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This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study aimed at evaluating the efficacy and safety of stapokibart in adolescent patients with seasonal allergic rhinitis, and observing the quality of life, Pharmakokinetics(PK), Pharmacodynamics (PD) characteristics, and immunogenicity of subjects.
Allergic rhinitis (AR) is a non infectious chronic inflammatory disease of the nasal mucosa that is mainly mediated by immunoglobulin E (IgE) in atopic individuals exposed to allergens.
All participants will receive standard of care treatment as concomitant medications. Stapokibart or placebo will be administered as add-on therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stapokibart group | Experimental |
| |
| Placebo group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stapokibart | Biological | subcutaneous injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in daily reflective total nasal symptom scores (rTNSS) over 2 weeks of treatment | The total nasal symptom score (TNSS) is the sum of the four symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, where each symptom is scored on a scale of 0 to 3. | Up to week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in daily rTNSS over 4 weeks of treatment | The total nasal symptom score (TNSS) is the sum of the four symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, where each symptom is scored on a scale of 0 to 3. | Up to week 4 |
| Mean change from baseline in the daily AM and PM reflective total nasal symptom score (AM and PM rTNSS) over 2 and 4 weeks of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qian Jia | Contact | 028-88610620 | clinicaltrial@keymedbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Luo Zhang | Beijing Tongren Hospital Affiliated to Capital Medical University | Principal Investigator |
| Chengshuo Wang | Beijing Tongren Hospital Affiliated to Capital Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tongren Hospital, CMU | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| Placebo |
| Drug |
subcutaneous injection |
|
The total nasal symptom score (TNSS) is the sum of the four symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, where each symptom is scored on a scale of 0 to 3. |
| Up to week 4 |
| Mean change and mean percent change from baseline in daily AM pre-dose instantaneous total nasal symptom score (iTNSS) over 2 weeks and 4 weeks of treatment | The total nasal symptom score (TNSS) is the sum of the four symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, where each symptom is scored on a scale of 0 to 3. | Up to week 4 |
| Mean percent change from baseline in daily rTNSS over 2 and 4 weeks of treatment | The total nasal symptom score (TNSS) is the sum of the four symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, where each symptom is scored on a scale of 0 to 3. | Up to week 4 |
| Mean change from baseline in daily rTNSS (including AM rTNSS and PM rTNSS) for individual nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing) over 2 and 4 weeks of treatment | The total nasal symptom score (TNSS) is the sum of the four symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, where each symptom is scored on a scale of 0 to 3. | Up to week 4 |
| Mean change and mean percent change from baseline in daily reflective total ocular symptom score (rTOSS) over 2 weeks or 4 weeks of treatment | The total ocular symptom score (TOSS) is the sum of three symptom scores for itchy/burning eyes, watery eyes, and red eyes, where each symptom is scored on a scale of 0 to 3. | Up to week 4 |
| Mean change from baseline in daily AM and PM reflective total ocular symptom score (AM and PM rTOSS) over 2 weeks and 4 weeks of treatment | The total ocular symptom score (TOSS) is the sum of three symptom scores for itchy/burning eyes, watery eyes, and red eyes, where each symptom is scored on a scale of 0 to 3. | Up to week 4 |
| Mean change from baseline in daily AM pre-dose instantaneous total ocular symptom score (iTOSS) over 2 weeks and 4 weeks of treatment | The total ocular symptom score (TOSS) is the sum of three symptom scores for itchy/burning eyes, watery eyes, and red eyes, where each symptom is scored on a scale of 0 to 3. | Up to week 4 |
| Mean percent change from baseline in daily rTOSS over 2 weeks and 4 weeks of treatment | The total ocular symptom score (TOSS) is the sum of three symptom scores for itchy/burning eyes, watery eyes, and red eyes, where each symptom is scored on a scale of 0 to 3. | Up to week 4 |
| Mean percent change from baseline in daily AM pre-dose iTOSS over 2 weeks and 4 weeks of treatment | The total ocular symptom score (TOSS) is the sum of three symptom scores for itchy/burning eyes, watery eyes, and red eyes, where each symptom is scored on a scale of 0 to 3. | Up to week 4 |
| Mean change from baseline in daily rTOSS (including AM and PM rTOSS) for individual symptoms (itching/burning eyes, tearing/watering eyes, and eye redness) over 2 weeks and 4 weeks of treatment | The total ocular symptom score (TOSS) is the sum of three symptom scores for itchy/burning eyes, watery eyes, and red eyes, where each symptom is scored on a scale of 0 to 3. | Up to week 4 |
| The change from baseline in rhinoconjunctivitis quality of life questionnaire (RQLQ(S)≥12) score in allergic rhinitis participants over 2 weeks and 4 weeks of treatment | The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ(S)≥12) is a 28-item, self-administered, disease-specific (AR) quality of life scale used by participants to assess quality of life over a week. | Up to week 4 |
| Incidence of adverse events (AEs) | Evaluate the incidence of treatment-emergency adverse events. | Up to week 12 |
| Serum Stapokibart concentration | Collect the blood samples for Pharmacokinetics analysis | Up to week 12 |
| Change and percent change from baseline of human thymus and activation-regulated chemokine (TARC) | Collect the blood samples for Pharmacodynamics analysis | Up to week 12 |
| change and percent change from baseline of total immunoglobulin E (IgE) | Collect the blood samples for Pharmacodynamics analysis | Up to week 12 |
| change and percent change from baseline of counts and ratios of eosinophil in blood | Collect the blood samples for Pharmacodynamics analysis | Up to week 12 |
| The development of anti-drug antibody (ADA) and neutralizing antibody (Nab) | Collect the blood samples for anti-drug antibody testing | Up to week 12 |
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |