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New hope for sickle cell pain: canakinumab shows promise in kids

NCT ID NCT02961218

Symptom relief Sponsor: Novartis Pharmaceuticals 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug called canakinumab (ACZ885) in 49 children and young adults aged 8-20 with sickle cell anemia. The goal was to see if it could reduce daily pain compared to a placebo. Participants rated their pain daily using a 0-10 scale, and researchers measured changes over 12 weeks. The trial was completed and focused on safety and pain relief.

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

49 people

The number who actually took part.

Started

Apr 2017

Finished

Apr 2020

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

8 to 20 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: * Male and female subjects ages 8-20 years of age (both inclusive) diagnosed with sickle cell anemia (HbSS) or sickle beta0 thalassemia (documented by family studies, or analysis of either hemoglobin or DNA). * Patient's written informed consent from those ≥18 years of age must be obtained before any assessment is performed. Parent or legal guardian's written informed consent and child's assent, if appropriate, are required before any assessment is performed for patients \< 18 years of age. * Detectable baseline of background or episodic pain measured by daily e-diary over 1 to 2 weeks during screening period as defined below: Average daily pain score ≥ 1 cm without analgesic use over a period of at least 7 days and/or, At least one episode of pain requiring analgesic use during a period of up to 14 days. * History of ≥2 vaso-occlusive pain episodes in the past year, as defined as pain with no other, non-sickle cell identifiable cause that requires analgesia and interferes with the patient's normal daily routine. Exclusion Criteria: * History of known hypersensitivity to canakinumab. * Ongoing or treatment with the past 3 months with red blood cell transfusion therapy, or have evidence of iron overload requiring chelation therapy. * Transcranial Doppler ultrasound in the past year or at screening in patients with an accessible transtemporal window, demonstrating velocity in middle or anterior cerebral or internal carotid artery ≥200 cm/sec. * Administration of any other blood products within 3 weeks of screening visit. Other protocol-defined inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

inherited hemoglobinopathy sickle cell disease sickle cell-beta zero-thalassemia

As listed by the trial registrant

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

Sickle cell anemia

Contacts and locations

Locations

  • Novartis Investigative Site

    Atlanta, Georgia, 30329, United States

  • Novartis Investigative Site

    Augusta, Georgia, 30912, United States

  • Novartis Investigative Site

    Greenville, North Carolina, 27834, United States

  • Novartis Investigative Site

    Toronto, Ontario, M5G 1X8, Canada

  • Novartis Investigative Site

    Hamburg, 20246, Germany

  • Novartis Investigative Site

    Afula, 1834111, Israel

  • Novartis Investigative Site

    Johannesburg, Guateng, 2193, South Africa

  • Novartis Investigative Site

    Adana, 01330, Turkey (Türkiye)

  • Novartis Investigative Site

    Ankara, 06100, Turkey (Türkiye)

  • Novartis Investigative Site

    Mersin, 33343, Turkey (Türkiye)

  • Novartis Investigative Site

    Wolverhampton, Staffordshire, WS11 5XY, United Kingdom

  • Novartis Investigative Site

    London, E1 1BB, United Kingdom

  • Novartis Investigative Site

    London, NW1 2BU, United Kingdom

  • Novartis Investigative Site

    London, SE1 7EH, United Kingdom

  • Novartis Investigative Site

    London, SE5 9RS, United Kingdom

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Other studies related to the condition(s) this trial covers.