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Protein Therapy

Luspatercept for Thalassemia (BEYOND Trial)

Phase 2
Waitlist Available
Research Sponsored by Celgene
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 from first dose and up to 2 years following last dose, up to approximately 56 months
Awards & highlights

Summary

This trial tests luspatercept, a medication that helps the body make more red blood cells, in adults with non-transfusion dependent beta-thalassemia. These patients have anemia but don't need regular blood transfusions. The goal is to see if luspatercept can improve their anemia and overall health. Luspatercept is a newly approved treatment for anemia in beta-thalassemia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose and up to 2 years following last dose, up to approximately 56 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose and up to 2 years following last dose, up to approximately 56 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants Achieving Erythroid Response (Week 13 to Week 24)
Secondary study objectives
Apparent Clearance (CL/F) of Luspatercept
Apparent Volume of Distribution of the Central Compartment (V1/F) of Luspatercept
Area Under the Curve From Steady State (AUCss) of Luspatercept
+26 more

Side effects data

From 2021 Phase 3 trial • 336 Patients • NCT02604433
42%
Upper respiratory tract infection
35%
Headache
32%
Back pain
23%
Arthralgia
22%
Bone pain
22%
Cough
21%
Pyrexia
18%
Oropharyngeal pain
18%
Diarrhoea
17%
Fatigue
16%
Pharyngitis
15%
Pain in extremity
13%
Abdominal pain
13%
Nausea
13%
Vomiting
13%
Myalgia
13%
Dizziness
12%
Asthenia
11%
Abdominal pain upper
11%
Influenza
10%
Hypertension
9%
Dyspepsia
9%
Influenza like illness
9%
Musculoskeletal pain
9%
Nasal congestion
8%
Nasopharyngitis
8%
Gastroenteritis
8%
Urticaria
7%
Toothache
7%
Tonsillitis
7%
Hyperuricaemia
6%
Pain
6%
Urinary tract infection
6%
Viral upper respiratory tract infection
6%
Neck pain
6%
Osteoporosis
5%
Constipation
5%
Injection site pain
5%
Transfusion reaction
5%
Alanine aminotransferase increased
5%
Spinal pain
5%
Lethargy
5%
Menstruation irregular
5%
Liver iron concentration increased
4%
Fall
4%
Musculoskeletal chest pain
2%
Anaemia
1%
Septic shock
1%
Extramedullary haemopoiesis
1%
Deep vein thrombosis
1%
Transient ischaemic attack
1%
Cerebrovascular accident
1%
Cholangitis
1%
Cholecystitis acute
1%
Cellulitis
1%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Luspatercept + BSC
Placebo + BSC

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Luspatercept (ACE-536) plus Best Supportive Care (BSC)Experimental Treatment2 Interventions
Arm Description: Luspatercept, subcutaneous(ly) (SC) once every 21 days
Group II: Placebo plus Best Supportive Care (BSC)Placebo Group2 Interventions
normal saline solution subcutaneous(ly) (SC) once every 21 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Luspatercept
2018
Completed Phase 3
~1240

Find a Location

Who is running the clinical trial?

Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)Industry Sponsor
32 Previous Clinical Trials
4,122 Total Patients Enrolled
4 Trials studying Thalassemia
550 Patients Enrolled for Thalassemia
CelgeneLead Sponsor
645 Previous Clinical Trials
130,404 Total Patients Enrolled
6 Trials studying Thalassemia
1,433 Patients Enrolled for Thalassemia
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USAIndustry Sponsor
32 Previous Clinical Trials
4,122 Total Patients Enrolled
4 Trials studying Thalassemia
550 Patients Enrolled for Thalassemia
~19 spots leftby Sep 2025
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