SinusitisPhase 2NCT05865496
A Study to Evaluate 611 in Patients With Chronic Rhinosinusitis With Nasal Polyps
A Phase 2 study testing 611 in people with Sinusitis and Nasal Polyps, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 4 sites in China.
Trial summary
This study will evaluate the effect and safety of 611 in patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sinusitis, Nasal Polyps, Polyps
- What is being tested?
- 611
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 4 sitesChina
- Study dates
- 30 Jun 2023to 31 Jul 2024
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female and male patients aged ≥18 and ≤ 75 years at the time of screening.
- Bilateral CRSwNP.
- Bilateral NPS of ≥5 with a minimum score of 2 in each nasal cavity
- Nasal Congestion Score of > 2 at screening and a weekly average severity of > 1 at time of randomization.
- Patients whose bilateral sino-nasal polyposis remains inadequately controlled despite prior treatment with SCS anytime within the past 2 years; and/or had a medical contraindication/intolerance to SCS; and/or received nasal polyp surgery 6 months before signing the ICF.
Who cannot join
- Patients with other nasal diseases or symptoms.
- Patients who are taking or have taken the following prohibited therapies as specified, e.g., systemic steroids within 4 weeks prior to screening, less than 3 months or 5 half-lives for biologic therapy prior to screening.
- Patients who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
- History of cancer.
- Known or suspected history of immunosuppression.
- Known with allergic or intolerant to mometasone furoate spray or 611/placebo.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Site 03
Beijing, Beijing Municipality, 100005
Site 01
Beijing, Beijing Municipality, 100730
Site 04
Wuhan, Hubei, 430022
Site 02
Xuzhou, Jiangsu, 221004
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II Clinical Study to Evaluate the Efficacy and Safety of 611 in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
This study will evaluate the effect and safety of 611 in patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP).
Read the detailed description
The main purpose is to evaluate the effect of 611 on a background of mometasone furoate nasal spray (MFNS) in reducing endoscopic nasal polyp score (NPS) and nasal congestion/obstruction score (NCS) severity in eligible patients with CRSwNP whose disease remains inadequately controlled despite daily treatment with intranasal corticosteroid (INCS) therapy in comparison to placebo.
- Conditions
- Sinusitis, Nasal Polyps, Polyps
- Being tested
- 611, Placebo
- Medical subject headings
- Sinusitis, Nasal Polyps, Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
611Drug
611 subcutaneous (SC) injection.
PlaceboDrug
Placebo subcutaneous (SC) injection.
| Study group | Role | What they receive |
|---|---|---|
| 611 Dose A | Experimental | 611 300 mg Q2W, subcutaneous (SC) injection. Receives: Drug: 611 |
| 611 Dose B | Experimental | 611 450 mg Q4W, subcutaneous (SC) injection. Receives: Drug: 611 |
| Placebo | Placebo comparator | Placebo subcutaneous (SC) injection. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline at Week 16 in Bilateral Nasal Polyp Score (NPS)
NPS is evaluated by nasal endoscopy. For each nostril, NPS is graded based on polyp size from 0 = no polyps to 4 = large polyps causing complete obstruction of inferior nasal cavity; lower score = smaller sized polyps. Bilateral NPS is the sum of right and left nostril scores, ranges from 0 (no polyps) to 8 (large polyps), higher score = more severe disease.
Measured: Up to 16 weeks
Change From Baseline at Week 16 in Nasal Congestion Symptom Severity Score (NCS)
NCS is assessed by the participants daily from visit 1 and throughout the study on a scale of 0 to 3, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms, with higher scores indicates more severity.
Measured: Up to 16 weeks
Secondary outcomes (5)
Change From Baseline to the End of study in Lund Mackay Score
The Lund Mackay Score scoring system rates each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses using following grading: 0 = normal, 1 = partial opacification, 2 = total opacification. The total score is the sum of scores from each side and ranges from 0 (normal) to 24 (more opacified); higher score indicated more severe disease.
Measured: Up to 16 weeks
Change From Baseline to the End of study in Total Nasal Symptom Score (TNSS)
TNSS is a composite of nasal congestion, loss of smell, and rhinorrhea (anterior/posterior nasal discharge), each access on 0-3 categorical scale (where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms). Total score ranges from 0 (no symptoms) to 12 (severe symptoms). Higher score indicated more severe symptoms.
Measured: Up to 16 weeks
Change From Baseline to the End of study in the University of Pennsylvania Smell Identification Test (UPSIT) Score
The UPSIT is a 40-item test to measure the individual's ability to detect odors. Total score ranges from 0 (anosmia) to 40 (normal sense of smell), lower score indicated severe smell loss.
Measured: Up to 16 weeks
Change From Baseline to the End of study in 22-item Sino-nasal Outcome Test (SNOT-22) Scores
The SNOT-22 is a validated questionnaire that used to assess the impact of chronic rhinosinusitis phenotype with nasal polyps (CRSwNP) on health-related quality of life (HRQoL). It is a 22 item questionnaire with each item assigned a score ranging from 0 (no problem) to 5 (problem as bad as it can be). The total score may range from 0 (no disease) to 110 (worst disease), lower scores representing better health related quality of life.
Measured: Up to 16 weeks
611 Concentration in Serum
The concentration of 611 in Serum.
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start30 Jun 2023
- Primary completion31 May 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SinusitisStudies of the same condition, open and under way.
- More trials run by Sunshine Guojian Pharmaceutical (Shanghai) 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qinghong Zhou, BS, Study director, Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.Luo Zhang, MD, Principal investigator, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05865496
- Sponsor's protocol ID
- SSGJ-611-CRS-II-01
- Status last verified
- Jan 2024
- First submitted
- 25 Apr 2023
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II Clinical Study to Evaluate the Efficacy and Safety of 611 in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
- ClinicalTrials.gov ID
- NCT05865496
- Acronym / sponsor ID
- SSGJ-611-CRS-II-01
- Conditions
- Sinusitis, Nasal Polyps, Polyps
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 19 May 2023 (actual)
- 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.
This study will evaluate the effect and safety of 611 in patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP).
Detailed description
The main purpose is to evaluate the effect of 611 on a background of mometasone furoate nasal spray (MFNS) in reducing endoscopic nasal polyp score (NPS) and nasal congestion/obstruction score (NCS) severity in eligible patients with CRSwNP whose disease remains inadequately controlled despite daily treatment with intranasal corticosteroid (INCS) therapy in comparison to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 611 Dose A | Experimental | Drug: 611611 300 mg Q2W, subcutaneous (SC) injection. |
| 611 Dose B | Experimental | Drug: 611611 450 mg Q4W, subcutaneous (SC) injection. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo subcutaneous (SC) injection. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female and male patients aged ≥18 and ≤ 75 years at the time of screening.
- Bilateral CRSwNP.
- Bilateral NPS of ≥5 with a minimum score of 2 in each nasal cavity
- Nasal Congestion Score of > 2 at screening and a weekly average severity of > 1 at time of randomization.
- Patients whose bilateral sino-nasal polyposis remains inadequately controlled despite prior treatment with SCS anytime within the past 2 years; and/or had a medical contraindication/intolerance to SCS; and/or received nasal polyp surgery 6 months before signing the ICF.
Key exclusion criteria (6 listed)
- Patients with other nasal diseases or symptoms.
- Patients who are taking or have taken the following prohibited therapies as specified, e.g., systemic steroids within 4 weeks prior to screening, less than 3 months or 5 half-lives for biologic therapy prior to screening.
- Patients who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
- History of cancer.
- Known or suspected history of immunosuppression.
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 |
|---|---|---|
| 611611 subcutaneous (SC) injection. | Drug | 611 Dose A, 611 Dose B |
| PlaceboPlacebo subcutaneous (SC) injection. | Drug | Placebo |
Primary outcome
Change From Baseline at Week 16 in Bilateral Nasal Polyp Score (NPS)
Time frame: Up to 16 weeks
NPS is evaluated by nasal endoscopy. For each nostril, NPS is graded based on polyp size from 0 = no polyps to 4 = large polyps causing complete obstruction of inferior nasal cavity; lower score = smaller sized polyps. Bilateral NPS is the sum of right and left nostril scores, ranges from 0 (no polyps) to 8 (large polyps), higher score = more severe disease.
Change From Baseline at Week 16 in Nasal Congestion Symptom Severity Score (NCS)
Time frame: Up to 16 weeks
NCS is assessed by the participants daily from visit 1 and throughout the study on a scale of 0 to 3, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms, with higher scores indicates more severity.
5 secondary outcomes
Change From Baseline to the End of study in Lund Mackay Score
Time frame: Up to 16 weeks
Change From Baseline to the End of study in Total Nasal Symptom Score (TNSS)
Time frame: Up to 16 weeks
Change From Baseline to the End of study in the University of Pennsylvania Smell Identification Test (UPSIT) Score
Time frame: Up to 16 weeks
Change From Baseline to the End of study in 22-item Sino-nasal Outcome Test (SNOT-22) Scores
Time frame: Up to 16 weeks
611 Concentration in Serum
Time frame: Up to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- 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.
Qinghong Zhou, BS study director
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Luo Zhang, MD principal investigator
Beijing Tongren Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 611 in people with Sinusitis and Nasal Polyps, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 4 sites in China.
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 5 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: status not confirmed, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. 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?
Results are not available in the source record.
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?
Change From Baseline at Week 16 in Bilateral Nasal Polyp Score (NPS) (time frame: Up to 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2024.