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ACTIVE NOT RECRUITING Phase 2

A Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab as Adjunct Treatment in Prevention of Vaso-Occlusive Episodes (VOE) in Sickle Cell Disease (SCD)

NCT05075824 · View on ClinicalTrials.gov ↗

Study Summary

This study is designed to evaluate the efficacy, safety and pharmacokinetics of crovalimab compared with placebo as adjunct therapy in the prevention of VOEs in participants with SCD.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Crovalimab

Study Locations (20)

Other

  • HEMORIO — Rio de Janeiro
  • Hospital Samaritano — São Paulo
  • CHU Henri Mondor — Créteil
  • International Cancer Institute (ICI) — Eldoret
  • Gertrude's Children Hospital — Nairobi
  • Hopital Nini — Tripoli
  • Amsterdam UMC Location VUMC — Amsterdam
  • Charlotte Maxeke Johannesburg Hospital — Johannesburg

São Paulo

  • UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu — Botucatu
  • Hospital das Clínicas Faculdades Médicas de Ribeirão Preto — Ribeirão Preto
  • Hospital de Base de Sao Jose do Rio Preto — São José do Rio Preto
  • Beneficencia Portuguesa de Sao Paulo — São Paulo

Michigan

  • Children's Hospital of Michigan — Detroit

Mississippi

  • Mississippi Center for Advanced Medicine — Madison

New York

  • Icahn School of Medicine at Mount Sinai — New York

North Carolina

  • East Carolina University — Greenville

Estado de Bahia

  • Hospital Sao Rafael - HSR — Salvador

Rio Grande do Sul

  • Hospital das Clinicas - UFRGS — Porto Alegre

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 2022-03-09
Est. Completion 2026-03-31
Phase Phase 2

Sponsor

Hoffmann-La Roche

758 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05075824

The ClinicalTrials.gov registry entry for NCT05075824 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05075824 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Other, São Paulo, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05075824 about?

NCT05075824 is a clinical study titled "A Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab as Adjunct Treatment in Prevention of Vaso-Occlusive Episodes (VOE) in Sickle Cell Disease (SCD)". This study is designed to evaluate the efficacy, safety and pharmacokinetics of crovalimab compared with placebo as adjunct therapy in the prevention of VOEs in participants with SCD.

What is the current status of trial NCT05075824?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2022-03-09. Estimated completion is 2026-03-31.

What conditions does trial NCT05075824 study?

This clinical trial studies the following conditions: Sickle Cell Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05075824?

The interventions under investigation include: Placebo (DRUG), Crovalimab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05075824?

This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05075824 being conducted?

This trial has 20 study locations across Michigan, Mississippi, New York, North Carolina, Estado de Bahia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial