Allergic RhinitisPhase 2NCT06028490
A Study of IL4Rα Monoclonal Antibody in Patients With Uncontrolled Seasonal Allergic Rhinitis.
A Phase 2 study testing GR1802 injection-1 and GR1802 injection-2 in people with Allergic Rhinitis, run by Zheng Liu ENT 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 75 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- GR1802 injection-1 and GR1802 injection-2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 7 Sep 2023to Nov 2023
- 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
- Subjects meet the diagnosis of SAR which has been prevalent for at least 2 years, and: standard treatment regimen for SAR was ineffective or subjective symptom control was unsatisfactory in the subject; positive test for at least one allergen associated with the development of SAR; pre-baseline symptom episodes of ≥ 4 days/week and a baseline TNSS of ≥ 6 points.
- Consent to highly effective contraception
Who cannot join
- Other nasal comorbidities or co-morbidities/states that may be present at the time of screening；
- It is expected that subjects' exposure to allergens in their home or work environments may change significantly during the study period.
- Patients with asthma requiring stable use of inhaled controlled medications;
- Previous or current malignant tumor within 5 years prior to screening;
- Presence of other acute or chronic diseases or abnormal laboratory tests at the time of screening that, in the investigator's assessment, may have a more serious impact on the efficacy or safety assessment of the subject;
- Live/live attenuated vaccine within 3 months prior to baseline;
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- Subjects with very limited outdoor activity during the daytime, as inferred from their regular daily routine;
- Unwillingness or inability to comply with the permitted and prohibited medication/treatment specifications of the study, inability to meet the pre-randomization drug elution cycle specified in the protocol;
- Women who are pregnant or breastfeeding;
- History of alcohol or drug abuse within 3 months prior to screening.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hosptial affiliated to Tongji Medical college of Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Rongfei Zhu, 18986292602, zrf13092@163.com
Zheng liu, 18607110505, zhengliuent@hotmail.com
About this study
Official title: The Efficacy and Safety of IL4Rα Monoclonal Antibody in Patients With Uncontrolled Seasonal Allergic Rhinitis Under Conventional Treatment: A Randomized, Double-Blind, Placebo-controlled Investigator Initiated Trial.
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.
- Conditions
- Allergic Rhinitis
- Being tested
- GR1802 injection-1, GR1802 injection-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.
GR1802 injection-1Biological
Also called Xeligekimab
subcutaneous，dose*1
GR1802 injection-2Biological
Also called Xeligekimab
subcutaneous，dose*2
PlaceboBiological
subcutaneous，dose*2
| Study group | Role | What they receive |
|---|---|---|
| Interleukin-4 receptor responders 1 | Experimental | Recombinant fully human anti-IL4Rα monoclonal antibody drug. Receives: Biological: GR1802 injection-1 |
| Interleukin-4 receptor responders 2 | Experimental | Recombinant fully human anti-IL4Rα monoclonal antibody drug. Receives: Biological: GR1802 injection-2 |
| Placebo | Placebo comparator | Recombinant fully human anti-IL4Rα monoclonal antibody drug. 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.
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: week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start7 Sep 2023
- Primary completionNov 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zheng Liu ENT
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zheng Liu ENT, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06028490
- Sponsor's protocol ID
- 2081-IIT-SAR
- Status last verified
- Sep 2023
- First submitted
- 31 Aug 2023
- Last updated
- 11 Sep 2023
- Results posted
- 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 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of IL4Rα Monoclonal Antibody in Patients With Uncontrolled Seasonal Allergic Rhinitis Under Conventional Treatment: A Randomized, Double-Blind, Placebo-controlled Investigator Initiated Trial.
- ClinicalTrials.gov ID
- NCT06028490
- Acronym / sponsor ID
- 2081-IIT-SAR
- Conditions
- Allergic Rhinitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Zheng Liu ENTUniversity, hospital or other
- Study start
- 7 Sep 2023 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 8 Sep 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.
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.
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: GR1802 injection-1Recombinant fully human anti-IL4Rα monoclonal antibody drug. |
| Interleukin-4 receptor responders 2 | Experimental | Biological: GR1802 injection-2Recombinant fully human anti-IL4Rα monoclonal antibody drug. |
| Placebo | Placebo comparator | Biological: PlaceboRecombinant fully human anti-IL4Rα monoclonal antibody drug. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects meet the diagnosis of SAR which has been prevalent for at least 2 years, and: standard treatment regimen for SAR was ineffective or subjective symptom control was unsatisfactory in the subject; positive test for at least one allergen associated with the development of SAR; pre-baseline symptom episodes of ≥ 4 days/week and a baseline TNSS of ≥ 6 points.
- Consent to highly effective contraception
Key exclusion criteria (10 listed)
- Other nasal comorbidities or co-morbidities/states that may be present at the time of screening；
- It is expected that subjects' exposure to allergens in their home or work environments may change significantly during the study period.
- Patients with asthma requiring stable use of inhaled controlled medications;
- Previous or current malignant tumor within 5 years prior to screening;
- Presence of other acute or chronic diseases or abnormal laboratory tests at the time of screening that, in the investigator's assessment, may have a more serious impact on the efficacy or safety assessment of the subject;
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 |
|---|---|---|
| GR1802 injection-1Also: Xeligekimabsubcutaneous，dose*1 | Biological | Interleukin-4 receptor responders 1 |
| GR1802 injection-2Also: Xeligekimabsubcutaneous，dose*2 | Biological | Interleukin-4 receptor responders 2 |
| Placebosubcutaneous，dose*2 | Biological | Placebo |
Primary outcome
Average change from baseline in daily retrospective total nasal symptom score (rTNSS) during treatment period.
Time frame: week 4
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- 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.
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 GR1802 injection-1 and GR1802 injection-2 in people with Allergic Rhinitis, run by Zheng Liu ENT 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 2 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: status not confirmed, as of the sponsor's last update on 11 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zheng Liu, PHD (027-83665555, zhengliuent@hotmail.com), or a site near the patient. 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: week 4). 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 11 Sep 2023.