New hope for sickle cell patients: drug cuts painful erections
NCT ID NCT03938454
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a drug called crizanlizumab in 36 men with sickle cell disease who suffer from priapism—painful erections lasting an hour or more. The goal was to see if the drug could reduce how often these events happen. Participants received the drug by IV and reported their symptoms over 26 weeks. The results suggest crizanlizumab may help control this painful complication, but larger studies are needed to confirm.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Crizanlizumab (a monoclonal antibody given by IV infusion)
- What this could lead to
- If successful, this could lead to a new treatment option to reduce painful erections in men with sickle cell disease.
- What could go wrong
- This is a small, early-phase trial with only 36 participants and no placebo group, so results may not apply to everyone. The drug may cause side effects like infusion reactions or infections.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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36 people
The number who actually took part.
- Started
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Oct 2019
- Finished
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Nov 2023
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
12 to 100 years
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria * Male patients aged 12 years and above * Confirmed diagnosis of SCD by hemoglobin electrophoresis or high-performance liquid chromatography. All SCD genotypes were eligible (HbSS, HbSβ0, HbSC, HbSβ+, and others) * Experienced 4 or more priapic events (unwanted erection lasting at least 60 minutes) over the 14 weeks preceding study participation * Experienced at least 3 priapic events (unwanted erection lasting at least 60 minutes) during the 12-week Screening period with at least 1 event occurring within 4 weeks prior to the first treatment * If receiving hydroxyurea/hydroxycarbamide or L-glutamine or erythropoietin stimulating agent or voxelotor, must have been receiving the drug for at least 14 weeks prior to screening and planned to continue taking the drug at the same dose and schedule during the trial * If receiving prophylactic treatment for priapism, must have been receiving the drug for at least 14 weeks prior to screening and planned to continue taking the drug at the same dose and schedule during the trial * Written informed consent (or assent/parental consent for minor participants) prior to any screening procedures Exclusion criteria: * Had penile prosthetic implants or shunts or any other surgical procedure on the penis performed within 12 months prior to consenting was not allowed * Took drugs/medications that may induce priapism over the 14 weeks preceding study entry * Received leuprolide acetate (Lupron) or any other gonadotropin releasing hormone receptor agonist agent within 3 months before pre-screening * Had an erection lasting more than 12 hours over the 14 weeks preceding study entry * Had an erection lasting more than 12 hours during the 12 weeks of the Screening period
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Brody School of Medicine
Greenville, North Carolina, 27834, United States
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Childrens Hosp Boston Dept of Hematology
Boston, Massachusetts, 02115, United States
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Childrens National Hospital
Washington D.C., District of Columbia, 20010, United States
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Duke University Medical Center
Durham, North Carolina, 27710, United States
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Emory University School of Medicine
Atlanta, Georgia, 30303, United States
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Foundation for Sickle Cell Disease Research
Hollywood, Florida, 33021, United States
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LSU Medical Center
Shreveport, Louisiana, 71130, United States
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Montefiore Medical Center
The Bronx, New York, 10461, United States
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Prisma Health Upstate
Greenville, South Carolina, 29615, United States
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University Of Alabama
Birmingham, Alabama, 35294, United States
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University of Connecticut Health Center
Farmington, Connecticut, 06030, United States
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University of Pittsburgh
Pittsburgh, Pennsylvania, 15213-2548, United States
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University of Texas Medical School
Houston, Texas, 77030, United States
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