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A clinical trial to evaluate the safety and effectiveness of crovalimab in reducing pain crises, also called vaso-occlusive episodes (VOE), in people with sickle cell disease (SCD)
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)
- Blood Disorder
- Sickle Cell Disease
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:
Active, not recruiting
This trial runs in
Cities
- Adana
- Amsterdam
- Bahia
- Bayrut
- Créteil
- Detroit
- Eldoret
- Greenville
- Johannesburg
- London
- Madison
- Madrid
- Mersin
- Nairobi
- Napoli
- New York
- Porto Alegre
- Rio de Janeiro
- Sevilla
- São Paulo
- Tripoli
- Verona
- Zaragoza
Trial Identifier:
NCT05075824 2020-004839-25 BO42451
Trial 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.
Hoffmann-La Roche
Sponsor
Phase 2
Phase
NCT05075824, BO42451, 2020-004839-25
Trial Identifier
All
Gender
≥12 Years & ≤ 55 Years
Age
No
Healthy Volunteers
Background and study aims:
1. HOW DOES THE BO42451 CLINICAL TRIAL WORK?
This clinical trial is recruiting people who have sickle cell disease (SCD).
The purpose of this clinical trial is to compare the effects, good or bad, of crovalimab versus placebo on patients with SCD. In this clinical trial, you will get either crovalimab or placebo.
2. HOW DO I TAKE PART IN THIS CLINICAL TRIAL?
You will be able to take part in this clinical trial, if you:
- Have been diagnosed with a certain type of SCD (sickle cell anaemia or sickle cell beta zero thalassaemia)
- Are between 12‒55 years of age
- Have had at least two (but no more than 10) pain attacks (crises) requiring a medical visit in the previous year
- Are up to date with certain vaccinations
You will not be eligible to take part in this clinical trial if you:
- Have previously received a stem cell transplant
- Are participating in a chronic transfusion program
- Are pregnant, breastfeeding or intending to become pregnant during or within 10.5 months after the last dose of study treatment
- Have had a recent infection
You may also not be able to take part in the clinical trial if you have certain other medical conditions or if you have previously received certain medications.
If you think this clinical trial may be suitable for you and would like to take part, please talk to your doctor. If your doctor thinks that you might be able to take part in this clinical trial, he/she may refer you to the closest clinical trial doctor. They will give you all the information you need to make your decision about taking part in the clinical trial. You can also find the clinical trial locations on this page.
You will have some further tests to make sure you will be able to take the treatments given in this clinical trial. Some of these tests or procedures may be part of your regular medical care. They may be done even if you do not take part in the clinical trial. If you have had some of the tests recently, they may not need to be done again.
Before starting the clinical trial, you will be told about any risks and benefits of taking part in the trial. You will also be told what other treatments are available so that you may decide if you still want to take part.
For safety reasons while taking part in the clinical trial, women who are not currently pregnant but can become pregnant will need to agree to either use a reliable birth control method or not have heterosexual intercourse.
3. WHAT TREATMENT WILL I BE GIVEN IF I JOIN THIS CLINICAL TRIAL?
Everyone who joins this clinical trial will be split into two groups randomly (like flipping a coin) and will receive either:
- Crovalimab as an infusion into the vein on Day 1, and then as an injection under the skin (subcutaneous) on Day 2. After this, crovalimab will be given as a subcutaneous injection once a week in Weeks 2, 3, 4, and 5, and then once every four weeks until study completion (roughly 48 weeks after starting treatment)
OR
- Placebo as an infusion into the vein on Day 1, and then as an injection under the skin (subcutaneous) on Day 2. After this, placebo will be given as a subcutaneous injection once a week in Weeks 2, 3, 4, and 5, and then once every four weeks until study completion (roughly 48 weeks after starting treatment)
You will have an equal chance of being placed in either group.
During the clinical trial, you can continue to have standard treatment for SCD as recommended by your clinical trial doctor.
This is a ‘placebo-controlled’ clinical trial, which means that one of the groups will be given a saline (salt water) infusion with no active ingredients (also known as a ‘placebo’). A placebo is used as a control, to make sure any health effects are from the clinical trial treatment rather than other factors.
Neither you nor your clinical trial doctor can choose or know the group you are in. An exception is made if your clinical trial doctor needs to know which group you are in for safety reasons.
4. HOW OFTEN WILL I BE SEEN IN FOLLOW-UP APPOINTMENTS AND FOR HOW LONG?
You will be given the clinical trial treatment crovalimab or placebo for 48 weeks. You are free to stop this treatment at any time. During the study, you will be seen regularly by the clinical trial doctor, and you will also have some telephone check-ups. These appointments will include checks to see how you are responding to the treatment and any side effects that you may be having. Once you have received your final dose of treatment, you will have 2 additional safety follow up visits: one clinic visit 24 weeks after the final dose and one telephone call with your clinical trial doctor 46 weeks after the final dose to check on any side effects you may have had.
The clinical trial will last for a total of 91 weeks (about 2 years), including the additional safety follow-ups.
5. WHAT HAPPENS IF I AM UNABLE TO TAKE PART IN THIS CLINICAL TRIAL?
If this clinical trial is not suitable for you, you will not be able to take part. Your doctor will suggest other clinical trials that you may be able to take part in or other treatments that you can be given. You will not lose access to any of your regular care.
For more information about this clinical trial see the For Expert tab on the specific ForPatient page or follow this link to ClinicalTrials.gov
Trial-identifier: NCT05075824
Trial 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.
Hoffmann-La Roche
Sponsor
Phase 2
Phase
NCT05075824, BO42451, 2020-004839-25
Trial Identifier
Crovalimab, Placebo
Treatments
Sickle Cell Disease
Condition
Official Title
A randomized, double-blind, phase IIa study evaluating efficacy, safety, pharmacokinetics and pharmacodynamics of crovalimab as adjunct treatment in prevention of vaso-occlusive episodes (VOE) in sickle cell disease (SCD)
Eligibility Criteria
All
Gender
≥12 Years & ≤ 55 Years
Age
No
Healthy Volunteers
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.
For the latest version of this information please go to www.forpatients.roche.com