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NCT04912869 · ClinicalTrials.gov registry record · Phase 1

A Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Crovalimab for the Management of Acute Uncomplicated Vaso-Occlusive Episodes (VOE) in Participants With Sickle Cell Disease (SCD).

A Phase 1 study, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 1
Development phase
30
Enrollment target

NCT04912869: Completed Phase 1 study, sponsored by Hoffmann-La Roche.

NCT04912869 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04912869, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 1
Development phase
30 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate crovalimab for the treatment of a sickle cell pain crisis (also known as a VOE) that requires hospitalisation in adult and adolescent participants with SCD. The primary objective of this study is safety and will additionally evaluate pharmacokinetics (how crovalimab is processed by your body), pharmacodynamics (how your body reacts to crovalimab) and the preliminary efficacy of crovalimab compared with placebo.

Interventions

  • DRUG Placebo
  • DRUG Crovalimab

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2022-03-26
Est. Completion 2025-08-15
Phase Phase 1
Hoffmann-La Roche

909 total trials

What the finished NCT04912869 record still lists

NCT04912869 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT04912869 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04912869 about?

NCT04912869 is a clinical study titled "A Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Crovalimab for the Management of Acute Uncomplicated Vaso-Occlusive Episodes (VOE) in Participants With Sickle Cell Disease (SCD).". The purpose of this study is to evaluate crovalimab for the treatment of a sickle cell pain crisis (also known as a VOE) that requires hospitalisation in adult and adolescent participants with SCD. The primary objective of this study is safety and will additionally evaluate pharmacokinetics (how cro...

What is the current status of trial NCT04912869?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2022-03-26. Estimated completion is 2025-08-15.

What interventions are being tested in trial NCT04912869?

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

Who is sponsoring clinical trial NCT04912869?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04912869's enrollment target sits among peer trials

30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT04912869, the US trial registry maintained by the National Library of Medicine. NCT04912869 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.