Eosinophilic Chronic RhinosinusitisPhase 2NCT02772419
Study of Benralizumab (KHK4563) in Patients With Eosinophilic Chronic Rhinosinusitis
A Phase 2 study testing benralizumab in people with Eosinophilic Chronic Rhinosinusitis, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.
Trial summary
The objective of this study is to evaluate the efficacy and safety of SC administrations of Benralizumab or Placebo in the subjects with Eosinophilic Chronic Rhinosinusitis in a multicenter, randomized, double-blind, placebo-controlled study. The pharmacokinetics and immunogenicity will be assessed secondarily. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Eosinophilic Chronic Rhinosinusitis
- What is being tested?
- benralizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteJapan
- Study dates
- Jun 2016to 27 Mar 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 20 years to 75 years of age
- Eosinophilic chronic rhinosinusitis with a total score of ≥ 11 according to the diagnosis of eosinophilic chronic rhinosinusitis at enrollment
- A minimum bilateral nasal polyp score of 3 out of the maximum score of 8 (with a score of at least 1 out of the maximum score of 4 for each nostril) at screening and at enrollment
- Weight of ≥ 40 kg at screening
Who cannot join
- A Sino-Nasal Outcome Test-22 (SNOT-22) score of < 7 at enrollment
- Any nasal surgery (including polypectomy) within 1 year prior to the date of consent
- Hospitalization for ≥ 24 hours for treatment of asthma exacerbation, within 12 weeks prior to the date of consent
- Exposure to any commercially available (e.g., omalizumab) or investigational biologic agent within 16 weeks or 5 half-lives prior to enrollment, whichever is longer
- Use of systemic corticosteroids (including oral corticosteroids) or corticosteroid nasal solution (except spraying) within 4 weeks prior to enrollment or planned use of such medications during the double-blind period
- Prior treatment with benralizumab
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2, Double-Blind, Placebo-Controlled Study of Benralizumab (KHK4563) in Patients With Eosinophilic Chronic Rhinosinusitis
The objective of this study is to evaluate the efficacy and safety of SC administrations of Benralizumab or Placebo in the subjects with Eosinophilic Chronic Rhinosinusitis in a multicenter, randomized, double-blind, placebo-controlled study. The pharmacokinetics and immunogenicity will be assessed secondarily.
Read the detailed description
Screening Period (maximum 4 weeks) , Randomized Treatment Period (24 weeks)
- Conditions
- Eosinophilic Chronic Rhinosinusitis
- Being tested
- benralizumab, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
benralizumabDrug
SC administration
benralizumabDrug
SC administration
PlaceboDrug
SC administration
| Study group | Role | What they receive |
|---|---|---|
| benralizumab A | Experimental | Subcutaneous (SC) administration Receives: Drug: benralizumab |
| benralizumab B | Experimental | SC administration Receives: Drug: benralizumab |
| Placebo | Placebo comparator | Placebo SC administration Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from baseline in nasal polyp score at Week 12
Measured: baseline and 12 weeks post-dose
Secondary outcomes (11)
The change from baseline in nasal polyp score
Measured: Pre-dose and 4,8,12,16,20,24 weeks post-dose
The change from baseline in Computed tomography (CT) score
Measured: baseline and 12 weeks post-dose
Number of subjects discontinued from the study due to aggravation of eosinophilic chronic rhinosinusitis
Measured: Up to 24 weeks after dosing
Time to discontinuation (days) from the study due to aggravation of eosinophilic chronic rhinosinusitis
Measured: Up to 24 weeks after dosing
The change from baseline in Blood eosinophil count
Measured: Pre-dose and 4,8,12,16,20,24 weeks post-dose
The change from baseline in Nasal Airway Resistance
Nasal airway resistance (Pa/cm^3/s)
Measured: Pre-dose and 4,8,12,24 weeks post-dose
The change from baseline in the averaged values of the Olfactory thresholds
Olfactory thresholds are assessed by T\&T Olfactometer Test Score (Five kinds of smell with eight (5 to -2) phases).
Measured: Pre-dose and 4,8,12,24 weeks post-dose
The change from baseline in the improvement of olfactory dysfunction
Olfactory dysfunction (1 to 5) is calculated by the Olfactory thresholds.
Measured: Pre-dose and 4,8,12,24 weeks post-dose
The change from baseline in Sino-Nasal Outcome Test-2 (SNOT-22)
Symptom score are assessed by VAS (nasal congestion, anterior and posterior nasal drip, loss of the sense of smell, headache, and impairment in activity of daily living)
Measured: Pre-dose and 4,8,12, 16, 20, 24 weeks post-dose
The change from baseline in Symptom score by Visual Analog Scale (VAS)
Symptom score are assessed by VAS (nasal congestion, anterior and posterior nasal drip, loss of the sense of smell, headache, and impairment in activity of daily living)
Measured: Pre-dose and 4,8,12, 16, 20, 24 weeks post-dose
Incidence of treatment-emergent adverse events (TEAEs) or drug-related TEAEs and their nature
Measured: Up to 24 weeks after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study startJun 2016
- Primary completion27 Mar 2017
- Study completion27 Mar 2017
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 Eosinophilic Chronic RhinosinusitisStudies of the same condition, open and under way.
- More trials run by Kyowa Kirin Co., Ltd.The sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02772419
- Sponsor's protocol ID
- 4563-005
- Status last verified
- Apr 2018
- First submitted
- 25 Apr 2016
- Last updated
- 23 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Tokunaga T, Sakashita M, Haruna T, Asaka D, Takeno S, Ikeda H, Nakayama T, Seki N, Ito S, Murata J, Sakuma Y, Yoshida N, Terada T, Morikura I, Sakaida H, Kondo K, Teraguchi K, Okano M, Otori N, Yoshikawa M, Hirakawa K, Haruna S, Himi T, Ikeda K, Ishitoya J, Iino Y, Kawata R, Kawauchi H, Kobayashi M, Yamasoba T, Miwa T, Urashima M, Tamari M, Noguchi E, Ninomiya T, Imoto Y, Morikawa T, Tomita K, Takabayashi T, Fujieda S. Novel scoring system and algorithm for classifying chronic rhinosinusitis: the JESREC Study. Allergy. 2015 Aug;70(8):995-1003. doi: 10.1111/all.12644. Epub 2015 May 26.
PubMed 25945591
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-Blind, Placebo-Controlled Study of Benralizumab (KHK4563) in Patients With Eosinophilic Chronic Rhinosinusitis
- ClinicalTrials.gov ID
- NCT02772419
- Acronym / sponsor ID
- 4563-005
- Conditions
- Eosinophilic Chronic Rhinosinusitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2016 (actual)
- Primary completion
- 27 Mar 2017 (actual)
- Study completion
- 27 Mar 2017 (actual)
- First posted
- 13 May 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.
The objective of this study is to evaluate the efficacy and safety of SC administrations of Benralizumab or Placebo in the subjects with Eosinophilic Chronic Rhinosinusitis in a multicenter, randomized, double-blind, placebo-controlled study. The pharmacokinetics and immunogenicity will be assessed secondarily.
Detailed description
Screening Period (maximum 4 weeks) , Randomized Treatment Period (24 weeks)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| benralizumab A | Experimental | Drug: benralizumabSubcutaneous (SC) administration |
| benralizumab B | Experimental | Drug: benralizumabSC administration |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo SC administration |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients 20 years to 75 years of age
- Eosinophilic chronic rhinosinusitis with a total score of ≥ 11 according to the diagnosis of eosinophilic chronic rhinosinusitis at enrollment
- A minimum bilateral nasal polyp score of 3 out of the maximum score of 8 (with a score of at least 1 out of the maximum score of 4 for each nostril) at screening and at enrollment
- Weight of ≥ 40 kg at screening
Key exclusion criteria (6 listed)
- A Sino-Nasal Outcome Test-22 (SNOT-22) score of < 7 at enrollment
- Any nasal surgery (including polypectomy) within 1 year prior to the date of consent
- Hospitalization for ≥ 24 hours for treatment of asthma exacerbation, within 12 weeks prior to the date of consent
- Exposure to any commercially available (e.g., omalizumab) or investigational biologic agent within 16 weeks or 5 half-lives prior to enrollment, whichever is longer
- Use of systemic corticosteroids (including oral corticosteroids) or corticosteroid nasal solution (except spraying) within 4 weeks prior to enrollment or planned use of such medications during the double-blind period
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 |
|---|---|---|
| benralizumabSC administration | Drug | benralizumab A |
| benralizumabSC administration | Drug | benralizumab B |
| PlaceboSC administration | Drug | Placebo |
Primary outcome
The change from baseline in nasal polyp score at Week 12
Time frame: baseline and 12 weeks post-dose
11 secondary outcomes
The change from baseline in nasal polyp score
Time frame: Pre-dose and 4,8,12,16,20,24 weeks post-dose
The change from baseline in Computed tomography (CT) score
Time frame: baseline and 12 weeks post-dose
Number of subjects discontinued from the study due to aggravation of eosinophilic chronic rhinosinusitis
Time frame: Up to 24 weeks after dosing
Time to discontinuation (days) from the study due to aggravation of eosinophilic chronic rhinosinusitis
Time frame: Up to 24 weeks after dosing
The change from baseline in Blood eosinophil count
Time frame: Pre-dose and 4,8,12,16,20,24 weeks post-dose
The change from baseline in Nasal Airway Resistance
Time frame: Pre-dose and 4,8,12,24 weeks post-dose
The change from baseline in the averaged values of the Olfactory thresholds
Time frame: Pre-dose and 4,8,12,24 weeks post-dose
The change from baseline in the improvement of olfactory dysfunction
Time frame: Pre-dose and 4,8,12,24 weeks post-dose
The change from baseline in Sino-Nasal Outcome Test-2 (SNOT-22)
Time frame: Pre-dose and 4,8,12, 16, 20, 24 weeks post-dose
The change from baseline in Symptom score by Visual Analog Scale (VAS)
Time frame: Pre-dose and 4,8,12, 16, 20, 24 weeks post-dose
Incidence of treatment-emergent adverse events (TEAEs) or drug-related TEAEs and their nature
Time frame: Up to 24 weeks after dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2018.
- Background: PubMed 25945591Tokunaga T, Sakashita M, Haruna T, Asaka D, Takeno S, Ikeda H, Nakayama T, Seki N, Ito S, Murata J, Sakuma Y, Yoshida N, Terada T, Morikura I, Sakaida H, Kondo K, Teraguchi K, Okano M, Otori N, Yoshikawa M, Hirakawa K, Haruna S, Himi T, Ikeda K, Ishitoya J, Iino Y, Kawata R, Kawauchi H, Kobayashi M, Yamasoba T, Miwa T, Urashima M, Tamari M, Noguchi E, Ninomiya T, Imoto Y, Morikawa T, Tomita K, Takabayashi T, Fujieda S. Novel scoring system and algorithm for classifying chronic rhinosinusitis: the JESREC Study. Allergy. 2015 Aug;70(8):995-1003. doi: 10.1111/all.12644. Epub 2015 May 26.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 benralizumab in people with Eosinophilic Chronic Rhinosinusitis, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 23 Apr 2018. 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 Japan. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change from baseline in nasal polyp score at Week 12 (time frame: baseline and 12 weeks post-dose). 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 NCT02772419, 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 23 Apr 2018.