AsthmaPhase 2RITENCT02947945
Reslizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) Study
A Phase 2 study testing Reslizumab in people with Asthma, run by National Jewish Health at 1 site in United States.
Trial summary
Reslizumab is a type of medicine called a monoclonal antibody that is made in the research clinic; it works by blocking a specific protein in the body called interleukin-5. The study medicine, reslizumab, is not yet approved for doctors to treat patients with EGPA. It is considered an experimental drug in this study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Reslizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2017to Dec 2018
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed Consent: Able to give written informed consent prior to participation in the study, which will include the ability to comply with the requirements and restrictions listed in the consent form. Subjects must be able to read, comprehend, and write at a level sufficient to complete study related materials.
- Gender and Age: Male or female subjects >18 years old
- EGPA diagnosis: subjects who have been diagnosed with EGPA for at least 6 months based on the history or presence of: asthma plus eosinophilia (>1.0x109/L and/or >10% of leucocytes) plus at least two of the following additional features of EGPA:
- A biopsy showing histopathological evidence of eosinophilic vasculitis, or perivascular eosinophilic infiltration, or eosinophil-rich granulomatous inflammation;
- Neuropathy, mono or poly (motor deficit or nerve conduction abnormality);
- Pulmonary infiltrates, non-fixed;
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- Sino-nasal abnormality;
- Cardiomyopathy (established by echocardiography or MRI);
- Glomerulonephritis (haematuria, red cell casts, proteinuria);
- Alveolar haemorrhage (by bronchoalveolar lavage);
- Palpable purpura;
- ANCA positive (MPO or PR3).
- Subjects who have received a cyclophosphamide (CYC) induction regimen may be included a minimum of 2 weeks after the last dose of daily oral CYC, or 3 weeks after the last dose of pulsed IV CYC prior to visit 1, if their total WBC is ≥4x109/L prior to visit 1.
- Subjects who have received a methotrexate, azathioprine, or mycophenolate mofetil induction regimen may be included if on a stable dose for at least 4 weeks prior to visit 1.
- Corticosteroid therapy: Subject must be on a stable dose of oral prednisolone or prednisone of ≥5 mg/day for at least 4 weeks prior to visit 1.
- Immunosuppressive therapy: If receiving immunosuppressive therapy (including methotrexate, azathioprine, or mycophenolate mofetil, but excluding restricted medications below) the dosage must be stable for the 4 weeks prior to visit 1 and during the study (dose reductions for safety reasons will be permitted).
- Female subjects: To be eligible for entry into the study, females of childbearing potential (FCBP) must commit to consistent and correct use of an acceptable method of birth control beginning with consent, for the duration of the trial.
Who cannot join
- Hypereosinophilic Syndrome
- Wegener's Granulomatosis
- Malignancy
- Parasitic disease
- Pregnant or nursing
- If female and of child-bearing potential, must have negative pregnancy test and must adhere to acceptable method of contraception (with <1% failure rate) during the study and for four months after the study.
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- Any other medical illness that precludes study involvement
- Patients who are currently receiving or have previously received reslizumab or any other type of anti-interleukin therapy (i.e. mepolizumab, lebrikizumab etc.) within the last three months.
- Taking cyclophosphamide
- Any patients with a known hypersensitivity to reslizumab or any of its excipients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Jewish Health
Denver, Colorado, 80206
Michael Wechsler, MD, 303-398-1085, wechslerm@njhealth.org
About this study
Official title: Open-Label, to Evaluate the Efficacy and Safety of Reslizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) Study: RITE Study
Reslizumab is a type of medicine called a monoclonal antibody that is made in the research clinic; it works by blocking a specific protein in the body called interleukin-5. The study medicine, reslizumab, is not yet approved for doctors to treat patients with EGPA. It is considered an experimental drug in this study.
Read the detailed description
This study is open-label which means that all subjects will receive the study medication. The study medicine - reslizumab - will be given to the participants in addition to the medicines they are already taking to treat their EGPA such as oral steroids (e.g. prednisone) and medicines that reduce the activity of their immune system (the study doctor will tell the participants which medications these are) - this is what is meant by 'standard of care' and can vary in different countries. Drugs that are sometimes used (i.e., 'standard of care') to reduce the activity of the immune system in EGPA (in addition to oral steroids) include azathioprine, methotrexate, mycophenolate mofetil and cyclophosphamide. Information about how the study drug affects the human body and health will be collected through a number of tests, procedures and questions.
The study medicine, reslizumab, will be given to the participants at a dose of 3mg/kg intravenously (within a vein) every four weeks for 28 weeks for a total of 7 treatments. During the treatment phase of this study, a study staff member will call the participants every two weeks to see how they are doing, what medications they are taking, and if they are able to decrease their steroid use. The study is a total of 11 study visits in a 44 week time period. Everyone who takes part in the study will continue to receive his/her existing treatments for EGPA (although the dose of oral steroids may be reduced during the study).
- Conditions
- Asthma
- Being tested
- Reslizumab
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReslizumabDrug
Also called Cinqair
All subjects will receive Reslizumab
| Study group | Role | What they receive |
|---|---|---|
| Open-Label | Other | all subjects will receive the study medication- reslizumab. Receives: Drug: Reslizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Document the safety of reslizumab therapy in patients with EGPA
All adverse events will be reported to the sponsor and the IRB in accordance with the policy of National Jewish Health and the FDA. Adverse events will be recorded on Case Report Forms as non-serious or serious events (DAEs). Serious adverse events, whether or not considered related to the investigational drug, will be recorded on the Serious Adverse Event form and faxed to the IRB and the sponsor as soon as site personnel are aware of the event. Every attempt will be made to collect discharge summaries for each hospitalization should they occur to provide further details.
Measured: up to 12 months
Secondary outcomes (1)
Demonstrate the steroid sparing effect of reslizumab therapy by titrating corticosteroid dosage
Goal is to demonstrate the steroid sparing effect of reslizumab therapy by titrating corticosteroid dosage while using this anti-IL-5 therapy or to reduce the rate of EGPA exacerbations during the study period. Change in steroid dose will be assessed by comparing the corticosteroid dose of subjects at the end of the steroid stable phase and compare to steroid dose at the end of the treatment period. Change in the rate of exacerbations will be assessed by comparing the rate of exacerbations during the study period with the rate during the washout and safety-monitoring period as well as with the self-reported rate of exacerbations from the year prior to the study.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study start12 Sep 2017
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Collaborators
- Teva Pharmaceuticals USA
- Responsible party
- Principal investigator, Michael Wechsler, National Jewish Health
- Investigators
- Michael Wechsler, MD, Principal investigator, National Jewish Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02947945
- Sponsor's protocol ID
- HS-3025
- Acronym
- RITE
- Status last verified
- Sep 2017
- First submitted
- 17 Oct 2016
- Last updated
- 14 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Manka LA, Guntur VP, Denson JL, Dunn RM, Dollin YT, Strand MJ, Wechsler ME. Efficacy and safety of reslizumab in the treatment of eosinophilic granulomatosis with polyangiitis. Ann Allergy Asthma Immunol. 2021 Jun;126(6):696-701.e1. doi: 10.1016/j.anai.2021.01.035. Epub 2021 Feb 4.
PubMed 33548468
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, to Evaluate the Efficacy and Safety of Reslizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) Study: RITE Study
- ClinicalTrials.gov ID
- NCT02947945
- Acronym / sponsor ID
- RITE / HS-3025
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Collaborators
- Teva Pharmaceuticals USA
- Study start
- 12 Sep 2017 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 28 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Reslizumab is a type of medicine called a monoclonal antibody that is made in the research clinic; it works by blocking a specific protein in the body called interleukin-5. The study medicine, reslizumab, is not yet approved for doctors to treat patients with EGPA. It is considered an experimental drug in this study.
Detailed description
This study is open-label which means that all subjects will receive the study medication. The study medicine - reslizumab - will be given to the participants in addition to the medicines they are already taking to treat their EGPA such as oral steroids (e.g. prednisone) and medicines that reduce the activity of their immune system (the study doctor will tell the participants which medications these are) - this is what is meant by 'standard of care' and can vary in different countries. Drugs that are sometimes used (i.e., 'standard of care') to reduce the activity of the immune system in EGPA (in addition to oral steroids) include azathioprine, methotrexate, mycophenolate mofetil and cyclophosphamide. Information about how the study drug affects the human body and health will be collected through a number of tests, procedures and questions.
The study medicine, reslizumab, will be given to the participants at a dose of 3mg/kg intravenously (within a vein) every four weeks for 28 weeks for a total of 7 treatments. During the treatment phase of this study, a study staff member will call the participants every two weeks to see how they are doing, what medications they are taking, and if they are able to decrease their steroid use. The study is a total of 11 study visits in a 44 week time period. Everyone who takes part in the study will continue to receive his/her existing treatments for EGPA (although the dose of oral steroids may be reduced during the study).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-Label | Other | Drug: Reslizumaball subjects will receive the study medication- reslizumab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Informed Consent: Able to give written informed consent prior to participation in the study, which will include the ability to comply with the requirements and restrictions listed in the consent form. Subjects must be able to read, comprehend, and write at a level sufficient to complete study related materials.
- Gender and Age: Male or female subjects >18 years old
- EGPA diagnosis: subjects who have been diagnosed with EGPA for at least 6 months based on the history or presence of: asthma plus eosinophilia (>1.0x109/L and/or >10% of leucocytes) plus at least two of the following additional features of EGPA:
- Subjects who have received a cyclophosphamide (CYC) induction regimen may be included a minimum of 2 weeks after the last dose of daily oral CYC, or 3 weeks after the last dose of pulsed IV CYC prior to visit 1, if their total WBC is ≥4x109/L prior to visit 1.
- Subjects who have received a methotrexate, azathioprine, or mycophenolate mofetil induction regimen may be included if on a stable dose for at least 4 weeks prior to visit 1.
Key exclusion criteria (10 listed)
- Hypereosinophilic Syndrome
- Wegener's Granulomatosis
- Malignancy
- Parasitic disease
- Pregnant or nursing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReslizumabAlso: CinqairAll subjects will receive Reslizumab | Drug | Open-Label |
Primary outcome
Document the safety of reslizumab therapy in patients with EGPA
Time frame: up to 12 months
All adverse events will be reported to the sponsor and the IRB in accordance with the policy of National Jewish Health and the FDA. Adverse events will be recorded on Case Report Forms as non-serious or serious events (DAEs). Serious adverse events, whether or not considered related to the investigational drug, will be recorded on the Serious Adverse Event form and faxed to the IRB and the sponsor as soon as site personnel are aware of the event. Every attempt will be made to collect discharge summaries for each hospitalization should they occur to provide further details.
1 secondary outcome
Demonstrate the steroid sparing effect of reslizumab therapy by titrating corticosteroid dosage
Time frame: up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2017.
- Derived from this study: PubMed 33548468Manka LA, Guntur VP, Denson JL, Dunn RM, Dollin YT, Strand MJ, Wechsler ME. Efficacy and safety of reslizumab in the treatment of eosinophilic granulomatosis with polyangiitis. Ann Allergy Asthma Immunol. 2021 Jun;126(6):696-701.e1. doi: 10.1016/j.anai.2021.01.035. Epub 2021 Feb 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Wechsler, MD principal investigator
National Jewish Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Reslizumab in people with Asthma, run by National Jewish Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Wechsler, MD (303-398-1443, wechslerm@njhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Document the safety of reslizumab therapy in patients with EGPA (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02947945, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2017.