Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT06439082 · ClinicalTrials.gov registry record · Phase 3

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)

A Phase 3 study of Sickle Cell Disease, sponsored by Novartis Pharmaceuticals.

Recruiting
Registry status
Phase 3
Development phase
315
Enrollment target
20
Study locations

NCT06439082 is a Phase 3 study of Sickle Cell Disease that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 315 participants, roughly in line with the 291-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target. The trial reports 20 study locations across 14 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT06439082, a Phase 3 study of Sickle Cell Disease, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.

RECRUITING
Registry status
Phase 3
Development phase
315 participants
Enrollment target
20
Study locations

Study Summary

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.

Conditions Studied

Sickle Cell Disease

Interventions

  • DRUG Placebo
  • BIOLOGICAL Crizanlizumab

Study Locations (20)

São Paulo

  • Novartis Investigative Site - Campinas
  • Novartis Investigative Site - Ribeirão Preto
  • Novartis Investigative Site - Sao Jose Rio Preto
  • Novartis Investigative Site - São Paulo
  • Novartis Investigative Site - São Paulo

Georgia

  • Augusta University Georgia - Augusta
  • WCG Sonar Clinical Research - Riverdale

North Carolina

  • East Carolina University - Greenville
  • Wake Forest University Baptist Medical Center - Winston-Salem

Alabama

  • University Of Alabama - Birmingham

District of Columbia

  • Childrens National Hospital - Washington D.C.

Florida

  • University of Florida - Jacksonville

Kentucky

  • Norton Children s Hospital - Louisville

Maryland

  • The Johns Hopkins University School of Medicine - Baltimore

Trial Details

FieldValue
Enrollment Target 315 participants
Start Date 2024-10-24
Est. Completion 2030-04-19
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

1,375 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06439082

The ClinicalTrials.gov registry entry for NCT06439082 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 315 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 291-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Sickle Cell Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT06439082 reports 20 study locations spanning 14 distinct geographic areas - top geographies include São Paulo, Georgia, North Carolina.

Frequently Asked Questions

What is clinical trial NCT06439082 about?

NCT06439082 is a clinical study titled "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)". 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.

What is the current status of trial NCT06439082?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 315 participants. The study started on 2024-10-24. Estimated completion is 2030-04-19.

What conditions does trial NCT06439082 study?

This clinical trial studies the following conditions: Sickle Cell Disease.

What interventions are being tested in trial NCT06439082?

The interventions under investigation include: Placebo (DRUG), Crizanlizumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT06439082?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06439082 being conducted?

This trial has 20 study locations across Alabama, District of Columbia, Florida, Georgia, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Sickle Cell Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Sickle Cell Disease

All registered trials for this condition

Alabama

All trials with a study site in Alabama

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.