A Study to Investigate the Efficacy and Safety of Crizanlizumab (5 mg/kg) Compared With Placebo in Adolescent and Adult Sickle Cell Disease Patients Who Experience Frequent Vaso-Occlusive Crises (SPARKLE)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT06439082
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Crizanlizumab — BIOLOGICAL
    Crizanlizumab is supplied in single use 10 mL glass vials at a concentration of 10 mg/mL. One vial contains 100 mg of crizanlizumab. This is a concentrate for solution for IV infusion.
  • Placebo — DRUG
    Placebo is supplied in single use 10 mL glass vials at a concentration of 0 mg/mL. This is a concentrate for solution for IV infusion.

Study Details

A phase III, multi-center, randomized, placebo-controlled, double-blind study to assess efficacy and safety of crizanlizumab (5 mg/kg) versus placebo, with or without hydroxyurea/hydroxycarbamide therapy, in adolescent and adult Sickle Cell Disease patients with frequent vaso-occlusive crises.

Key Dates

Start date
Oct 24, 2024
Status verified
May 2026
Primary completion
Mar 23, 2029
Completion
Apr 19, 2030

Study Design

Enrollment
315 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Crizanlizumab (SEG101) at 5.0 mg/kg
    Participants receive Crizanlizumab (SEG101) at 5.0 mg/kg and standard of care.
  • Placebo Comparator: Placebo
    Participants receive the placebo drug and standard of care.

Primary Outcome Measure

Annualized rate of VOCs that are healthcare professional (HCP)-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) in each treatment arm [ Time Frame: 1 year ]

Central Contacts

  • Novartis Pharmaceuticals
    1-888-669-6682
    [email protected]
  • Novartis Pharmaceuticals
    +41613241111

Locations (14)

FacilityCityStateZIPSite coordinators
University Of AlabamaBirminghamAlabama35233
Jeanine Dumas
[email protected]
+1 205 638 9285
Chibuzo Churchill Ilonze (PRINCIPAL_INVESTIGATOR)
Ctr for Inherited Blood DisordersOrangeCalifornia92868
Vanessa Salinas (PRINCIPAL_INVESTIGATOR)
Childrens National HospitalWashington D.C.District of Columbia20010
Taylor Quinn
[email protected]
202-476-5000
Andrew Campbell (PRINCIPAL_INVESTIGATOR)
University of FloridaJacksonvilleFlorida32209
Tatiana Elias-Grajeda
[email protected]
Gabriela Bastidas (PRINCIPAL_INVESTIGATOR)
Augusta University GeorgiaAugustaGeorgia30912
Latanya Bowman
[email protected]
706-721-2941
Abdullah Kutlar (PRINCIPAL_INVESTIGATOR)
WCG Sonar Clinical ResearchRiverdaleGeorgia30274
Ify Anierobi
[email protected]
Anthony Onyegbula (PRINCIPAL_INVESTIGATOR)
Norton Children s HospitalLouisvilleKentucky40202
Meagan Despain
[email protected]
Ashok Raj (PRINCIPAL_INVESTIGATOR)
The Johns Hopkins University School of MedicineBaltimoreMaryland21205
Goodness Che
[email protected]
410-955-2812
Lydia Pecker (PRINCIPAL_INVESTIGATOR)
Southern Specialty ResearchFlowoodMississippi39232
Wendy Thomson
[email protected]
Sharon Pennington (PRINCIPAL_INVESTIGATOR)
Childrens Hospital at MontefioreThe BronxNew York10467
Karen Ireland
[email protected]
718-741-2384
Kaitlin Strumph. (PRINCIPAL_INVESTIGATOR)
East Carolina UniversityGreenvilleNorth Carolina27834
Tori Donadio
[email protected]
Beng Fuh (PRINCIPAL_INVESTIGATOR)
Wake Forest University Baptist Medical CenterWinston-SalemNorth Carolina27157
Julie Fountain
[email protected]
Alex George (PRINCIPAL_INVESTIGATOR)
SpoknwrdclinicaltrialsEastonPennsylvania18045
Anne Murunga
[email protected]
Hayman Salib (PRINCIPAL_INVESTIGATOR)
U of TX Health Science CtHoustonTexas77030
Eyuel Baherey
[email protected]
Modupe Idowu (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By condition
Sickle cell disease
By research site
University Of Alabama· Birmingham, ALCtr for Inherited Blood Disorders· Orange, CAChildrens National Hospital· Washington D.C., DCUniversity of Florida· Jacksonville, FLAugusta University Georgia· Augusta, GAWCG Sonar Clinical Research· Riverdale, GA

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