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NCT03264989 · ClinicalTrials.gov registry record · Phase 2

Pharmacokinetics and Pharmacodynamics Study of SEG101 (Crizanlizumab) in Sickle Cell Disease (SCD) Patients With Vaso- Occlusive Crisis (VOC)

A Phase 2 study, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
57
Enrollment target

NCT03264989: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.

NCT03264989 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 57 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03264989, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
57 participants
Enrollment target

Study Summary

The purpose of the CSEG101A2202 study was to characterize the Pharmacokinetic (PK) and Pharmacodynamic (PD) of SEG101/crizanlizumab and to evaluate the safety and efficacy of SEG101/crizanlizumab in sickle cell disease (SCD) patients.

Primary Outcome

To characterize PK of crizanlizumab at 5.0 mg/kg in SCD patients. AUCd15: The AUC from time zero to the last measurable concentration sampling time (tlast) (mass x time x volume-1) after single dose AUCtau: The AUC calculated to the end of a dosing interval (tau) at steady-state (amount x time x volume-1)

Interventions

  • DRUG crizanlizumab

Trial Details

FieldValue
Enrollment Target 57 participants
Start Date 2017-12-19
Est. Completion 2023-06-26
Phase Phase 2
Novartis Pharmaceuticals

1,375 total trials

What the finished NCT03264989 record still lists

NCT03264989 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (57% lower).

The record links to 0 conditions, and to 1 intervention - of which crizanlizumab is the first listed.

NCT03264989 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03264989 about?

NCT03264989 is a clinical study titled "Pharmacokinetics and Pharmacodynamics Study of SEG101 (Crizanlizumab) in Sickle Cell Disease (SCD) Patients With Vaso- Occlusive Crisis (VOC)". The purpose of the CSEG101A2202 study was to characterize the Pharmacokinetic (PK) and Pharmacodynamic (PD) of SEG101/crizanlizumab and to evaluate the safety and efficacy of SEG101/crizanlizumab in sickle cell disease (SCD) patients.

What is the current status of trial NCT03264989?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 57 participants. The study started on 2017-12-19. Estimated completion is 2023-06-26.

What interventions are being tested in trial NCT03264989?

The interventions under investigation include: crizanlizumab (DRUG).

Who is sponsoring clinical trial NCT03264989?

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

How this trial's enrollment target compares

Where NCT03264989's enrollment target sits among peer trials

57 1141st of 2000 higher than 855 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03264989, the US trial registry maintained by the National Library of Medicine. NCT03264989 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.