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Monoclonal Antibodies

crizanlizumab for 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%
Back pain
13%
Pain in extremity
13%
Chest pain
13%
Oedema peripheral
13%
Nausea
11%
Road traffic accident
11%
COVID-19
11%
Oropharyngeal pain
11%
Pruritus
9%
Vomiting
9%
Diarrhoea
9%
Toothache
9%
Urinary tract infection
9%
Decreased appetite
9%
Pharyngitis
9%
Insomnia
9%
Fatigue
9%
Hypertension
7%
Osteonecrosis
7%
Gastroenteritis
7%
Dysuria
7%
Pulmonary embolism
7%
Pneumonia
7%
Tooth infection
7%
Constipation
7%
Post-traumatic pain
7%
Joint swelling
7%
Cough
7%
Gastritis
7%
Dehydration
7%
Abdominal pain upper
7%
Hypoxia
4%
Anxiety
4%
Deafness neurosensory
4%
Acute sinusitis
4%
Cystitis
4%
Depression
4%
Blood creatine phosphokinase increased
4%
Pain
4%
Skin laceration
4%
Rash
2%
Peripheral swelling
2%
Subarachnoid haemorrhage
2%
Sepsis
2%
Gait disturbance
2%
Mouth ulceration
2%
Tendon rupture
2%
SARS-CoV-2 test positive
2%
Type 2 diabetes mellitus
2%
Ocular icterus
2%
Endocarditis
2%
Urinary incontinence
2%
Abdominal pain
2%
Intervertebral disc protrusion
2%
Acute respiratory failure
2%
Arthritis infective
2%
Device related bacteraemia
2%
Nervous system disorder
2%
Tachycardia
2%
Nasopharyngitis
2%
Tendon disorder
2%
Acute kidney injury
2%
Salmonella bacteraemia
2%
Staphylococcal infection
2%
Haemorrhoidal haemorrhage
2%
Alanine aminotransferase increased
2%
Diverticulum
2%
Stomatitis
2%
Prostatomegaly
2%
Cerebrovascular accident
2%
Multiple organ dysfunction syndrome
2%
Staphylococcal bacteraemia
2%
Small intestinal obstruction
2%
Encephalopathy
2%
Blood bilirubin increased
2%
Rhinovirus infection
2%
Breast cancer
2%
Tooth erosion
2%
Pulmonary oedema
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
2,906 Previous Clinical Trials
4,209,682 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 Nov 2025
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