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New drug aims to block sickle cell pain crises

NCT ID NCT05075824

Prevention Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a drug called crovalimab in 95 people with sickle cell disease to see if it could prevent vaso-occlusive episodes (painful blockages in blood vessels). Participants received either crovalimab or a placebo alongside their usual treatments. The goal was to measure how many pain episodes occurred over a year and whether the drug was safe.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Crovalimab (a lab-made antibody given by IV and injection)
What this could lead to
If it works, crovalimab could become a new option to reduce painful blockages in blood vessels for people with sickle cell disease.
What could go wrong
This is an early Phase 2 study with only 95 participants, so results may not apply to everyone. The drug may not reduce pain episodes more than placebo, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

95 people

The number who actually took part.

Started

Mar 2022

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 55 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Body weight \>=40 kg. * Male or female with confirmed diagnosis of HbSS (SCD genotype of sickle cell anemia) or HbSβ0 (SCD genotype of sickle cell beta zero thalassemia). * Two or more (\>=2) to \<=10 documented VOEs in the 12 months prior to randomisation. * If receiving concurrent SCD-directed therapy, the participant must have been on a stable dose for a minimum of 3 months prior to study enrollment. There should be no plans to modify the participants' dosing throughout the study duration, other than for safety reasons. * If receiving erythropoietin, the participant must have been prescribed this medication for the preceding 3 months and be dose-stabilised for at least 3 months prior to study enrollment. * Vaccination against N. meningitides serotypes A, C, W, and Y and Vaccinations against H. influenza type B and S. pneumonia. * Participants who have been vaccinated (partially or in full) against SARS-CoV-2 with a locally approved vaccine are eligible to be enrolled in the study, 3 days or longer after inoculation. * Adequate hepatic and renal function. * For women of childbearing potential: agreement to remain abstinent or use contraception during the treatment period and for 10.5 months after the final dose of study treatment. Exclusion Criteria: * History of hematopoietic stem cell transplant. * Participating in a chronic transfusion program and/or planning on undergoing an exchange transfusion during the duration of the study. * History of hypersensitivity, allergic, or anaphylactic reactions to any ingredient contained in the study treatment. * Received active treatment on another investigational trial within 28 days (or within five half-lives of that agent, whichever is greater) prior to screening visit, or plans to participate in another investigational drug trial. * Hemoglobin \<6 g/dL. * Known or suspected hereditary complement deficiency. * Active systemic bacterial, viral, or fungal infection within 14 days before first drug administration. * Presence of fever (\>=38 degrees Celsius) within 7 days before the first drug administration. * Immunised with a live attenuated vaccine within 1 month before first drug administration. * Pregnant or breastfeeding, or intending to become pregnant during the study or within 10.5 months after the final dose of study treatment. * Known HIV infection with documented CD4 count \<200 cells/microliter within 24 weeks prior to screening. * History of N. meningitidis infection within the prior 6 months.

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Conditions

The condition(s) this trial relates to.

sickle cell disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sickle cell disease

Contacts and locations

Locations

  • Adana Acibadem Hospital; Pediatric Hematology

    Adana, 01130, Turkey (Türkiye)

  • Amsterdam UMC Location VUMC

    Amsterdam, 1081 HV, Netherlands

  • Azienda Ospedaliera di Verona-Policlinico G.B. Rossi

    Verona, Veneto, 37134, Italy

  • Beneficencia Portuguesa de Sao Paulo

    São Paulo, São Paulo, 01323-900, Brazil

  • CHU Henri Mondor

    Créteil, 64010, France

  • Central Middlesex Hospital

    London, NW10 7NS, United Kingdom

  • Charlotte Maxeke Johannesburg Hospital

    Johannesburg, 2193, South Africa

  • Children's Hospital of Michigan

    Detroit, Michigan, 48201, United States

  • Cukurova University Medical Faculty Balcali Hospital

    Adana, 1330, Turkey (Türkiye)

  • East Carolina University

    Greenville, North Carolina, 27834, United States

  • Gertrude's Children Hospital

    Nairobi, Kenya

  • HEMORIO

    Rio de Janeiro, 20211-030, Brazil

  • Hammersmith Hospital

    London, W12 0HS, United Kingdom

  • Hopital Nini

    Tripoli, Lebanon

  • Hospital General Univ. Gregorio Maranon

    Madrid, 28009, Spain

  • Hospital Samaritano

    São Paulo, 01232-010, Brazil

  • Hospital Sao Rafael - HSR

    Salvador, Estado de Bahia, 41253-190, Brazil

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009, Spain

  • Hospital das Clinicas - UFRGS

    Porto Alegre, Rio Grande do Sul, Brazil

  • Hospital das Clínicas Faculdades Médicas de Ribeirão Preto

    Ribeirão Preto, São Paulo, 14051-140, Brazil

  • Hospital de Base de Sao Jose do Rio Preto

    São José do Rio Preto, São Paulo, 15090-000, Brazil

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • International Cancer Institute (ICI)

    Eldoret, 30100, Kenya

  • Mersin Universitesi Tip Fakultesi Hastanesi

    Mersin, 33343, Turkey (Türkiye)

  • Mississippi Center for Advanced Medicine

    Madison, Mississippi, 39110, United States

  • UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu

    Botucatu, São Paulo, 18618-970, Brazil

  • Università degli Studi della Campania Luigi Vanvitelli

    Naples, Campania, 80138, Italy

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