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Monoclonal Antibodies

A Study to Evaluate the Safety and Efficacy of Crizanlizumab in Sickle Cell Disease Related Priapism (SPARTAN Trial)

Phase 2
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 26 and 52 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a medication to see if it can help treat priapism in people with sickle cell disease.

Eligible Conditions
  • Priapism

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 26 and 52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 26 and 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percent change in priapic events from baseline to 26 weeks
Secondary study objectives
Percent change in acute priapic events from baseline to 26 weeks
Rate of complicated vaso-occlusive crises
Rate of priapic events
+1 more

Side effects data

From 2023 Phase 2 trial • 57 Patients • NCT03264989
29%
Pyrexia
27%
Hypokalaemia
27%
Headache
22%
Upper respiratory tract infection
18%
Arthralgia
13%
Nausea
13%
Back pain
13%
Chest pain
13%
Oedema peripheral
13%
Pain in extremity
11%
Road traffic accident
11%
COVID-19
11%
Oropharyngeal pain
11%
Pruritus
9%
Decreased appetite
9%
Diarrhoea
9%
Toothache
9%
Pharyngitis
9%
Insomnia
9%
Vomiting
9%
Urinary tract infection
9%
Fatigue
9%
Hypertension
7%
Dysuria
7%
Pulmonary embolism
7%
Tooth infection
7%
Pneumonia
7%
Osteonecrosis
7%
Constipation
7%
Post-traumatic pain
7%
Cough
7%
Gastritis
7%
Dehydration
7%
Abdominal pain upper
7%
Joint swelling
7%
Gastroenteritis
7%
Hypoxia
4%
Anxiety
4%
Deafness neurosensory
4%
Acute sinusitis
4%
Skin laceration
4%
Depression
4%
Blood creatine phosphokinase increased
4%
Pain
4%
Cystitis
4%
Rash
2%
Subarachnoid haemorrhage
2%
Sepsis
2%
Mouth ulceration
2%
SARS-CoV-2 test positive
2%
Encephalopathy
2%
Gait disturbance
2%
Urinary incontinence
2%
Intervertebral disc protrusion
2%
Endocarditis
2%
Ocular icterus
2%
Type 2 diabetes mellitus
2%
Arthritis infective
2%
Abdominal pain
2%
Tachycardia
2%
Peripheral swelling
2%
Device related bacteraemia
2%
Nervous system disorder
2%
Salmonella bacteraemia
2%
Staphylococcal infection
2%
Nasopharyngitis
2%
Acute kidney injury
2%
Tooth erosion
2%
Stomatitis
2%
Alanine aminotransferase increased
2%
Diverticulum
2%
Prostatomegaly
2%
Acute respiratory failure
2%
Cerebrovascular accident
2%
Multiple organ dysfunction syndrome
2%
Staphylococcal bacteraemia
2%
Small intestinal obstruction
2%
Blood bilirubin increased
2%
Rhinovirus infection
2%
Breast cancer
2%
Pulmonary oedema
2%
Tendon disorder
2%
Haemorrhoidal haemorrhage
2%
Tendon rupture
2%
Hyperglycaemic hyperosmolar nonketotic syndrome
2%
Wound sepsis
2%
Sickle cell anaemia with crisis
2%
Acute myocardial infarction
2%
Vertigo positional
100%
80%
60%
40%
20%
0%
Study treatment Arm
Crizanlizumab 5.0 mg/kg
Crizanlizumab 7.5 mg/kg
All Participants

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: CrizanlizumabExperimental Treatment1 Intervention
5 mg/kg by intravenous infusion at Week 1 Day 1, Week 3 Day 1 and Day 1 of every 4-week cycle until Week 51
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
crizanlizumab
2017
Completed Phase 4
~240

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,916 Previous Clinical Trials
4,253,849 Total Patients Enrolled

Media Library

Crizanlizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03938454 — Phase 2
Priapism Research Study Groups: Crizanlizumab
Priapism Clinical Trial 2023: Crizanlizumab Highlights & Side Effects. Trial Name: NCT03938454 — Phase 2
Crizanlizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03938454 — Phase 2
~6 spots leftby Dec 2025
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