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Taking peoplePhase 4

Continued Access to Crizanlizumab for People With Sickle Cell Disease

Allows people with sickle cell disease to keep receiving crizanlizumab after a prior study.

Key facts

Who runs it
Novartis Pharmaceuticals
Where
Barcelona and Madrid, SpainSee the 2 sitesAlso in 10 other countries, 23 sites
Registry title
Rollover Study for Patients With Sickle Cell Disease Who Have Completed a Prior Novartis-Sponsored Crizanlizumab Study
Status
Recruiting
Phase
Phase 4
People taking part
130 people, planned
Started
10 Jun 2021
Expected to end
10 Jun 2031
Type of study
Interventional
Treatments tested
  • Crizanlizumab
Record updated
8 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people with sickle cell disease who are already getting crizanlizumab in a Novartis parent study and are benefiting from it. It lets them keep the treatment.

Age
From 6 Months to 100 Years.
Sex
All sexes can join.
Disease stage
Sickle cell disease. The person must be benefiting from crizanlizumab, as judged by the investigator.
Earlier treatment
Must be getting crizanlizumab in a Novartis-sponsored parent study and have completed the treatment schedule planned there. Must not have permanently stopped crizanlizumab in the parent study before it ended.

Main reasons for not taking part

  • Stopped crizanlizumab for good in the parent study before it ended
  • Ongoing treatment-related Grade 3 or higher side effects, or any ongoing side effect needing a dose break
  • Taking part in another investigational trial, or planning to
  • Pregnant or nursing women
  • Women who could have children and will not use highly effective contraception during dosing and until 15 weeks after stopping crizanlizumab

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • Written informed consent/assent, according to local guidelines, signed by the adult patients. In the population under 18 years, it will be signed by the patient and/or by the parents or legal guardian prior to enrolling in the rollover study and receiving study medication
  • SCD patient currently enrolled in a Novartis-sponsored study receiving crizanlizumab and has fulfilled all the requirements in the parent study. Patient is currently benefiting from the treatment with crizanlizumab as determined by the investigator and has completed the treatment schedule as planned in the parent study
  • Patient has demonstrated compliance to the planned visit schedule in the parent study, and in the opinion of the investigator has shown willingness and ability to comply with future visit schedules

Who cannot take part

  • Concurrent participation in any other investigational clinical trial other than the parent study or plan to participate in any other investigational clinical trial
  • Women of childbearing potential who are unwilling to be on highly effective contraceptives during dosing and until 15 weeks after stopping treatment with crizanlizumab
  • Patient had permanently discontinued from crizanlizumab study treatment in the parent study before the parent study completion
  • Ongoing/unresolved treatment-related Grade 3 or higher AEs, and/or any ongoing AE requiring dose interruption. Patients meeting all other eligibility criteria may be enrolled once toxicities have resolved unless those toxicities were grade 4
  • Pregnant or nursing women
  • SCD patients who do not meet parent study protocol criteria to continue with crizanlizumab

Where in Spain

Also in 10 other countries, 23 sites

  • Vall d'Hebron Institute of OncologyBarcelona, SpainNo longer taking part
  • Hospital General Universitario Gregorio MarañónMadrid, SpainNo longer taking part

About the trial

What the trial wants to find out

This is a multi-center multi-national rollover study to allow continued access to crizanlizumab for patients with sickle cell disease (SCD) who are on crizanlizumab treatment in a Novartis-sponsored study (parent study) and are benefiting from the treatment as judged by the investigator.

The group in the trial

  • CrizanlizumabTreatment being tested

    All participants will receive crizanlizumab (SEG101) at the same dose/schedule as in the parent study.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
An Open-label, Multi-center, Phase IV, Rollover Study for Patients With Sickle Cell Disease Who Have Completed a Prior Novartis-Sponsored Crizanlizumab Study
Plain-language title
Continued Access to Crizanlizumab for People With Sickle Cell DiseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
8 June 2026