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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

BEYOND Trial Summary

This trial is testing a new drug, luspatercept, to see if it is better than placebo at treating adults with non-transfusion dependent beta-thalassemia. The trial is divided into 3 parts, and approximately 150 people will be enrolled.

BEYOND Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first dose and up to 2 years following last dose, up to approximately 56 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants Achieving Erythroid Response (Week 13 to Week 24)

Secondary outcome measures

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%

Vomiting

13%

Nausea

13%

Abdominal pain

13%

Dizziness

13%

Myalgia

12%

Asthenia

11%

Abdominal pain upper

11%

Influenza

10%

Hypertension

Dyspepsia

Influenza like illness

Musculoskeletal pain

Nasal congestion

Urticaria

Gastroenteritis

Nasopharyngitis

Toothache

Tonsillitis

Hyperuricaemia

Pain

Urinary tract infection

Viral upper respiratory tract infection

Neck pain

Osteoporosis

Spinal pain

Lethargy

Injection site pain

Menstruation irregular

Alanine aminotransferase increased

Constipation

Transfusion reaction

Liver iron concentration increased

Musculoskeletal chest pain

Fall

Anaemia

Deep vein thrombosis

Extramedullary haemopoiesis

Septic shock

Transient ischaemic attack

Cerebrovascular accident

Cholangitis

Cholecystitis acute

Cellulitis

Pneumonia

100%

80%

60%

40%

20%

Study treatment Arm

Luspatercept + BSC

Placebo + BSC

BEYOND 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

~1050

Do I qualify?Apply below to find out

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

636 Previous Clinical Trials

128,826 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the extent of research on Luspatercept?

"Luspatercept was first studied in 2018 at Local Institution 102. Out of the 18,302 completed studies on this medication, 12 are currently ongoing with a large number based out of Los Angeles, California."

Answered by AI

If I am interested, how can I sign up for this experiment?

"Unfortunately, this particular study is not currently enrolling patients. Although, according to the latest update on November 11th, 2022, it was last edited on February 1st, 2018. There are other trials open for enrollment though. 61 studies exploring thalassemia and 12 Luspatercept related trials are still looking for participants."

Answered by AI

Have other medical trials like this one been conducted in the past?

"Luspatercept has been studied since 2018, with the very first trial sponsored by Celgene. After the initial study involving 145 patients in 2018, Luspatercept received its Phase 2 drug approval. There are currently 12 live trials for Luspatercept being conducted across 110 cities and 34 countries."

Answered by AI

How many individuals are testing this medication?

"Right now, this particular study isn't enrolling new patients. The listing originally went up on February 1st, 2018 but was updated as recently as November 11th, 2022. There are other ongoing trials though: 61 for thalassemia and 12 for Luspatercept specifically."

Answered by AI

What are the observed risks of Luspatercept use?

"Luspatercept is still being clinically tested for both efficacy and safety. Right now, it has been given a score of 2."

Answered by AI

What is the purpose of this clinical trial?

"The purpose of this study is to assess the percentage of participants achieving erythroid response over a 24-week period. Secondary outcomes include the percentage of participants who are transfusion-free for 48 weeks, the maximum concentration from steady state (Cmax,ss) of luspatercept, and the apparent clearance (CL/F) of luspatercept."

Answered by AI

Recent research and studies

BloodJournal

Luspatercept Improves Hemoglobin Levels and Blood Transfusion Requirements in a Study of Patients with Β-thalassemia

Piga, Antonio, Silverio Perrotta, Maria Rita Gamberini, Ersi Voskaridou, Angela Melpignano, Aldo Filosa, Vincenzo Caruso, et al.. 2019. “Luspatercept Improves Hemoglobin Levels and Blood Transfusion Requirements in a Study of Patients with Β-thalassemia”. Blood. American Society of Hematology. doi:10.1182/blood-2018-10-879247.

BloodJournal

Luspatercept Improves Hemoglobin Levels and Blood Transfusion Requirements in a Study of Patients with Β-thalassemia

The Lancet HaematologyJournal

Luspatercept for the Treatment of Anaemia in Non-transfusion-dependent Β-thalassaemia (BEYOND): A Phase 2, Randomised, Double-blind, Multicentre, Placebo-controlled Trial

Taher, Ali T, Maria Domenica Cappellini, Antonis Kattamis, Ersi Voskaridou, Silverio Perrotta, Antonio G Piga, Aldo Filosa, et al.. 2022. “Luspatercept for the Treatment of Anaemia in Non-transfusion-dependent Β-thalassaemia (BEYOND): A Phase 2, Randomised, Double-blind, Multicentre, Placebo-controlled Trial”. The Lancet Haematology. Elsevier BV. doi:10.1016/s2352-3026(22)00208-3.

clinicaltrials.govStudy

A Study to Determine the Efficacy and Safety of Luspatercept in Adults With Non Transfusion Dependent Beta (β)-Thalassemia