CLINICAL TRIAL

CBP-201 for Nasal Polyps

Waitlist Available · 18+ · All Sexes · Chongqing, China

This study is evaluating whether a drug may help treat chronic sinusitis.

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About the trial for Nasal Polyps

Eligible Conditions
Polyps · Chronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP) · Nasal Polyps · Sinusitis

Treatment Groups

This trial involves 3 different treatments. CBP-201 is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
CBP-201
DRUG
Experimental Group 2
CBP-201
DRUG
Control Group 3
Placebo
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CBP-201
2020
Completed Phase 2
~230

Eligibility

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Female and male patients aged ≥ 18 and ≤ 75 years at the time of screening.
Patients who are diagnosed with chronic rhinosinusitis with bilateral polyps despite treatment with systemic corticosteroid within the past 2 years and/or medical contraindication/intolerance to systemic corticosteroids. The polyps have a minimum bilateral NPS of 5 out of a maximum score of 8 with at least a score of 2 for each nostril at screening and baseline evaluated by endoscopy.
Nasal congestion/blockade/obstruction with moderate or severe symptom severity (Nasal Congestion Score of > 2) at screening and a weekly average severity of > 1 at time of randomization.
Patients using a documented stable dose of nasal mometasone at least 200 mcg/day, or an equivalent daily dose of another INCS, for at least 28 days before randomization and willing to continue the dose for the duration of the study. Note: For patients who are using an alternative INCS product other than mometasone furoate nasal spray (MFNS) prior to the screening visit, the investigator must switch the patient to MFNS at V1.
Patients willing to enter Patient Diary daily symptom assessments and maintain stable dosing with MFNS with a compliance of at least 70% in the 7 days preceding randomization. Note: Patients must use nasal mometasone at least 200 mcg/day, or equivalent, for at least 28 days before randomization, which can include days prior to screening with supportive documentation. Run-in can be 7-31 days with the compliance determined in the week prior to dosing.
Willing and able to comply with all study visits and study-related procedures, in the opinion of the Investigator.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: From Baseline to Week 32
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: From Baseline to Week 32.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether CBP-201 will improve 2 primary outcomes and 22 secondary outcomes in patients with Nasal Polyps. Measurement will happen over the course of From Baseline to Week 24.

Change in average daily loss of smell score
FROM BASELINE TO WEEK 24
Change from baseline at Week 24 in average daily loss of smell score
Change in University of Pennsylvania Smell Identification Test (UPSIT)
FROM BASELINE AT WEEK 24
Change from baseline at Week 24 in University of Pennsylvania Smell Identification Test (UPSIT).
Change in average daily anterior rhinorrhea score
FROM BASELINE TO WEEK 24
Change from baseline at Week 24 in average daily anterior rhinorrhea score
Change in average daily nasal congestion score (NCS)
FROM BASELINE AT WEEK 24
Change from baseline at Week 24 in average daily nasal congestion score (NCS).
Change in daily subject-assessed nasal peak inspiratory flow (NPIF)
FROM BASELINE TO WEEK 24
Change from baseline at Week 24 in daily subject-assessed nasal peak inspiratory flow (NPIF).
Change in 22-item Sinonasal Outcome Test (SNOT-22)
FROM BASELINE TO WEEK 24
Change from baseline at Week 24 in 22-item Sinonasal Outcome Test (SNOT-22)
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does cbp-201 improve quality of life for those with nasal polyps?

Cbp-201 is feasible and safe for treating patients with nasal polyps. Treatment for nasal polyps with Cbp-201 improves quality of life for those who experience this treatment.

Anonymous Patient Answer

What causes nasal polyps?

The cause of polyps is not understood. Many possible causes have been described under the head of risk factors and disease. A number of environmental and genetic factors may affect the development of nasal polyps, including exposure to certain substances in the workplace. The polyps may be caused by inflammation. They also may develop if too much debris and moisture builds up in the nasal cavity. The exact nature of this relationship is not clear. Smoking does not appear to have an extra influence on polyp development. Many factors may be involved in the development of polyps; however, none of them are clearly established. Because of this ambiguity, physicians should not take anything for granted.

Anonymous Patient Answer

Can nasal polyps be cured?

Nasal polyposis occurs in 50% of the general population. It is usually of limited duration and may not influence quality of life. Nasal polyps can be treated successfully for a considerable period of time, if proper treatment is given.

Anonymous Patient Answer

What are common treatments for nasal polyps?

This article describes treatment options for nasal polyps based on etiology, location of the polyp, and risk of recurrence. In selecting treatment options for nasal polyps, we consider etiology, location, and other factors such as age, symptoms, and comorbidities. For nasal polyps, there are a multitude of treatment options. These include endoscopic, surgical, and ablative approaches. These treatment options provide satisfactory outcomes and a decreased recurrence rate.

Anonymous Patient Answer

What are the signs of nasal polyps?

It is not unusual for patients to report several symptoms in the face of nasal polyps. In cases where nasal polyps are suspected, there should still be a high index of suspicion; these include any of the above symptoms, along with facial appearance, blood or mucus discharge, facial

Anonymous Patient Answer

What is nasal polyps?

There are many types of polyps, none of which can be diagnosed by examination (e.g. a CT scan). The correct diagnosis involves an accurate knowledge of the nasal anatomy.

Anonymous Patient Answer

How many people get nasal polyps a year in the United States?

Nasal polyps are extremely common—more than two thousand people get them every year. The polyps grow in the nose and can block nasal breathing. You may think that they are the result of allergies and cold air. They are not because both allergies and cold air can grow polyps. Sometimes people have only one nasal polyp. A polyp will form in each nostril. If only one polyp is present, you need a doctor for [sniffing tests.] If you have multiple nasal polyps a doctor will recommend one nostril needs [nasal surgery.

Anonymous Patient Answer

How does cbp-201 work?

Cbp-201 is a new immunomodulator that has been demonstrated to be effective in treating a variety of autoimmune diseases with limited toxicity and side effects. However, the exact mechanism by which Cbp-201 works is unknown. Cbp-201 is a cyclic dimer and may cause DNA disruption via interaction with the DNA repair enzyme DNA-PKcs.

Anonymous Patient Answer

What is the latest research for nasal polyps?

The main factors associated with increased levels of inflammatory markers include advancing age, obesity, and smoking. However, there appears to be a protective effect in those who reported sleep disturbance and use of steroid inhalers. Future studies are required to confirm these findings before these markers can be adopted to predict future risks.

Anonymous Patient Answer

What are the latest developments in cbp-201 for therapeutic use?

The development of cbp-201 has been ongoing for many years. Recent improvements include a longer treatment duration (28 weeks). Furthermore, this drug is approved for use in the United States. For patients with NSCLC, treatment with cbp-201 showed an improvement in median time to progression (TTP), overall survival (OS), and progression-free survival (PFS). After this data were published, a new and improved oral formulation of cbp-201 has been developed and approved by the European Medicines Agency in 2018. In clinical trials of cbp-201, patients tolerated the treatment well and had a manageable safety profile.

Anonymous Patient Answer

Who should consider clinical trials for nasal polyps?

The incidence of a nasal polyp is approximately 1 in 1000 among white healthy individuals. Since no therapy is definitively proven effective for nasal polyposis, it is extremely important to consider clinical trials of such therapy for this condition when the appropriate patients are available. Recent findings showed that nasal polyp patients who have symptomatic nasal obstruction are the best candidates for nasal polyp clinical trials; their symptom relief and nasal obstruction rate would not be improved by any other treatment option.

Anonymous Patient Answer

What is cbp-201?

A new diagnostic tool for nasal polyps was developed. As nasal polyps with cbp-201 were frequently located in the middle turbinates, the role of cbp-201 in allergic rhinitis may be underestimated.

Anonymous Patient Answer
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