A Phase 3 interventional study of Rupatifen Fumarate Capsules and Rupatadine Fumarate Tablets in Seasonal Allergic Rhinitis, sponsored by Fujian Mindong Rejuvenation Pharmaceutical Co., Ltd.. Recruiting at 18 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Fujian Mindong Rejuvenation Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment
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.
404 studies on the registry are indexed under Rhinitis, Allergic, Seasonal; 24 are open to participants now.
This study's planned enrollment of 550 is above the median of 131 across 366 interventional studies indexed under Rhinitis, Allergic, Seasonal.
Browse Rhinitis, Allergic, Seasonal studies →This is the only study on the registry with Fujian Mindong Rejuvenation Pharmaceutical Co., Ltd. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Rupatifen Fumarate Capsules and Rupatadine Fumarate Tablets Placebo
Drug: Rupatifen Fumarate Capsules · Drug: Rupatadine Fumarate Tablets Placebo
Rupatadine Fumarate Tablets and Rupatifen Fumarate Capsules Placebo
Drug: Rupatadine Fumarate Tablets · Drug: Rupatifen Fumarate Capsules Placebo
Rupatifen Fumarate Capsules Placebo and Rupatadine Fumarate Tablets Placebo
Drug: Rupatifen Fumarate Capsules Placebo · Drug: Rupatadine Fumarate Tablets Placebo
Oral administration, one capsule once daily for 14 consecutive days
Oral administration, one tablet once daily for 14 consecutive days
Oral administration, one capsule once daily for 14 consecutive days
Oral administration, one tablet once daily for 14 consecutive days
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.
Time frame: From baseline (Day 1 pre-dose) through Day 15 (end of treatment)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Screening period, Day 1, Day 8, and Day 15 (end of treatment)
Started Aug 2026 (actual). Primary completion is estimated for Oct 2027, 14 months after the start.
Of 31 industry-sponsored phase 3 interventional studies under Rhinitis, Allergic, Seasonal, half reached primary completion within 4 months of starting (the median), counting those still running; a quarter within 1 and three quarters within 14. This study's planned 14 months is above that.
Counting every sponsor, half of 37 studies reached it within 4 months; a quarter within 2 and three quarters within 14.
How these figures are worked out, and which studies are left out of them.
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Rhinitis, Allergic, Seasonal →