To Evaluate the Efficacy and Safety of TQC3564 Tablets in the Treatment of Persistent Allergic Rhinitis

NCT05607446 | Terminated Phase 1 DMC

• 1 other identifier: TQC3564-Ib-02
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

A clinical study to evaluate the efficacy and safety of tqc3564 tablets in the treatment of persistent allergic rhinitis. A total of 24 patients will be enrolled.

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Total nasal symptom Score (TNSS)

  Change in the investigator-assessed total nasal symptom score (TNSS) from baseline to 14 days. TNSS was the sum score of 4 nasal symptoms with a minimum score of 0 units and a maximum score of 12 units, with higher score corresponding to increased nasal allergy symptoms.

  Baseline, Day 14

Secondary Outcomes (7)

• Total ocular symptom score(TOSS)

  Baseline, Day 14

• Individual Total Nasal Symptom Score (TNSS)

  Baseline, Day 14

• Individual Total Ocular Symptom Score (TOSS)

  Baseline, Day 14

• Daily symptoms score (dSS)

  Baseline, Day 14

• Rescue medication proportion

  Day 1-32

Study Arms (4)

TQC3564 tablets

EXPERIMENTAL

Orally administer TQC3564 tablets for 14 days.

Drug: TQC3564 tablets

placebo tablets

PLACEBO COMPARATOR

Orally administer placebo tablets for 14 days.

Drug: Placebo tablets

TQC3564 tablets + montelukast sodium tablets

EXPERIMENTAL

Orally administer TQC3546 tablets combined with Montelukast sodium tablets for 14 days.

Drug: TQC3564 tablets, montelukast sodium tablets

placebo tablets + montelukast sodium tablets

PLACEBO COMPARATOR

Orally administer placebo tablets combined with Montelukast sodium tablets for 14 days.

Drug: Placebo tablets, montelukast sodium tablets

Interventions

TQC3564 tablets DRUG

TQC3564 tablets are CRTH2 antagonists.

TQC3564 tablets

Placebo tablets DRUG

The intervention drug is placebo.

placebo tablets

TQC3564 tablets, montelukast sodium tablets DRUG

The intervention drugs are TQC3564 tablets combined with montelukast sodium tablets. TQC3564 is a CRTH2 antagonist, montelukast sodium is Leukotriene receptor antagonist.

TQC3564 tablets + montelukast sodium tablets

Placebo tablets, montelukast sodium tablets DRUG

The intervention drugs are placebo combined with montelukast sodium tablets. Montelukast sodium is Leukotriene receptor antagonist.

placebo tablets + montelukast sodium tablets

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18\~65 years old, male or female;
• Meet the clinical diagnostic criteria for allergic rhinitis, and the diagnosis is based on the "Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (2015, Tianjin)" issued by the Rhinology Group of the Otolaryngology Head and Neck Surgery Branch of the Chinese Medical Association:
• Symptoms: sneezing 2 or more symptoms, such as watery mucus, nasal itching and nasal congestion, persist or accumulate for more than 1 hour per day, and may be accompanied by eye symptoms such as itching, watering and redness;
• Signs: Pale and edema of the nasal mucosa is common. Nasal watery secretions;
• Allergen test: at least one allergen SPT and/or serum-specific IgE positive (test results within 12 months before screening);
• Female subjects of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; negative serum pregnancy test within 14 days before study enrollment , and must be non-lactating subjects; male subjects should agree to use contraception during the study period and for 6 months after the end of the study period.
• The subjects voluntarily joined the study, signed the informed consent, and had good compliance.

You may not qualify if:

• Patients with non-allergic rhinitis, such as drug-induced rhinitis, vasomotor rhinitis, non-allergic rhinitis eosinophilic rhinitis, etc.; patients with severe nasal septum deviation, sinusitis, nasal polyps, hypertrophic rhinitis Other nasal organic lesions;
• In the nasal examination at the end of the screening period or the introduction period, there is any erosion of the nasal mucosa, septal ulcer or perforation of the nasal septum;
• Those who have undergone sinus surgery within 3 months before the screening period or who have not fully healed the nasal wound;
• The subject has uncontrolled diabetes mellitus, that is, fasting blood glucose (FBG) \> 10mmol/L in the laboratory test during the screening period;
• History of allergy to any study drug or similar chemical drugs (CRTh2 antagonists);
• History of severe allergic reaction to any allergen, such as anaphylactic shock or life-threatening asthma, previous intubation, respiratory arrest, hospitalization for asthma or acute asthma attack within the past 3 months;
• Those who were found to respond to placebo during the lead-in period (with rhinitis symptoms of moderate or above during the screening period, those with mild or no symptoms during the lead-in period, or baseline rTNSS mean \<6 points were defined as placebo responders;
• Women who are pregnant or breastfeeding, or who plan to become pregnant or breastfeeding during the study period;
• Any subject deemed unsuitable for participation in this clinical study by the investigator.

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

Xiangya Hospital Central South University

Changsha, Hunan, 410008, China

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

montelukast

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2022
• First Posted: November 7, 2022
• Study Start: September 14, 2022
• Primary Completion: May 9, 2023
• Study Completion: December 14, 2023
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)