
Rash
11%
Throat irritation
11%
Transfusion related complication
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Post PEX + Placebo 12H Post PEX
SHP655 40 IU/kg Post PEX + Placebo 12H Post PEX
SHP655 40 IU/kg Post PEX + SHP655 40 IU/kg 12H Post PEX

RAISE Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SHP655Experimental Treatment1 Intervention
Participants with baseline SCD will receive a single intravenous (IV) infusion at one of the 3 dose levels of 40, 80 and 160 International units per kilogram (IU/kg) in a dose escalation manner for 14 days.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive placebo matched to SHP655 of the 3 dose levels of 40 IU/kg, 80 IU/kg, and 160 IU/kg as single IV infusion for 14 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apadamtase alfa
Not yet FDA approved

Find a Location

Who is running the clinical trial?

ShireLead Sponsor
456 Previous Clinical Trials
97,273 Total Patients Enrolled
Takeda Development Center Americas, Inc.Industry Sponsor
56 Previous Clinical Trials
12,011 Total Patients Enrolled
Study DirectorStudy DirectorTakeda
1,207 Previous Clinical Trials
489,661 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study of SHP655 (rADAMTS13) in Sickle Cell Disease
2019. "A Study of SHP655 (rADAMTS13) in Sickle Cell Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03997760.
~3 spots leftby Apr 2025
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