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NCT05472324
Evaluate the Efficacy and Safety of TQC2731 Injection in Patients With Severe Asthma.
Phase 2 trial testing TQC2731 injection in Severe Asthma in 205 participants. Completed in 5 March 2025.
5 March 2025
Quick facts
| Lead sponsor | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 205 |
| Start date | 23 September 2022 |
| Primary completion | 5 March 2025 |
| Estimated completion | 5 March 2025 |
| Sites | 2 locations across China |
Drugs / interventions tested
- TQC2731 injection — full drug profile →
- Placebo
Conditions studied
- Severe Asthma — all drugs for Severe Asthma →
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. — full company profile →
Who can join
Adults 18 to 75, any sex, with Severe Asthma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a phase II, multicenter, double-blind, randomized, parallel group, placebo-controlled clinical study to evaluate the effect of three doses of TQC2731 on Annualized Asthma Exacerbation Rates(AAER) in adult subjects with poor control of severe asthma. It is estimated that 220 subjects will be included. The subjects will receive TQC2731 (70 mg Q4w, 210 mg Q4w, 420 mg Q4w) or placebo (Q4w) administered by Subcutaneous (SC) in the ratio of 1:1:1:1. The study comprised a 5 to 6-week screening period, a 52-week treatment period and a 12-week follow-up period. During the treatment period, the study drug will be administered from day 0 until week 48. The study drug was not administered at the 52nd week.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Therapeutic monoclonal antibodies in allergy: Targeting IgE, cytokine, and alarmin pathways.
Eggel A, Pennington LF, Jardetzky TS. · · 2024 · cited 45× · PMID 39158477 · DOI 10.1111/imr.13380 -
Biologic drugs in the treatment of chronic inflammatory pulmonary diseases: recent developments and future perspectives.
Plichta J, Kuna P, Panek M. · · 2023 · cited 34× · PMID 37334374 · DOI 10.3389/fimmu.2023.1207641 -
Targeting alarmins in asthma: From bench to clinic.
Akenroye A, Boyce JA, Kita H. · · 2025 · cited 24× · PMID 39855362 · DOI 10.1016/j.jaci.2025.01.017 -
Regulation of Airway Epithelial-Derived Alarmins in Asthma: Perspectives for Therapeutic Targets.
Hansi RK, Ranjbar M, Whetstone CE, Gauvreau GM. · · 2024 · cited 7× · PMID 39457624 · DOI 10.3390/biomedicines12102312 -
From the bench to the clinic: basophils and type 2 epithelial cytokines of thymic stromal lymphopoietin and IL-33.
Obata-Ninomiya K, Jayaraman T, Ziegler SF. · · 2024 · cited 1× · PMID 39654685 · DOI 10.1002/cti2.70020
Verify or expand the search:
- PubMed search for NCT05472324
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of TQC2731 injection
Trials testing the same drug.
- NCT06036927 — A Clinical Study of TQC2731 Injection in the Treatment of Chronic Rhinosinusitis With Nasal Polyps · Phase 2 · completed
Other recruiting trials for Severe Asthma
Currently open trials in the same condition.
- NCT07363642 — Phase 3b Study in Patients With Severe Asthma Treated With Tezepelumab · Phase 3 · recruiting
- NCT07328035 — Remission in Adults With Severe Asthma in Thailand · recruiting
- NCT07530770 — Real-World Effectiveness of Benralizumab in Allergic Bronchopulmonary Aspergillosis · recruiting
- NCT06903780 — Experience of Biologic Treatments for Severe Asthma: a Survey · recruiting
- NCT06681545 — Exploring the Lived Experience of Young Adults With Severe Asthma · recruiting
Other Chia Tai Tianqing Pharmaceutical Group Co., Ltd. trials
Trials by the same sponsor.
- NCT06990776 — A Clinical Trial to Evaluate the Efficacy and Safety of TQA3605 Tablets in Treatment-naive Chronic HBV-infected Subjects · Phase 2 · withdrawn
- NCT06851442 — Clinical Trial of Evaluating TQB3912 Tablets Combined With Fulvestrant Injection±TQB3616 Capsules for Locally Advanced o · Phase 1, PHASE2 · terminated
- NCT06711991 — A Clinical Trial of TQC3927 Powder for Inhalation in Chronic Obstructive Pulmonary Disease · Phase 1 · completed
- NCT06672276 — To Evaluate the Pharmacokinetics and Safety of TQD3606 for Injection in Subjects With Renal Insufficiency · Phase 1 · completed
- NCT06644417 — Clinical Study of TQA3605 Tablets Combined With Nucleoside (Acid) Analogs (NAs) Drugs Compared With NAs Drugs in the Tre · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05472324 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Last refreshed: 20 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05472324.
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