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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

SPARTAN Trial Summary

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

Eligible Conditions
  • Priapism

SPARTAN Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent change in priapic events from baseline to 26 weeks
Secondary outcome measures
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
28%
Pyrexia
25%
Hypokalaemia
25%
Headache
21%
Upper respiratory tract infection
18%
Arthralgia
14%
Nausea
12%
COVID-19
12%
Vomiting
12%
Chest pain
12%
Road traffic accident
12%
Back pain
11%
Diarrhoea
11%
Oedema peripheral
11%
Pain in extremity
11%
Pruritus
9%
Pharyngitis
9%
Constipation
9%
Fatigue
9%
Oropharyngeal pain
7%
Gastroenteritis
7%
Toothache
7%
Decreased appetite
7%
Dehydration
7%
Osteonecrosis
7%
Anxiety
7%
Insomnia
7%
Hypoxia
7%
Hypertension
7%
Urinary tract infection
5%
Ocular icterus
5%
Cystitis
5%
Pneumonia
5%
Tooth infection
5%
Pulmonary embolism
5%
Deafness neurosensory
5%
Abdominal pain upper
5%
Gastritis
5%
Pain
5%
Post-traumatic pain
5%
Skin laceration
5%
Blood creatine phosphokinase increased
5%
Joint swelling
5%
Cough
5%
Rash
5%
Dysuria
5%
Depression
5%
Acute sinusitis
4%
Nasopharyngitis
4%
Acute kidney injury
4%
Tachycardia
4%
Peripheral swelling
4%
Alanine aminotransferase increased
4%
Blood bilirubin increased
4%
Tendon disorder
2%
Pulmonary oedema
2%
Tooth erosion
2%
Nervous system disorder
2%
Urine odour abnormal
2%
Cholelithiasis
2%
Otitis media acute
2%
Brain injury
2%
Cerebrovascular accident
2%
Encephalopathy
2%
Subarachnoid haemorrhage
2%
Prostatomegaly
2%
Staphylococcal infection
2%
Tendon rupture
2%
Acute respiratory failure
2%
Tympanic membrane perforation
2%
Supraventricular extrasystoles
2%
Tornwaldt cyst
2%
Ear pain
2%
Retinal detachment
2%
Retinal drusen
2%
Retinopathy sickle cell
2%
Cytopenia
2%
Sickle cell anaemia with crisis
2%
Acute myocardial infarction
2%
Cardiac arrest
2%
Vertigo positional
2%
Abdominal pain
2%
Haemorrhoidal haemorrhage
2%
Gait disturbance
2%
Hypertransaminasaemia
2%
Device related bacteraemia
2%
Rhinovirus infection
2%
Sepsis
2%
Staphylococcal bacteraemia
2%
Diverticulum
2%
Wound sepsis
2%
Pancreatitis
2%
Gun shot wound
2%
SARS-CoV-2 test positive
2%
Type 2 diabetes mellitus
2%
Drug withdrawal syndrome
2%
Mouth ulceration
2%
Small intestinal obstruction
2%
Multiple organ dysfunction syndrome
2%
Aspartate aminotransferase increased
2%
Haematocrit decreased
2%
Hyperamylasaemia
2%
Hypophosphataemia
2%
Osteosclerosis
2%
Transient ischaemic attack
2%
Ischaemic hepatitis
2%
Anaphylactic reaction
2%
Salmonella bacteraemia
2%
Hyperglycaemic hyperosmolar nonketotic syndrome
2%
Appendicitis
2%
Stomatitis
2%
Arthritis infective
2%
Endocarditis
2%
Tooth fracture
2%
Breast cancer
2%
Dermal cyst
2%
Intervertebral disc protrusion
2%
Malnutrition
2%
Micturition urgency
2%
Anaemia
2%
Urinary incontinence
2%
Microalbuminuria
100%
80%
60%
40%
20%
0%
Study treatment Arm
All Participants
Crizanlizumab 5.0 mg/kg
Crizanlizumab 7.5 mg/kg

SPARTAN 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
2,865 Previous Clinical Trials
4,199,249 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

Frequently Asked Questions

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

In how many different hospitals is this trial taking place?

"To limit the amount of travel required for participants, this study is enrolling at 19 sites which are primarily located in Atlanta, New york and Boston with a few other clinics around these cities."

Answered by AI

Is this study enrolling new participants at the moment?

"The study is recruiting patients, as seen on clinicaltrials.gov. This information was first posted on October 16th, 2019 and last updated November 16th, 2021."

Answered by AI

Are there other examples where crizanlizumab has been used in medical trials?

"There are currently 10 ongoing crizanlizumab clinical trials, 1 of which is in Phase 3. Greenville, South carolina hosts many of these studies; however, there are 400 research sites for this medication across the United States."

Answered by AI

How many participants will this trial have in total?

"In order to move forward, this clinical trial requires 56 patients that adhere to the pre-specified inclusion criteria. Those that qualify can participate in this trial from multiple locations, such as Childrens Healthcare of Atlanta or NYC H Hospital Queens Cancer Center."

Answered by AI

Could you explain the dangers associated with crizanlizumab?

"There is currently some data supporting the safety of crizanlizumab, but none yet indicating that it is an effective medication. Therefore, we have given it a score of 2."

Answered by AI

To your knowledge, does a similar study exist?

"According to data that is currently available, there have been 10 different clinical trials for crizanlizumab. These trials were spread out over 144 cities and 36 countries with the earliest one taking place in 2017. The first trial was sponsored by Novartis Pharmaceuticals and had 57 participants. This study completed its Phase 2 drug approval stage in 2017 and 1 additional trial has been conducted since then."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Safety and Efficacy of Crizanlizumab in Sickle Cell Disease Related Priapism
2019. "A Study to Evaluate the Safety and Efficacy of Crizanlizumab in Sickle Cell Disease Related Priapism". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03938454.
~6 spots leftby May 2025
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