Rupatifen Fumarate Capsules in Patients With Seasonal Allergic Rhinitis

A Randomized, Double-blind, Positive-control and Placebo-controlled Phase Ⅲ Clinical Study to Evaluate the Efficacy and Safety in Rupatifen Fumarate Capsules for the Seasonal Allergic Rhinitis Patients

This Phase Ⅲ randomized, double-blind, active- and placebo-controlled trial aims to assess the efficacy and safety of Rupatifen Fumarate Capsules for seasonal allergic rhinitis. Eligible participants will be randomized to Rupatifen Fumarate Capsules, Rupatadine Fumarate Tablets (active comparator), or matching placebo. All treatments are administered once daily at a consistent time with a 24 ± 2-hour interval between doses for 2 consecutive weeks.

Study Overview

• Status: Not yet recruiting
• Conditions: Seasonal Allergic Rhinitis
• Intervention / Treatment: Drug: Rupatifen Fumarate Capsules; Drug: Rupatadine Fumarate Tablets Placebo; Drug: Rupatadine Fumarate Tablets; Drug: Rupatifen Fumarate Capsules Placebo

• Study Type: Interventional
• Enrollment (Estimated): 550
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Xiuzhen Liu; Phone Number: +86 59183770223; Email: xiuzhen.liu@chinaljx.com

Study Locations

• China
  • Beijing, China
    • Beijing Tongren Hospital, Capital Medical University
  • Beijing, China
    • Emergency General Hospital
  • Tianjin, China
    • Tianjin People's Hospital
  • Hebei
    • Shijiazhuang, Hebei, China
      • Hebei General Hospital
    • Shijiazhuang, Hebei, China
      • Hebei Provincial Hospital of Traditional Chinese Medicine
  • Inner Mongolia
    • Chifeng, Inner Mongolia, China
      • Chifeng Municipal Hospital
  • Shandong
    • Jinan, Shandong, China
      • Shandong Second Provincial General Hospital
  • Shanxi
    • Taiyuan, Shanxi, China
      • Second Hospital of Shanxi Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged from 18 to 65 years inclusive, no restriction on gender.
• Clinical diagnosis shall comply with Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (Revised 2022) issued by Rhinology Group, Chinese Society of Otorhinolaryngology Head and Neck Surgery, Chinese Medical Association; documented medical history of seasonal allergic rhinitis ≥2 years (subject's self-reported history is acceptable). Prior to randomization, subjects shall test positive for one or more locally prevalent seasonal allergens (e.g., tree pollen, grass pollen). Any of the following allergen testing results are recognized: skin prick test (SPT), intradermal test or serum specific immunoglobulin E (sIgE). Specific immunoglobulin E (sIgE) results obtained within 1 year prior to randomization demonstrating positivity to relevant seasonal allergens are acceptable. Clinical manifestations shall meet the following: a) Symptoms: ≥2 of paroxysmal sneezing, rhinorrhea, nasal pruritus and nasal congestion; total daily symptom duration ≥1 hour, with possible accompanying ocular manifestations including lacrimation, ocular pruritus and conjunctival hyperemia. b) Signs: typical pale and edematous nasal mucosa with watery nasal discharge. c) Allergic symptoms manifest seasonally in spring and/or autumn, and subjects are in an active symptomatic episode at screening.
• At screening, reflective Total Nasal Symptom Score (rTNSS) ≥6 points, nasal congestion subscore ≥2 points, and at least one subscore ≥2 points among rhinorrhea, nasal pruritus and sneezing.
• Subjects are willing to provide written informed consent and comply with study procedures, including proper completion of subject diary cards; capable of adhering to scheduled study medication, laboratory examinations and other trial-related assessments.
• Subjects satisfying all criteria below after the 1-week run-in phase are eligible to proceed to the treatment observation period: 1)The reflective Total Nasal Symptom Score (rTNSS) ≥6 points prior to study drug administration on Day -7 (first day of run-in) and prior to the first dose in treatment period; nasal congestion subscore ≥2 points plus ≥2 points in at least one of rhinorrhea, nasal pruritus or sneezing. The mean baseline reflective Total Nasal Symptom Score (rTNSS) ≥6 points, calculated as the average of seven reflective Total Nasal Symptom Score (rTNSS) assessments: morning and evening of Day -3, Day -2, Day -1 plus morning of Day 1; 2) Diary completion rate during run-in period ≥80%; 3) Total number of recorded reflective Total Nasal Symptom Score (rTNSS) and instantaneous Total Nasal Symptom Score (iTNSS) scores in run-in period ≥12 times, with no missing values for the seven baseline assessments; 4) Run-in study drug administration frequency ≥6 times; 5) No rescue medication administered throughout the run-in period.

Exclusion Criteria:

• (Medical inquiry) Patients with asthma requiring long-term treatment (subjects with occasional asthmatic symptoms such as dyspnea or exercise-induced asthma who require no medication during the trial may be enrolled).
• Subjects with infectious conjunctivitis or other ocular infections (allergic conjunctivitis excluded).
• Subjects with concomitant nasal diseases or conditions at screening (e.g., acute/chronic sinusitis, nasal polyps, deviated nasal septum, rhinitis medicamentosa, cerebrospinal fluid rhinorrhea, status within 1 year post nasal surgery, etc.) that may interfere with efficacy assessment as judged by the investigator (self-reported history is acceptable).
• (Medical inquiry) Active respiratory tract infection occurring within 14 days prior to screening or throughout the run-in period, including but not limited to bronchitis, pneumonia, upper respiratory tract infection or sinus infection.
• (Medical inquiry) Subjects receiving sinus surgery within 3 months before screening or with incompletely healed nasal trauma.
• (Medical inquiry) Severe pulmonary disease or impaired pulmonary function such as chronic obstructive pulmonary disease (COPD).
• (Medical inquiry) Subjects with cardiac disorders requiring treatment; male subjects with QT interval corrected by Fridericia's formula (QTcF) greater than 470 ms, female subjects with QT interval corrected by Fridericia's formula (QTcF) greater than 480 ms, uncorrectable hypokalemia, progressive arrhythmias including bradycardia or acute myocardial ischemia who are deemed ineligible for enrollment per investigator's judgment.
• (Medical inquiry) Subjects receiving allergen immunotherapy within 6 months prior to screening.
• Subjects with severe hepatic or renal disorders, or abnormal hepatic and renal laboratory results: alanine aminotransferase (ALT) / aspartate aminotransferase (AST) greater than or equal to 2 times the upper limit of normal (ULN), or creatinine (Cr) greater than 1.2 times the upper limit of normal (ULN).
• (Medical inquiry) Inadequate washout of prohibited medications prior to screening; specified washout periods for common medicines are listed below: Intranasal or systemic decongestants, anticholinergics, intranasal antihistamines: 3 days; Systemic antihistamines (cetirizine, fexofenadine, loratadine, desloratadine etc.): 10 days; Mast cell stabilizers, tricyclic antidepressants, anti-allergic herbal medicines, leukotriene receptor antagonists: 2 weeks; Systemic glucocorticoids: 4 weeks; potent topical or intranasal glucocorticoids: 2 weeks; anti-immunoglobulin E (Anti-IgE) therapy, interleukin-4 (IL-4R) inhibitors (dupilumab, tezepelumab etc.): 3 months or 5 elimination half-lives, whichever is longer; allergen immunotherapy: 6 months. For other unlisted drugs relevant to allergic rhinitis treatment in this trial: washout of no less than 5 elimination half-lives or 3 days prior to run-in period initiation, whichever is longer.
• (Medical inquiry) Subjects unable to discontinue concomitant medications that may interfere with efficacy evaluation throughout the trial, including but not limited to tricyclic antidepressants, systemic/potent topical/intranasal glucocorticoids, decongestants (except rescue medication), antihistamines, leukotriene receptor antagonists, mast cell stabilizers (cromolyn sodium, nedocromil sodium, lodoxamide tromethamine, pemirolast potassium, tranilast etc.), central nervous system depressants, anti-immunoglobulin E (anti-IgE) agents (omalizumab), anticholinergics and anti-allergic herbal medicines, regular nasal irrigation.
• (Medical inquiry) Subjects who have received moderate or potent Cytochrome P450 3A4 (CYP3A4) inhibitors or other Cytochrome P450 3A4 (CYP3A4) isoenzyme inhibitors within 2 weeks before screening or cannot discontinue such agents during the trial (examples: ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin, conivaptan, lopinavir, voriconazole, erythromycin, fluconazole, cobicistat-containing formulations etc.).
• (Medical inquiry) Subjects planning to travel to areas outside endemic pollen regions during the run-in period, or planning out-of-town travel for consecutive greater than or equal to 2 days or cumulative greater than or equal to 3 days during the trial.
• (Medical inquiry) Subjects engaged in precision operations including vehicle driving, machinery operation or high-altitude work.
• (Medical inquiry) Subjects with documented alcohol addiction within the past 5 years (alcoholism defined as weekly intake greater than 14 alcohol units; 1 unit is approximately equal to 360 mL beer / 45 mL 40% alcohol by volume (ABV) distilled spirits / 150 mL wine), drug abuse or tobacco addiction (daily cigarette consumption greater than 10 cigarettes), or unable to abstain from alcohol throughout the trial.
• Subjects with known hypersensitivity to investigational medicinal product or its excipients.
• Pregnant or lactating females; female subjects or male subjects (or their female partners) planning pregnancy during the entire trial and within 3 months after trial completion.
• (Medical inquiry) Subjects participating in another clinical trial with investigational product within 3 months prior to screening.
• Subjects with any condition deemed by the investigator to impair ability to provide informed consent or comply with study protocol, or whose trial participation would compromise trial outcomes or personal safety.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rupatifen Fumarate Capsules; Rupatifen Fumarate Capsules and Rupatadine Fumarate Tablets Placebo	Drug: Rupatifen Fumarate Capsules; Oral administration, one capsule once daily for 14 consecutive days; Drug: Rupatadine Fumarate Tablets Placebo; Oral administration, one tablet once daily for 14 consecutive days
Active Comparator: Rupatadine Fumarate Tablets; Rupatadine Fumarate Tablets and Rupatifen Fumarate Capsules Placebo	Drug: Rupatadine Fumarate Tablets; Oral administration, one tablet once daily for 14 consecutive days; Drug: Rupatifen Fumarate Capsules Placebo; Oral administration, one capsule once daily for 14 consecutive days
Placebo Comparator: Placebo; Rupatifen Fumarate Capsules Placebo and Rupatadine Fumarate Tablets Placebo	Drug: Rupatadine Fumarate Tablets Placebo; Oral administration, one tablet once daily for 14 consecutive days; Drug: Rupatifen Fumarate Capsules Placebo; Oral administration, one capsule once daily for 14 consecutive days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in the average reflective Total Nasal Symptom Score (rTNSS) during the treatment period	The reflective Total Nasal Symptom Score (rTNSS) assesses 4 core nasal symptoms: sneezing, rhinorrhea, nasal pruritus, and nasal congestion. Each symptom is scored from 0 (none) to 3 (severe). The total score ranges from 0 to 12 points, with higher scores indicating more severe nasal symptoms.	From baseline (Day 1 pre-dose) through Day 15 (end of treatment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in average instant Total Nasal Symptom Score (iTNSS) during treatment	The instant Total Nasal Symptom Score (iTNSS) assesses 4 core nasal symptoms: sneezing, rhinorrhea, nasal pruritus, and nasal congestion. Each symptom is scored from 0 (none) to 3 (severe). The total score ranges from 0 to 12 points, with higher scores indicating more severe nasal symptoms.	From baseline (Day 1 pre-dose) through Day 15 (end of treatment)
Time to onset after the first dose on Day 1 (assessed based on instant Total Nasal Symptom Score (iTNSS) scores)	Time to onset after the first dose on Day 1 (assessed based on instant Total Nasal Symptom Score (iTNSS) scores); The instant Total Nasal Symptom Score (iTNSS) assessments will be conducted at 0.5 hour (±10 minutes), 1 hour (±10 min), 1.5 hours (±10 minutes), 2 hours (±10 minutes), 3 hours (±10 minutes), 4 hours (±30 minutes), 6 hours (±30 minutes) and 8 hours (±30 minutes) following the first dose during the treatment period. Time to onset is defined as the first time point after the first treatment dose at which the change from baseline in instant Total Nasal Symptom Score (iTNSS) for the investigational product group is statistically significantly superior to that of the placebo group, and this superiority is sustained from this time point through the end of the 24-hour dosing interval. The instant Total Nasal Symptom Score (iTNSS) ranges from 0 to 12 points, with higher scores indicating more severe nasal symptoms.	0.5 hour (±10 minutes), 1 hour (±10 minutes), 1.5 hours (±10 minutes), 2 hours (±10 minutes), 3 hours (±10 minutes), 4 hours (±30 minutes), 6 hours (±30 minutes), and 8 hours (±30 minutes) following the first dose during the treatment period.
Number of days with nasal congestion score ≤ 1 during the treatment period	Nasal congestion is a sub-item of the Total Nasal Symptom Score (TNSS) scale, scored from 0 (none) to 3 (severe). Higher scores indicate more severe nasal congestion.	Day 1 through Day 15 (14-day treatment period)
Change from baseline in average morning reflective Total Nasal Symptom Score (rTNSS) during the treatment period	Morning reflective Total Nasal Symptom Score (rTNSS) is assessed once daily before morning dosing. The score ranges from 0 to 12 points, with higher scores indicating more severe nasal symptoms.	From baseline (Day 1 pre-dose morning) through Day 15 morning
Change from baseline in average evening reflective Total Nasal Symptom Score (rTNSS) during the treatment period	Evening reflective Total Nasal Symptom Score (rTNSS) is assessed once daily in the evening. The score ranges from 0 to 12 points, with higher scores indicating more severe nasal symptoms.	From baseline (Day 1 evening) through Day 14 evening
Change from baseline in average morning instant Total Nasal Symptom Score (iTNSS) during the treatment period	Morning instant Total Nasal Symptom Score (iTNSS) is assessed once daily in the morning. The score ranges from 0 to 12 points, with higher scores indicating more severe nasal symptoms.	From baseline (Day 1 morning) through Day 15 morning
Change from baseline in average evening instant Total Nasal Symptom Score (iTNSS) during the treatment period	Evening instant Total Nasal Symptom Score (iTNSS) is assessed once daily in the evening. The score ranges from 0 to 12 points, with higher scores indicating more severe nasal symptoms.	From baseline (Day 1 evening) through Day 14 evening
Change from baseline in individual nasal symptoms scores during the treatment period	Individual nasal symptoms include sneezing, rhinorrhea, nasal pruritus, and nasal congestion. Each symptom is scored from 0 (none) to 3 (severe), with higher scores indicating more severe symptoms.	From baseline (Day 1 pre-dose) through Day 15 (end of treatment)
Change from baseline in average reflective Total Ocular Symptom Score (rTOSS) during the treatment period	The reflective Total Ocular Symptom Score (rTOSS) assesses 3 core ocular symptoms: lacrimation, ocular pruritus, and conjunctival hyperemia. Each symptom is scored from 0 (none) to 3 (severe). The total score ranges from 0 to 9 points, with higher scores indicating more severe ocular symptoms.	From baseline (Day 1 pre-dose) through Day 15 (end of treatment)
Change from baseline in average Standardized Rhinoconjunctivitis Quality of Life Questionnaire_Seasonal Allergic (RQLQ (S)-SA) scores during the treatment period	The Standardized Rhinoconjunctivitis Quality of Life Questionnaire_Seasonal Allergic (RQLQ(S)-SA) is a validated patient-reported outcome measure evaluating the impact of rhinoconjunctivitis on daily activities and quality of life. Higher scores indicate greater impairment of quality of life.	From baseline (Day 1 pre-dose) through Day 15 (end of treatment)
Area Under the Curve (AUC) of change from baseline in reflective Total Nasal Symptom Score (rTNSS) during the treatment period	The reflective Total Nasal Symptom Score (rTNSS) ranges from 0 to 12 points, with higher scores indicating more severe nasal symptoms. Area Under the Curve (AUC) is calculated over the full 14-day treatment period.	From baseline (Day 1 pre-dose) through Day 15 (end of treatment)
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)	All adverse events will be graded for severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0, and coded by system organ class and preferred term per Medical Dictionary for Regulatory Activities (MedDRA). Treatment relationship (definitely, probably, possibly related) will be assessed by the investigator.	From start of run-in period (Day -7) through end of follow-up period (approximately 7 days after last dose)
Number of participants with clinically significant abnormal pulse rate	Pulse rate is measured in beats per minute (bpm). Values judged as clinically significant abnormal by the investigator will be recorded.	Screening period, Day 1, Day 8, and Day 15 (end of treatment)
Number of participants with clinically significant abnormal respiratory rate	Respiratory rate is measured in respirations per minute (rpm). Values judged as clinically significant abnormal by the investigator will be recorded.	Screening period, Day 1, Day 8, and Day 15 (end of treatment)
Number of participants with clinically significant abnormal blood pressure	Blood pressure is measured in Millimeter of Mercury (mmHg). Values judged as clinically significant abnormal by the investigator will be recorded.	Screening period, Day 1, Day 8, and Day 15 (end of treatment)
Number of participants with clinically significant abnormal body temperature	Body temperature is measured in degrees Celsius (°C). Values judged as clinically significant abnormal by the investigator will be recorded.	Screening period, Day 1, Day 8, and Day 15 (end of treatment)
Physical examinations (including general appearance, skin and mucous membranes, head, neck, chest, abdomen, spine/extremities, nervous system, and other systems)	Physical examinations include general appearance, skin and mucous membranes, head, neck, chest, abdomen, spine/extremities, nervous system, and other systems. Any newly emerged clinically significant abnormal physical signs, or abnormal signs that have deteriorated significantly compared with baseline, as judged by the investigator, shall be documented as adverse events.	Screening period, Day 1, Day 15 (end of treatment)
Number of participants with clinically relevant abnormal laboratory parameters requiring intervention to study treatment (blood routine, urine routine, blood biochemistry, coagulation function)	Values judged as clinically significant abnormal by the investigator will be recorded.	Screening period, Day 1, Day 15 (end of treatment)
Change in 12-lead electrocardiogram (ECG) heart rate	Heart rate is measured via 12-lead electrocardiogram (ECG) in beats per minute (bpm). Values judged as clinically significant abnormal by the investigator will be recorded.	Screening period, Day 1, Day 8, and Day 15 (end of treatment)
Change in 12-lead electrocardiogram (ECG) P-R Interval	P-R interval is measured via 12-lead electrocardiogram (ECG) in milliseconds (ms). Values judged as clinically significant abnormal by the investigator will be recorded.	Screening period, Day 1, Day 8, and Day 15 (end of treatment)
Change in 12-lead electrocardiogram (ECG) R-R Interval	R-R interval is measured via 12-lead electrocardiogram (ECG) in milliseconds (ms). Values judged as clinically significant abnormal by the investigator will be recorded.	Screening period, Day 1, Day 8, and Day 15 (end of treatment)
Change in 12-lead electrocardiogram (ECG) Q-T Interval	Q-T interval is measured via 12-lead electrocardiogram (ECG) in milliseconds (ms). Values judged as clinically significant abnormal by the investigator will be recorded.	Screening period, Day 1, Day 8, and Day 15 (end of treatment)
Change in 12-lead electrocardiogram (ECG) QRS complex Interval	QRS complex interval is measured via 12-lead electrocardiogram (ECG) in milliseconds (ms). Values judged as clinically significant abnormal by the investigator will be recorded.	Screening period, Day 1, Day 8, and Day 15 (end of treatment)
Change in QT interval corrected by Fridericia's formula (QTcF) on 12-lead electrocardiogram (ECG)	QTcF is the QT interval corrected for heart rate using the Fridericia formula, measured via 12-lead electrocardiogram (ECG) in milliseconds (ms). Values judged as clinically significant abnormal by the investigator will be recorded.	Screening period, Day 1, Day 8, and Day 15 (end of treatment)

Collaborators and Investigators

• Sponsor: Fujian Mindong Rejuvenation Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: July 1, 2026
• First Submitted That Met QC Criteria: July 14, 2026
• First Posted (Actual): July 17, 2026

Study Record Updates

• Last Update Posted (Actual): July 17, 2026
• Last Update Submitted That Met QC Criteria: July 14, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Allergic Rhinitis; Antihistamine; Inhibition of platelet aggregation
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Nose Diseases; Otorhinolaryngologic Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
• Other Study ID Numbers: LJX-LPTF-Ⅲ01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No