Allergic RhinitisPhase 2MERAKNCT05470647
A Study of CM310 in Patients With Uncontrolled Seasonal Allergic Rhinitis
A Phase 2 study testing Interleukin-4 receptor responders 1 and Interleukin-4 receptor responders 2 in people with Allergic Rhinitis, run by Beijing Tongren Hospital at 1 site in China.
Trial summary
Allergic rhinitis (AR) is a non-infectious chronic inflammatory disease of the nasal mucosa mainly mediated by immunoglobulin E after exposure to allergens in atopic individuals. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Interleukin-4 receptor responders 1 and Interleukin-4 receptor responders 2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 1 siteChina
- Study dates
- 17 Aug 2022to 28 Dec 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily sign the informed consent form.
Who cannot join
- Have any condition that are not suitable for participating in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, 100000
About this study
Official title: The Efficacy and Safety of CM310 Injection in Patients With Uncontrolled Seasonal Allergic Rhinitis Under Conventional Treatment: A Randomized, Double-Blind, Placebo-controlled Investigator Initiated Trial (IIT) Study
Allergic rhinitis (AR) is a non-infectious chronic inflammatory disease of the nasal mucosa mainly mediated by immunoglobulin E after exposure to allergens in atopic individuals. The typical symptoms of AR are paroxysmal sneezing, watery rhinorrhea, itching, and nasal congestion, which may be accompanied by ocular symptoms, including eye itching, tearing, redness, and burning sensation, which are more common in patients with hay fever allergies. Bronchial asthma is associated with bronchial asthma in 40% of patients with AR, suggesting a comorbid feature of allergic disease.
Read the detailed description
AR is a common clinical chronic nasal disease, affecting 10% to 20% of the world's population, and has become a global health problem. AR not only seriously affects the quality of life of patients, resulting in patient fatigue, impaired learning, attention, and decision-making ability, but also causes a heavy social burden.
AR has a variety of classification methods. According to the type of allergen, it can be divided into seasonal (SAR, common allergens are seasonal allergens such as pollen) and perennial (PAR, common allergens are indoor allergens such as dust mites or occupational allergies), which is a classification method often used in clinical studies. According to the course of the disease, it can be divided into intermittent (symptom onset < 4 days/week, or < 4 consecutive weeks) and persistent (symptom onset ≥ 4 days/week, and ≥ 4 consecutive weeks). According to the severity of the disease, it can be divided into minor AR (mild symptoms, with no significant impact on quality of life) and moderate-severe AR (more severe or severe symptoms, with significant impact on quality of life). The results of the cooperative survey showed that persistent moderate-to-severe disease was the most common in the overall population, accounting for 52.2%, indicating that the treatment and control of AR has become an urgent problem to be solved.
- Conditions
- Allergic Rhinitis
- Being tested
- Interleukin-4 receptor responders 1, Interleukin-4 receptor responders 2, Placebo
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interleukin-4 receptor responders 1Biological
Interleukin-4 receptor was injected subcutaneously.
Interleukin-4 receptor responders 2Biological
Interleukin-4 receptor was injected subcutaneously.
PlaceboBiological
Placebo was injected subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| Interleukin-4 receptor responders 1 | Experimental | Interleukin-4 receptor was injected subcutaneously, once every two weeks. Receives: Biological: Interleukin-4 receptor responders 1 |
| Interleukin-4 receptor responders 2 | Experimental | Interleukin-4 receptor was injected subcutaneously, once a week. Receives: Biological: Interleukin-4 receptor responders 2 |
| Controls | Placebo comparator | Placebo was injected subcutaneously. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average change from baseline in daily retrospective total nasal symptom score (rTNSS) during treatment period.
Average change from baseline in daily retrospective total nasal symptom score (rTNSS) during treatment period. The Total Nasal Symptom Score (TNSS) is the sum of the four symptom scores of runny nose, nasal congestion, nasal itching, and sneezing, with each symptom scoring from 0 to 3.
Measured: up to week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start17 Aug 2022
- Primary completion24 Sep 2022
- Study completion28 Dec 2022
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 Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe 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
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luo zhang, Study chair, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05470647
- Sponsor's protocol ID
- CM310_IIS_SAR05
- Acronym
- MERAK
- Status last verified
- Oct 2023
- First submitted
- 19 Jul 2022
- Last updated
- 19 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang Y, Yan B, Zhu Z, Wang X, Song X, Zhu D, Ma T, Zhang Y, Meng C, Wang G, Wang C, Zhang L. Efficacy and safety of stapokibart (CM310) in uncontrolled seasonal allergic rhinitis (MERAK): an investigator-initiated, placebo-controlled, randomised, double-blind, phase 2 trial. EClinicalMedicine. 2024 Feb 6;69:102467. doi: 10.1016/j.eclinm.2024.102467. eCollection 2024 Mar.
PubMed 38356731
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of CM310 Injection in Patients With Uncontrolled Seasonal Allergic Rhinitis Under Conventional Treatment: A Randomized, Double-Blind, Placebo-controlled Investigator Initiated Trial (IIT) Study
- ClinicalTrials.gov ID
- NCT05470647
- Acronym / sponsor ID
- MERAK / CM310_IIS_SAR05
- Conditions
- Allergic Rhinitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 17 Aug 2022 (actual)
- Primary completion
- 24 Sep 2022 (actual)
- Study completion
- 28 Dec 2022 (actual)
- First posted
- 22 Jul 2022 (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.
Allergic rhinitis (AR) is a non-infectious chronic inflammatory disease of the nasal mucosa mainly mediated by immunoglobulin E after exposure to allergens in atopic individuals. The typical symptoms of AR are paroxysmal sneezing, watery rhinorrhea, itching, and nasal congestion, which may be accompanied by ocular symptoms, including eye itching, tearing, redness, and burning sensation, which are more common in patients with hay fever allergies. Bronchial asthma is associated with bronchial asthma in 40% of patients with AR, suggesting a comorbid feature of allergic disease.
Detailed description
AR is a common clinical chronic nasal disease, affecting 10% to 20% of the world's population, and has become a global health problem. AR not only seriously affects the quality of life of patients, resulting in patient fatigue, impaired learning, attention, and decision-making ability, but also causes a heavy social burden.
AR has a variety of classification methods. According to the type of allergen, it can be divided into seasonal (SAR, common allergens are seasonal allergens such as pollen) and perennial (PAR, common allergens are indoor allergens such as dust mites or occupational allergies), which is a classification method often used in clinical studies. According to the course of the disease, it can be divided into intermittent (symptom onset < 4 days/week, or < 4 consecutive weeks) and persistent (symptom onset ≥ 4 days/week, and ≥ 4 consecutive weeks). According to the severity of the disease, it can be divided into minor AR (mild symptoms, with no significant impact on quality of life) and moderate-severe AR (more severe or severe symptoms, with significant impact on quality of life). The results of the cooperative survey showed that persistent moderate-to-severe disease was the most common in the overall population, accounting for 52.2%, indicating that the treatment and control of AR has become an urgent problem to be solved.
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 |
|---|---|---|
| Interleukin-4 receptor responders 1 | Experimental | Biological: Interleukin-4 receptor responders 1Interleukin-4 receptor was injected subcutaneously, once every two weeks. |
| Interleukin-4 receptor responders 2 | Experimental | Biological: Interleukin-4 receptor responders 2Interleukin-4 receptor was injected subcutaneously, once a week. |
| Controls | Placebo comparator | Biological: PlaceboPlacebo was injected subcutaneously. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Voluntarily sign the informed consent form.
Key exclusion criteria (1 listed)
- Have any condition that are not suitable for participating in this study.
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 |
|---|---|---|
| Interleukin-4 receptor responders 1Interleukin-4 receptor was injected subcutaneously. | Biological | Interleukin-4 receptor responders 1 |
| Interleukin-4 receptor responders 2Interleukin-4 receptor was injected subcutaneously. | Biological | Interleukin-4 receptor responders 2 |
| PlaceboPlacebo was injected subcutaneously. | Biological | Controls |
Primary outcome
Average change from baseline in daily retrospective total nasal symptom score (rTNSS) during treatment period.
Time frame: up to week 2
Average change from baseline in daily retrospective total nasal symptom score (rTNSS) during treatment period. The Total Nasal Symptom Score (TNSS) is the sum of the four symptom scores of runny nose, nasal congestion, nasal itching, and sneezing, with each symptom scoring from 0 to 3.
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 19 Oct 2023.
- Derived from this study: PubMed 38356731Zhang Y, Yan B, Zhu Z, Wang X, Song X, Zhu D, Ma T, Zhang Y, Meng C, Wang G, Wang C, Zhang L. Efficacy and safety of stapokibart (CM310) in uncontrolled seasonal allergic rhinitis (MERAK): an investigator-initiated, placebo-controlled, randomised, double-blind, phase 2 trial. EClinicalMedicine. 2024 Feb 6;69:102467. doi: 10.1016/j.eclinm.2024.102467. eCollection 2024 Mar.
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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.
Luo zhang study chair
Beijing Tongren Hospital
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 Interleukin-4 receptor responders 1 and Interleukin-4 receptor responders 2 in people with Allergic Rhinitis, run by Beijing Tongren Hospital at 1 site 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 1 inclusion and 1 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 19 Oct 2023. 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 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?
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?
Average change from baseline in daily retrospective total nasal symptom score (rTNSS) during treatment period. (time frame: up to week 2). 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 NCT05470647, 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 19 Oct 2023.