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NCT07146126: Pumecitinib
A Phase III Study to Assess the Efficacy and Safety of PG-011 Nasal Spray in Adults With Moderate to Severe Seasonal Allergic Rhinitis
Phase 3 trial testing PG-011 nasal spray 0.6%(twice daily) in Seasonal Allergic Rhinitis in 600 participants. Not yet recruiting.
30 June 2026
Quick facts
| Lead sponsor | Prime Gene Therapeutics Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 600 |
| Start date | 15 September 2025 |
| Primary completion | 30 June 2026 |
| Estimated completion | 30 July 2026 |
| Sites | 38 locations across China |
Drugs / interventions tested
- PG-011 nasal spray 0.6%(twice daily) — full drug profile →
- Placebo
Conditions studied
- Seasonal Allergic Rhinitis — all drugs for Seasonal Allergic Rhinitis →
- SAR — all drugs for SAR →
Sponsor
Prime Gene Therapeutics Co., Ltd. — full company profile →
Who can join
Adults 18 to 65, any sex, with Seasonal Allergic Rhinitis or SAR. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The study is a multicenter, randomized, double-blind, placebo-controlled seamless and adaptive-designed phase IIb/III study encompassing a phase IIb and a phase III component, phase IIb is a dose-ranging part and has been done, and phase III is a pivotal study part which is registered this time. The goal of this phase III study is to evaluate the efficacy, safety, and pharmacokinetics of PG-011 nasal spray for treating adults with moderate to severe seasonal allergic rhinitis (SAR). Investigators will compare PG-011 nasal spray to a placebo (a look-alike substance that contains no drug) to see if PG-011 nasal spray works to treat moderate to severe seasonal allergic rhinitis
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07146126
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Seasonal Allergic Rhinitis
Currently open trials in the same condition.
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- NCT06846385 — Phase II/III Seamless Clinical Study of MG-K10 Humanized Monoclonal Antibody Injection in Treatment of Seasonal Allergic · Phase 2, PHASE3 · recruiting
- NCT07291284 — Efficacy and Safety of LP-003 Injection in Patients With Moderate to Severe Seasonal Allergic Rhinitis · Phase 3 · active not recruiting
- NCT06300203 — Study of CM310 in Patients With Uncontrolled Seasonal Allergic Rhinitis · Phase 2 · recruiting
- NCT04815668 — Acupuncture at the Sphenopalatine Ganglion in the Treatment of Moderate-to-severe Seasonal Allergic Rhinitis · NA · recruiting
Other Prime Gene Therapeutics Co., Ltd. trials
Trials by the same sponsor.
- NCT07013097 — A Phase I Clinical Trial to Evaluate the Single Dose Ascending and Food Effects of PG-033 in Healthy Adults · Phase 1 · recruiting
- NCT06587685 — A Study to Assess the Efficacy and Safety of PG-011 Gel in Adolescents and Adults With Atopic Dermatitis · Phase 3 · recruiting
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 NCT07146126 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Prime Gene Therapeutics Co., Ltd.
- Last refreshed: 28 August 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/NCT07146126.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing