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NCT03814746 · ClinicalTrials.gov registry record · Phase 3

Study of Two Doses of Crizanlizumab Versus Placebo in Adolescent and Adult Sickle Cell Disease Patients

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

Active
Registry status
Phase 3
Development phase
255
Enrollment target
20
Study locations

NCT03814746 is a Phase 3 study of Sickle Cell Disease (SCD) that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 255 participants, below the 351-participant average among 4 other Sickle Cell Disease (SCD) trials with a reported enrollment target (27% lower). The trial reports 20 study locations across 16 states.

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The verdict

NCT03814746, a Phase 3 study of Sickle Cell Disease (SCD), is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
255 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to compare the efficacy and safety of 2 doses of crizanlizumab (5.0 mg/kg and 7.5 mg/kg) versus placebo in adolescent and adult sickle cell disease (SCD) patients with history of vaso-occlusive crisis (VOC) leading to healthcare visit.

Conditions Studied

Sickle Cell Disease (SCD)

Interventions

  • DRUG Placebo
  • DRUG Crizanlizumab (SEG101)

Study Locations (20)

São Paulo

  • Novartis Investigative Site - Ribeirão Preto
  • Novartis Investigative Site - São Paulo
  • Novartis Investigative Site - São Paulo
  • Novartis Investigative Site - São Paulo

Other

  • Novartis Investigative Site - Brussels
  • Novartis Investigative Site - Edegem

Georgia

  • Childrens Healthcare of Atlanta - Atlanta

Massachusetts

  • Boston Medical Center - Boston

North Carolina

  • Levine Cancer Insitute Carolinas Healthcare System - Charlotte

Tennessee

  • Univ of Tenn Health Sciences Ctr - Memphis

Texas

  • U of TX Health Science Ct - Houston

Brussels Capital

  • Novartis Investigative Site - Brussels

Trial Details

FieldValue
Enrollment Target 255 participants
Start Date 2019-07-26
Est. Completion 2026-11-23
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

1,375 total trials

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What the Registry Record Tells You About NCT03814746

The ClinicalTrials.gov registry entry for NCT03814746 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 255 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 351-participant average among 4 other Sickle Cell Disease (SCD) trials with a reported enrollment target (27% lower). 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 (SCD) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT03814746 reports 20 study locations spanning 16 distinct geographic areas - top geographies include São Paulo, Other, Georgia.

Frequently Asked Questions

What is clinical trial NCT03814746 about?

NCT03814746 is a clinical study titled "Study of Two Doses of Crizanlizumab Versus Placebo in Adolescent and Adult Sickle Cell Disease Patients". The purpose of this study is to compare the efficacy and safety of 2 doses of crizanlizumab (5.0 mg/kg and 7.5 mg/kg) versus placebo in adolescent and adult sickle cell disease (SCD) patients with history of vaso-occlusive crisis (VOC) leading to healthcare visit.

What is the current status of trial NCT03814746?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 255 participants. The study started on 2019-07-26. Estimated completion is 2026-11-23.

What conditions does trial NCT03814746 study?

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

What interventions are being tested in trial NCT03814746?

The interventions under investigation include: Placebo (DRUG), Crizanlizumab (SEG101) (DRUG).

Who is sponsoring clinical trial NCT03814746?

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

Where is trial NCT03814746 being conducted?

This trial has 20 study locations across Georgia, Massachusetts, North Carolina, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.